A randomized controlled trial of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) to improve serious mental illness outcomes in a community setting.

OBJECTIVE: To determine if the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) improves functional impairment, psychiatric symptoms, and sleep and circadian functioning. METHOD: Adults diagnosed with serious mental illness (SMI) and sleep and circadian dysfunction (N = 121) were randomly allocated to TranS-C plus usual care (TranS-C + UC; n = 61; 8 individual weekly sessions) or 6 months of Usual Care followed by Delayed Treatment with TranS-C (UC-DT; n = 60). Schizophrenia (45%) and anxiety disorders (47%) were common. Blind assessments were conducted pre-treatment, post-treatment, and 6 months later (6FU). The latter two were the post-randomization points of interest. The location was Alameda County Behavioral Health Care Services (ACBHCS), a Community Mental Health Center (CMHC) in California. RESULTS: For the primary outcomes, relative to UC-DT, TranS-C + UC was associated with reduction in functional impairment (b = -3.18, p = 0.025, d = -0.58), general psychiatric symptoms (b = -5.88, p = 0.001, d = -0.64), sleep disturbance (b = -5.55, p < .0001, d = -0.96), and sleep-related impairment (b = -9.14, p < .0001, d = -0.81) from pre-treatment to post-treatment. These effects were maintained to 6-month follow-up (6FU; d = -0.42 to -0.82), except functional impairment (d = -0.37). For the secondary outcomes, relative to UC-DT, TranS-C + UC was associated with improvement in sleep efficiency and on the Sleep Health Composite score from pre-treatment to 6FU. TranS-C + UC was also associated with reduced total wake time and wake time variability from pre-treatment to post-treatment, as well as reduced hallucinations and delusions, bedtime variability, and actigraphy measured waking activity count variability from pre-treatment to 6FU. CONCLUSIONS: A novel transdiagnostic treatment, delivered within a CMHC setting, improves selected measures of functioning, symptoms of comorbid disorders, and sleep and circadian outcomes. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Addressing the Challenges of Recruitment and Retention in Sleep and Circadian Clinical Trials.

Objective/Background: Sleep and circadian disorders are prevalent worldwide and frequently comorbid with physical and mental illnesses. Thus, recruiting and retaining samples for sleep and circadian research are high priorities. The aims of this paper are to highlight barriers to recruitment and retention for participants with sleep or circadian dysfunction, and to share strategies used across two randomized controlled trials (RCTs) testing the efficacy of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) to address these challenges. Participants: The first RCT recruited 176 adolescents with an evening circadian chronotype, who were at risk in at least one of five health domains: behavioral, cognitive, emotional, physical, and social. The second RCT recruited 121 low-income, racial or ethnic minority adults diagnosed with severe mental illness (SMI) and comorbid sleep or circadian dysfunction. Methods: The current study examined participant, environment, and research factors that impacted recruitment and retention of participants with sleep or circadian dysfunction, and identified strategies to enhance recruitment and retention. Results: Strategies used to recruit participants included community-based recruiting, reducing stigma, and alleviating burdensome sleep data collection. Strategies used to retain participants in our studies included flexible scheduling, mitigating participant barriers, building rapport with participants through empathic and positive interactions, creative problem solving, consulting participant networks, and utilizing incentives and other positive engagement tools. Conclusion: Both at-risk adolescents and low-income, minority adults with comorbid SMI and sleep or circadian dysfunction experience significant barriers to research participation. Recruitment and retention strategies were creatively tailored to meet the unique barriers of these diverse populations.

Modifying the Impact of Eveningness Chronotype ("Night-Owls") in Youth: A Randomized Controlled Trial.

OBJECTIVE: To determine whether an intervention to reduce eveningness chronotype improves sleep, circadian, and health (emotional, cognitive, behavioral, social, physical) outcomes. METHOD: Youth aged 10 to 18 years with an evening chronotype and who were "at risk" in 1 of 5 health domains were randomized to: (a) Transdiagnostic Sleep and Circadian Intervention for Youth (TranS-C; n = 89) or (b) Psychoeducation (PE; n = 87) at a university-based clinic. Treatments were 6 individual, weekly 50-minute sessions during the school year. TranS-C addresses sleep and circadian problems experienced by youth by integrating evidence-based treatments derived from basic research. PE provides education on the interrelationship between sleep, stress, diet, and health. RESULTS: Relative to PE, TranS-C was not associated with greater pre-post change for total sleep time (TST) or bed time (BT) on weeknights but was associated with greater reduction in evening circadian preference (pre-post increase of 3.89 points, 95% CI = 2.94-4.85, for TranS-C, and 2.01 points, 95% CI = 1.05-2.97 for PE, p = 0.006), earlier endogenous circadian phase, less weeknight-weekend discrepancy in TST and wakeup time, less daytime sleepiness, and better self-reported sleep via youth and parent report. In terms of functioning in the five health domains, relative to PE, TranS-C was not associated with greater pre-post change on the primary outcome. However, there were significant interactions favoring TranS-C on the Parent-Reported Composite Risk Scores for cognitive health. CONCLUSION: For at-risk youth, the evidence supports the use of TranS-C over PE for improving sleep and circadian functioning, and improving health on selected outcomes. CLINICAL TRIAL REGISTRATION INFORMATION: Triple Vulnerability? Circadian Tendency, Sleep Deprivation and Adolescence. https://clinicaltrials.gov; NCT01828320.

Can integrating the Memory Support Intervention into cognitive therapy improve depression outcome? Study protocol for a randomized controlled trial.

BACKGROUND: The Memory Support Intervention was developed in response to evidence showing that: (1) patient memory for treatment is poor, (2) poor memory for treatment is associated with poorer adherence and poorer outcome, (3) the impact of memory impairment can be minimized by the use of memory support strategies and (4) improved memory for treatment improves outcome. The aim of this study protocol is to conduct a confirmatory efficacy trial to test whether the Memory Support Intervention improves illness course and functional outcomes. As a "platform" for the next step in investigating this approach, we focus on major depressive disorder (MDD) and cognitive therapy (CT). METHOD/DESIGN: Adults with MDD (n = 178, including 20% for potential attrition) will be randomly allocated to CT + Memory Support or CT-as-usual and will be assessed at baseline, post treatment and at 6 and 12 months' follow-up (6FU and 12FU). We will compare the effects of CT + Memory Support vs. CT-as-usual to determine if the new intervention improves the course of illness and reduces functional impairment (aim 1). We will determine if patient memory for treatment mediates the relationship between treatment condition and outcome (aim 2). We will evaluate if previously reported poor treatment response subgroups moderate target engagement (aim 3). DISCUSSION: The Memory Support Intervention has been developed to be "transdiagnostic" (relevant to a broad range of mental disorders) and "pantreatment" (relevant to a broad range of types of treatment). This study protocol describes a "next step" in the treatment development process by testing the Memory Support Intervention for major depressive disorder (MDD) and cognitive therapy (CT). If the results are promising, future directions will test the applicability to other kinds of interventions and disorders and in other settings. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT01790919 . Registered on 6 October 2016.

A transdiagnostic sleep and circadian treatment to improve severe mental illness outcomes in a community setting: study protocol for a randomized controlled trial.

BACKGROUND: Severe mental illness (SMI) is common, chronic and difficult to treat. Sleep and circadian dysfunctions are prominent correlates of SMI, yet have been minimally studied in ways that reflect the complexity of the sleep problems experienced. Prior treatment studies have been disorder-focused-they have treated a specific sleep problem in a specific diagnostic group. However, real life sleep and circadianproblems are not so neatly categorized, particularly in SMI where features of insomnia overlap with hypersomnia, delayed sleep phase and irregular sleep-wake schedules. Accordingly, the aim of this studyprotocol is to test the hypothesis that a Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) will improve functional impairment, disorder-focused symptoms and sleep and circadian functioning. Participants across DSM diagnoses and across common sleep and circadian problems are eligible. The elements of TranS-C are efficacious across SMI in research settings with research-based providers. The next step is to test TranS-C in a community setting. Accordingly, this study is being conducted within Alameda County Behavioral Health Care Services (ACBHCS), the Community Mental Health Centre (CMHC) for Alameda County. METHODS/DESIGN: 120 adults diagnosed with SMI and sleep and circadian dysfunction within ACBHCS will be randomly allocated to TranS-C (n = 60) or 6-months of Usual Care followed by Delayed Treatment with TranS-C (UC-DT; n = 60). TranS-C is modularized and delivered across eight to twelve 50-minute, weekly, individual sessions. All participants will be assessed before and immediately following treatment and again 6 months later. Primary analysis will examine whether TranS-C significantly improves functional impairment, disorder-specific symptoms and sleep and circadian functioning, relative to UC-DT. Exploratory analysis will examine whether improvements in sleep and circadian functioning predict reduction in functional impairment and disorder-specific symptoms, and whether the intervention effects are mediated by improved sleep and circadian functioning and moderated by previously reported risk factors (demographics, symptom severity, medications, psychiatric and medical comorbidity). DISCUSSION: This trial tests an important and understudied mechanism-dysregulated sleep and circadian rhythms-in SMI, a novel transdiagnostic treatment approach, in a community setting so as to contribute to the goal of bridging the gap between research and practice. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02469233 . Registered on 9 June 2015.

Improving outcome for mental disorders by enhancing memory for treatment.

Patients exhibit poor memory for treatment. A novel Memory Support Intervention, derived from basic science in cognitive psychology and education, is tested with the goal of improving patient memory for treatment and treatment outcome. Adults with major depressive disorder (MDD) were randomized to 14 sessions of cognitive therapy (CT)+Memory Support (n = 25) or CT-as-usual (n = 23). Outcomes were assessed at baseline, post-treatment and 6 months later. Memory support was greater in CT+Memory Support compared to the CT-as-usual. Compared to CT-as-usual, small to medium effect sizes were observed for recall of treatment points at post-treatment. There was no difference between the treatment arms on depression severity (primary outcome). However, the odds of meeting criteria for 'response' and 'remission' were higher in CT+Memory Support compared with CT-as-usual. CT+Memory Support also showed an advantage on functional impairment. While some decline was observed, the advantage of CT+Memory Support was evident through 6-month follow-up. Patients with less than 16 years of education experience greater benefits from memory support than those with 16 or more years of education. Memory support can be manipulated, may improve patient memory for treatment and may be associated with an improved outcome.

Impact of comorbid anxiety and depressive disorders on treatment response to cognitive behavior therapy for insomnia.

OBJECTIVE: To evaluate the impact of comorbid anxiety or depressive disorders on treatment response to cognitive-behavior therapy (CBT) for insomnia, behavior therapy (BT), or cognitive therapy (CT). METHOD: Participants were 188 adults (117 women; Mage = 47.4 years) with chronic insomnia, including 45 also presenting a comorbid anxiety or mild to moderate depressive disorder. They were randomized to BT (n = 63), CT (n = 65), or CBT (n = 60). Outcome measures were the proportion of treatment responders (decrease of ≥8 points on the Insomnia Severity Index; ISI) and remissions (ISI score < 8) and depression and anxiety symptoms. RESULTS: Proportion of treatment responders and remitters in the CBT condition was not significantly different between the subgroups with and without comorbidity. However, the proportion of responders was lower in the comorbidity subgroup compared to those without comorbidity in both the BT (34.4% vs. 81.6%; p = .007) and CT (23.6% vs. 57.6%; p = .02) alone conditions, although remission rates and prepost ISI change scores were not. Pre to post change scores on the depression (-10.6 vs. -3.9; p < .001) and anxiety measures (-9.2 vs. -2.5; p = .01) were significantly greater in the comorbidity subgroup relative to the subgroup without comorbidity but only for those treated with the full CBT; no difference was found for those treated with either BT or CT alone. CONCLUSIONS: The presence of a comorbid anxiety or mild to moderate depressive disorder did not reduce the efficacy of CBT for insomnia, but it did for its single BT and CT components when used alone. (PsycINFO Database Record

Cognitive-behavioral treatment of insomnia and depression in adolescents: A pilot randomized trial.

We tested whether augmenting conventional depression treatment in youth by treating sleep issues with cognitive behavioral therapy for insomnia (CBT-I) improved depression outcomes. We randomized youth 12-20 years of age to 10 weekly sessions of a sleep hygiene control condition (SH) combined with CBT for depression (CBT-D) (n = 20), or an experimental condition consisting of CBT-I combined with CBT-D (n = 21). We assessed outcomes through 26 weeks of follow-up and found medium-large effects favoring the experimental CBT-I arm on some sleep outcomes (actigraphy total sleep time and Insomnia Severity Index "caseness") and depression outcomes (higher percentage recovered, faster time to recovery), but little effect on other measures. Total sleep time improved by 99 min from baseline to week 12 in the CBT-I arm, but not in the SH arm. In addition, our pilot yielded important products to facilitate future studies: the youth-adapted CBT-I program; the study protocol; estimates of recruitment, retention, and attrition; and performance and parameters of candidate outcome measures. ClinicalTrials.gov Identifier NCT00949689.

Treating insomnia improves mood state, sleep, and functioning in bipolar disorder: a pilot randomized controlled trial.

OBJECTIVE: To determine if a treatment for interepisode bipolar disorder I patients with insomnia improves mood state, sleep, and functioning. METHOD: Alongside psychiatric care, interepisode bipolar disorder I participants with insomnia were randomly allocated to a bipolar disorder-specific modification of cognitive behavior therapy for insomnia (CBTI-BP; n = 30) or psychoeducation (PE; n = 28) as a comparison condition. Outcomes were assessed at baseline, the end of 8 sessions of treatment, and 6 months later. This pilot was conducted to determine initial feasibility and generate effect size estimates. RESULTS: During the 6-month follow-up, the CBTI-BP group had fewer days in a bipolar episode relative to the PE group (3.3 days vs. 25.5 days). The CBTI-BP group also experienced a significantly lower hypomania/mania relapse rate (4.6% vs. 31.6%) and a marginally lower overall mood episode relapse rate (13.6% vs. 42.1%) compared with the PE group. Relative to PE, CBTI-BP reduced insomnia severity and led to higher rates of insomnia remission at posttreatment and marginally higher rates at 6 months. Both CBTI-BP and PE showed statistically significant improvement on selected sleep and functional impairment measures. The effects of treatment were well sustained through follow-up for most outcomes, although some decline on secondary sleep benefits was observed. CONCLUSIONS: CBTI-BP was associated with reduced risk of mood episode relapse and improved sleep and functioning on certain outcomes in bipolar disorder. Hence, sleep disturbance appears to be an important pathway contributing to bipolar disorder. The need to develop bipolar disorder-specific sleep diary scoring standards is highlighted.

Comparative efficacy of behavior therapy, cognitive therapy, and cognitive behavior therapy for chronic insomnia: a randomized controlled trial.

OBJECTIVE: To examine the unique contribution of behavior therapy (BT) and cognitive therapy (CT) relative to the full cognitive behavior therapy (CBT) for persistent insomnia. METHOD: Participants were 188 adults (117 women; M age = 47.4 years, SD = 12.6) with persistent insomnia (average of 14.5 years duration). They were randomized to 8 weekly, individual sessions consisting of BT (n = 63), CT (n = 65), or CBT (n = 60). RESULTS: Full CBT was associated with greatest improvements, the improvements associated with BT were faster but not as sustained and the improvements associated with CT were slower and sustained. The proportion of treatment responders was significantly higher in the CBT (67.3%) and BT (67.4%) relative to CT (42.4%) groups at post treatment, while 6 months later CT made significant further gains (62.3%), BT had significant loss (44.4%), and CBT retained its initial response (67.6%). Remission rates followed a similar trajectory, with higher remission rates at post treatment in CBT (57.3%) relative to CT (30.8%), with BT falling in between (39.4%); CT made further gains from post treatment to follow up (30.9% to 51.6%). All 3 therapies produced improvements of daytime functioning at both post treatment and follow up, with few differential changes across groups. CONCLUSIONS: Full CBT is the treatment of choice. Both BT and CT are effective, with a more rapid effect for BT and a delayed action for CT. These different trajectories of changes provide unique insights into the process of behavior change via behavioral versus cognitive routes.