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.

Cognitive therapy for depression in tuberculosis treatment: protocol for multicentre pragmatic parallel arm randomised control trial with an internal pilot.

INTRODUCTION AND OBJECTIVES: There is an unmet need to develop high-quality evidence addressing tuberculosis (TB)-related mental health comorbidity, particularly in the context of lower-middle-income countries. This study aims to examine the effectiveness and cost-effectiveness of cognitive behavioural therapy (CBT) versus enhanced treatment as usual (ETAU) in improving depressive symptoms in people with TB and comorbid depression, enhancing adherence with anti-TB treatment (ATT) and its implementation in the real-world setting of Pakistan. METHODS: We will conduct a pragmatic parallel arm randomised control trial with an internal pilot. A brief psychological intervention based on CBT has been developed using a combination of qualitative and ethnographic studies. The inbuilt pilot trial will have a sample size of 80, while we plan to recruit 560 (280 per arm) participants in the definitive trial. Participants who started on ATT within 1 month of diagnosis for pulmonary and extrapulmonary TB or multidrug resistant TB (MDR-TB) and meeting the criteria for depression on Patient Health Questionnaire-9 (PHQ-9) will be randomised with 1:1 allocation to receive six sessions of CBT (delivered by TB healthcare workers) or ETAU. Data on the feasibility outcomes of the pilot will be considered to proceed with the definitive trial. Participants will be assessed (by a blinded assessor) for the following main trial primary outcomes: (1) severity of depression using PHQ-9 scale (interviewer-administered questionnaire) at baseline, weeks 8, 24 and 32 postrandomisation and (2) ATT at baseline and week 24 at the end of ATT therapy. ETHICS AND DISSEMINATION: Ethical approval has been obtained from Keele University Research Ethics Committee (ref: 2023-0599-792), Khyber Medical University Ethical Review Board (ref: DIR/KMU-EB/CT/000990) and National Bioethics Committee Pakistan (ref: No.4-87/NBC-998/23/587). The results of this study will be reported in peer-reviewed journals and academic conferences and disseminated to stakeholders and policymakers. TRIAL REGISTRATION NUMBER: ISRCTN10761003.

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 Cognitive Stimulation Therapy for Dementia in Brazil and India: Acceptability, Feasibility, and Lessons for Implementation.

BACKGROUND: Cognitive stimulation therapy (CST) is an evidence-based, group psychosocial intervention for people with dementia, and it has a positive impact on cognition and quality of life. CST has been culturally adapted for use globally. It was developed as a face-to-face intervention but has recently been adapted for online delivery. OBJECTIVE: In this study, we aimed to explore the feasibility and acceptability of online or virtual CST (vCST) delivery in India and Brazil, emphasizing barriers and facilitators to implementation. METHODS: A single-group, multisite, mixed methods, feasibility study was conducted, with nested qualitative interviews. Primary feasibility outcomes were recruitment rate, attendance, attrition, acceptability, and outcome measure completion. Exploratory pre- and postintervention measures, including cognition and quality of life, were assessed. Qualitative interviews were conducted with people with dementia, family caregivers, and group and organizational leaders following intervention delivery, and the data were analyzed using the Consolidated Framework for Implementation Research. RESULTS: A total of 17 vCST group sessions with 59 participants were conducted for 7 weeks, with 53% (31/59) of participants attending all 14 sessions. Attrition rate was 7% (4/59), and outcome measure completion rate at follow-up was 68% (40/59). Interviews took place with 36 stakeholders. vCST was acceptable to participants and group leaders and enabled vital access to services during pandemic restrictions. While online services broadened geographic access, challenges emerged concerning inadequate computer literacy, poor technology access, and establishing interpersonal connections online. Exploratory, uncontrolled analyses indicated positive trends in quality of life but negative trends in cognition and activities of daily living, but these results were not statistically significant. CONCLUSIONS: vCST demonstrated feasibility and acceptability, serving as a crucial resource during the pandemic but raised challenges related to technology access, computer literacy, and long-term implementation. The study highlights the potential of vCST while emphasizing ongoing development and solutions to address implementation challenges.

Feasibility and potential effectiveness of nurse-led video-coaching interventions for childhood, adolescent, and young adult cancer survivors: the REVIVER study.

BACKGROUND: Childhood, adolescent, and young adult (CAYA) cancer survivors, at risk for late effects, including cancer-related fatigue, cardiovascular issues, and psychosocial challenges, may benefit from interventions stimulating behaviour adjustments. Three nurse-led eHealth interventions (REVIVER) delivered via video calls and elaborating on person-centred care, cognitive behaviour therapy and/or motivational interviewing were developed. These interventions target: 1) fatigue management, 2) healthier lifestyle behaviours, and 3) self-efficacy and self-management. This study aimed to assess the feasibility and potential effectiveness of the REVIVER interventions for CAYA cancer survivors and healthcare professionals. METHODS: In a single-group mixed methods design, CAYA cancer survivors aged 16-54, more than five years post-treatment, were enrolled. Feasibility, assessed via Bowen's outcomes for feasibility studies, included acceptability, practicality, integration and implementation, demand and adherence. Qualitative data from semi-structured interviews and a focus group interview with survivors and healthcare professionals supplemented the evaluation. Paired sample t-tests assessed changes in self-reported quality of life, fatigue, lifestyle, self-management, and self-efficacy at baseline (T0), post-intervention (T1), and 6-month follow-up (T2). RESULTS: The interventions and video consults were generally acceptable, practical, and successfully integrated and implemented. Success factors included the nurse consultant (i.e., communication, approach, and attitude) and the personalised approach. Barriers included sustainability concerns, technical issues, and short intervention duration. Regarding demand, 71.4%, 65.4%, and 100% of eligible CAYA cancer survivors engaged in the fatigue (N = 15), lifestyle (N = 17) and empowerment (N = 3) intervention, respectively, with 5, 5 and 2 participants interviewed, correspondingly. Low interest (demand) in the empowerment intervention (N = 3) and dropout rates of one-third for both fatigue and empowerment interventions were noted (adherence). Improvements in quality of life, fatigue (fatigue intervention), lifestyle (lifestyle intervention), self-efficacy, and self-management were evident among survivors who completed the fatigue and lifestyle interventions, with medium and large effect sizes observed immediately after the intervention and six months post-intervention. CONCLUSIONS: Our study demonstrates the feasibility of nurse-led video coaching (REVIVER interventions) despite lower demand for the empowerment intervention and lower adherence to the fatigue and empowerment interventions. The medium and high effect sizes found for those who completed the interventions hold potential clinical significance for future studies investigating the effectiveness of the REVIVER interventions.

Effects of Training in Cognitive Behavioural Therapy and Motivational Interviewing on Mental Health Practitioner Behaviour: A Systematic Review and Meta-Analysis.

Effective training of mental health professionals is crucial for bridging the gap between research and practice when delivering cognitive behavioural therapy (CBT) and motivational interviewing (MI) within community settings. However, previous research has provided inconclusive evidence regarding the impact of training efforts. The current study aimed to systematically search, review and synthesize the literature on CBT and MI training to assess its effect on practitioner behavioural outcomes. Following prospective registration, a literature search was conducted for studies where mental health practitioners were exposed to training in face-to-face CBT or MI, reporting on at least one quantitative practitioner behavioural outcome. A total of 116 studies were eligible for the systematic review, and 20 studies were included in four meta-analyses. The systematic review highlights the need to establish psychometrically valid outcome measures for practitioner behaviour. Results of the meta-analyses suggest that training has a greater effect on practitioner behaviour change compared to receiving no training or reading a treatment manual. Training combined with consultation/supervision was found to be more effective than training alone, and no differences were found between face-to-face and online training. Results should be interpreted with caution due to methodological limitations in the primary studies, large heterogeneity, and small samples in the meta-analyses. Future directions are discussed.

Collaborative Care for Chronic Pain After Traumatic Brain Injury: A Randomized Clinical Trial.

Importance: Chronic pain after traumatic brain injury (TBI) is prevalent and associated with poor outcomes. By providing multidisciplinary care through expert consultation, a collaborative care (CC) treatment approach may reduce pain interference. Objective: To compare CC with usual care (UC) in decreasing pain interference. Design, Setting, and Participants: This randomized clinical trial was conducted from July 2018 through April 2021 at 2 hospital-based academic rehabilitation medicine clinics in Seattle, Washington. Participants included adults with mild-to-severe TBI (at least 6 months before enrollment) and chronic pain. Data analysis was performed from March 30, 2022, to August 30, 2023. Intervention: The CC intervention (called TBI Care) included up to 12 in-person or telephone visits over 16 weeks with a care manager (CM) who provided person-centered cognitive behavioral treatment. The CM met weekly with members of the expert team to review participants and discuss recommendations to optimize treatment. Main Outcomes and Measures: The primary outcome was pain interference on the Brief Pain Inventory at treatment conclusion (4 months after randomization). Secondary outcomes included pain interference at 8 months; pain severity; symptoms of depression, anxiety, and sleep disturbance; pain-related emergency department visits; community participation; and participant satisfaction. Linear mixed-effects regression was used for analysis. Results: A total of 1379 individuals were screened for eligibility, and 158 were randomized (79 to CC and 79 to UC). The participants were mostly women (92 participants [58%]) with a mean (SD) age of 46.8 (13.2) years and a mean (SD) of 15.3 (3.0) years of education. TBI occurred a mean (SD) of 4.0 (5.9) years (median [IQR], 1.9 [0.8-4.5] years) before enrollment. All TBI severities were included, and of 149 participants for whom TBI severity was known, the majority (97 participants [65%]) had mild TBI. In the CC group, 71 participants (90%) completed at least 11 sessions, and, at 4 months, this group had significantly lower pain interference scores compared with the UC group (mean [SD], 3.46 [2.17] vs 5.03 [2.28]). This difference was maintained at 8 months after randomization, with mean (SD) TBI care pain interference scores of 3.61 (2.22) for CC vs 4.68 (2.51) for UC. At 4 months, there was significantly lower pain severity in the CC group vs UC group (mean [SD] score, 3.63 [1.95] vs 4.90 [1.96]), as well as symptoms of depression (mean [SD] score, 8.07 [5.34] vs 11.31 [6.37]) and anxiety (mean [SD], 6.20 [5.17] vs 9.58 [6.00]). Satisfaction with pain treatment (mean [SD] score, 2.99 [1.23] vs 2.52 [1.25]), clinical care (mean [SD] score, 3.28 [1.00] vs 2.84 [1.26]), and overall health care (mean [SD] score, 3.25 [0.88] vs 2.82 [1.00]) were significantly higher in the CC group vs the UC group; global impression of change was significantly lower in the CC group vs the UC group (mean [SD] score, 2.74 [1.02] vs 3.47 [1.26]) (lower scores denote a better impression of change). Conclusions and Relevance: In this randomized clinical trial of CC compared with UC for patients with TBI, CC was effective at reducing pain interference and was sustained at 8-month follow-up. Further research is needed to examine the implementation and cost-effectiveness of CC for TBI in other health care settings. Trial Registration: ClinicalTrials.gov Identifier: NCT03523923.

Introduction to the special issue: Culturally sensitive approaches to conceptualization and treatment of psychiatric disorders.

Cognitive-behavioral therapy (CBT) is an effective treatment for a variety of psychiatric disorders. However, historic underrepresentation, misapplication of techniques, and neglected consideration for the unique experiences of marginalized groups-including racial, ethnic, sexual, and gender minorities-have led to mistrust of mental health treatment among these communities and decreased access to quality, evidence-based care. Although these treatments are not inherently harmful to individuals with marginalized identities, clinicians can cause harm if they do not consider the role of culture in their conceptualization, assessment, and treatment of individuals with marginalized identities. Thus, this Special Issue details important considerations for conceptualization, assessment, treatment, and research related to a variety of psychiatric disorders in individuals with marginalized identities. In particular, this Special Issue describes substance use disorders among Black men, eating disorders among queer and transgender individuals, obsessive-compulsive disorder in Hispanic and Latin American individuals, and social anxiety disorder in Black adolescents.

Cognitive behavioural interventions led by a physiotherapist in chronic non-specific low back pain: A systematic review and meta-analysis.

BACKGROUND: The effectiveness of physiotherapist-led Cognitive Behavioural Interventions (CBI) with or without physiotherapy is still unclear. OBJECTIVE: This systematic review (PROSPERO registration number CRD42022321073) aims to determine the effectiveness of physiotherapist-led CBI with or without physiotherapy in comparison to physiotherapy alone on quality of life, disabilities and catastrophization. METHODS: MEDLINE, Web of Science, Science Direct, and PEDro were searched for randomized controlled trials that investigate the use of CBI versus conventional physiotherapy in chronic NSLBP. To be included CBI had to be performed by a physiotherapist. The primary and secondary outcomes were respectively quality of life and disability. RESULTS: Fourteen studies were included in qualitative analysis, in which 4 did not meet the PEDro score of 6 or higher. Pooled standardized mean differences from 3 studies showed no difference in quality of life between groups for mental and physical sub-scores at 3 months (SMD 0.02, 95% CI -0.17 to 0.21 and SMD 0.07, 95% CI -0.12 to 0.26 respectively). Pooled standardized mean differences from 9 studies showed no difference in disability between groups at 3, 6 and 12 months (SMD = - 0.40, CI 95% -0.80 to 0.01; SMD -0.18, CI 95% = -0.41 to 0.05; and SMD -0.24, CI 95% = -0.48 to 0.00 respectively). CONCLUSION: Results of CBI, especially cognitive functional therapy, seem promising in disability management despite a substantial heterogeneity. Furthermore, we found no difference in quality of life.

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.

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.

Dose-response relationship in cognitive behavioral therapy for depression: A nonlinear metaregression analysis.

OBJECTIVE: Evidence on the optimal "dose" of cognitive behavioral therapy (CBT) for treating major depressive disorder is sparse. This analysis aimed to evaluate the dose-response curve in CBT using a nonlinear approach, whereby "dose" was defined as number of treatment sessions. The dose-response curve of CBT was compared to other psychotherapies and pharmacological treatments for depression. METHOD: A systematic review and metaregression analysis of randomized controlled trials (RCTs) examining the efficacy of CBT in adults with acute depression was conducted. Treatment arms examining other psychosocial or pharmacological interventions were also analyzed. Cubic spline metaregression techniques were used to model nonlinear dose-response curves. RESULTS: Seventy-two studies and 7,377 participants were included. Modeling the dose-response curve between change of depression symptom severity and the number of CBT sessions resulted in a nonlinear curve characterized by a strong improvement in symptom severity from baseline within the first eight sessions. Symptom reduction continues in the further course of the treatment, but at a slower pace. A similar pattern of symptom development was found for other therapies as well, although the prominence of early improvement and overall effect sizes vary across treatment arms. CONCLUSION: Results imply a general tendency for the strongest alleviation of depressive symptom severity in early stages of CBT treatment, thus, if aiming at symptom alleviation, speak for short CBT interventions. However, these findings have to be discussed in the light of the limited data regarding the sustainability of treatment effects in short-term therapies and effects beyond symptomatic changes. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Cognitive behavioural therapy for insomnia (CBT-I) in schizophrenia and schizoaffective disorder: protocol for a randomised controlled trial.

INTRODUCTION: Insomnia is a common symptom among patients with schizophrenia and schizoaffective disorder, negatively impacting symptom severity, functioning and well-being; however, it is rarely the direct focus of treatment. The main recommended treatment for insomnia is cognitive behavioural therapy (CBT-I). There is some evidence that CBT-I can also be used to treat insomnia in patients with schizophrenia, but only a few randomised controlled trials (RCTs) have been published. The aim of this ongoing RCT is to determine whether we can alleviate symptoms of insomnia and improve the quality of life in patients with schizophrenia and schizoaffective disorder through CBT-I delivered via the internet or in a group mode. METHODS AND ANALYSES: The aim of this study is to recruit 84-120 outpatients from the Psychosis Clinics of Helsinki University Hospital and the City of Helsinki Health Services. The main inclusion criteria are a diagnosis of schizophrenia or schizoaffective disorder and self-reported sleep problems. The study will be performed on a cyclic basis, with a target of 12-24 patients per cycle. Participants are randomly assigned into three groups: (1) a group receiving only treatment as usual (TAU), (2) internet-based individual therapy for insomnia (iCBT-I)+TAU or (3) group therapy for insomnia (GCBT-I) conducted via a virtual platform+TAU. The primary outcome measures are quantitative changes in the Insomnia Severity Index score and/or changes in health-related quality of life using the 15D quality of life measure. Secondary outcomes include self-reported variables for sleep, health, stress and the severity of psychotic and depressive symptoms; objective outcomes include actigraphy and bed sensor data to evaluate circadian rhythms and motor activity. Outcome measures are assessed at baseline and after the treatment period at weeks 12, 24 and 36. ETHICS AND DISSEMINATION: The Coordinating Ethics Committee of the Hospital District of Helsinki and Uusimaa, Finland, approved the study protocol. The results will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04144231.

Emotional Awareness and Expression Therapy vs Cognitive Behavioral Therapy for Chronic Pain in Older Veterans: A Randomized Clinical Trial.

Importance: Chronic pain is common and disabling in older adults, and psychological interventions are indicated. However, the gold standard approach, cognitive-behavioral therapy (CBT), produces only modest benefits, and more powerful options are needed. Objectives: To evaluate whether emotional awareness and expression therapy (EAET) is superior to CBT for treatment of chronic pain among predominantly male older veterans and whether higher baseline depression, anxiety, or posttraumatic stress disorder (PTSD) symptoms-key targets of EAET-moderate treatment response. Design, Setting, and Participants: This 2-arm randomized clinical trial was conducted from May 16, 2019, to September 14, 2023, in the US Department of Veterans Affairs Greater Los Angeles Healthcare System. The trial included a racially and ethnically diverse group of veterans aged 60 to 95 years with at least 3 months of musculoskeletal pain. Interventions: Emotional awareness and expression therapy or CBT, conducted concurrently, each presented as one 90-minute individual session followed by eight 90-minute group sessions. Main Outcomes and Measures: The primary outcome was Brief Pain Inventory pain severity (range, 0 to 10) from baseline to posttreatment (week 10, primary end point) and 6-month follow-up. Secondary outcomes included Patient Reported Outcomes Institute Measurement System Anxiety, Depression, Fatigue, General Life Satisfaction (NIH Toolbox), Pain Interference, and Sleep Disturbance Short Forms, Patient Global Impression of Change (PGIC), and Satisfaction with Therapy and Therapist Scale-Revised. A subset of participants completed the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition). All analyses were for the intention-to-treat population and included all randomized participants. Results: Among 126 randomized participants (66 in the EAET group and 60 in the CBT group; mean [SD] age, 71.9 [5.9] years; 116 [92%] male), 111 (88%) completed posttreatment, and 104 (82%) completed the 6-month follow-up. The EAET was superior to CBT for the primary outcome of reduction in pain severity at posttreatment (estimate, -1.59 [95% CI, -2.35 to -0.83]; P < .001) and follow-up (estimate, -1.01 [95% CI, -1.78 to -0.24]; P = .01). A greater percentage of participants in EAET vs CBT had clinically significant (at least 30%) pain reduction (63% vs 17%; odds ratio, 21.54 [95% CI, 4.66-99.56]; P < .001) at posttreatment. In addition, EAET was superior to CBT on 50% pain reduction (35% vs 7%; odds ratio, 11.77 [95% CI, 2.38-58.25]; P = .002), anxiety (estimate, -2.49 [95% CI, -4.30 to -0.68]; P = .006), depression (estimate, -3.06 [95% CI, -5.88 to -0.25]; P = .03), general life satisfaction (estimate, 1.23 [95% CI, 0.36-2.10]; P = .005), PTSD symptoms (estimate, -4.39 [95% CI, -8.44 to -0.34]; P = .03), PGIC score (estimate, 1.46 [95% CI, 0.77-2.15]; P < .001), and global treatment satisfaction (estimate, 0.28 [95% CI, 0.12-0.45]; P < .001) at posttreatment. Higher baseline depression (estimate, -1.55 [95% CI, -0.37 to 2.73]; P < .001), anxiety (estimate, -1.53 [95% CI, -2.19 to -0.88]; P < .001), and PTSD symptoms (estimate, -1.69 [95% CI, -2.96 to -0.42]; P = .009) moderated greater reduction in pain severity after EAET but not CBT. Conclusions and Relevance: The results of this randomized clinical trial suggest that EAET may be a preferred intervention for medically and psychiatrically complex patients with pain. The societal burden of chronic pain could be improved by further incorporating the principles of EAET into mainstream clinical pain medicine. Trial Registration: ClinicalTrials.gov Identifier: NCT03918642.

Focus on the effect of nursing care combined with cognitive intervention and functional training on negative emotion, compliance and quality of life in elderly patients with sudden deafness: A retrospective study.

To explore the effects of focused solution nursing combined with cognitive intervention combined with functional training on negative emotions, compliance and quality of life in elderly patients with sudden deafness. A total of 160 patients with sudden deafness in the elderly who were treated in our hospital from January 2019 to May 2021 were selected as the objects of this retrospective study. Based on different treatment approaches, subjects were divided into a control group and an observation group. Due to reasons such as the COVID-19 pandemic and transfers, 10 cases were lost to follow-up. In total, 75 cases were ultimately lost from both the control and observation groups. The control group implements cognitive intervention and functional training, and the observation group adopts focused solution nursing care on the basis of the control group. Observe and compare the effects of negative emotions, psychological distress, air conduction threshold level, compliance and quality of life of the 2 groups of patients. The air conduction hearing threshold level of the 2 groups of patients after nursing was lower than that before nursing and the observation group was lower than the control group. The positive coping scores of the 2 groups were significantly increased, and the negative coping scores were both significantly reduced and the observation group was in the 2 indicators. The degree of change was greater than that of the control group (P < .05). After nursing, the self-rating anxiety scale (SAS) and self-rating depression scale (SDS) of the observation group were lower than those of the control group (P < .05). The mental vitality score, social interaction score, emotional restriction score, and mental status of the observation group were significantly higher than those of the control group. The observation group's psychological compliance, activity compliance, dietary compliance, and treatment protocol compliance were significantly higher than those of the control group (P < .05). Adopting the focused solution model of nursing care can provide a better nursing recovery for elderly patients with sudden deafness, significantly improve the patient quality of life and anxiety and depression, improve patient compliance with treatment, and provide a certain reference for the nursing of elderly patients with sudden deafness.

Results of a cognitive behavior therapy-based intervention for antenatal anxiety on birth outcomes in Pakistan: a randomized control trial.

Antenatal anxiety is among the risk factors for adverse birth outcomes, which are common in Pakistan. Between 2019 and 2022, we conducted a randomized controlled trial to evaluate the effects of the Happy Mother-Healthy Baby program, designed to reduce anxiety during pregnancy through use of Cognitive Behavior Therapy, on birth outcomes with 796 women in Rwalpindi, Pakistan. We performed intent-to-treat analysis and per protocol analyses. Intention-to-treat analyses showed no difference in the odds of low birthweight (LBW) (Adj. OR = 0.82, 95% CI 0.55-1.28 p = 0.37), preterm birth (PTB) (Adj. OR = 1.20 95% CI 0.83-1.71, p = 0.33) or small-for-gestational age (SGA) birth, (Adj. OR = 0.76, 95% CI 0.56-1.09, p = 0.16). Among completers who received ≥ 5 intervention sessions, the odds of LBW and SGA were 39% and 32% lower (Adj. OR = 0.61, 95% CI 0.43-0.87, p < 0.01; Adj. OR = 0.68, 95% CI 0.53-0.89, p < 0.01). The significant LBW and SGA results among the intervention completers suggest that the program may be effective when a sufficient dose is received. However, confirmation of these findings is needed due to the fact that randomization is not maintained in completer analyses.Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT03880032, 19/03/2019.

[The prospect of using virtual reality technology in combination with psychotherapeutic methods in children with functional abdominalgia]. / Perspektiva primeneniya tekhnologii virtual'noi real'nosti v sochetanii s psikhoterapevticheskimi metodami u patsientov detskogo vozrasta s funktsional'noi abdominalgiei.

OBJECTIVE: The literature review addresses the effectiveness of psychotherapeutic methods in the treatment of functional abdominal pain syndrome and studying the prospects for using virtual reality technology in combination with psychotherapeutic methods according to the available literature. MATERIAL AND METHODS: A search was conducted for available literature in the eLibrary and PubMed databases, published for the period 2017-2022, using the keywords: abdominalgia, psychotherapeutic methods, gut-brain axis, virtual reality technology. RESULTS: Currently, the biopsychosocial concept of the etiopathogenesis of abdominal pain syndrome, which is not associated with an organic disease of the gastrointestinal tract, is used. A significant contribution to the formation of the disease is made by genetic, neuropsychological, neurophysiological factors, and disruption of the interaction of the gut-brain axis. Cognitive behavioral therapy, yoga, and hypnotherapy are applicable as effective psychotherapeutic methods in the complex treatment of abdominal pain syndrome in children. A promising direction is the use of virtual reality technology to increase the effectiveness of psychotherapeutic methods and reduce chronic abdominal pain syndrome by influencing the gut-brain axis. Practical research work devoted to this issue is currently rare. CONCLUSION: In the complex treatment of functional abdominal pain syndrome in children, various psychotherapeutic methods are used, the most effective are cognitive behavioral therapy and hypnotherapy. It is necessary to stimulate domestic research work studying the joint use of virtual reality technology and psychotherapeutic methods in children aged 7 to 18 years.

[Dynamics of cognitive functions using the rehabilitation program of cognitive training]. / Dinamika kognitivnykh funktsii pri ispol'zovanii reabilitatsionnoi programmy kognitivnogo treninga.

OBJECTIVE: To study the efficiency of the neuropsychological rehabilitation of patients with mild cognitive impairments. MATERIAL AND METHODS: The study included 103 elderly people, aged 59 to 88 years, including 90 women and 13 men with subjective complaints of memory loss (ICD-10: F06.70; F06.71; F06.78; F06.79). Participants were divided into experimental group (n=43) and comparison group (n=42). The estimated impact was the rehabilitation program «The psychosocial therapy and neurocognitive rehabilitation of elderly patients with cognitive impairments¼, within which the principle of complex stimulation of various parameters of the cognitive sphere was used in rehabilitation work with patients in the experimental group in accordance with the «Memory Clinic¼ program. The study was conducted using randomized, equalized comparison groups, and the principle of «triple-blind¼ research. Non-parametric statistics (SPSS) methods were used to assess differences. RESULTS: A significant difference between the comparison and experimental groups has been identified, primarily in relation to high-level mental processes associated with the function of the third structural-functional block according to A.R. Luria. After the training, the number of correct answers significantly increased (t(42)=-2.67, p<0.001) in the experimental group, while in the comparison group the indicator did not change (t(41)=0.50, p=0.617). The number of false alarms in the experimental group decreased significantly (t(42)=2.13, p=0.039). CONCLUSION: The results confirm the leading role of these processes in the hierarchy of mental functions, which suggests that they should primarily be targets of rehabilitation interventions.

Reducing stigma and promoting HIV wellness/mental health of sexual and gender minorities: RCT results from a group-based programme in Nigeria.

INTRODUCTION: High levels of HIV stigma as well as stigma directed towards sexual and/or gender minorities (SGMs) are well documented in the African setting. These intersecting stigmas impede psychosocial wellbeing and HIV prevention and care. Yet, there are few if any evidence-based interventions that focus on reducing internalized stigma and promoting mental health and HIV wellness for SGMs in Africa. We developed and evaluated a group-based intervention drawing on cognitive behavioural therapy (CBT) strategies for men who have sex with men (MSM) and transgender women (TGW) at risk for or living with HIV in Lagos, Nigeria. METHODS: The intervention comprised four weekly in-person group sessions facilitated by community health workers. We conducted a delayed intervention group randomized controlled trial (April-September 2022), with pre-post surveys plus 3-month follow-up (immediate group only), as well as qualitative research with participants and programme staff. Outcomes included internalized stigma related to SGM and HIV status, depression, resiliency/coping and pre-exposure prophylaxis (PrEP)/HIV treatment use. RESULTS: Mean age of the 240 participants was 26 years (range 18-42). Seventy-seven percent self-identified as MSM and 23% TGW; 27% were people with HIV. Most (88%) participants attended all four sessions, and 98% expressed high intervention satisfaction. There was significant pre-post improvement in each psychosocial outcome, in both the immediate and delayed arms. There were further positive changes for the immediate intervention group by 3-month follow-up (e.g. in intersectional internalized stigma, depression). While baseline levels of ever-PrEP use were the same, 75% of immediate-group participants reported currently using PrEP at 3 months post-intervention versus 53% of delayed-group participants right after the intervention (p<0.01). Participants post-intervention described (in qualitative interviews) less self-blame, and enhanced social support and resilience when facing stigma, as well as motivation to use PrEP, and indicated that positive pre-intervention changes in psychosocial factors found in the delayed group mainly reflected perceived support from the study interviewers. CONCLUSIONS: This study demonstrated the feasibility and acceptability of a group-based CBT model for MSM and TGW in Nigeria. There were also some indications of positive shifts related to stigma, mental health and PrEP, despite issues with maintaining the randomized design in this challenging environment.

Change in Defense Mechanisms During a Brief Cognitive Behavioral Therapy for Obsessive-Compulsive Disorder.

ABSTRACT: Defense mechanisms (DMs) are strategies used by the individuals to protect the ego. Therefore, compulsive behaviors in obsessive-compulsive disorder (OCD) can be recognized as DMs. We analyzed how DMs changed in a brief cognitive behavioral therapy (CBT) for OCD. This was a quasi-experimental study with 92 OCD patients (aged 18-60 years). We used the Mini International Neuropsychiatric Interview to confirm OCD diagnosis, and we assessed the DMs with the Defense Style Questionnaire at three time points. Through a latent change score modeling, we found that the mature mechanism presented a constant change during the therapy. This mechanism increased in average 0.37 points at each measured moment of CBT, showing a linear trajectory. Neurotic and immature mechanisms showed no significant changes during therapy. The increased use of the mature mechanism can be an indicator of improvement in OCD treatment, showing that patients intensified their more adaptive responses to conflicts.