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1.
JMIR Mhealth Uhealth ; 12: e49024, 2024 May 01.
Article in English | MEDLINE | ID: mdl-38717433

ABSTRACT

Background: Mobile health (mHealth) interventions have immense potential to support disease self-management for people with complex medical conditions following treatment regimens that involve taking medicine and other self-management activities. However, there is no consensus on what discrete behavior change techniques (BCTs) should be used in an effective adherence and self-management-promoting mHealth solution for any chronic illness. Reviewing the extant literature to identify effective, cross-cutting BCTs in mHealth interventions for adherence and self-management promotion could help accelerate the development, evaluation, and dissemination of behavior change interventions with potential generalizability across complex medical conditions. Objective: This study aimed to identify cross-cutting, mHealth-based BCTs to incorporate into effective mHealth adherence and self-management interventions for people with complex medical conditions, by systematically reviewing the literature across chronic medical conditions with similar adherence and self-management demands. Methods: A registered systematic review was conducted to identify published evaluations of mHealth adherence and self-management interventions for chronic medical conditions with complex adherence and self-management demands. The methodological characteristics and BCTs in each study were extracted using a standard data collection form. Results: A total of 122 studies were reviewed; the majority involved people with type 2 diabetes (28/122, 23%), asthma (27/122, 22%), and type 1 diabetes (19/122, 16%). mHealth interventions rated as having a positive outcome on adherence and self-management used more BCTs (mean 4.95, SD 2.56) than interventions with no impact on outcomes (mean 3.57, SD 1.95) or those that used >1 outcome measure or analytic approach (mean 3.90, SD 1.93; P=.02). The following BCTs were associated with positive outcomes: self-monitoring outcomes of behavior (39/59, 66%), feedback on outcomes of behavior (34/59, 58%), self-monitoring of behavior (34/59, 58%), feedback on behavior (29/59, 49%), credible source (24/59, 41%), and goal setting (behavior; 14/59, 24%). In adult-only samples, prompts and cues were associated with positive outcomes (34/45, 76%). In adolescent and young adult samples, information about health consequences (1/4, 25%), problem-solving (1/4, 25%), and material reward (behavior; 2/4, 50%) were associated with positive outcomes. In interventions explicitly targeting medicine taking, prompts and cues (25/33, 76%) and credible source (13/33, 39%) were associated with positive outcomes. In interventions focused on self-management and other adherence targets, instruction on how to perform the behavior (8/26, 31%), goal setting (behavior; 8/26, 31%), and action planning (5/26, 19%) were associated with positive outcomes. Conclusions: To support adherence and self-management in people with complex medical conditions, mHealth tools should purposefully incorporate effective and developmentally appropriate BCTs. A cross-cutting approach to BCT selection could accelerate the development of much-needed mHealth interventions for target populations, although mHealth intervention developers should continue to consider the unique needs of the target population when designing these tools.


Subject(s)
Behavior Therapy , Self-Management , Telemedicine , Treatment Adherence and Compliance , Humans , Self-Management/methods , Self-Management/psychology , Self-Management/statistics & numerical data , Telemedicine/methods , Telemedicine/statistics & numerical data , Telemedicine/standards , Treatment Adherence and Compliance/statistics & numerical data , Treatment Adherence and Compliance/psychology , Behavior Therapy/methods , Behavior Therapy/instrumentation , Behavior Therapy/statistics & numerical data , Behavior Therapy/standards , Chronic Disease/therapy , Chronic Disease/psychology
2.
BMJ Open ; 14(5): e080245, 2024 May 06.
Article in English | MEDLINE | ID: mdl-38719282

ABSTRACT

INTRODUCTION: Negative symptoms are frequently experienced by people with schizophrenia. People with negative symptoms often have impaired social functioning and reduced quality of life. There is some evidence that cognitive-behavioural therapy results in a modest reduction in negative symptoms. Behavioural activation may be an effective alternative treatment for negative symptoms.The study aims to examine the feasibility and acceptability of implementing a behavioural activation trial delivered in three community mental health services in South Australia to support adult consumers experiencing negative symptoms of schizophrenia. METHOD AND ANALYSIS: This randomised controlled study will recruit a total of 60 consumers aged 18 years or above with mild-moderate negative symptoms of schizophrenia. The consumers will be randomly allocated to receive behavioural activation plus usual mental healthcare or usual mental healthcare alone. The intervention group will receive twelve 30 min sessions of behavioural activation, which will be delivered twice weekly over 6 weeks. In addition, we aim to recruit nine mental health workers from the three rural mental health services who will complete a 10-week online training programme in behavioural activation. Changes in negative symptoms of schizophrenia and depressive symptoms will be assessed at three time points: (a) at baseline, at 6 weeks and 3 month follow-ups. Changes in health-related quality of life (Short Form F36; secondary outcome) will be assessed at two time points: (a) at baseline and (b) immediately at postintervention after 6 weeks. At the end of the trial, interviews will be conducted with purposively selected mental health workers and consumers. Descriptive statistics and thematic analysis will be used to assess feasibility and acceptability. ETHICS AND DISSEMINATION: The findings from our feasibility study will inform the design of a fully powered randomised controlled trial to test the effectiveness of behavioural activation as a treatment for negative symptoms in schizophrenia. The study protocol was approved by the Central Adelaide Local Health Network Human Research Ethics Committee. The findings from this study will be disseminated through peer-reviewed scientific journals and conferences. TRIAL REGISTRATION NUMBER: ACTRN12623000348651p.


Subject(s)
Feasibility Studies , Quality of Life , Schizophrenia , Humans , Schizophrenia/therapy , Adult , Cognitive Behavioral Therapy/methods , Community Mental Health Services/methods , Female , Randomized Controlled Trials as Topic , Male , Schizophrenic Psychology , South Australia , Behavior Therapy/methods , Australia
3.
Medicine (Baltimore) ; 103(19): e38180, 2024 May 10.
Article in English | MEDLINE | ID: mdl-38728460

ABSTRACT

BACKGROUND: Poststroke depression (PSD) is one of the most common stroke complications. It not only leads to a decline in patients' quality of life but also increases the mortality of patients. In this study, the method of combining Chinese traditional exercise Baduanjin with psychotherapy was used to intervene in patients with PSD and to explore the improvement of sleep, mood, and serum levels of brain-derived neurotrophic factor (BDNF), 5-hydroxytryptamine (5-HT), and interleukin-6 (IL-6) levels in patients with PSD by combined treatment. METHODS: A total of 100 patients with PSD who met the inclusion criteria were randomly assigned to Baduanjin group (n = 50) or control group (n = 50). The control group received treatment with escitalopram oxalate and rational emotive behavior therapy, while the experimental group received Baduanjin training in addition to the treatment given to the control group. Changes in sleep efficiency, sleep total time, sleep latency, arousal index, Hamilton Anxiety Rating Scale, Hamilton Depression Scale score, serum BDNF, 5-HT, IL-6 levels, and Modified Barthel Index were measured at baseline, 4 weeks and 8 weeks after intervention, and the results were compared between the 2 groups. RESULTS: Significantly improvements in the sleep efficiency, sleep total time, serum 5-HT, BDNF levels, and Modified Barthel Index score were detected at week 4 in the Baduanjin group than in the control group (P < .05). Additionally, the sleep latency, arousal index, Hamilton Anxiety Rating Scale, Hamilton Depression Scale scores and IL-6 levels in the Baduanjin group were lower than those in the control group (P < .05). After 8 weeks of treatment, the above indexes in the Baduanjin group were further improved compared with the control group (P < .05), and the above indexes of the 2 groups were significantly improved compared with the baseline (P < .001). CONCLUSION: Baduanjin exercise combined with rational emotive behavior therapy effectively improves the mood and sleep status of patients with PSD; It increases the serum levels of 5-HT and BDNF while reducing the level of serum proinflammatory factor IL-6; additionally, the intervention alleviates the degree of neurological impairment, upgrades the ability of daily living, and improves the quality of life.


Subject(s)
Affect , Brain-Derived Neurotrophic Factor , Depression , Sleep , Stroke , Humans , Male , Female , Middle Aged , Stroke/complications , Stroke/psychology , Stroke/therapy , Brain-Derived Neurotrophic Factor/blood , Depression/therapy , Depression/etiology , Aged , Interleukin-6/blood , Behavior Therapy/methods , Serotonin/blood , Combined Modality Therapy , Exercise Therapy/methods , Medicine, Chinese Traditional/methods , Treatment Outcome
4.
JMIR Mhealth Uhealth ; 12: e53798, 2024 May 02.
Article in English | MEDLINE | ID: mdl-38696250

ABSTRACT

BACKGROUND: The development of digital applications based on behavioral therapies to support patients with knee osteoarthritis (KOA) has attracted increasing attention in the field of rehabilitation. This paper presents a systematic review of research on digital applications based on behavioral therapies for people with KOA. OBJECTIVE: This review aims to describe the characteristics of relevant digital applications, with a special focus on the current state of behavioral therapies, digital interaction technologies, and user participation in design. The secondary aim is to summarize intervention outcomes and user evaluations of digital applications. METHODS: A systematic literature search was conducted using the keywords "Knee Osteoarthritis," "Behavior Therapy," and "Digitization" in the following databases (from January 2013 to July 2023): Web of Science, Embase, Science Direct, Ovid, and PubMed. The Mixed Methods Assessment Tool (MMAT) was used to assess the quality of evidence. Two researchers independently screened and extracted the data. RESULTS: A total of 36 studies met the inclusion criteria and were further analyzed. Behavioral change techniques (BCTs) and cognitive behavioral therapy (CBT) were frequently combined when developing digital applications. The most prevalent areas were goals and planning (n=31) and repetition and substitution (n=27), which were frequently used to develop physical activity (PA) goals and adherence. The most prevalent combination strategy was app/website plus SMS text message/telephone/email (n=12), which has tremendous potential. This area of application design offers notable advantages, primarily manifesting in pain mitigation (n=24), reduction of physical dysfunction (n=21), and augmentation of PA levels (n=12). Additionally, when formulating design strategies, it is imperative to consider the perspectives of stakeholders, especially in response to the identified shortcomings in application design elucidated within the study. CONCLUSIONS: The results demonstrate that "goals and planning" and "repetition and substitution" are frequently used to develop PA goals and PA behavior adherence. The most prevalent combination strategy was app/website plus SMS text message/telephone/email, which has tremendous potential. Moreover, incorporating several stakeholders in the design and development stages might enhance user experience, considering the distinct variations in their requirements. To improve the efficacy and availability of digital applications, we have several proposals. First, comprehensive care for patients should be ensured by integrating multiple behavioral therapies that encompass various aspects of the rehabilitation process, such as rehabilitation exercises and status monitoring. Second, therapists could benefit from more precise recommendations by incorporating additional intelligent algorithms to analyze patient data. Third, the implementation scope should be expanded from the home environment to a broader social community rehabilitation setting.


Subject(s)
Behavior Therapy , Osteoarthritis, Knee , Humans , Osteoarthritis, Knee/therapy , Osteoarthritis, Knee/psychology , Behavior Therapy/methods , Behavior Therapy/instrumentation , Mobile Applications/standards , Mobile Applications/statistics & numerical data
5.
Sci Rep ; 14(1): 11264, 2024 05 17.
Article in English | MEDLINE | ID: mdl-38760498

ABSTRACT

Dialectical behavior therapy (DBT) is widely acknowledged as an effective treatment for individuals with borderline personality disorder (BPD). However, the optimal treatment duration within DBT remains a topic of investigation. This retrospective, naturalistic non-randomized study aimed to compare the efficacy of 8 week and 12 week DBT interventions with equivalent content, focusing on the change of BPD-specific symptomatology as the primary outcome and depressive symptoms as the secondary outcome. Overall, 175 patients who participated in DBT and received either 8 week or 12 week intervention were included in the analysis. Routine inpatient treatment was adapted from standard DBT with the modules: skill training, interpersonal skills, dealing with feelings, and mindfulness. Measurements were taken at baseline, mid-point, and endpoint. The borderline symptom list-23 (BSL-23) was used for the assessment of borderline-specific symptoms, while the Beck depression inventory-II (BDI-II) was used for the assessment of depressive symptoms. Statistical analysis was conducted using linear mixed models. Effect sizes were calculated for both measures. The results of the analysis indicated an improvement in both groups over time. Effect sizes were d = 1.29 for BSL-23 and d = 1.79 for BDI-II in the 8 week group, and d = 1.16 for BSL-23 and d = 1.58 for BDI-II in the 12 week group. However, there were no differences in the change of BPD-specific symptoms or the severity of depressive symptoms between the 8 week and 12 week treatment duration groups. Based on these findings, shorter treatment durations, like 8 weeks, could be a viable alternative, offering comparable therapeutic benefits, potential cost reduction, and improved accessibility. However, further research is needed to explore factors influencing treatment outcomes and evaluate the long-term effects of different treatment durations in DBT for BPD.Trial registration: drks.de (DRKS00030939) registered 19/12/2022.


Subject(s)
Borderline Personality Disorder , Dialectical Behavior Therapy , Inpatients , Humans , Borderline Personality Disorder/therapy , Borderline Personality Disorder/psychology , Female , Adult , Male , Dialectical Behavior Therapy/methods , Retrospective Studies , Treatment Outcome , Young Adult , Depression/therapy , Middle Aged , Behavior Therapy/methods
6.
Expert Rev Neurother ; 24(6): 585-596, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38738544

ABSTRACT

INTRODUCTION: Sleep disorders represent an important comorbidity in individuals with ADHD. While the links between ADHD and sleep disturbances have been extensively investigated, research on the management of sleep disorders in individuals with ADHD is relatively limited, albeit expanding. AREAS COVERED: The authors searched PubMed, Medline, PsycInfo, Embase+Embase Classic, Web of Sciences databases, and clinicaltrials.gov up to 4 January 2024, for randomized controlled trials (RCTs) of any intervention for sleep disorders associated with ADHD. They retained 16 RCTs (eight on pharmacological and eight on non-pharmacological interventions), supporting behavioral intervention and melatonin, and nine ongoing RCTs registered on clinicaltrials.gov. EXPERT OPINION: The pool of RCTs testing interventions for sleep disorders in individuals with ADHD is expanding. However, to inform clinical guidelines, there is a need for additional research in several areas, including 1) RCTs based on a precise phenotyping of sleep disorders; 2) pragmatic RCTs recruiting neurodevelopmental populations representative of those seen in clinical services; 3) trials testing alternative interventions (e.g. suvorexant or light therapy) or ways to deliver them (e.g. online); 4) sequential and longer-term RCTs; 5) studies testing the impact of sleep interventions on outcomes other than sleep; 6) and implementation of advanced evidence synthesis and precision medicine approaches.


Subject(s)
Attention Deficit Disorder with Hyperactivity , Sleep Wake Disorders , Humans , Attention Deficit Disorder with Hyperactivity/therapy , Attention Deficit Disorder with Hyperactivity/complications , Child , Sleep Wake Disorders/therapy , Randomized Controlled Trials as Topic , Melatonin/therapeutic use , Behavior Therapy
7.
BMJ Open ; 14(5): e076852, 2024 May 20.
Article in English | MEDLINE | ID: mdl-38772581

ABSTRACT

OBJECTIVES: Patients with chronic conditions enrolled in high-deductible health plans (HDHPs) face cost-related access barriers and high out-of-pocket spending. Our objectives were to develop a novel behavioural intervention to help HDHP enrollees with chronic conditions use cost-conscious strategies and evaluate the intervention's preliminary effectiveness, acceptability and feasibility. DESIGN: Prospective. SETTING: Online (USA). PARTICIPANTS: 36 US adults enrolled in an HDHP through their employer or an exchange with diabetes, hypertension, asthma, coronary artery disease and/or chronic obstructive pulmonary disease. 31/36 participants completed the study. INTERVENTION: We developed a 5-week intervention consisting of a website with educational modules on discussing costs with clinicians, saving for future healthcare costs, comparing healthcare prices and quality, preparing for appointments, following up after appointments and planning for future healthcare needs; and emails encouraging participants to access each module. OUTCOMES: We conducted a single-arm proof-of-concept pilot study of the intervention. Baseline and postintervention surveys measured primary outcomes of health insurance literacy and confidence in using cost-conscious strategies. 10 participants completed postintervention interviews. RESULTS: 31 (86%) participants completed a baseline and postintervention survey. Mean health insurance literacy scores (20-80 scale) improved from 56.5 to 67.1 (p<0.001). Mean confidence scores (0-10 scale) improved for talking to a healthcare provider about cost (6.1-7.6, p=0.0094), saving for healthcare (5.8-6.6, p=0.068), comparing prices (5.4-6.9, p=0.005) and comparing quality (6.1 to 7.6, p=0.0034). Participants found the website easy to use and helpful for learning about cost-conscious strategies on postintervention interviews. CONCLUSIONS: Our novel behavioural intervention was acceptable to HDHP enrollees with chronic conditions, feasible to deliver and associated with increased health insurance literacy and confidence in using cost-conscious strategies. This intervention should be tested in a definitive randomised controlled trial that is fully powered to evaluate its effects on cost-related access barriers, out-of-pocket spending and health outcomes in this growing patient population.


Subject(s)
Deductibles and Coinsurance , Humans , Pilot Projects , Male , Female , Chronic Disease/therapy , Middle Aged , Adult , Prospective Studies , United States , Deductibles and Coinsurance/economics , Proof of Concept Study , Internet-Based Intervention/economics , Aged , Health Expenditures , Behavior Therapy/economics , Behavior Therapy/methods
8.
JMIR Hum Factors ; 11: e50098, 2024 May 16.
Article in English | MEDLINE | ID: mdl-38753421

ABSTRACT

BACKGROUND: Digital interventions are gaining increasing interest due to their structured nature, ready availability, and self-administered capabilities. Perinatal women have expressed a desire for such interventions. In this regard, behavioral activation interventions may be particularly suitable for digital administration. OBJECTIVE: This study aims to exploratorily investigate and compare the feasibility of the internet-based self-help guided versus unguided version of the Brief Behavioral Activation Treatment for Depression-Revised, an empirically supported in-person behavioral activation protocol, targeting pregnant women with subclinical depression symptoms. A user-centered design is used, whereby data are collected with the intent of evaluating how to adjust the intervention in line with pregnant women's needs. Usability and user engagement were evaluated. METHODS: A total of 11 Italian pregnant women with subclinical depressive symptoms based on the Patient Health Questionnaire-9 (scoring<15) participated in this study; of them, 6 (55%) women were randomly assigned to the guided group (age: mean 32.17, SD 4.36 years) and 5 (45%) to the unguided group (age: mean 31, SD 4.95 years). The Moodle platform was used to deliver the interventions in an e-learning format. It consisted of 6 core modules and 3 optional modules; the latter aimed at revising the content of the former. In the guided group, each woman had weekly chats with their assigned human guide to support them in the homework revisions. The intervention content included text, pictures, and videos. Semistructured interviews were conducted, and descriptive statistics were analyzed. RESULTS: Collectively, the data suggest that the guided intervention was better accepted than the unguided one. However, the high rates of dropout (at T6: guided group: 3/6, 50%; unguided: 4/5, 80%) suggest that a digital replica of Behavioral Activation Treatment for Depression-Revised may not be feasible in an e-learning format. The reduced usability of the platform used was reported, and homework was perceived as too time-consuming and effort-intensive. Moreover, the 6 core modules were deemed sufficient for the intervention's goals, suggesting that the 3 optional modules could be eliminated. Nevertheless, participants from both groups expressed satisfaction with the content and found it relevant to their pregnancy experiences. CONCLUSIONS: Overall, the findings have emphasized both the intervention's merits and shortcomings. Results highlight the unsuitability of replicating an in-person protocol digitally as well as of the use of nonprofessional tools for the implementation of self-help interventions, ultimately making the intervention not feasible. Pregnant women have nonetheless expressed a desire to receive psychological support and commented on the possibilities of digital psychosocial supports, particularly those that are app-based. The information collected and the issues identified here are important to guide the development and co-design of a more refined platform for the intervention deployment and to tailor the intervention's content to pregnant women's needs.


Subject(s)
Depression , Pregnant Women , Humans , Female , Pregnancy , Adult , Depression/therapy , Depression/psychology , Pregnant Women/psychology , Behavior Therapy/methods , Italy , Internet-Based Intervention , Surveys and Questionnaires , Pregnancy Complications/psychology , Pregnancy Complications/therapy
9.
JAMA Netw Open ; 7(5): e248468, 2024 May 01.
Article in English | MEDLINE | ID: mdl-38700867

ABSTRACT

Importance: Behavior therapy is a recommended intervention for Tourette syndrome (TS) and chronic tic disorder (CTD), but availability is limited and long-term effects are uncertain. Objective: To investigate the long-term efficacy and cost-effectiveness of therapist-supported, internet-delivered exposure and response prevention (ERP) vs psychoeducation for youths with TS or CTD. Design, Setting, And Participants: This 12-month controlled follow-up of a parallel group, superiority randomized clinical trial was conducted at a research clinic in Stockholm, Sweden, with nationwide recruitment. In total, 221 participants aged 9 to 17 years with TS or CTD were enrolled between April 26, 2019, and April 9, 2021, of whom 208 (94%) provided 12-month follow-up data. Final follow-up data were collected on June 29, 2022. Outcome assessors were masked to treatment allocation throughout the study. Interventions: A total of 111 participants were originally randomly allocated to 10 weeks of therapist-supported, internet-delivered ERP and 110 participants to therapist-supported, internet-delivered psychoeducation. Main Outcomes And Measures: The primary outcome was within-group change in tic severity, measured by the Total Tic Severity Score of the Yale Global Tic Severity Scale (YGTSS-TTSS), from the 3-month follow-up to the 12-month follow-up. Treatment response was defined as 1 (very much improved) or 2 (much improved) on the Clinical Global Impression-Improvement scale. Analyses were intention-to-treat and followed the plan prespecified in the published study protocol. A health economic evaluation was performed from 3 perspectives: health care organization (including direct costs for treatment provided in the study), health care sector (additionally including health care resource use outside of the study), and societal (additionally including costs beyond health care [eg, parent's absenteeism from work]). Results: In total, 221 participants were recruited (mean [SD] age, 12.1 [2.3] years; 152 [69%] male). According to the YGTSS-TTSS, there were no statistically significant changes in tic severity from the 3-month to the 12-month follow-up in either group (ERP coefficient, -0.52 [95% CI, -1.26 to 0.21]; P = .16; psychoeducation coefficient, 0.00 [95% CI, -0.78 to 0.78]; P > .99). A secondary analysis including all assessment points (baseline to 12-month follow-up) showed no statistically significant between-group difference in tic severity from baseline to the 12-month follow-up (coefficient, -0.38 [95% CI, -1.11 to 0.35]; P = .30). Treatment response rates were similar in both groups (55% in ERP and 50% in psychoeducation; odds ratio, 1.25 [95% CI, 0.73-2.16]; P = .42) at the 12-month follow-up. The health economic evaluation showed that, from a health care sector perspective, ERP produced more quality-adjusted life years (0.01 [95% CI, -0.01 to 0.03]) and lower costs (adjusted mean difference -$84.48 [95% CI, -$440.20 to $977.60]) than psychoeducation at the 12-month follow-up. From the health care organization and societal perspectives, ERP produced more quality-adjusted life years at higher costs, with 65% to 78% probability of ERP being cost-effective compared with psychoeducation when using a willingness-to-pay threshold of US $79 000. Conclusions And Relevance: There were no statistically significant changes in tic severity from the 3-month through to the 12-month follow-up in either group. The ERP intervention was not superior to psychoeducation at any time point. While ERP was not superior to psychoeducation alone in reducing tic severity at the end of the follow-up period, ERP is recommended for clinical implementation due to its likely cost-effectiveness and support from previous literature. Trial Registration: ClinicalTrials.gov Identifier: NCT03916055.


Subject(s)
Cost-Benefit Analysis , Tourette Syndrome , Humans , Tourette Syndrome/therapy , Male , Female , Child , Adolescent , Follow-Up Studies , Internet , Sweden , Treatment Outcome , Internet-Based Intervention , Behavior Therapy/methods , Behavior Therapy/economics
10.
BMJ Open ; 14(5): e084844, 2024 May 01.
Article in English | MEDLINE | ID: mdl-38692731

ABSTRACT

INTRODUCTION: Although short-term benefits follow parenteral ketamine for treatment-resistant major depressive disorder (TR-MDD), there are challenges that prevent routine use of ketamine by clinicians. These include acute dissociative effects of parenteral ketamine, high relapse rates following ketamine dosing and the uncertain role of psychotherapy. This randomised controlled trial (RCT) seeks to establish the feasibility of evaluating repeated oral doses of ketamine and behavioural activation therapy (BAT), compared with ketamine treatment alone, for TR-MDD. We also aim to compare relapse rates between treatment arms to determine the effect size of adding BAT to oral ketamine. METHODS AND ANALYSIS: This is a prospectively registered, two-centre, single-blind RCT. We aim to recruit 60 participants with TR-MDD aged between 18 and 65 years. Participants will be randomised to 8 weeks of oral ketamine and BAT, or 8 weeks of oral ketamine alone. Feasibility will be assessed by tracking attendance for ketamine and BAT, acceptability of treatment measures and retention to the study follow-up protocol. The primary efficacy outcome measure is the Montgomery-Asberg Depression Rating Scale (MADRS) measured weekly during treatment and fortnightly during 12 weeks of follow-up. Other outcome measures will assess the tolerability of ketamine and BAT, cognition and activity (using actigraphy). Participants will be categorised as non-responders, responders, remitters and relapsed during follow-up. MADRS scores will be analysed using a linear mixed model. For a definitive follow-up RCT study to be recommended, the recruitment expectations will be met and efficacy outcomes consistent with a >20% reduction in relapse rates favouring the BAT and ketamine arm will be achieved. ETHICS AND DISSEMINATION: Ethics approval was granted by the New Zealand Central Health and Disability Ethics Committee (reference: 2023 FULL18176). Study findings will be reported to participants, stakeholder groups, conferences and peer-reviewed publications. TRIAL REGISTRATION NUMBER: UTN: U1111-1294-9310, ACTRN12623000817640p.


Subject(s)
Depressive Disorder, Treatment-Resistant , Ketamine , Humans , Ketamine/administration & dosage , Ketamine/therapeutic use , Depressive Disorder, Treatment-Resistant/therapy , Depressive Disorder, Treatment-Resistant/drug therapy , Adult , Single-Blind Method , Middle Aged , Depressive Disorder, Major/therapy , Depressive Disorder, Major/drug therapy , Male , Female , Randomized Controlled Trials as Topic , Behavior Therapy/methods , Young Adult , Adolescent , Treatment Outcome , Prospective Studies , Aged
11.
BMJ Open ; 14(5): e080546, 2024 May 30.
Article in English | MEDLINE | ID: mdl-38816046

ABSTRACT

OBJECTIVES: Electronic health record (EHR) systems are used extensively in healthcare; their design can influence clinicians' behaviour. We conducted a systematic review of EHR-based interventions aimed at changing the clinical practice of general practitioners in the UK, assessed their effectiveness and applied behaviour change theory to identify lessons for other settings. DESIGN: Mixed methods systematic review. DATA SOURCES: MEDLINE, EMBASE, CENTRAL and APA PsycINFO were searched up to March 2023. ELIGIBILITY CRITERIA: Quantitative and qualitative findings from randomised controlled trials (RCTs) controlled before-and-after studies and interrupted time series of EHR-based interventions in UK general practice were included. DATA EXTRACTION AND SYNTHESIS: Quantitative synthesis was based on Cochrane's Synthesis without Meta-analysis. Interventions were categorised using the Behaviour Change Wheel and MINDSPACE frameworks and effectiveness determined by vote-counting using direction of effect. Inductive thematic synthesis was used for qualitative studies. RESULTS: Database searching identified 3824 unique articles; 10 were included (from 2002 to 2021), comprising eight RCTs and two associated qualitative studies. Four of seven quantitative studies showed a positive effect on clinician behaviour and three on patient-level outcomes. Behaviour change techniques that may trigger emotions and required less cognitive engagement appeared to have positive effects. Qualitative findings indicated that interventions reassured clinicians of their decisions but were sometimes ignored. CONCLUSION: Despite widespread use, there is little high quality, up-to-date experimental evidence evaluating the effectiveness of EHR-based interventions in UK general practice. The evidence suggested EHR-based interventions may be effective at changing behaviour. Persistent, simple action-oriented prompts appeared more effective than complex interventions requiring greater cognitive engagement. However, studies lacked detail in intervention design and theory behind design choices. Future research should seek to optimise EHR-based behaviour change intervention design and delineate limitations, providing theory-based justification for interventions. This will be of increasing importance with the growing use of EHRs to influence clinicians' decisions. PROSPERO REGISTRATION NUMBER: CRD42022341009.


Subject(s)
Electronic Health Records , General Practitioners , Humans , United Kingdom , Practice Patterns, Physicians' , General Practice/methods , Behavior Therapy/methods
12.
Syst Rev ; 13(1): 137, 2024 May 21.
Article in English | MEDLINE | ID: mdl-38773659

ABSTRACT

BACKGROUND: Adherence to physiotherapeutic treatment and recommendations is crucial to achieving planned goals and desired health outcomes. This overview of systematic reviews synthesises the wide range of additional interventions and behaviour change techniques used in physiotherapy, exercise therapy and physical therapy to promote adherence and summarises the evidence of their efficacy. METHODS: Seven databases (PEDro, PubMed, Cochrane Library, Web of Science, Scopus, PsycINFO and CINAHL) were systematically searched with terms related to physiotherapy, motivation, behaviour change, adherence and efficacy (last searched on January 31, 2023). Only systematic reviews of randomised control trials with adults were included. The screening process and quality assessment with AMSTAR-2 were conducted independently by the two authors. The extracted data was synthesised narratively. In addition, four meta-analyses were pooled in a panoramic meta-analysis. RESULTS: Of 187 reviews identified in the search, 19 were included, comprising 205 unique trials. Four meta-analyses on the effects of booster sessions, behaviour change techniques, goal setting and motivational interventions showed a significantly small overall effect (SMD 0.24, 95% CI 0.13, 0.34) and no statistical heterogeneity (I2 = 0%) in the panoramic meta-analysis. Narrative synthesis revealed substantial clinical and methodological diversity. In total, the certainty of evidence is low regarding the efficacy of the investigated interventions and techniques on adherence, due to various methodological flaws. Most of the RCTs that were included in the reviews analysed cognitive and behavioural interventions in patients with musculoskeletal diseases, indicating moderate evidence for the efficacy of some techniques, particularly, booster sessions, supervision and graded exercise. The reviews provided less evidence for the efficacy of educational and psychosocial interventions and partly inconsistent findings. Most of the available evidence refers to short to medium-term efficacy. The combination of a higher number of behaviour change techniques was more efficacious. CONCLUSIONS: The overview of reviews synthesised various potentially efficacious techniques that may be combined for a holistic and patient-centred approach and may support tailoring complex interventions to the patient's needs and dispositions. It also identifies various research gaps and calls for a more holistic approach to define and measure adherence in physiotherapy. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42021267355.


Subject(s)
Physical Therapy Modalities , Systematic Reviews as Topic , Humans , Adult , Patient Compliance , Motivation , Exercise Therapy/methods , Behavior Therapy/methods
13.
J Prev Alzheimers Dis ; 11(3): 639-648, 2024.
Article in English | MEDLINE | ID: mdl-38706280

ABSTRACT

BACKGROUND: Many Alzheimer's Disease (AD) clinical trials have failed to demonstrate treatment efficacy on cognition. It is conceivable that a complex disease like AD may not have the same treatment effect due to many heterogeneities of disease processes and individual traits. OBJECTIVES: We employed an individual-level treatment response (ITR) approach to determine the characteristics of treatment responders and estimated time saved in cognitive decline using the Internet-based Conversational Engagement Clinical Trial (I-CONECT) behavioral intervention study as a model. DESIGN AND SETTING: I-CONECT is a multi-site, single-blind, randomized controlled trial aimed to improve cognitive functions through frequent conversational interactions via internet/webcam. The experimental group engaged in video chats with study staff 4 times/week for 6 months; the control group received weekly 10-minute check-in phone calls. PARTICIPANTS: Out of 186 randomized participants, current study used 139 participants with complete information on both baseline and 6-month follow-up (73 with mild cognitive impairment (MCI), 66 with normal cognition; 64 in the experimental group, and 75 in the control group). MEASUREMENTS: ITR scores were generated for the Montreal Cognitive Assessment (MoCA) (global cognition, primary outcome) and Category Fluency Animals (CFA) (semantic fluency, secondary outcome) that showed significant efficacy in the trial. ITR scores were generated through 300 iterations of 3-fold cross-validated random forest models. The average treatment difference (ATD) curve and the area between the curves (ABC) were estimated to measure the heterogeneity of treatment responses. Responder traits were identified using SHapley Additive exPlanations (SHAP) and decision tree models. The time saved in cognitive decline was explored to gauge clinical meaningfulness. RESULTS: ABC statistics showed substantial heterogeneity in treatment response with MoCA but modest heterogeneity in treatment response with CFA. Age, cognitive status, time spent with family and friends, education, and personality were important characteristics that influenced treatment responses. Intervention group participants in the upper 30% of ITR scores demonstrated potential delays of 3 months in semantic fluency (CFA) and 6 months in global cognition (MoCA), assuming a 5-fold faster natural cognitive decline compared to the control group during the post-treatment period. CONCLUSIONS: ITR-based analyses are valuable in profiling treatment responders for features that can inform future trial design and clinical practice. Reliably measuring time saved in cognitive decline is an area of ongoing research to gain insight into the clinical meaningfulness of treatment.


Subject(s)
Alzheimer Disease , Cognitive Dysfunction , Precision Medicine , Humans , Male , Female , Cognitive Dysfunction/therapy , Precision Medicine/methods , Alzheimer Disease/therapy , Alzheimer Disease/psychology , Aged , Single-Blind Method , Internet , Behavior Therapy/methods , Aged, 80 and over
14.
J Med Internet Res ; 26: e54375, 2024 May 24.
Article in English | MEDLINE | ID: mdl-38787601

ABSTRACT

BACKGROUND: With the development of emerging technologies, digital behavior change interventions (DBCIs) help to maintain regular physical activity in daily life. OBJECTIVE: To comprehensively understand the design implementations of habit formation techniques in current DBCIs, a systematic review was conducted to investigate the implementations of behavior change techniques, types of habit formation techniques, and design strategies in current DBCIs. METHODS: The process of this review followed the PRISMA (Preferred Reporting Item for Systematic Reviews and Meta-Analyses) guidelines. A total of 4 databases were systematically searched from 2012 to 2022, which included Web of Science, Scopus, ACM Digital Library, and PubMed. The inclusion criteria encompassed studies that used digital tools for physical activity, examined behavior change intervention techniques, and were written in English. RESULTS: A total of 41 identified research articles were included in this review. The results show that the most applied behavior change techniques were the self-monitoring of behavior, goal setting, and prompts and cues. Moreover, habit formation techniques were identified and developed based on intentions, cues, and positive reinforcement. Commonly used methods included automatic monitoring, descriptive feedback, general guidelines, self-set goals, time-based cues, and virtual rewards. CONCLUSIONS: A total of 32 commonly design strategies of habit formation techniques were summarized and mapped to the proposed conceptual framework, which was categorized into target-mediated (generalization and personalization) and technology-mediated interactions (explicitness and implicitness). Most of the existing studies use the explicit interaction, aligning with the personalized habit formation techniques in the design strategies of DBCIs. However, implicit interaction design strategies are lacking in the reviewed studies. The proposed conceptual framework and potential solutions can serve as guidelines for designing strategies aimed at habit formation within DBCIs.


Subject(s)
Habits , Humans , Behavior Therapy/methods , Exercise , Health Behavior
15.
Ann Behav Med ; 58(6): 432-444, 2024 May 23.
Article in English | MEDLINE | ID: mdl-38721982

ABSTRACT

BACKGROUND: Health behaviors play a significant role in chronic disease management. Rather than being independent of one another, health behaviors often co-occur, suggesting that targeting more than one health behavior in an intervention has the potential to be more effective in promoting better health outcomes. PURPOSE: We aimed to conduct a systematic review and meta-analysis of randomized trials of interventions that target more than one behavior to examine the effectiveness of multiple health behavior change interventions in patients with chronic conditions. METHODS: Five electronic databases (Web of Science, PubMed, CINAHL, EMBASE, and Cochrane) were systematically searched in November 2023, and studies included in previous reviews were also consulted. We included randomized trials of interventions aiming to change more than one health behavior in individuals with chronic conditions. Two independent reviewers screened and extracted data, and used Cochrane's Risk of Bias 2 tool. Meta-analyses were conducted to estimate the effects of interventions on change in health behaviors. Results were presented as Cohen's d for continuous data, and risk ratio for dichotomous data. RESULTS: Sixty-one studies were included spanning a range of chronic diseases: cardiovascular (k = 25), type 2 diabetes (k = 15), hypertension (k = 10), cancer (k = 7), one or more chronic conditions (k = 3), and multiple conditions (k = 1). Most interventions aimed to change more than one behavior simultaneously (rather than in sequence) and most targeted three particular behaviors at once: "physical activity, diet and smoking" (k = 20). Meta-analysis of 43 eligible studies showed for continuous data (k = 29) a small to substantial positive effect on behavior change for all health behaviors (d = 0.081-2.003) except for smoking (d = -0.019). For dichotomous data (k = 23) all analyses showed positive effects of targeting more than one behavior on all behaviors (RR = 1.026-2.247). CONCLUSIONS: Targeting more than one behavior at a time is effective in chronic disease management and more research should be directed into developing the science of multiple behavior change.


Many recommendations suggest engaging in more than one health behavior to manage a chronic disease; however, most research trying to understand or support health behavior tends to focus on only one behavior. We wanted to clarify if interventions aiming to support people in changing more than one health behavior are effective and promote better health outcomes. We aimed to conduct a systematic review to summarize the effects of studies reporting randomized trials of interventions that target more than one behavior in people with a chronic condition. We found and analyzed 61 studies published up to November 2023 covering people with a variety of chronic diseases: cardiovascular conditions, type 2 diabetes, hypertension, cancer, and, in some studies, people with multiple conditions. Most interventions tried to change three particular behaviors at once (physical activity, diet, and smoking) and, overall, interventions that tried to change more than one behavior had positive effects on diet, physical activity, medication adherence, and alcohol consumption, but not smoking cessation. Findings highlight the benefits of targeting more than one behavior in health behavior change interventions. Future research could seek to identify if findings are similar across settings and populations and how they can inform routine healthcare and self-management interventions.


Subject(s)
Health Behavior , Humans , Chronic Disease/therapy , Behavior Therapy/methods , Randomized Controlled Trials as Topic
16.
Respir Care ; 69(6): 678-685, 2024 May 28.
Article in English | MEDLINE | ID: mdl-38806226

ABSTRACT

A self-management intervention is a personalized approach to individuals aiming to engage individuals in a behavior change to develop skills to live better with their condition. Self-management involves an iterative process between participants and providers in which goals are formulated and feedback is given. All respiratory societies advocate self-management as part of chronic care because it may improve quality of life and health-care utilization. Self-management is an integral part of pulmonary rehabilitation. Self-management interventions usually involve education and exercise prescription, and that is an asset of current programs; however, recent reports indicate that effective strategies for motivation and a behavior change focus are often missed. A recent systematic review on self-management urges the need for a specific aspect and characteristic of self-management interventions: iterative interactions between participants and health-care professionals competent in using behavior change practices to elicit participants' motivation, confidence, and competence to develop skills to better manage their disease. A recent review of self-care intervention in chronic disease states that the major deficits found in self-care interventions included a lack of attention and/or innovation to the psychological consequences of chronic illness, technology, and behavior change techniques to help patients manage symptoms. There is a need for exploration of mechanisms to explain the relationships between both anxiety and depression, and adherence to treatment in COPD. The latter is particularly appropriate for pulmonary rehabilitation, for which greater adherence is needed. This report aims to introduce basic aspects of behavior change and a proposed roadmap to introduce behavior change into pulmonary rehabilitation and chronic care programs.


Subject(s)
Motivation , Pulmonary Disease, Chronic Obstructive , Self-Management , Humans , Behavior Therapy/methods , Chronic Disease/psychology , Health Behavior , Patient Compliance/psychology , Patient Education as Topic , Pulmonary Disease, Chronic Obstructive/psychology , Pulmonary Disease, Chronic Obstructive/therapy , Pulmonary Disease, Chronic Obstructive/rehabilitation , Quality of Life , Self Care/psychology , Self-Management/methods , Self-Management/psychology
17.
Ned Tijdschr Geneeskd ; 1682024 Apr 16.
Article in Dutch | MEDLINE | ID: mdl-38630073

ABSTRACT

About 20% of adults experience excessive daytime sleepiness or severe fatigue. Causes include somatic conditions, psychiatric disorders, and medication or drug use. Treatment depends on the underlying cause. If sleepiness persists despite optimal treatment of the underlying condition, exclusion of other causes, and behavioral interventions, wakefulness-promoting agents may be considered. However, no established pharmacological strategy exists for symptomatic treatment. Modafinil and stimulants like methylphenidate may offer some benefit based on experiences with narcolepsy or idiopathic hypersomnia. Studies in specific patient groups (e.g., multiple sclerosis, Parkinson's disease, traumatic brain injury, cancer-related fatigue) show variable results. The use of wakefulness-promoting agents is discouraged for addressing unexplained fatigue, as seen in the context of chronic fatigue syndrome.


Subject(s)
Brain Injuries, Traumatic , Central Nervous System Stimulants , Wakefulness-Promoting Agents , Adult , Humans , Wakefulness-Promoting Agents/therapeutic use , Central Nervous System Stimulants/therapeutic use , Modafinil/therapeutic use , Behavior Therapy
18.
Eur Rev Med Pharmacol Sci ; 28(7): 2750-2759, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38639514

ABSTRACT

OBJECTIVE: Hyperglycemic mothers and their offspring are at increased risk of various maternal and neonatal complications such as macrosomia, future type 2 diabetes, and metabolic abnormalities. Early diagnosis and individualized dietary management, exercise, and emotional well-being are expected to reduce these risks. The study aims to identify the effect of the Nutrition and Behavior Modification Program (NBMP) on maternal and neonatal outcomes of hyperglycemic mothers. PATIENTS AND METHODS: A pre-experimental study was performed among 89 hyperglycemic mothers. Glycemic control at 28 and 36 weeks, weight gain during pregnancy, pre-eclampsia, pregnancy-induced hypertension (PIH), mode of delivery, duration of exercise, emotional well-being, neonates' birth weight, incidence of hypoglycemia, and NICU admission were compared among the study and control groups. The intervention group received an individualized NBMP from their diagnosis of hyperglycemia until delivery. RESULTS: The results showed a significant difference in blood glucose between the study periods and groups at p<0.05 as per repeated ANOVA. Also, diet scores had a significant influence on BMI and glycemic control at p<0.05. Logistic regression models, adjusted for potential confounders including baseline blood glucose, age, economic status, previous GDM, family history of DM as well as baseline BMI, diet score, physical activity, and maternal well-being score, indicated that the NBMP reduced the blood glucose and BMI significantly at p<0.05 in the study group. NBMP also reduced the risk of SGA/LGA and preterm/post-mature birth, as well as increased the exercise duration and emotional well-being of mothers. CONCLUSIONS: The study's conclusions draw attention to the possible roles that maternal wellness, physical activity, and diet may have in reducing risks for both hyperglycemic mothers and their newborns. The NBMP resulted in higher adherence to lifestyle changes. Further research on a larger sample of hyperglycemic mothers is recommended to expand the generalizability of the findings.


Subject(s)
Diabetes Mellitus, Type 2 , Diabetes, Gestational , Pregnancy , Female , Infant, Newborn , Humans , Blood Glucose/metabolism , Fetal Macrosomia/epidemiology , Behavior Therapy
20.
PLoS One ; 19(4): e0297986, 2024.
Article in English | MEDLINE | ID: mdl-38630668

ABSTRACT

In recent years, virtual reality (VR) technology has emerged as a powerful tool in the field of therapeutic landscapes. For hospitalized patients or individuals with limited mobility, VR provides highly personalized therapy by simulating authentic natural environments within a safe, convenient, and engaging setting. This study investigated the effectiveness of immersing patients in virtual natural environments for health recovery and compared the varying impacts of different types of landscapes on patients' recovery levels. The aim was to complement traditional medical approaches and enhance environmental design in the field of public health. Researchers systematically reviewed databases (January 2018 to August 2, 2023) to identify randomized controlled trials comparing the efficacy of virtual nature immersion with other treatments. The inclusion/exclusion criteria were established based on the population, intervention, comparison, outcomes, study design, and other aspects (expanded PICO) framework. The Cochrane tool was employed to assess the risk of bias. Meta-analysis was conducted by pooling the mean differences with a 95% confidence interval. Among 30 trials, a total of 2123 patients met the inclusion criteria, with 15 studies included in the meta-analysis. 30 trials met the criteria. Results show significant improvements in pain, anxiety, fear, and some physiological indicators with virtual nature-based treatments. On the other hand, natural scenes incorporating blue and green elements have been applied more extensively and have shown more significant effects. In comparison to conventional methods, this study strongly advocates that virtual reality environments are a crucial tool in bridging the gap between patients and nature, demonstrating their potential to reshape medical interventions and improve environmental design in the field of public health.


Subject(s)
Anxiety , Public Health , Humans , Randomized Controlled Trials as Topic , Anxiety Disorders , Behavior Therapy
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