For Whom and for How Long Does the "Be a Mom" Intervention Work? A Secondary Analysis of Data From a Randomized Controlled Trial Exploring the Mid-Term Efficacy and Moderators of Treatment Response.

This study explored clinical and sociodemographic moderators of treatment response to "Be a Mom", an internet-based cognitive behavioral therapy (iCBT) intervention, from baseline to postintervention, in women at high risk for postpartum depression (PPD). The study also assessed the stability of women's treatment gains from baseline to 4-months postintervention (follow-up). This open-label randomized controlled trial (RCT) involved a sample of 1,053 postpartum Portuguese women identified as being at high risk for PPD (i.e., having a score of 5.5 or higher on the Postpartum Depression Predictors Inventory-Revised); participants were allocated to "Be a Mom" intervention group or a waiting-list control group, and completed self-report measures at baseline, postintervention, and a 4-month follow-up (554 women completed follow-up assessments). Depressive and anxiety symptoms were measured using the Edinburgh Postnatal Depression Scale and the anxiety subscale of the Hospital Anxiety and Depression Scale, and flourishing/positive mental health was assessed with the Mental Health Continuum. Regression models and linear mixed models were used to examine moderators of treatment and the mid-term efficacy of the "Be a Mom" intervention, respectively. The results revealed that treatment completion, higher depression scores at baseline, and higher income levels were linked to greater symptom reduction and positive mental health enhancement. Moreover, the efficacy of the "Be a Mom" intervention was supported at the 4-month follow-up. The "Be a Mom" intervention appears to be an effective iCBT tool for reducing psychological distress and enhancing positive mental health in women at risk for PPD, with therapeutic improvements maintained over a 4-month period.

Web-Based Therapist-Guided Mindfulness-Based Cognitive Behavioral Therapy for Body Dysmorphic Disorder: Pilot Randomized Controlled Trial.

BACKGROUND: Internet-based cognitive behavioral therapy (CBT) and stand-alone mindfulness meditation interventions are gaining empirical support for a wide variety of mental health conditions. In this study, we test the efficacy of web-based therapist-guided mindfulness-based cognitive behavioral therapy (CBT-M) for body dysmorphic disorder (BDD), a psychiatric disorder characterized by preoccupations with perceived defects in appearance. OBJECTIVE: This study aims to determine whether CBT-M for BDD delivered on the web is feasible and acceptable and whether mindfulness meditation adds to CBT treatment effects for BDD. METHODS: In this 8-week, 2-arm, parallel pilot randomized controlled trial, n=28 adults (aged between 18 and 55 years) were randomly allocated to an experimental group (web-based therapist-guided CBT-M) or a control group (web-based therapist-guided CBT). Study retention, accrual, and intervention adherence were assessed, along with self-report measures for BDD, depression, anxiety, and pain intensity taken at baseline and postintervention. RESULTS: This study was feasible to implement and deemed acceptable by participants. After 8 weeks, significant improvements were found on all outcome measures for both treatment groups, and large between-group effect sizes favoring CBT-M were found for BDD symptom severity (d=-0.96), depression (d=-1.06), pain severity (d=-1.12), and pain interference (d=-1.28). However, linear mixed models demonstrated no significant differences between the groups over 8 weeks. CONCLUSIONS: The results suggest that mindfulness meditation may add to beneficial web-based CBT treatment effects for BDD. An adequately powered randomized control trial of web-based CBT-M is warranted. TRIAL REGISTRATION: ClinicalTrials.gov NCT05402475, http://clinicaltrials.gov/ct2/show/NCT05402475.

Online acceptance and commitment therapy (iACT) for adults with persistent physical symptoms - 3-month follow-up study of a randomized controlled trial.

OBJECTIVE: Persistent physical symptoms (PPS) represent a major health problem affecting daily functioning. This RCT aimed to examine whether a guided Internet-based treatment based on acceptance and commitment therapy (ACT) provided additional benefits compared to Treatment as Usual (TAU) in reducing somatic complaints and psychological distress in adults with PPS. METHODS: A total of 103 adults with PPS related to indoor environments, chronic fatigue or both conditions were assigned to receive either either a 14-week intervention (video-based case conceptualization + Internet-based ACT) combined with TAU (iACT + TAU; n = 50) or TAU alone (n = 53). Somatic symptoms, depression, anxiety, insomnia, and psychological flexibility were assessed from pre-intervention to a 3-month follow-up. Additionally, the association between changes in psychological flexibility from pre- to post-intervention and changes in symptoms from pre to 3-month follow-up was explored. Analyses were conducted using a multigroup method with full information maximum likelihood estimator. RESULTS: The results revealed a significant interaction effect, indicating reductions in somatic symptoms and symptoms of depression and anxiety with moderate to large between-group effects (d = 0.71-1.09). No significant interaction effect was observed in insomnia and measures of psychological flexibility. CONCLUSION: Internet-based ACT, when combined with Treatment as Usual, demonstrated efficacy for individuals with PPS associated with indoor environments and chronic fatigue. These findings are pertinent for primary healthcare providers, suggesting that the current treatment model could serve as a low-threshold first-line treatment option. THE CLINICAL TRIAL REGISTRATION NUMBER: NCT04532827.

Effectiveness of Web-Based Mindfulness-Based Interventions for Patients With Cancer: Systematic Review and Meta-Analyses.

BACKGROUND: Cancer has emerged as a considerable global health concern, contributing substantially to both morbidity and mortality. Recognizing the urgent need to enhance the overall well-being and quality of life (QOL) of cancer patients, a growing number of researchers have started using online mindfulness-based interventions (MBIs) in oncology. However, the effectiveness and optimal implementation methods of these interventions remain unknown. OBJECTIVE: This study evaluates the effectiveness of online MBIs, encompassing both app- and website-based MBIs, for patients with cancer and provides insights into the potential implementation and sustainability of these interventions in real-world settings. METHODS: Searches were conducted across 8 electronic databases, including the Cochrane Library, Web of Science, PubMed, Embase, SinoMed, CINAHL Complete, Scopus, and PsycINFO, until December 30, 2022. Randomized controlled trials involving cancer patients aged ≥18 years and using app- and website-based MBIs compared to standard care were included. Nonrandomized studies, interventions targeting health professionals or caregivers, and studies lacking sufficient data were excluded. Two independent authors screened articles, extracted data using standardized forms, and assessed the risk of bias in the studies using the Cochrane Bias Risk Assessment Tool. Meta-analyses were performed using Review Manager (version 5.4; The Cochrane Collaboration) and the meta package in R (R Foundation for Statistical Computing). Standardized mean differences (SMDs) were used to determine the effects of interventions. The Reach, Effectiveness, Adoption, Implementation, and Maintenance framework was used to assess the potential implementation and sustainability of these interventions in real-world settings. RESULTS: Among 4349 articles screened, 15 (0.34%) were included. The total population comprised 1613 participants, of which 870 (53.9%) were in the experimental conditions and 743 (46.1%) were in the control conditions. The results of the meta-analysis showed that compared with the control group, the QOL (SMD 0.37, 95% CI 0.18-0.57; P<.001), sleep (SMD -0.36, 95% CI -0.71 to -0.01; P=.04), anxiety (SMD -0.48, 95% CI -0.75 to -0.20; P<.001), depression (SMD -0.36, 95% CI -0.61 to -0.11; P=.005), distress (SMD -0.50, 95% CI -0.75 to -0.26; P<.001), and perceived stress (SMD -0.89, 95% CI -1.33 to -0.45; P=.003) of the app- and website-based MBIs group in patients with cancer was significantly alleviated after the intervention. However, no significant differences were found in the fear of cancer recurrence (SMD -0.30, 95% CI -1.04 to 0.44; P=.39) and posttraumatic growth (SMD 0.08, 95% CI -0.26 to 0.42; P=.66). Most interventions were multicomponent, website-based health self-management programs, widely used by international and multilingual patients with cancer. CONCLUSIONS: App- and website-based MBIs show promise for improving mental health and QOL outcomes in patients with cancer, and further research is needed to optimize and customize these interventions for individual physical and mental symptoms. TRIAL REGISTRATION: PROSPERO CRD42022382219; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=382219.

A Personalized and Interactive Web-Based Advance Care Planning Intervention for Older Adults (Koda Health): Pilot Feasibility Study.

Background: Advance care planning (ACP) is a process that involves patients expressing their personal goals, values, and future medical care preferences. Digital applications may help facilitate this process, though their use in older adults has not been adequately studied. Objective: This pilot study aimed to evaluate the reach, adoption, and usability of Koda Health, a web-based patient-facing ACP platform, among older adults. Methods: Older adults (aged 50 years and older) who had an active Epic MyChart account at an academic health care system in North Carolina were recruited to participate. A total of 2850 electronic invitations were sent through MyChart accounts with an embedded hyperlink to the Koda platform. Participants who agreed to participate were asked to complete pre- and posttest surveys before and after navigating through the Koda Health platform. Primary outcomes were reach, adoption, and System Usability Scale (SUS) scores. Exploratory outcomes included ACP knowledge and readiness. Results: A total of 161 participants enrolled in the study and created an account on the platform (age: mean 63, SD 9.3 years), with 80% (129/161) of these participants going on to complete all steps of the intervention, thereby generating an advance directive. Participants reported minimal difficulty in using the Koda platform, with an overall SUS score of 76.2. Additionally, knowledge of ACP (eg, mean increase from 3.2 to 4.2 on 5-point scale; P<.001) and readiness (eg, mean increase from 2.6 to 3.2 on readiness to discuss ACP with health care provider; P<.001) significantly increased from before to after the intervention. Conclusions: This study demonstrated that the Koda Health platform is feasible, had above-average usability, and improved ACP documentation of preferences in older adults. Our findings indicate that web-based health tools like Koda may help older individuals learn about and feel more comfortable with ACP while potentially facilitating greater engagement in care planning.

Booster effects and mechanisms of web-based personalised normative feedback alcohol intervention for college students: A pragmatic randomised controlled trial.

BACKGROUND: To evaluate the effects of booster and no booster versions of web-based alcohol Personalised Normative Feedback (PNF) and whether descriptive norms mediated and/or participant motivation moderated the effectiveness of the intervention in real world conditions (i.e. no financial incentives). METHODS: Pragmatic randomised controlled trial with 1-, 3-, and 6-month assessments. Brazilian college students reporting alcohol use in the last 12 months (N=931) were recruited from May/2020 to December/2022 and allocated to 1) No booster/single PNF(S-PNF); 2) Booster/multiple PNF(M-PNF); or 3) Assessment-only control. We applied Helmert coding [1: Any intervention (S-PNF or M-PNF) vs. Control; and 2: S-PNF vs. M-PNF]. PRIMARY OUTCOMES: typical number of drinks/week and maximum number of drinks/week; secondary outcomes: drinking frequency and number of consequences. Three-months assessment was the primary interval. Descriptive norms were tested as mediator. Interest, importance, and readiness to change were examined as moderators. RESULTS: Compared to control, any intervention did not influence primary outcomes at 3-months or 6-months, but did at 1-month, when reduced typical drinking (IRR:0.77, 95%CI:0.66;0.90) and maximum number of drinks (IRR:0.69, 95%CI:0.58;0.82). There was an intervention effect on the consequences at 3-months. No differences were observed between S-PNF and M-PNF. No mediation effects were found at 3-months. At 6-months, there was an indirect effect on typical drinking through norms at 3-months (b=-0.82, 95%CI:-2.03;-0.12) and effects on maximum drinks through norms at 1-month (b=-0.54, 95%CI:-1.65;-0.02). No support for moderation was found. CONCLUSIONS: Intervention reduced alcohol drinking at 1 month only and was not effective thereafter. Mechanisms of effect remain unclear.

The effects of a web-based 24-hour movement behavior lifestyle education program on mental health and psychological well-being in parents of children with autism spectrum disorder: A randomized controlled trial.

BACKGROUND AND PURPOSE: Compared with parents of neurotypical children or children diagnosed with other disabilities, parents of children with autism spectrum disorder (ASD) often experience poorer mental health, greater stress, and more depression and anxiety symptoms. This study aimed to assess the effects of a web-based 24-h movement behavior lifestyle education program on mental health and psychological well-being in parents of children with ASD. METHODS: This study employed a randomized controlled trial utilizing the Health Action Process Approach (HAPA) as a theoretical framework. A total of 318 parents of children with ASD were enrolled and randomly assigned to the experimental or control group. The experimental group received an 8-week web-based 24-h movement behavior lifestyle education program, while the control group followed their usual routine. Two instruments, the Depression Anxiety and Stress Scale (DASS-21) and the Satisfaction With Life Scale (SWLS), were used to measure mental health and psychological well-being, respectively. The data were collected at two time points-at the beginning and the end of the intervention. RESULTS: Compared with the baseline and control groups, the experimental group demonstrated significant improvements in all outcome measures (p < 0.01). There were significant differences in the DASS-21 and SWLS scores between the two groups before and after the intervention (p ≤ 0.01). CONCLUSION: This study represents the first randomized controlled trial involving a web-based 24-h movement behavior lifestyle education program specifically designed to address the mental health and psychological well-being of parents of children with ASD. The findings confirm the potential impact of 24-h movement behavior lifestyle education as a functional and effective strategy for parents of children with ASD.

Web-Based, Human-Guided, or Computer-Guided Transdiagnostic Cognitive Behavioral Therapy in University Students With Anxiety and Depression: Randomized Controlled Trial.

BACKGROUND: Internet-based cognitive behavioral interventions (iCBTs) are efficacious treatments for depression and anxiety. However, it is unknown whether adding human guidance is feasible and beneficial within a large educational setting. OBJECTIVE: This study aims to potentially demonstrate the superiority of 2 variants of a transdiagnostic iCBT program (human-guided and computer-guided iCBT) over care as usual (CAU) in a large sample of university students and the superiority of human-guided iCBT over computer-guided iCBT. METHODS: A total of 801 students with elevated levels of anxiety, depression, or both from a large university in the Netherlands were recruited as participants and randomized to 1 of 3 conditions: human-guided iCBT, computer-guided iCBT, and CAU. The primary outcome measures were depression (Patient Health Questionnaire) and anxiety (Generalized Anxiety Disorder scale). Secondary outcomes included substance use-related problems (Alcohol Use Disorder Identification Test and Drug Abuse Screening Test-10 items). Linear mixed models were used to estimate the effects of time, treatment group, and their interactions (slopes). The primary research question was whether the 3 conditions differed in improvement over 3 time points (baseline, midtreatment, and after treatment) in terms of depression and anxiety symptoms. Results were analyzed according to the intention-to-treat principle using multiple imputation. Patients were followed exploratively from baseline to 6 and 12 months. RESULTS: In both short-term and long-term analyses, the slopes for the 3 conditions did not differ significantly in terms of depression and anxiety, although both web-based interventions were marginally more efficacious than CAU over 6 months (P values between .02 and .03). All groups showed significant improvement over time (P<.001). For the secondary outcomes, only significant improvements over time (across and not between groups) were found for drug use (P<.001). Significant differences were found in terms of adherence, indicating that participants in the human-guided condition did more sessions than those in the computer-guided condition (P=.002). CONCLUSIONS: The transdiagnostic iCBT program offers a practical, feasible, and efficacious alternative to usual care to tackle mental health problems in a large university setting. There is no indication that human guidance should be preferred over technological guidance. The potential preference of human support also depends on the scale of implementation and cost-effectiveness, which need to be addressed in future trials. TRIAL REGISTRATION: International Clinical Trials Registry Platform NL7328/NTR7544; https://trialsearch.who.int/Trial2.aspx?TrialID=NL-OMON26795.

Supporting self-management of low back pain with an internet intervention with and without telephone support in primary care (SupportBack 2): a randomised controlled trial of clinical and cost-effectiveness.

BACKGROUND: Low back pain is prevalent and a leading cause of disability. We aimed to determine the clinical and cost-effectiveness of an accessible, scalable internet intervention for supporting behavioural self-management (SupportBack). METHODS: Participants in UK primary care with low back pain without serious spinal pathology were randomly assigned 1:1:1 using computer algorithms stratified by disability level and telephone-support centre to usual care, usual care and SupportBack, or usual care and SupportBack with physiotherapist telephone-support (three brief calls). The primary outcome was low back pain-related disability (Roland Morris Disability Questionnaire [RMDQ] score) at 6 weeks, 3 months, 6 months, and 12 months using a repeated measures model, analysed by intention to treat using 97·5% CIs. A parallel economic evaluation from a health services perspective was used to estimate cost-effectiveness. People with lived experience of low back pain were involved in this trial from the outset. This completed trial was registered with ISRCTN, ISRCTN14736486. FINDINGS: Between Nov 29, 2018, and Jan 12, 2021, 825 participants were randomly assigned (274 to usual care, 275 to SupportBack only, 276 to SupportBack with telephone-support). Participants had a mean age of 54 (SD 15), 479 (58%) of 821 were women and 342 (42%) were men, and 591 (92%) of 641 were White. Follow-up rates were 687 (83%) at 6 weeks, 598 (73%) at 3 months, 589 (72%) at 6 months, and 652 (79%) at 12 months. For the primary analysis, 736 participants were analysed (249 usual care, 245 SupportBack, and 242 SupportBack with telephone support). At a significance level of 0·025, there was no difference in RMDQ over 12 months with SupportBack versus usual care (adjusted mean difference -0·5 [97·5% CI -1·2 to 0·2]; p=0·085) or SupportBack with telephone-support versus usual care (-0·6 [-1·2 to 0·1]; p=0·048). There were no treatment-related serious adverse events. The economic evaluation showed that the SupportBack group dominated usual care, being both more effective and less costly. Both interventions were likely to be cost-effective at a threshold of £20 000 per quality adjusted life year compared with usual care. INTERPRETATION: The SupportBack internet interventions did not significantly reduce low back pain-related disability over 12 months compared with usual care. They were likely to be cost-effective and safe. Clinical effectiveness, cost-effectiveness, and safety should be considered together when determining whether to apply these interventions in clinical practice. FUNDING: National Institute for Health and Care Research Health Technology Assessment (16/111/78).

Web-Based Mindfulness-Based Cognitive Therapy for Adults With a History of Depression: Protocol for a Randomized Controlled Trial.

BACKGROUND: Depression poses a major threat to public health with an increasing prevalence in the United States. Mindfulness-based interventions, such as mindfulness-based cognitive therapy (MBCT), are effective methods for managing depression symptoms and may help fortify existing efforts to address the current disease burden. The in-person group format of MBCT, however, incurs barriers to care such as expenses, childcare needs, and transportation issues. Alternate delivery modalities such as MBCT delivered via the web can be investigated for their capacity to overcome these barriers and still reduce symptoms of depression with adequate feasibility and efficacy. OBJECTIVE: This study protocol aims to examine the feasibility and efficacy of MBCT delivered via the web for the treatment of depression. METHODS: To attain study aims, 2 phases will be implemented using a waitlist control design. A total of 128 eligible participants will be randomized into either an 8-week MBCT intervention group plus treatment as usual (MBCT + TAU; group 1) or an 8-week waitlist control group (group 2). In phase I (8 weeks), group 1 will complete the intervention and group 2 will proceed with TAU. In phase II (8 weeks), group 2 will complete the intervention and group 1 will continue with TAU until reaching an 8-week follow-up. TAU may consist of receiving psychotherapy, pharmacotherapy, or combined treatment. Data collection will be completed at baseline, 8 weeks (postintervention for group 1 and preintervention for group 2), and 16 weeks (follow-up for group 1, postintervention for group 2). The primary outcomes will include (1) current, residual, or chronic depression symptoms and (2) psychiatric distress. Secondary outcomes will include perceived stress and facets of mindfulness. The feasibility will be measured by assessing protocol adherence, retention, attendance, and engagement. Finally, the extent of mindfulness self-practice and executive functioning skills will be assessed as mediators of intervention outcomes. RESULTS: This study began screening and recruitment in December 2022. Data collection from the first cohort occurred in January 2023. By November 2023, a total of 30 participants were enrolled out of 224 who received screening. Data analysis began in February 2024, with an approximate publication of results by August 2024. Institutional review board approval took place on September 11, 2019. CONCLUSIONS: This trial will contribute to examining mindfulness-based interventions, delivered via the web, for improving current, residual, or chronic depression symptoms. It will (1) address the feasibility of MBCT delivered via the web; (2) contribute evidence regarding MBCT's efficacy in reducing depression symptoms and psychiatric distress; and (3) assess the impact of MBCT on several important secondary outcomes. Findings from this study will develop the understanding of the causal pathways between MBCT delivered via the web and depression symptoms further, elucidating the potential for future larger-scale designs. TRIAL REGISTRATION: ClinicalTrials.gov NCT05347719; https://www.clinicaltrials.gov/ct2/show/NCT05347719. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/53966.

The effect of an online acceptance and commitment intervention on the meaning-making process in cancer patients following hematopoietic cell transplantation: study protocol for a randomized controlled trial enhanced with single-case experimental design.

BACKGROUND: Hematopoietic cell transplantation (HCT) is a highly invasive and life-threatening treatment for hematological neoplasms and some types of cancer that can challenge the patient's meaning structures. Restoring meaning (i.e., building more flexible and significant explanations of the disease and treatment burden) can be aided by strengthening psychological flexibility by means of an Acceptance and Commitment Therapy (ACT) intervention. Thus, this trial aims to examine the effect of the ACT intervention on the meaning-making process and the underlying mechanisms of change in patients following HCT compared to a minimally enhanced usual care (mEUC) control group. The trial will be enhanced with a single-case experimental design (SCED), where ACT interventions will be compared between individuals with various pre-intervention intervals. METHODS: In total, 192 patients who qualify for the first autologous or allogeneic HCT will be recruited for a two-armed parallel randomized controlled trial comparing an online self-help 14-day ACT training to education sessions (recommendations following HCT). In both conditions, participants will receive once a day a short survey and intervention proposal (about 5-10 min a day) in the outpatient period. Double-blinded assessment will be conducted at baseline, during the intervention, immediately, 1 month, and 3 months after the intervention. In addition, 6-9 participants will be invited to SCED and randomly assigned to pre-intervention measurement length (1-3 weeks) before completing ACT intervention, followed by 7-day observations at the 2nd and 3rd post-intervention measure. The primary outcome is meaning-related distress. Secondary outcomes include psychological flexibility, meaning-making coping, meanings made, and well-being as well as global and situational meaning. DISCUSSION: This trial represents the first study that integrates the ACT and meaning-making frameworks to reduce meaning-related distress, stimulate the meaning-making process, and enhance the well-being of HCT recipients. Testing of an intervention to address existential concerns unique to patients undergoing HCT will be reinforced by a statistically rigorous idiographic approach to see what works for whom and when. Since access to interventions in the HCT population is limited, the web-based ACT self-help program could potentially fill this gap. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT06266182. Registered on February 20, 2024.

A Self-Guided Internet-Based Intervention for the Reduction of Gambling Symptoms: A Randomized Clinical Trial.

Importance: Most individuals with problem gambling or gambling disorder remain untreated due to barriers to treatment. Limited research exists on alternative treatments. Objective: To investigate the efficacy of a self-guided internet-based intervention for individuals with gambling problems and to identify potential outcome moderators. Design, Setting, and Participants: This single-center randomized clinical trial was conducted from July 13, 2021, to December 31, 2022, at the University Medical Center Hamburg-Eppendorf. Participants were recruited across Germany for 2 assessments (before intervention [t0] and 6 weeks after intervention [t1]). Eligible participants were individuals aged 18 to 75 years with gambling problems, internet access, German proficiency, and willingness to participate in 2 online assessments. Intervention: The self-guided internet-based intervention was based on cognitive behavioral therapy, metacognitive training, acceptance and commitment therapy, and motivational interviewing. Main Outcome and Measures: The primary outcome was change in gambling-related thoughts and behavior as measured with the pathological gambling adaption of the Yale-Brown Obsessive-Compulsive Scale. Secondary outcomes were change in depressive symptoms, gambling severity, gambling-specific dysfunctional thoughts, attitudes toward online interventions, treatment expectations, and patient satisfaction. Results: A total of 243 participants (154 [63.4%] male; mean [SD] age, 34.73 [10.33] years) were randomized to an intervention group (n = 119) that gained access to a self-guided internet-based intervention during 6 weeks or a wait-listed control group (n = 124). Completion at t1 was high (191 [78.6%]). Results showed a significantly greater reduction in gambling-related thoughts and behavior (mean difference, -3.35; 95% CI, -4.79 to -1.91; P < .001; Cohen d = 0.59), depressive symptoms (mean difference, -1.05; 95% CI, -1.87 to -0.22; P = .01; Cohen d = 0.33), and gambling severity (mean difference, -1.46; 95% CI, -2.37 to -0.54; P = .002; Cohen d = 0.40) but not in gambling-specific dysfunctional thoughts (mean difference, -1.62; 95% CI, -3.40 to 0.15; P = .07; Cohen d = 0.23) favoring the intervention group. Individuals in the intervention group who had a positive treatment expectation and more severe gambling-specific dysfunctional thoughts and gambling symptoms benefited more on the primary outcome relative to the control group. Conclusions and Relevance: In this randomized clinical trial, the effectiveness of a self-guided internet-based intervention for individuals with self-reported problematic gambling behavior was demonstrated when measured 6 weeks after start of the intervention. The study's findings are particularly relevant given the increasing need for accessible and scalable solutions to address problematic gambling. Trial Registration: bfarm.de Identifier: DRKS00024840.

Feasibility of Web-Based Single-Session Empowered Relief in Patients With Chronic Pain Taking Methadone or Buprenorphine: Protocol for a Single-Arm Trial.

BACKGROUND: Chronic pain affects tens of millions of US adults and continues to rise in prevalence. Nonpharmacologic behavioral pain treatments are greatly needed and yet are often inaccessible, particularly in settings where medication prescribing is prioritized. OBJECTIVE: This study aims to test the feasibility of a live-instructor, web-based 1-session pain relief skills class in an underserved and potentially at-risk population: people with chronic pain prescribed methadone or buprenorphine either solely for pain or for comorbid opioid use disorder (OUD). METHODS: This is a national, prospective, single-arm, uncontrolled feasibility trial. The trial is untethered from medical care; to enhance participants' willingness to join the study, no medical records or drug-monitoring records are accessed. At least 45 participants will be recruited from outpatient pain clinics and from an existing research database of individuals who have chronic pain and are taking methadone or buprenorphine. Patient-reported measures will be collected at 6 time points (baseline, immediately post treatment, 2 weeks, and months 1-3) via a web-based platform, paper, or phone formats to include individuals with limited internet or computer access and low literacy skills. At baseline, participants complete demographic questions and 13 study measures (Treatment Expectations, Body Pain Map, Medication Use, Pain Catastrophizing Scale [PCS], Patient-Reported Outcomes Measurement Information System [PROMIS] Measures, and Opioid Craving Scale). Immediately post treatment, a treatment satisfaction and acceptability measure is administered on a 0 (very dissatisfied) to 10 (completely satisfied) scale, with 3 of these items being the primary outcome (perceived usefulness, participant satisfaction, and likelihood of using the skills). At each remaining time point, the participants complete all study measures minus treatment expectations and satisfaction. Participants who do not have current OUD will be assessed for historical OUD, with presence of OUD (yes or no), and history of OUD (yes or no) reported separately. Feasibility threshold is set as an overall group treatment satisfaction rating of 8 of 10. In-depth qualitative interviews will be conducted with about 10 participants to obtain additional data on patient perceptions, satisfactions, needs, and wants. To assess preliminary efficacy, we will examine changes in pain catastrophizing, pain intensity, pain bothersomeness, sleep disturbance, pain interference, depression, anxiety, physical function, global impression of change, and opioid craving at 1 month post treatment. RESULTS: This project opened to enrollment in September 2021 and completed the recruitment in October 2023. The data collection was completed in February 2024. Results are expected to be published in late 2024. CONCLUSIONS: Results from this trial will inform the feasibility and preliminary efficacy of Empowered Relief in this population and will inform the design of a future randomized controlled trial testing web-based Empowered Relief in chronic pain and comorbid OUD. TRIAL REGISTRATION: ClinicalTrials.gov NCT05057988; https://clinicaltrials.gov/study/NCT05057988. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/53784.

Addressing the unmet needs of women with breast cancer in Mexico: a non-randomised pilot study of the digital ePRO intervention.

OBJECTIVES: This study aimed to explore the acceptability, feasibility, usability, and preliminary effect of an electronic patient-reported outcome (ePRO) intervention for patients with breast cancer in Mexico. DESIGN: We conducted a multimethod non-randomised pilot study. We used a pre-test/post-test design for quantitative assessment of the intervention's effect on patients' supportive care needs and quality of life. We conducted in-depth interviews (IDIs) with participants and healthcare workers to explore the intervention's benefits and barriers and understand its feasibility. PARTICIPANTS: 50 women aged 20-75 diagnosed with stage I-III breast cancer were enrolled within 2 weeks of starting neoadjuvant or adjuvant treatment with chemotherapy or radiotherapy. We excluded illiterate women and those with visual impairment, cognitive disability or severe depression. IDIs were conducted with 18 participants and 10 healthcare providers. SETTING: Oncology services in three public hospitals of the Mexican Social Security Institute. INTERVENTION: The ePRO intervention consisted of a responsive web application for weekly symptom reporting combined with proactive follow-up by nurses guided by predefined clinical algorithms for 6 weeks. RESULTS: 50 women were enrolled out of 66 eligible patients approached (75.8%). All 50 completed the 4-week follow-up assessment (100% retention). Completion of the symptom registry declined from 100% in week 1 to 66% in week 6. Participants experienced decreases in supportive care needs and increased quality of life. The ePRO application was rated highly usable. Participants and health professionals both perceived intervention benefits. Drawbacks included poor fit for women receiving radiotherapy and challenges using the application for women with low digital literacy or experiencing severe symptoms. CONCLUSIONS: This pilot study provided evidence of the high usability and potential efficacy of a web-based ePRO intervention. We revised recruitment during the pilot to include multiple facilities, and we will further revise for the randomised trial to address barriers to successful ePRO implementation. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov ID: NCT05925257.

Web-based occupational stress prevention in German micro- and small-sized enterprises - process evaluation results of an implementation study.

BACKGROUND: Structural and behavioral interventions to manage work-related stress are effective in employees. Nonetheless, they have been implemented insufficiently, particularly in micro- and small-sized enterprises (MSE). Main barriers include a lack of knowledge and limited resources, which could potentially be overcome with simplified web-based alternatives for occupational stress prevention. However, there is a lack of implementation research about web-based prevention in realistic settings of MSE. OBJECTIVE: The aim of this study is to evaluate the implementation process and success of an integrated web-based platform for occupational stress prevention ("System P") and to identify potential barriers for its uptake and use in MSE in Germany. METHODS: This study with a mixed-methods approach investigates eight process-related outcomes in a quantitative part I (adoption, reach, penetration, fidelity/dose, costs, acceptability) and a qualitative part II (acceptability, appropriateness and feasibility). Part I has a pre-post design with two measurements (6 months apart) with 98 individual participants and part II consists of 12 semi-structured interviews with managers and intercorporate stakeholders. RESULTS: Part I revealed shortcomings in the implementation process. Adoption/Reach: Despite extensive marketing efforts, less than 1% of the contacted MSE responded to the offer of System P. A total of 40 MSE registered, 24 of which, characterized by good psychosocial safety climate, adopted System P. Penetration: Within these 24 MSE, 15% of the employees used the system. Fidelity/Dose: 11 MSE started a psychosocial risk-assessment (PRA), and no MSE finished it. The stress-management training (SMT) was started by 25 users and completed by 8. COSTS: The use of System P was free of charge, but the time required to engage with was an indirect cost. Part II added insights on the perception of the web-based intervention: Acceptance of System P by users and stakeholders was good and it was assessed as appropriate for MSE. Results for feasibility were mixed. CONCLUSIONS: Although System P was generally perceived as useful and appropriate, only a small number of contacted MSE implemented it as intended. Prior experience and sensitivity for occupational (stress) prevention were mentioned as key facilitators, while (perceived) indirect costs were a key barrier. Enabling MSE to independently manage stress prevention online did not result in successful implementation. Increasing external support could be a solution. ⁺ FULL PROJECT NAME: "PragmatiKK - Pragmatische Lösungen für die Implementation von Maßnahmen zur Stressprävention in Kleinst- und Kleinbetrieben" (= Pragmatic solutions for the implementation of stress prevention interventions in micro and small-sized enterprises). TRIAL REGISTRATION: German Register of Clinical Studies (DRKS) DRKS00026154, date of registration 2021-09-16.

Investigating non-inferiority of internet-delivered versus face-to-face cognitive behavioural therapy for insomnia (CBT-I): a randomised controlled trial (iSleep well).

BACKGROUND: Insomnia is a highly prevalent disorder associated with numerous adverse health outcomes. Cognitive behavioural therapy for insomnia (CBT-I) is recommended as first-line treatment by clinical guidelines but is accessible to only a minority of patients suffering from insomnia. Internet-delivered CBT-I (iCBT-I) could contribute to the widespread dissemination of this first-line treatment. As there is insufficient evidence regarding non-inferiority, this study directly aims to compare therapist-guided internet-delivered versus face-to-face CBT-I in terms of insomnia severity post-treatment. Furthermore, a health-economic evaluation will be conducted, and potential benefits and disadvantages of therapist-guided iCBT-I will be examined. METHODS: This study protocol describes a randomised controlled two-arm parallel-group non-inferiority trial comparing therapist-guided iCBT-I with face-to-face CBT-I in routine clinical care. A total of 422 patients with insomnia disorder will be randomised and treated at 16 study centres throughout Germany. Outcomes will be assessed at baseline, 10 weeks after randomisation (post), and 6 months after randomisation (follow-up). The primary outcome is insomnia severity measured using the Insomnia Severity Index. Secondary outcomes include depression-related symptoms, quality of life, fatigue, physical activity, daylight exposure, adverse events related to treatment, and a health-economic evaluation. Finally, potential moderator variables and several descriptive and exploratory outcomes will be assessed (e.g. benefits and disadvantages of internet-delivered treatment). DISCUSSION: The widespread implementation of CBT-I is a significant healthcare challenge. The non-inferiority of therapist-guided iCBT-I versus face-to-face CBT-I will be investigated in an adequately powered sample in routine clinical care, with the same therapeutic content and same level of therapist qualifications provided with both interventions. If this trial demonstrates the non-inferiority of therapist-guided iCBT-I, healthcare providers may be more confident recommending this treatment to their patients, contributing to the wider dissemination of CBT-I. TRIAL REGISTRATION: Trial registration number in the German Clinical Trials Register: DRKS00028153 ( https://drks.de/search/de/trial/DRKS00028153 ). Registered on 16th May 2023.

Choosing Health: acceptability and feasibility of a theory-based, online-delivered, tailored weight loss, and weight loss maintenance intervention.

Few weight loss and weight loss maintenance interventions are tailored to include factors demonstrated to predict the user's behavior. Establishing the feasibility and acceptability of such interventions is crucial. The aim of this study was to assess the acceptability and feasibility of a theory-based, tailored, online-delivered weight loss and weight loss maintenance intervention (Choosing Health). We conducted a mixed methods process evaluation of the Choosing Health tailored intervention, nested in a randomized controlled trial (N = 288) with an embedded N-of-1 study, investigating participants' and implementers' experiences related to intervention context, implementation, and mechanisms of impact. Measures included: (i) surveys, (ii) data-prompted interviews (DPIs) with study participants, (iii) semi-structured interviews with implementers, and (iv) intervention access and engagement data. Five themes described the acceptability of the intervention to participants: (i) monitoring behavior change and personal progress to better understand the weight management process, (ii) working collaboratively with the intervention implementers to achieve participants' goals, (iii) perceived benefits of non-judgmental and problem-solving tone of the intervention, (iv) changes in personal perception of the weight management process due to intervention tailoring, and (v) insufficient intervention content tailoring. The intervention delivery was feasible, however, emails and text messages differed in terms of accessibility and resources required to deliver the content. The use of Ecological Momentary Assessment as a technique to gather personal data for further tailoring was acceptable, and facilitated behavior change monitoring. Personalization of the intervention content above and beyond domain-specific issues, for example, by addressing participants' social roles may better match their needs. Support from the implementers and feedback on body composition changes may increase participants' engagement.

People with overweight and obesity can benefit from participating in behavior change programs that are individually adjusted to participants' psychological characteristics. It is important to provide knowledge of how to design acceptable and feasible, widely accessible, sustainable tailored interventions for weight loss, and weight loss maintenance. We designed Choosing Health­a tailored intervention that matched intervention content to psychological factors that were demonstrated to influence each participant's behavior. This study assessed whether the Choosing Health program was acceptable and feasible from the point of view of program participants and people who worked directly with the participants. The intervention tailoring supported participants in changing the way they thought about the weight loss process, and regular tailored messages served as a cue to maintain healthy habits. However, tailoring based on psychological characteristics was insufficient for many participants, as they would have preferred more personalized content. We provide guidance on good practices to gather data for tailored support, monitor behavior change progress, and for communicating with participants, to improve the acceptability of tailored interventions. We also compare how acceptable participants found methods of intervention delivery (SMS messages, emails, handbook) to advise which methods are the most acceptable and preferred by participants.

START NOW WebApp-promoting emotion regulation and resilience in residential youth care and correctional institutions: study protocol for a cluster randomized controlled trial.

BACKGROUND: Adolescents and young adults in residential care and correctional institutions face various challenges, leading to negative life outcomes. Implementation barriers within these institutions, such as limited financial and spatial resources, pose significant hurdles to providing necessary support. Web-based approaches address these challenges by offering cost-effective, accessible solutions. This study aims to assess the efficacy of a newly developed web-based version of the existing evidence-based START NOW skills training in fostering emotion regulation and resilience among institutionalized adolescents and young adults. We present the study protocol (Version 5, August 2023) of the trial titled "Implementation of an e-version of the skills training START NOW for promoting emotion regulation and resilience in residential youth care and correctional institutions". METHODS: The study is a monocentric, prospective, confirmatory randomized controlled trial with 150 institutionalized adolescents and young adults with a need to improve resilience (predefined cut-offs). Participating institutions will be randomized to one of three conditions: (i) 9-week web-based group training guided by a facilitator, (ii) 9-week web-based self-help training, (iii) and treatment as usual. The primary endpoint is the change in psychological flexibility, assessed by the Avoidance and Fusion Questionnaire for Youth score, from baseline to follow-up 12 weeks post skills training. Secondary objectives encompass assessing pre-post changes in psychological flexibility and other psychological health-related outcome measures in participating adolescents, young adults, and caretakers from baseline, to post training, and to 12- and 24-week follow-ups. DISCUSSION: This study evaluates the efficacy of START NOW as web-based training for institutionalized adolescents and young adults, providing valuable insights into web-based interventions and aiming to optimize support levels. TRIAL REGISTRATION {2A AND 2B}: ClinicalTrials.gov NCT05313581. Registered on 6 April 2022.

Effectiveness of web-based intervention on reducing symptom burden, improving self-management capabilities and self-efficacy among prostate cancer survivors: a systematic review and meta-analysis protocol.

INTRODUCTION: Prostate cancer is the most common malignant disease within the male genitourinary system. Advances in cancer screening and treatment have significantly ameliorated the survival rates of patients with prostate cancer. Nonetheless, prostate cancer survivors report various degrees of cancer-related symptoms. These symptoms cause physiological and psychological suffering, leading to a deterioration of quality of life. Web-based interventions may facilitate the management of symptoms due to their flexibility, accessibility and convenience. However, the efficacy of web-based interventions in reducing symptom burden remains to be confirmed. Consequently, this systematic review and meta-analysis aims to comprehensively synthesise existing evidence, evaluate the effectiveness of web-based interventions in reducing symptom burden among patients and furnish a reference for clinical practice. METHODS AND ANALYSIS: This protocol strictly adheres to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocol guidelines. We will comprehensively search six databases (PubMed, Web of Science, Cochrane, Embase, CINAHL and PsycINFO) from their inception to March 2024 in order to identify clinical trials on the efficacy of web-based interventions for prostate cancer survivors. Two reviewers will independently conduct study selection, data extraction and quality assessment. The risk bias of included studies will be assessed using the Cochrane Risk of Bias Tool for randomised trials 2.0, and the strength of evidence will be assessed using Grading of Recommendations Assessment, Development and Evaluation (GRADE) guideline. Meta-analysis will be performed using STATA V.16.0, and the effect size will be calculated using the standardised mean difference and its 95% CI. Heterogeneity will be assessed using Cochran's Q statics and inconsistency will be measured using the I2 statistics. Potential sources of bias will be evaluated. ETHICS AND DISSEMINATION: Ethics approval is not required for this review as no human participants will be involved. The results will be disseminated via a peer-reviewed journal or an academic conference. PROSPERO REGISTRATION NUMBER: CRD42023457718.

A Web-Based Intervention Using "Five Ways to Wellbeing" to Promote Well-Being and Mental Health: Randomized Controlled Trial.

BACKGROUND: Compromised well-being and mental health problems pose a significant threat to individuals and societies worldwide. Resource-intensive psychological treatments alone cannot alleviate this burden. There is a need for low-cost, evidence-based interventions aimed at preventing illness and promoting well-being. Five activity domains appear to be linked with well-being promotion across populations: connecting with others, being active, taking notice, learning, and being generous/giving. The activities mentioned are part of the Five Ways to Wellbeing framework and the web-based intervention Five Ways to Wellbeing for All (5waysA). OBJECTIVE: This randomized controlled trial aims to test the effects of the 5waysA intervention, a web-based, low-cost, well-being-promoting measure targeting the general population. To date, the Five Ways to Wellbeing framework has not been tested in this specific format. The 5waysA intervention comprises 2 webinars and SMS text message reminders delivered over a 10-week period. METHODS: In 2021, a total of 969 study participants from various regions across Norway were openly recruited through a web page. They were then randomly assigned to either an intervention group or 1 of 2 waiting list control groups, namely, active or passive. Self-reported life satisfaction (Satisfaction With Life Scale [SWLS]), flourishing (Flourishing Scale [FS]), positive emotions, anxiety, and depression symptoms (Hopkins Symptom Checklist-8 [HSCL-8]) were assessed before the intervention, at 4 weeks into the intervention, and 1-2 weeks after the intervention (over 10 weeks). Data analysis was conducted using linear mixed (multilevel) models. RESULTS: After 10 weeks, 453 participants (171 in the intervention group and 282 in the waiting list control group) were assessed on outcome variables, with a dropout rate of 53.2% (516/969). Results revealed a significantly greater increase in the intervention group compared with the controls for SWLS (b=0.13, 95% CI 0.03-0.23; P=.001), FS (b=0.19, 95% CI 0.08-0.30; P=.001), positive emotions (b=0.43, 95% CI 0.27-0.60; P<.001), and these factors combined into a global well-being measure (b=0.28, CI 0.16-0.39; P<.001). Effect sizes (Cohen d) for the well-being outcomes ranged from 0.30 to 0.49. In addition, a significant decrease in anxiety and depressive symptoms was observed (b=-0.17, 95% CI -0.30 to -0.04; P=.001) with an effect size (Cohen d) of -0.20. CONCLUSIONS: The findings suggest that the web-based 5waysA intervention could serve as an effective approach for enhancing well-being and mental health within the general population. This study offers individuals, policy makers, and local stakeholders an accessible and potentially cost-effective well-being intervention that could be easily implemented. TRIAL REGISTRATION: ClinicalTrials.gov NCT04784871; https://clinicaltrials.gov/study/NCT04784871.