Lack of evidence for predictive utility from resting state fMRI data for individual exposure-based cognitive behavioral therapy outcomes: A machine learning study in two large multi-site samples in anxiety disorders.

Data-based predictions of individual Cognitive Behavioral Therapy (CBT) treatment response are a fundamental step towards precision medicine. Past studies demonstrated only moderate prediction accuracy (i.e. ability to discriminate between responders and non-responders of a given treatment) when using clinical routine data such as demographic and questionnaire data, while neuroimaging data achieved superior prediction accuracy. However, these studies may be considerably biased due to very limited sample sizes and bias-prone methodology. Adequately powered and cross-validated samples are a prerequisite to evaluate predictive performance and to identify the most promising predictors. We therefore analyzed resting state functional magnet resonance imaging (rs-fMRI) data from two large clinical trials to test whether functional neuroimaging data continues to provide good prediction accuracy in much larger samples. Data came from two distinct German multicenter studies on exposure-based CBT for anxiety disorders, the Protect-AD and SpiderVR studies. We separately and independently preprocessed baseline rs-fMRI data from n = 220 patients (Protect-AD) and n = 190 patients (SpiderVR) and extracted a variety of features, including ROI-to-ROI and edge-functional connectivity, sliding-windows, and graph measures. Including these features in sophisticated machine learning pipelines, we found that predictions of individual outcomes never significantly differed from chance level, even when conducting a range of exploratory post-hoc analyses. Moreover, resting state data never provided prediction accuracy beyond the sociodemographic and clinical data. The analyses were independent of each other in terms of selecting methods to process resting state data for prediction input as well as in the used parameters of the machine learning pipelines, corroborating the external validity of the results. These similar findings in two independent studies, analyzed separately, urge caution regarding the interpretation of promising prediction results based on neuroimaging data from small samples and emphasizes that some of the prediction accuracies from previous studies may result from overestimation due to homogeneous data and weak cross-validation schemes. The promise of resting-state neuroimaging data to play an important role in the prediction of CBT treatment outcomes in patients with anxiety disorders remains yet to be delivered.

Development and Current State of Digital Therapeutics for Irritable Bowel Syndrome.

BACKGROUND & AIMS: Irritable bowel syndrome (IBS) is a common, debilitating disorder characterized by abdominal pain and disordered bowel habits. Current pharmacologic treatments often provide incomplete symptom relief and may be poorly tolerated. Furthermore, alleviation of gastrointestinal symptoms does not always translate into improved quality of life for IBS patients. Current treatment guidelines recommend brain-gut behavior therapy (BGBT) in conjunction with other IBS therapies, and, in randomized controlled trials, BGBT has been shown to improve symptoms, patient satisfaction, functioning, and quality of life. Access to BGBT is limited by lack of adequately trained gastrointestinal psychologists, patient time constraints, and cost. Furthermore, clinician knowledge that BGBT is specific, and different from psychotherapy approaches for common mental health disorders, may limit referrals even where available. This review provides an overview of the pathophysiology of IBS, disease burden, unmet therapeutic needs, evidence base of novel digital therapeutics for IBS, and guidance on the introduction and appropriateness of these interventions for patients. METHODS: We searched the literature for available published data relating to the use of novel digital therapeutics to provide cognitive behavioral therapy and gut-directed hypnotherapy in the treatment of irritable bowel syndrome. RESULTS: Clinical trial data support the development and utility of digital therapeutics designed to deliver self-guided cognitive behavioral therapy and hypnotherapy for the treatment of IBS. CONCLUSIONS: BGBTs are effective, guideline-recommended treatments for IBS. Digital therapeutic devices offer accessible, cost-effective treatment options for delivery of adjunctive BGBT for the treatment of IBS. The decision to recommend digital BGBTs should be guided by careful patient assessment that includes mental health screening and risk assessment.

Preliminary Impact of Group-Based Interventions on Stigma, Mental Health, and Treatment Adherence Among Adolescents Living with Human Immunodeficiency Virus in Uganda.

OBJECTIVE: To examine the preliminary impact of group cognitive behavioral therapy and multiple family group-based family strengthening to address HIV stigma and improve the mental health functioning of adolescents living with HIV in Uganda. STUDY DESIGN: We analyzed data from the Suubi4Stigma study, a 2-year pilot randomized clinical trial that recruited adolescents living with HIV (10-14 years) and their caregivers (n = 89 dyads), from 9 health clinics. We fitted separate three-level mixed-effects linear regression models to test the effect of the interventions on adolescent outcomes at 3 and 6 months post intervention initiation. RESULTS: The average age was 12.2 years and 56% of participants were females. Participants in the multiple family group-based family strengthening intervention reported lower levels of internalized stigma (mean difference = -0.008, 95% CI = -0.015, -0.001, P = .025) and depressive symptoms at 3 months (mean difference = -0.34, 95% CI = -0.53, -0.14, P < .001), compared with usual care. On the other hand, participants in the group cognitive behavioral therapy intervention reported lower levels of anticipated stigma at 3 months (mean difference = -0.039, 95% CI = -0.072, -0.006), P = .013) and improved self-concept at 6 months follow-up (mean difference = 0.04, 95% CI = 0.01, 0.01, P = .025). CONCLUSION: Outcome trends from this pilot study provide compelling evidence to support testing the efficacy of these group-based interventions on a larger scale. TRIAL REGISTRATION: The study is registered in the Clinical trials.gov database (Identifier #: NCT04528732).

Comparative analysis of treatment options for chronic heart failure and depression: a systematic review and Bayesian network meta-analysis.

Different interventions have been evaluated for the treatment of depression in heart failure (HF) patients. However, clear and established recommendations are lacking. PubMed, Scopus, and Web of Science databases were systematically searched for randomized controlled trials (RCT) evaluating the effect of various treatment options on depression scores in heart failure patients. The primary outcome was a change in depression scores presented as standardized mean difference (SMD). A Bayesian network for meta-analysis was constructed. Twenty-five RCTs were included, randomizing 6014 patients with confirmed heart failure and depression between 2003 and 2022. Compared to treatment as usual (TAU), only cognitive behavioral therapy (CBT) (SMD - 0.60, CI95% [- 1.0, - 0.17]) leads to a significant reduction in depression scores. Other interventions did not improve depression scores significantly. Our results show that for patients with HF and depression, CBT can significantly improve measures of depression, being the most efficacious treatment.

Long-term outcomes of once weekly v. twice weekly sessions of cognitive behavioral therapy and interpersonal psychotherapy for depression.

BACKGROUND: Twice weekly sessions of cognitive behavioral therapy (CBT) and interpersonal psychotherapy (IPT) for major depressive disorder (MDD) lead to less drop-out and quicker and better response compared to once weekly sessions at posttreatment, but it is unclear whether these effects hold over the long run. AIMS: Compare the effects of twice weekly v. weekly sessions of CBT and IPT for depression up to 24 months since the start of treatment. METHODS: Using a 2 × 2 factorial design, this multicentre study randomized 200 adults with MDD to once or twice weekly sessions of CBT or IPT over 16-24 weeks, up to a maximum of 20 sessions. Main outcome measures were depression severity, measured with the Beck Depression Inventory-II and the Longitudinal Interval Follow-up Evaluation. Intention-to-treat analyses were conducted. RESULTS: Compared with patients who received once weekly sessions, patients who received twice weekly sessions showed a significant decrease in depressive symptoms up through month 9, but this effect was no longer apparent at month 24. Patients who received CBT showed a significantly larger decrease in depressive symptoms up to month 24 compared to patients who received IPT, but the between-group effect size at month 24 was small. No differential effects between session frequencies or treatment modalities were found in response or relapse rates. CONCLUSIONS: Although a higher session frequency leads to better outcomes in the acute phase of treatment, the difference in depression severity dissipated over time and there was no significant difference in relapse.

Cognitive-behavioral therapy for patients with post-COVID-19 condition (CBT-PCC): a feasibility trial.

BACKGROUND: The post-COVID-19 condition describes the persistence or onset of somatic symptoms (e.g. fatigue) after acute COVID-19. Based on an existing cognitive-behavioral treatment protocol, we developed a specialized group intervention for individuals with post-COVID-19 condition. The present study examines the feasibility, acceptance, and effectiveness of the program for inpatients in a neurological rehabilitation setting. METHODS: The treatment program comprises eight sessions and includes psychoeducational and experience-based interventions on common psychophysiological mechanisms of persistent somatic symptoms. A feasibility trial was conducted using a one-group design in a naturalistic setting. N = 64 inpatients with a history of mild COVID-19 that fulfilled WHO criteria for post-COVID-19 condition were enrolled. After each session, evaluation forms were completed and psychometric questionnaires on somatic and psychopathological symptom burden were collected pre- and post-intervention. RESULTS: The treatment program was well received by participants and therapists. Each session was rated as comprehensible and overall satisfaction with the sessions was high. Pre-post effect sizes (of standard rehabilitation incl. new treatment program; intention-to-treat) showed significantly reduced subjective fatigue (p < 0.05, dav = 0.33) and improved disease coping (ps < 0.05, dav = 0.33-0.49). CONCLUSIONS: Our results support the feasibility and acceptance of the newly developed cognitive-behavioral group intervention for individuals with post-COVID-19 condition. Yet, findings have to be interpreted cautiously due to the lack of a control group and follow-up measurement, the small sample size, and a relatively high drop-out rate.

Changes in evening-shifted loss of control eating severity following treatment for binge-eating disorder.

BACKGROUND: Loss of control eating is more likely to occur in the evening and is uniquely associated with distress. No studies have examined the effect of treatment on within-day timing of loss of control eating severity. We examined whether time of day differentially predicted loss of control eating severity at baseline (i.e. pretreatment), end-of-treatment, and 6-month follow-up for individuals with binge-eating disorder (BED), hypothesizing that loss of control eating severity would increase throughout the day pretreatment and that this pattern would be less pronounced following treatment. We explored differential treatment effects of cognitive-behavioral guided self-help (CBTgsh) and Integrative Cognitive-Affective Therapy (ICAT). METHODS: Individuals with BED (N = 112) were randomized to receive CBTgsh or ICAT and completed a 1-week ecological momentary assessment protocol at baseline, end-of-treatment, and 6-month follow-up to assess loss of control eating severity. We used multilevel models to assess within-day slope trajectories of loss of control eating severity across assessment periods and treatment type. RESULTS: Within-day increases in loss of control eating severity were reduced at end-of-treatment and 6-month follow-up relative to baseline. Evening acceleration of loss of control eating severity was greater at 6-month follow-up relative to end-of-treatment. Within-day increases in loss of control severity did not differ between treatments at end-of-treatment; however, evening loss of control severity intensified for individuals who received CBTgsh relative to those who received ICAT at 6-month follow-up. CONCLUSIONS: Findings suggest that treatment reduces evening-shifted loss of control eating severity, and that this effect may be more durable following ICAT relative to CBTgsh.

A randomized controlled trial of a digital cognitive-behavioral therapy program (COMPASS) for managing depression and anxiety related to living with a long-term physical health condition.

BACKGROUND: To evaluate the clinical efficacy of COMPASS, a therapist-supported digital therapeutic for reducing psychological distress (anxiety/depression) in people living with long-term physical health conditions (LTCs). METHODS: A two-armed randomized-controlled trial recruiting from LTC charities. Participants with anxiety and/or depression symptoms related to their LTC(s) were randomized (concealed allocation via independent administrator) to COMPASS (access to 11 tailored modules plus five thirty-minute therapist support sessions) or standard charity support (SCS). Assessments were completed online pre-randomization, at 6- and 12-weeks post-randomization. Primary outcome was Patient Health Questionnaire Anxiety and Depression Scale; PHQ-ADS measured at 12-weeks. Analysis used intention-to-treat principles with adjusted mean differences estimated using linear mixed-effects models. Data-analyst was blinded to group allocation. RESULTS: 194 participants were randomized to COMPASS (N = 94) or SCS (N = 100). At 12-weeks, mean level of psychological distress was 6.82 (95% confidence interval; CI 4.55-9.10) points lower (p < 0.001) in the COMPASS arm compared with SCS (standardized mean difference of 0.71 (95% CI 0.48-0.95)). The COMPASS arm also showed moderate significant treatment effects on secondary outcomes including depression, anxiety and illness-related distress and small significant effects on functioning and quality-of-life. Rates of adverse events were comparable across the arms. Deterioration in distress at 12-weeks was observed in 2.2% of the SCS arm, and no participants in the COMPASS arm. CONCLUSION: Compared with SCS, COMPASS digital therapeutic with minimal therapist input reduces psychological distress at post-treatment (12-weeks). COMPASS offers a potentially scalable implementation model for health services but its translation to these contexts needs further evaluating. TRIAL REGISTRATION: NCT04535778.

Tai Chi compared with cognitive behavioral therapy and the reversal of systemic, cellular and genomic markers of inflammation in breast cancer survivors with insomnia: A randomized clinical trial.

BACKGROUND: Insomnia contributes to inflammation in breast cancer survivors. This study evaluates whether insomnia treatment reverses inflammation in breast cancer survivors with insomnia. METHODS: Participants (n = 90) were randomized to 3 months of Tai Chi (n = 45) or cognitive behavioral therapy for insomnia (CBT-I)(n = 45), and followed for one year post-intervention to 15 month endpoint. Our previous report found that Tai Chi as compared to CBT-I resulted in similar rates of insomnia response and remission over 15 months. Here, we analyze changes in plasma C-reactive protein and pro- and anti-inflammatory cytokines, Toll-like receptor (TLR)-4 stimulated monocyte production of interleukin (IL)-6 and tumor necrosis factor-α (TNF), and cellular pro-inflammatory and anti-viral gene expression (Conserved Transcriptional Response to Adversity RNA profile; CTRA) over 15 months. RESULTS: Insomnia treatment resulted in decreases in the TLR-4 stimulated monocyte production of IL-6, TNF, and their co-expression, as well as decreases in the CTRA profile, decreases inflammatory gene transcripts, and increases in anti-viral gene transcripts over 15 months (all P's < 0.01). In addition, as compared to CBT-I, Tai Chi resulted in greater decreases in plasma IL-6 (P < 0.05), and greater decreases in TLR-4 activated monocyte production of IL-6 and co-expression of IL-6 and TNF at 15 month endpoint. CBT-I resulted in greater increases in anti-viral gene transcripts. CONCLUSIONS: Administration of either CBT-I or Tai Chi effectively treats insomnia, and shows additional benefits of reducing cellular and genomic markers of inflammation, and increasing anti-viral genomic markers in breast cancer survivors with insomnia. Tai Chi, as compared to CBT-I, yields greater and more durable decreases in systemic- and cellular inflammation. Targeting insomnia might mitigate the risk of inflammation-related co-morbidities in breast cancer survivors.

Substance use outcomes from the Child/Adolescent Anxiety Multimodal Extended Long-term Study (CAMELS).

BACKGROUND: Substance use problems and anxiety disorders are both highly prevalent and frequently cooccur in youth. The present study examined the benefits of successful anxiety treatment at 3-12 years after treatment completion on substance use outcomes (i.e. diagnoses and lifetime expected use). METHODS: The sample was from the Child/Adolescent Anxiety Multimodal Extended Long-term Study (CAMELS), a naturalistic follow-up study to the Child/Adolescent Anxiety Multimodal Study (CAMS) which randomized youth to cognitive behavioral therapy (CBT; Coping cat), medication (sertraline), their combination, or pill placebo. The first CAMELS visit occurred an average of 6.5 years following CAMS randomization. Participants were 319 youth (65.4% of the CAMS sample), aged 7-17 years at CAMS baseline assessment with a mean age of 17.6 years (range: 11-26 years) at the time of the first CAMELS follow-up. Substance use outcomes included diagnoses as well as lifetime substance use (i.e. alcohol and tobacco use). RESULTS: Eleven of 319 (3.4%) CAMELS participants were diagnosed with a substance use disorder at the initial follow-up visit. When compared to the population lifetime rate of 11.4%, the rate of diagnoses in the posttreated sample was significantly lower. Additionally, rates of lifetime alcohol use were lower than population rates at the initial and final follow-up visits. Rates of lifetime tobacco use were similarly lower than lifetime population rates at the initial visit (driven by significantly lower rates in the CBT treatment condition), but higher by the final visit. Furthermore, treatment remission (but not treatment response) was associated with a lower rate of substance use diagnoses at the initial follow-up visit, although rates of lifetime alcohol and tobacco use did not differ by treatment outcome. CONCLUSIONS: Anxiety treatments confer a beneficial impact on problematic substance use (i.e. diagnoses) as well as on expected substance use (i.e. alcohol and tobacco use) for on average, a period of 6.5 years.

Executive functioning and treatment outcome among adolescents undergoing cognitive-behavioral therapy for binge-eating disorder.

BACKGROUND: Cognitive-behavioral therapy (CBT) is an evidence-supported treatment for adolescents with binge-eating disorder (BED). Executive dysfunctions, which are associated with binge eating and elevated body weight in youth, may undermine CBT outcomes by making it difficult for youth to engage with or adhere to treatment, including recalling and/or implementing intervention strategies in real-world contexts. METHODS: We assessed 73 adolescents [82.2% female; Mage = 15.0 ± 2.5 year; M baseline standardized body mass index (zBMI) = 1.9 ± 1.0 kg/m2] with BED at baseline, posttreatment, 6-, 12-, and 24-month follow-up. Linear mixed models examined the effects of baseline executive functioning (EF) on loss of control (LOC) eating and weight change following CBT. Linear and logistic regressions probed associations between EF, attendance, and attrition. RESULTS: More impulsive decision-making, as reflected in higher baseline scores on the Iowa Gambling Task, predicted better attendance (ß = .07; p = .019) and more frequent LOC eating following treatment (ß = .12; p = .017). Lower cognitive flexibility, as reflected in lower baseline T-scores on the Comprehensive Trail Making Test complex sequencing index, predicted higher zBMI following treatment (ß = -.03; p = .003). Inhibition, concentration, attention, and parent-reported EF behavior symptoms were not associated with outcome, attendance, or attrition. CONCLUSIONS: More impulsive decision-making and lower cognitive flexibility were associated with suboptimal response to CBT for BED, although findings should be interpreted with caution in light of the sample size and waitlist control design. Future research should examine whether strengthening EF could improve eating and weight outcomes among adolescents with BED who have lower pre-treatment EF.

Cognitive-behavioral and mindfulness-based interventions for distress in patients with advanced cancer: A meta-analysis.

OBJECTIVE: Various psychosocial interventions have been developed to reduce distress and improve quality of life (QoL) in patients with advanced cancer, many of which are traditional cognitive-behavioral interventions (CBIs) or mindfulness-based interventions (MBIs). The aims of this meta-analysis were to determine and compare the overall effects of traditional CBIs and MBIs on distress and QoL in this population and to explore potential moderators of intervention efficacy. METHODS: A systematic search was conducted in CINAHL, Embase, PsycINFO, PubMed, and Web of Science. Randomized controlled trials (RCTs) comparing CBIs or MBIs to controls on distress and QoL outcomes were eligible for inclusion. Random effects meta-analyses using standardized baseline to post-intervention mean differences were calculated using Hedges's g. Meta-regressions were used to compare intervention effects and examine potential moderators. RESULTS: Across 37 RCTs (21 CBIs, 14 MBIs, 2 combination therapies), there was a small decrease in distress (Hedges's g = 0.21) and a minimal improvement in QoL (Hedges's g = 0.15). Traditional CBIs and MBIs did not differ in effect sizes. Heterogeneity was significant across distress effect sizes but not across QoL effects. Interventions delivered to individuals (vs. dyads/group) had larger effects on QoL. No moderators of intervention effects on distress were found. CONCLUSIONS: Findings suggest traditional CBIs and MBIs produce small reductions in distress compared to controls in patients with advanced cancer, although effects on QoL appear minimal. Given limitations in the number of studies and their quality, rigorous trials are needed to directly compare the impact of traditional CBIs and MBIs in this population.

Pain coping, multidisciplinary care, and mHealth: Patients' views on managing advanced cancer pain.

OBJECTIVE: Pain is common among people with advanced cancer. While opioids provide significant relief, incorporating psycho-behavioral treatments may improve pain outcomes. We examined patients' experiences with pain self-management and how their self-management of chronic, cancer-related pain may be complemented by behavioral mobile health (mHealth) interventions. METHODS: We conducted semi-structured qualitative interviews with patients with advanced cancer and pain. Each participant reviewed content from our behavioral mHealth application for cancer pain management and early images of its interface. Participants reflected on their experiences self-managing cancer pain and on app content. Interviews were transcribed verbatim and analyzed using a combination of inductive and deductive thematic analysis. RESULTS: Patients (n = 28; 54% female; mean age = 53) across two geographic regions reported using psychological strategies (e.g., reframing negative thoughts, distraction, pain acceptance, social support) to manage chronic cancer-related pain. Patients shared their perspectives on the integration of psycho-behavioral pain treatments into their existing medical care and their experiences with opioid hesitancy. Patient recommendations for how mHealth interventions could best support them coalesced around two topics: 1.) convenience in accessing integrated pharmacological and psycho-behavioral pain education and communication tools and 2.) relevance of the specific content to their clinical situation. CONCLUSIONS: Integrated pharmacological and psycho-behavioral pain treatments were important to participants. This underscores a need to coordinate complimentary approaches when developing cancer pain management interventions. Participant feedback suggests that an mHealth intervention that integrates pain treatments may have the capacity to increase advanced cancer patients' access to destigmatizing, accessible care while improving pain self-management.

A retrospective cost-effectiveness analysis of different cognitive-behavioral therapy for insomnia intervention delivery approaches in adult cancer survivors.

BACKGROUND: Cognitive-behavioral therapy for insomnia (CBT-I) is considered the gold standard treatment for insomnia. Prior trials have delivered CBT-I across a range of treatment sessions. Understanding the economics of varying treatment approaches is essential for future implementation considerations. METHODS: We conducted a retrospective cost-effectiveness analysis from the provider's perspective, comparing the implementation of a three-session CBT-I program for cancer survivors (CBT-I-CS) versus a stepped care treatment approach consisting of an initial single sleep education session followed by CBT-I-CS if elevated insomnia symptoms persisted. The effectiveness measure used was the percentage of participants whose insomnia had remitted by the end of each program. RESULTS: Stepped care delivery was more effective than CBT-I-CS alone, resulting in 35.4% more remitted patients by the end of the overall program. For a $480 willingness to pay threshold per percentage of remitted patients, stepped care CBT-I-CS reached a 98% probability of being cost-effective, while CBT-I-CS alone had only a 2% probability. Larger group sessions in the first step of a stepped care delivery model resulted in more favorable cost-effectiveness. CONCLUSIONS: A stepped care delivery model may be a more cost-effective approach if it can be implemented efficiently. These findings inform policies aimed at improving cancer survivors' access to much-needed insomnia treatment in settings where financial resources for CBT-I may be limited, and be an important barrier to treatment dissemination. CLINICAL TRIAL REGISTRATION: These analyses were not registered.

Differential Psychological Treatment Effects in Patients With Late-Life Depression and a History of Childhood Maltreatment.

OBJECTIVE: This is the first interventional study to assess the impact of childhood maltreatment (CM) on psychological treatment outcomes in patients with late-life depression (LLD). METHODS: This is a secondary analysis of a multicenter, randomized controlled trial with 251 participants aged ≥60 years with moderate to severe depression. Participants were randomly assigned to cognitive behavioral therapy for late life depression (LLD-CBT) or to a supportive intervention (SUI). Treatment outcomes were measured by changes in the Geriatric Depression Scale (GDS). RESULTS: In the intention-to-treat sample (n = 229), both LLD-CBT (n = 115) and SUI (n = 114) significantly reduced depressive symptoms in patients with CM, with large effects at post-treatment (d = 0.95 [95% CI: 0.65 to 1.25] in LLD-CBT; d = 0.82 [95% CI: 0.52 to 1.12] in SUI). A significant treatment group*CM interaction (F(1,201.31) = 4.71; p = .031) indicated greater depressive symptom reduction in LLD-CBT compared to SUI at week 5 and post-treatment for patients without CM, but not at 6-month follow-up. Across both treatments, higher severity of the CM subtype 'physical neglect' was associated with a smaller depressive symptom reduction (F(1,207.16) = 5.37; p = .021). CONCLUSIONS: Specific and non-specific psychotherapy effectively reduced depressive symptoms in older individuals with depression and early trauma. For patients without early trauma, LLD-CBT may be preferable over SUI. Considering early trauma subtypes may contribute to develop personalized treatment approaches.

Caregiver Experiences With an Internet-Delivered Insomnia Intervention: SHUTi-CARE Trial Primary Qualitative Analysis.

BACKGROUND: Digital health interventions show potential to increase caregivers' access to psychosocial care; however, it is unclear to what extent existing interventions may need to be tailored to meet caregivers' unique needs. PURPOSE: This study aimed to determine whether-and if so, how-an efficacious Internet-delivered insomnia program should be modified for caregivers. The generalizability of these findings beyond the tested program was also examined. METHODS: Higher-intensity family caregivers (N = 100; age M = 52.82 [SD = 13.10], 75% non-Hispanic White, 66% ≥college degree) received access to an Internet-based cognitive-behavioral therapy for insomnia (CBT-I) program. Participants who completed one or more intervention "Cores" provided open-ended feedback on their experience; nonusers (completed no Cores) shared their barriers. RESULTS: Most caregivers who used the program (n = 82, 82%) found it feasible, citing its user-friendly, fully automated online format. Many reported that CBT-I strategies were helpful, although some faced challenges in implementing these strategies due to the unpredictability of their caregiving responsibilities. Opinions were divided on the utility of tailoring the program for caregivers. Nonusers (n = 18, 18%) primarily cited concerns about time burden and lifestyle compatibility as usage barriers. CONCLUSIONS: Delivering fully automated behavioral interventions through the Internet appears suitable for many caregivers. Extensive tailoring may not be required for most caregivers to benefit from an existing online CBT-I program, although additional guidance on integrating CBT-I strategies in the context of challenging sleep schedules and environments may help a subset of caregivers. Future research should explore how such tailoring may enhance digital health intervention uptake and effectiveness for caregivers.

This study examined family caregivers' experiences using an online cognitive-behavioral therapy for insomnia program. The aim was to determine if the program needed changes to better fit caregivers' needs. Researchers gave 100 caregivers with insomnia access to Sleep Healthy Using the Internet (SHUTi), an online insomnia program that had no caregiver-specific tailoring. Of the 82 caregivers who used the program, most found the program easy to use and helpful, although some struggled with behavioral strategies because of their unpredictable caregiving duties. There was no clear consensus among caregivers on whether tailoring would be helpful. The 18 caregivers who did not use the program most commonly said that they did not have enough time to use the program or that they felt it would not work well with their lifestyle. Overall, findings suggest that providing interventions via the Internet is a good fit for many caregivers. Many caregivers benefitted from an online insomnia program without being tailored specifically for caregivers, although some additional guidance on how to follow behavioral strategies may be helpful to some caregivers.

Caregivers' Internet-Delivered Insomnia Intervention Engagement and Benefit: SHUTi-CARE Trial Primary Quantitative Analysis.

BACKGROUND: Delivering insomnia treatment by the Internet holds promise for increasing care access to family caregivers, but their ability to adhere to and benefit from such fully-automated programs has not been rigorously tested. PURPOSE: This fully-powered, single-group trial tested whether characteristics of the caregiving context influence high-intensity caregivers' engagement with and benefit from an empirically validated Internet intervention for insomnia. METHODS: At baseline, caregivers providing unpaid time- and responsibility-intensive care who reported insomnia (N = 100; age M = 52.82 [SD = 13.10], 75% non-Hispanic white, 66% ≥college degree) completed questionnaires about caregiving context and sleep, then 10 prospectively-collected online daily sleep diaries. Caregivers then received access to SHUTi (Sleep Healthy Using the Internet), which has no caregiver-specific content, for 9 weeks, followed by post-assessment (questionnaires, diaries). Engagement was tracked by the SHUTi delivery system. RESULTS: Sixty caregivers completed SHUTi, 22 initiated but did not complete SHUTi, and 18 did not initiate SHUTi. Caregivers were more likely to use SHUTi (than not use SHUTi) when their care recipient (CR) had worse functioning, and were more likely to complete SHUTi when supporting more CR activities of daily living (ADL; ps < .03). Higher caregiver guilt, more CR problem behaviors, and being bedpartners with the CR related to more improved sleep outcomes, whereas supporting more CR instrumental ADL related to less improvement (ps < .05). CONCLUSIONS: Factors associated with greater caregiving burden, including greater CR impairment and caregiving guilt, were generally associated with better engagement and outcomes. Caregivers with substantial burdens can adhere to and benefit from a fully automated insomnia program without caregiver-specific tailoring.

This study examined how family caregivers, who often have trouble sleeping due to their responsibilities, used an online insomnia treatment program. The goal was to determine if certain aspects of caregiving would influence how caregivers engage with or benefit from the program. Researchers surveyed 100 caregivers with insomnia about their caregiving situation and sleep, and caregivers also kept online sleep diaries for 10 days. Afterward, caregivers used an online insomnia program with no caregiver-specific content called Sleep Healthy Using the Internet (SHUTi) for 9 weeks. Caregivers' usage was monitored, and they repeated measures of sleep outcomes and 10 online sleep diaries. Sixty caregivers completed SHUTi, 22 partially completed the program, and 18 did not initiate the program. Caregivers who cared for individuals with more severe functional limitations were more likely to use and complete SHUTi. Additionally, caregivers experiencing more guilt and those who managed more challenging behaviors from the person they cared for tended to report greater improvements in their sleep. This study suggests that caregivers, even those with significant care responsibilities, can use and benefit from an online insomnia treatment program like SHUTi, even when it has not been specifically tailored for caregivers.

One-Day Peer-Delivered Cognitive Behavioral Therapy-Based Workshops for Postpartum Depression: A Randomized Controlled Trial.

INTRODUCTION: Myriad treatment barriers prevent birthing parents with postpartum depression (PPD) from receiving timely treatment. We aimed to determine whether a peer-delivered online 1-day cognitive behavioral therapy (CBT)-based workshop added to treatment as usual (TAU) improves PPD and its comorbidities and is more cost-effective than TAU alone. METHODS: This parallel-group, randomized controlled trial took place in Ontario, Canada (June 7, 2021, to February 18, 2022). Participants were ≥18 years old, had an infant ≤12 months old, and an Edinburgh Postnatal Depression Scale (EPDS) score ≥10. Participants were allocated to receive the workshop plus TAU (n = 202) or TAU and waitlisted to complete the workshop 12 weeks later (n = 203). The primary outcome was change in PPD (EPDS score) from enrollment to 12 weeks later. The secondary outcome was cost-effectiveness and tertiary outcomes included anxiety, social support, partner relationship quality, the mother-infant relationship, parenting stress, and infant temperament. RESULTS: Participants had a mean age of 32.3 years (SD = 4.30) and 65% were White. The workshop led to a significant reduction in EPDS scores (15.95-11.37; d = 0.92, p < 0. 01) and was associated with higher odds of exhibiting a clinically significant decrease in EPDS scores (OR = 2.03; 95% CI: 1.26-3.29). The workshop plus TAU was more cost-effective than TAU alone. It also led to improvements in postpartum anxiety, infant-focused anxiety, parenting stress, and infant temperament. CONCLUSIONS: Peer-delivered 1-day CBT-based workshops can improve PPD and are a potentially scalable low-intensity treatment that could help increase treatment access.

Exploring the Relationship between Adherence to Therapy, Treatment Acceptability, and Clinical Outcomes in Adults with Attention-Deficit/Hyperactivity Disorder: Results from the COMPAS Multicenter Randomized Controlled Trial.

INTRODUCTION: Cognitive behavioral therapy and dialectical behavior therapy (DBT) can be effective in treating adults with ADHD, and patients generally consider these interventions useful. While adherence, as measured by attendance at sessions, is mostly sufficient, adherence to therapy skills has not been assessed. Furthermore, the relationship between patient evaluation of therapy effectiveness, treatment adherence, and clinical outcomes is understudied. OBJECTIVE: This study aimed to examine treatment acceptability and adherence in relation to treatment outcomes in a large randomized controlled trial comparing a DBT-based intervention with a nonspecific active comparison, combined with methylphenidate or placebo. METHOD: A total of 433 adult patients with ADHD were randomized. Participants reported how effective they found the therapy, and adherence was measured by attendance at therapy sessions and by self-reports. Descriptive, between-groups, and linear mixed model analyses were conducted. RESULTS: Participants rated psychotherapy as moderately effective, attended 78.40-94.37% of sessions, and used skills regularly. The best-accepted skills were sports and mindfulness. Groups receiving placebo and/or nonspecific clinical management rated their health condition and the medication effectiveness significantly worse than the psychotherapy and methylphenidate groups. Improvements in clinical outcomes were significantly associated with treatment acceptability. Subjective (self-reported) adherence to psychotherapy was significantly associated with improvements in ADHD symptoms, clinical global efficacy and response to treatment. DISCUSSION: These results further support the acceptability of DBT for adult ADHD and suggest the need to address adherence to treatment to maximize clinical improvements. Results may be limited by the retrospective assessment of treatment acceptability and adherence using an ad hoc instrument.

Longitudinal Clusters of Long-Term Trajectories in Patients with Early-Onset Chronic Depression: 2 Years of Naturalistic Follow-Up after Extensive Psychological Treatment.

INTRODUCTION: In clinical trials, mostly group-level treatment effects of repeated cross-sectional measures are analyzed. However, substantial heterogeneity regarding individual symptom profiles and the variability of treatment effects are often neglected, especially over the long-term course. To provide effective personalized treatments, investigations of these characteristics are urgently needed. METHODS: Depression severity ratings over 104 weeks of follow-up after year-long treatment with the Cognitive Behavioral Analysis System of Psychotherapy (CBASP) or Supportive Psychotherapy (SP) were analyzed. Longitudinal cluster analysis and multinomial logistic regression analysis were conducted to investigate intraindividual trajectories from one of the largest psychotherapy trials in early-onset chronic depression. RESULTS: Two-year post-study-treatment trajectories of N = 188 patients with early-onset chronic depression were grouped into four prototypical clusters. Overall, 16.0% of patients remitted (cluster 1) and most of them did not receive any treatment during the 2-year follow-up. However, 84.0% of patients continued to experience subthreshold (37.2% cluster 2) or major depressive symptoms (46.8% clusters 3-4) and spent on average more than half of the follow-up in pharmacological and psychological treatment. Hierarchical regression analysis indicated that previous study treatment with CBASP or SP did not significantly predict cluster allocation, while baseline variables accounted for a large proportion of explained variance (R2 N = 0.64). CONCLUSION: While some patients experienced stable remission over 2 years of follow-up, the majority of patients experienced subthreshold or major depressive symptoms regardless of former study treatment with CBASP or SP. This calls for a long-term perspective implementing staging and innovative treatment approaches such as the sequential model or modular psychotherapy.