Effect of cognitive behavioural therapy and yoga for generalised anxiety disorder on sleep quality in a randomised controlled trial: the role of worry, mindfulness, and perceived stress as mediators.

Sleep disturbances are present in ~65% of individuals with generalised anxiety disorder (GAD). Although both Kundalini yoga (KY) and cognitive behavioural therapy (CBT) are effective treatment options for GAD, little is known about how these treatments compare in improving sleep for GAD and what drives these changes. Accordingly, we examined the effects of CBT, KY, and stress education (SEdu; an attention control condition) on subjective sleep quality (as measured by the Pittsburgh Sleep Quality Index [PSQI] and Insomnia Severity Index [ISI]) in a randomised controlled trial of 226 adults with GAD (mean age 33.37 years; 70% female; 79% White). We hypothesised that both CBT and KY would outperform SEdu in improving sleep disturbances. Three potential mediators of sleep improvement (worry, mindfulness, perceived stress) were also examined. In line with hypotheses, PSQI and ISI scores significantly improved from pre- to post-treatment for all three treatment groups (all p < 0.001, all d > 0.97). However, contrary to predictions, sleep changes were not significantly greater for CBT or KY compared to SEdu. In mediation analyses, within-person deviations in worry, mindfulness, and stress each significantly mediated the effect of time on sleep outcomes. Degree of change in sleep attributable to worry (CBT > KY > SEdu) and perceived stress (CBT, KY > SEdu) was moderated by treatment group. Personalised medicine as well as combined treatment approaches should be studied to help reduce sleep difficulties for patients with GAD who do not respond.

Mechanisms of cognitive-behavioral therapy effects on symptoms of body dysmorphic disorder: a network intervention analysis.

BACKGROUND: Body dysmorphic disorder (BDD) is a severe and undertreated condition. Although cognitive-behavioral therapy (CBT) is the first-line psychosocial treatment for this common disorder, how the intervention works is insufficiently understood. Specific pathways have been hypothesized, but only one small study has examined the precise nature of treatment effects of CBT, and no prior study has examined the effects of supportive psychotherapy (SPT). METHODS: This study re-examined a large trial (n = 120) comparing CBT to SPT for BDD. Network intervention analyses were used to explore symptom-level data across time. We computed mixed graphical models at multiple time points to examine relative differences in direct and indirect effects of the two interventions. RESULTS: In the resulting networks, CBT and SPT appeared to differentially target certain symptoms. The largest differences included CBT increasing efforts to disengage from and restructure unhelpful thoughts and resist BDD rituals, while SPT was directly related to improvement in BDD-related insight. Additionally, the time course of differences aligned with the intended targets of CBT; cognitive effects emerged first and behavioral effects second, paralleling cognitive restructuring in earlier sessions and the emphasis on exposure and ritual prevention in later sessions. Differences in favor of CBT were most consistent for behavioral targets. CONCLUSIONS: CBT and SPT primarily affected different symptoms. To improve patient care, the field needs a better understanding of how and when BDD treatments and treatment components succeed. Considering patient experiences at the symptom level and over time can aid in refining or reorganizing treatments to better fit patient needs.

Efficacy of App-Based Cognitive Behavioral Therapy for Body Dysmorphic Disorder with Coach Support: Initial Randomized Controlled Clinical Trial.

INTRODUCTION: Body dysmorphic disorder (BDD) is severe, chronic, and undertreated. Apps could substantially improve treatment access. OBJECTIVE: We provide an initial test of the usability and efficacy of coach-supported app-based cognitive behavioral therapy (CBT) for BDD. The Perspectives app covers core treatment components: psychoeducation, cognitive restructuring, exposure with response prevention, mindfulness, attention retraining, and relapse prevention. METHODS: A randomized waitlist-controlled trial was conducted. Adults (N = 80) with primary BDD were assigned to 12 weeks of Perspectives or waitlist. Coaches promoted engagement and answered questions via in-app messaging and phone calls. BDD severity was measured at baseline, mid-treatment, and end of treatment by blinded independent evaluators (Yale-Brown Obsessive Compulsive Scale Modified for BDD; BDD-YBOCS). Secondary outcomes included BDD-related insight, depression, quality of life, and functioning. RESULTS: App uptake and satisfaction were high. In intent-to-treat analyses, Perspectives app-based CBT was associated with significantly lower BDD-YBOCS severity at end of treatment (M [SD]: 16.8 [7.5]) compared to the waitlist (26.7 [6.2]; p < 0.001, d = 1.44). App-based CBT was associated with greater improvements across all secondary measures, with medium to large effects. CONCLUSIONS: Perspectives, supported by a bachelor's-level coach, is an efficacious, scalable treatment for adults with BDD.

Rates of remission, sustained remission, and recurrence in a randomized controlled trial of cognitive behavioral therapy versus supportive psychotherapy for body dysmorphic disorder.

BACKGROUND: Little data exist on remission rates following psychotherapy for body dysmorphic disorder (BDD). METHODS: Using data from a large study of therapist-delivered cognitive behavior therapy (CBT) versus supportive psychotherapy (SPT) for BDD (N = 120), we estimated remission rates at treatment endpoint, and rates of delayed remission, sustained remission, and recurrence at 6-month follow-up. We also examined improvement in broader mental health outcomes among remitters. RESULTS: Full or partial remission rates at end-of-treatment were significantly higher following CBT (68%) than SPT (42%). At 6-month follow-up, an additional 10% (CBT) and 14% (SPT) experienced delayed remission, 52% (CBT) and 27% (SPT) experienced sustained remission, and 20% (CBT) and 14% (SPT) experienced recurrence. Remission was never achieved by 18% (CBT) and 45% (SPT). Participants in remission at end-of-treatment experienced significant improvements in functional impairment, depression severity, BDD-related insight, and quality of life compared to nonremitters. CONCLUSIONS: Full or partial remission rates are high following CBT for BDD and higher than after SPT.

Preparing for the Quit Day: Comparing Beliefs of Nondaily Versus Daily Young Adult Smokers as They Prepare for a Quit Attempt.

INTRODUCTION: Most smoking cessation approaches are modeled on heavy daily smoking. With increasing prevalence of nondaily smoking, it may be necessary to modify these approaches for nondaily smokers. AIMS: To provide information about beliefs and attitudes relevant to smoking cessation for nondaily smokers. METHODS: Secondary analysis of two prospective studies on young adult smokers (18-24 years of age) provided brief advice to quit smoking. Measures include baseline levels of constructs relevant to smoking cessation counseling and perceived benefits of and barriers to smoking cessation. RESULTS: Participants (n = 40 nondaily, 122 daily smokers) were predominantly White (70% and 84%, respectively), gender-balanced (50% and 43% female), full-time college students (89% and 95%). At baseline, nondaily smokers reported lower levels of nicotine dependence (p < .001; nondaily: Fagerström Test for Nicotine Dependence (FTND) = 0.8 ± 1.5, daily: FTND = 3.1 ± 1.9), lower urge to smoke (p < .001), greater self-efficacy when facing external smoking stimuli (p = .03), expecting to experience fewer positive effects (reduced negative affect, p = <.001, stimulation, p = .02), and valuing the importance of smoking effects less (ps < .01) than daily smokers. During counseling, nondaily smokers generated both fewer benefits of cessation (Wald X2(df = 1) = 4.91, p = .027) and fewer barriers (Wald X2(df = 1) = 5.99, p =.014) than daily smokers. Withdrawal was not listed by nondaily smokers as a barrier (p < .01). CONCLUSIONS: Constructs relevant to smoking cessation for daily smokers were less salient to young nondaily smokers, compared with moderately addicted young daily smokers, as indicated by responses to standardized scales and by the generation of fewer benefits and barriers in counseling. Interventions may need to find novel ways to engage nondaily smokers, particularly young adult, in smoking cessation efforts. IMPLICATIONS: This study is unique in eliciting benefits and barriers from nondaily smokers as they are about to make a quit attempt. This is a critically important point in time, as this is the point in time in which an action plan is formed and can be informed and enhanced by smoking cessation support. Our study further allowed direct comparison to daily smokers undergoing the same procedures, which allowed the identification of unique factors that may impact nondaily smokers in their quit attempt, which may guide intervention efforts. Use of a mixed method design further strengthen the rigor of this study.

Understanding the impact of complicated grief on combat related posttraumatic stress disorder, guilt, suicide, and functional impairment in a clinical trial of post-9/11 service members and veterans.

BACKGROUND: Complicated grief (CG) is a bereavement-specific syndrome distinct from but commonly comorbid with posttraumatic stress disorder (PTSD). While bereavement is common among military personnel (Simon et al., 2018), there is little research on the impact of CG comorbidity on PTSD treatment outcomes. METHODS: To evaluate the impact of comorbid CG on PTSD treatment outcomes we analyzed data from a randomized trial comparing prolonged exposure, sertraline, and their combination in veterans with a primary diagnosis of combat-related PTSD (n = 194). Assessment of PTSD, trauma-related guilt, functional impairment, and suicidal ideation and behavior occurred at baseline and weeks 6, 12, and 24 during the 24-week trial. RESULTS: CG was associated with lower PTSD treatment response (odds ratio (OR) = 0.29, 95% confidence interval (CI) [0.12, 0.69], p = 0.005) and remission (OR = 0.28, 95% CI [0.11, 0.71], p = 0.007). Those with CG had greater severity of PTSD (p = 0.005) and trauma-related guilt (<0.001) at baseline and endpoint. In addition, those with CG were more likely to experience suicidal ideation during the study (CG: 35%, 14/40 vs. no CG 15%, 20/130; OR = 3.01, 95% CI [1.29, 7.02], p = 0.011). CONCLUSIONS: Comorbid CG is associated with elevated PTSD severity and independently associated with poorer endpoint treatment outcomes in veterans with combat-related PTSD, suggesting that screening and additional intervention for CG may be needed.

Impact of sleep on complicated grief severity and outcomes.

BACKGROUND: Complicated grief (CG) is characterized by persistent, impairing grief after losing a loved one. Little is known about sleep disturbance in CG. Baseline prevalence of subjective sleep disturbance, impact of treatment on sleep, and impact of mid-treatment sleep on CG and quality of life outcomes were examined in adults with CG in secondary analyses of a clinical trial. METHODS: Patients with CG (n = 395, mean age =53.0; 78% female) were randomized to CGT+placebo, CGT+citalopram (CIT), CIT, or placebo. Subjective sleep disturbance was assessed by a grief-anchored sleep item (Pittsburgh Sleep Quality Index: PSQI-1) and a four-item sleep subscale of the Quick Inventory of Depressive Symptomatology (QIDS-4). Sleep disturbance was quantified as at least one QIDS-4 item with severity ≥2 or grief-related sleep disturbance ≥3 days a week for PSQI-1. Outcomes included the Inventory of Complicated Grief (ICG), Work and Social Adjustment Scale (WSAS), and Clinical Global Impressions Scale. RESULTS: Baseline sleep disturbance prevalence was 91% on the QIDS-4 and 46% for the grief-anchored PSQI-1. Baseline CG severity was significantly associated with sleep disturbance (QIDS-4: p = .015; PSQI-1: p = .001) after controlling for comorbid depression and PTSD. Sleep improved with treatment; those receiving CGT+CIT versus CIT evidenced better endpoint sleep (p = .027). Mid-treatment QIDS-4 significantly predicted improvement on outcome measures (all p < .01), though only WSAS remained significant after adjustment for mid-treatment ICG (p = .02). CONCLUSIONS: Greater CG severity is associated with poorer sleep beyond PTSD and depression comorbidity. Additional research including objective sleep measurement is needed to optimally elucidate and address sleep impairment associated with CG.

Combat-Related Posttraumatic Stress Disorder and Comorbid Major Depression in U.S. Veterans: The Role of Deployment Cycle Adversity and Social Support.

Posttraumatic stress disorder (PTSD) and major depressive disorder (MDD) commonly co-occur in combat veterans, and this comorbidity has been associated with higher levels of distress and more social and economic costs compared to one disorder alone. In a secondary analysis of a multisite randomized controlled trial of a sample of veterans with combat-related PTSD, we examined the associations among pre-, peri-, and postdeployment adversity, social support, and clinician-diagnosed comorbid MDD. Participants completed the Deployment Risk and Resilience Inventory and the Beck Depression Inventory-II as well as structured clinical interviews for diagnostic status. Among 223 U.S. veterans of the military operations in Iraq and Afghanistan (86.9% male) with primary combat-related PTSD, 69.5% had current comorbid MDD. After adjustment for sex, a linear regression model indicated that more concerns about family disruptions during deployment, f2 = 0.065; more harassment during deployment, f2 = 0.020; and lower ratings of postdeployment social support, f2 = 0.154, were associated with more severe self-reported depression symptoms. Interventions that enhance social support as well as societal efforts to foster successful postdeployment reintegration are critical for reducing the mental health burden associated with this highly prevalent comorbidity in veterans with combat-related PTSD.

Marijuana use and major depressive disorder are additively associated with reduced verbal learning and altered cortical thickness.

Marijuana (MJ) use and major depressive disorder (MDD) have both been associated with deficits in verbal learning and memory as well as structural brain abnormalities. It is not known if MJ use by those with MDD confers additional impairment. The goal of this study was to examine unique and combined effects of MDD and MJ use on verbal memory and brain structure. Young adults (n=141) aged 18-25 years with MJ use and no lifetime MDD (MJ, n=46), MDD and no MJ use (MDD, n=23), MJ use and lifetime MDD (MDD+MJ, n=24), and healthy controls without MDD or MJ use (CON, n=48) were enrolled. Participants completed the California Verbal Learning Test, Second Edition (CVLT-II), a measure of verbal learning and memory. A sub-sample of 82 participants also underwent a structural magnetic resonance imaging (MRI) scan. Group differences in CVLT-II performance, cortical thickness, and hippocampal volume were assessed. We found an additive effect of MDD and MJ on memory recall. Only MDD, but not MJ, was associated with poorer initial learning, fewer words recalled, more intrusion errors, and lower percent retention. There was also an additive effect of MDD and MJ use on reduced cortical thickness in the middle temporal gyrus. Findings indicate that MJ use and MDD have additive adverse associations with verbal recall and cortical thickness in the middle temporal gyrus, suggesting that MJ use among those with MDD may be contraindicated. Prospective studies are warranted to determine whether this association may be causal.

Using the text-messaging program SmokefreeTXT to support smoking cessation for nondaily smokers.

INTRODUCTION: Smoking cessation interventions for nondaily smokers are needed. The current study explores the fit of the text-messaging intervention SmokefreeTXT for nondaily smokers. METHODS: Adult nondaily smokers (N = 32; mean age = 35 ± 12, 64% female, 53% non-Hispanic White) were enrolled in SmokefreeTXT. SmokefreeTXT usage data were recorded passively, theorized mechanisms of change were assessed at baseline and 2, 6, and 12 weeks after the chosen quit day, and EMA protocols captured real-time cigarette reports at baseline, and during the first two weeks after the quit day. RESULTS: Most participants completed the SmokefreeTXT program and responded to system-initiated inquiries, but just-in-time interaction with the program was limited. In retrospective recall at treatment end, content of the text-messages was rated as "neutral" to "helpful." Within-person change was observed in theorized mechanisms, with less craving (p < 0.01), increased abstinence self-efficacy (external: p < 0.01; internal: p < 0.01), and poorer perceptions of pros of smoking (psychoactive benefits: p < 0.01, pleasure p < 0.01; and pros: p < 0.01) reported after SmokefreeTXT initiation compared to baseline. Exploratory analyses of real-time reports of smoking (225 cigarette reports in N = 17 who relapsed) indicated that cigarettes smoked in the first two weeks after quitting were more likely to occur to reduce craving (OR = 2.21[1.21-3.72]), and less likely to occur to socialize (OR = 0.06[0.01-0.24]), between 19:00 and 23:00 (OR = 0.34[0.17-0.66]), and on Saturdays (OR = 0.59[0.35-0.99]) than prior to quitting. CONCLUSIONS: While well accepted by nondaily smokers, SmokefreeTXT could potentially be improved by targeting cons of smoking, enhancing engagement with the just-in-time component of SmokefreeTXT, and tweaking the timing of text-messages.

A placebo-controlled randomized trial of D-cycloserine augmentation of cue exposure therapy for smoking cessation.

Recent studies underscore the importance of studying d-cycloserine (DCS) augmentation under conditions of adequate cue exposure treatment (CET) and protection from reconditioning experiences. In this randomized trial, we evaluated the efficacy of DCS for augmenting CET for smoking cessation under these conditions. Sixty-two smokers attained at least 18 hours abstinence following 4 weeks of smoking cessation treatment and were randomly assigned to receive a single dose of DCS (n=30) or placebo (n=32) prior to each of two sessions of CET. Mechanistic outcomes were self-reported cravings and physiologic reactivity to smoking cues. The primary clinical outcome was 6-week, biochemically-verified, continuous tobacco abstinence. DCS, relative to placebo, augmentation of CET resulted in lower self-reported craving to smoking pictorial and in vivo cues (d = 0.8 to 1.21) in a relevant subsample of participants who were reactive to cues and free from smoking-related reconditioning experiences. Select craving outcomes were correlated with smoking abstinence, and DCS augmentation was associated with a trend toward a higher continuous abstinence rate (33% vs. 13% for placebo augmentation). DCS augmentation of CET can significantly reduce cue-induced craving, supporting the therapeutic potential of DCS augmentation when applied under appropriate conditions for adequate extinction learning.

The loss of a fellow service member: Complicated grief in post-9/11 service members and veterans with combat-related posttraumatic stress disorder.

Bereavement is a potent and highly prevalent stressor among service members and veterans. However, the psychological consequences of bereavement, including complicated grief (CG), have been minimally examined. Loss was assessed in 204 post-9/11, when service members and veterans with combat-related posttraumatic stress disorder (PTSD) took part in a multicenter treatment study. Those who reported the loss of an important person completed the inventory of complicated grief (ICG; n = 160). Over three quarters (79.41%) of the sample reported an important lifetime loss, with close to half (47.06%) reporting the loss of a fellow service member (FSM). The prevalence of CG was 24.75% overall, and nearly one third (31.25%) among the bereaved. CG was more prevalent among veterans who lost a fellow service member (FSM) (41.05%, n = 39) compared to those bereaved who did not (16.92%, n = 11; OR = 3.41, 95% CI: 1.59, 7.36). CG was associated with significantly greater PTSD severity, functional impairment, trauma-related guilt, and lifetime suicide attempts. Complicated grief was prevalent and associated with adverse psychosocial outcomes in veterans and service members with combat-related PTSD. Clinicians working with this population should inquire about bereavement, including loss of a FSM, and screen for CG. Additional research examining CG in this population is needed.

Smiling Instead of Smoking: Development of a Positive Psychology Smoking Cessation Smartphone App for Non-daily Smokers.

PURPOSE: The usefulness of mobile technology in supporting smoking cessation has been demonstrated, but little is known about how smartphone apps could best be leveraged. The purpose of this paper is to describe the program of research that led to the creation of a smoking cessation app for non-daily smokers, so as to stimulate further ideas to create "smart" smartphone apps to support health behavior change. METHOD: Literature reviews to evaluate the appropriateness of the proposed app, content analyses of existing apps, and smoking cessation sessions with non-daily smokers (n = 38) to inform the design of the app. RESULTS: The literature reviews showed that (1) smoking cessation apps are sought after by smokers, (2) positive affect plays an important role in smoking cessation, (3) short, self-administered exercises consistently bring about enduring positive affect enhancements, and (4) low treatment-seeking rates of non-daily smokers despite high motivation to quit indicate a need for novel smoking cessation support. Directed content analyses of existing apps indicated that tailoring, two-way interactions, and proactive features are under-utilized in existing apps, despite the popularity of such features. Conventional content analyses of audio-recorded session tapes suggested that difficulty in quitting was generally linked to specific, readily identifiable occasions, and that social support was considered important but not consistently sought out. CONCLUSION: The "Smiling Instead of Smoking" (SIS) app is an Android app that is designed to act as a behavioral, in-the-pocket coach to enhance quitting success in non-daily smokers. It provides proactive, tailored behavioral coaching, interactive tools (e.g., enlisting social support), daily positive psychology exercises, and smoking self-monitoring.

How Smart are Smartphone Apps for Smoking Cessation? A Content Analysis.

INTRODUCTION: Smartphone technology is ideally suited to provide tailored smoking cessation support, yet it is unclear to what extent currently existing smartphone "apps" use tailoring, and if tailoring is related to app popularity and user-rated quality. METHODS: We conducted a content analysis of Android smoking cessation apps (n = 225), downloaded between October 1, 2013 to May 31, 2014. We recorded app popularity (>10,000 downloads) and user-rated quality (number of stars) from Google Play, and coded the existence of tailoring features in the apps within the context of using the 5As ("ask," "advise," "assess," "assist," and "arrange follow-up"), as recommended by national clinical practice guidelines. RESULTS: Apps largely provided simplistic tools (eg, calculators, trackers), and used tailoring sparingly: on average, apps addressed 2.1 ± 0.9 of the 5As and used tailoring for 0.7 ± 0.9 of the 5As. Tailoring was positively related to app popularity and user-rated quality: apps that used two-way interactions (odds ratio [OR] = 5.56 [2.45-12.62]), proactive alerts (OR = 3.80 [1.54-9.38]), responsiveness to quit status (OR = 5.28 [2.18-12.79]), addressed more of the 5As (OR = 1.53 [1.10-2.14]), used tailoring for more As (OR = 1.67 [1.21-2.30]), and/or used more ways of tailoring 5As content (OR = 1.35 [1.13-1.62]) were more likely to be frequently downloaded. Higher star ratings were associated with a higher number of 5As addressed (b = 0.16 [0.03-0.30]), a higher number of 5As with any level of tailoring (b = 0.14 [0.01-0.27]), and a higher number of ways of tailoring 5As content (b = 0.08 [0.002-0.15]). CONCLUSIONS: Publically available smartphone smoking cessation apps are not particularly "smart": they commonly fall short of providing tailored feedback, despite users' preference for these features.

Tree leaf out response to temperature: comparing field observations, remote sensing, and a warming experiment.

Leaf out time is a widely used indicator of climate change and represents a critical transition point of annual seasonality in most temperate ecosystems. We compared three sources of data to determine the effect of spring temperature on tree leaf out: field observations, remotely sensed satellite data, and experimental warming. All three methods recorded earlier leaf out with warmer spring temperatures. However, leaf out timing was more than twice as sensitive to temperature in the field study (advancing at a rate of 6.1 days/°C), as under experimental warming (2.1 days/°C), with remote sensing intermediate (3.7 days/°C). Researchers need to be aware of the currently unexplained differences among methodologies when using phenological data to parameterize or benchmark models that represent ecosystem processes. The mechanisms behind these discrepancies must be better understood if we are to confidently predict responses of leaf out timing to future climates.

Maintenance treatment with varenicline for smoking cessation in patients with schizophrenia and bipolar disorder: a randomized clinical trial.

IMPORTANCE: It is estimated that more than half of those with serious mental illness smoke tobacco regularly. Standard courses of pharmacotherapeutic cessation aids improve short-term abstinence, but most who attain abstinence relapse rapidly after discontinuation of pharmacotherapy. OBJECTIVE: To determine whether smokers diagnosed with schizophrenia and bipolar disease have higher rates of prolonged tobacco abstinence with maintenance pharmacotherapy than with standard treatment. DESIGN, SETTING, AND PARTICIPANTS: Randomized, double-blind, placebo-controlled, parallel-group, relapse-prevention clinical trial conducted in 10 community mental-health centers. Of 247 smokers with schizophrenia or bipolar disease recruited from March 2008-April 2012, 203 received 12-weeks' open-label varenicline and cognitive behavioral therapy and 87 met abstinence criteria to enter the relapse prevention intervention. INTERVENTIONS: Participants who had 2 weeks or more of continuous abstinence at week 12 of open treatment were randomly assigned to receive cognitive behavioral therapy and double-blind varenicline (1 mg, 2 per day) or placebo from weeks 12 to 52. Participants then discontinued study treatment and were followed up to week 76. MAIN OUTCOMES AND MEASURES: Seven-day rate of continuous abstinence at study week 52, the end of the relapse-prevention phase, confirmed by exhaled carbon monoxide. Secondary outcomes were continuous abstinence rates for weeks 12 through 64 based on biochemically verified abstinence and weeks 12 through 76, based on self-reported smoking behavior. RESULTS: Sixty-one participants completed the relapse-prevention phase; 26 discontinued participation (7 varenicline, 19 placebo) and were considered to have relapsed for the analyses; 18 of these had relapsed prior to dropout. At week 52, point-prevalence abstinence rates were 60% in the varenicline group (24 of 40) vs 19% (9 of 47) in the placebo group (odds ratio [OR], 6.2; 95% CI, 2.2-19.2; P < .001). From weeks 12 through 64, 45% (18 of 40) among those in the varenicline group vs 15% (7 of 47) in the placebo group were continuously abstinent (OR, 4.6; 95% CI, 1.5-15.7; P = .004), and from weeks 12 through 76, 30% (12 of 40) in the varenicline group vs 11% (5 of 47) in the placebo group were continuously abstinent (OR, 3.4; 95% CI, 1.02-13.6; P = .03). There were no significant treatment effects on psychiatric symptom ratings or psychiatric adverse events. CONCLUSIONS AND RELEVANCE: Among smokers with serious mental illness who attained initial abstinence with standard treatment, maintenance pharmacotherapy with varenicline and cognitive behavioral therapy improved prolonged tobacco abstinence rates compared with cognitive behavioral therapy alone after 1 year of treatment and at 6 months after treatment discontinuation. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00621777.

A randomized feasibility study of a positive psychology journaling intervention to support recovery from substance-use disorders.

BACKGROUND: Individuals in early recovery face significant biopsychosocial stressors causing a preponderance of negative affect. Novel interventions are needed to improve mood and well-being to support recovery. Positive Recovery Journaling (PRJ) combines elements of positive psychology, behavioral activation, and journaling to emphasize what is going right and to encourage small, positive steps that align with an individual's values to make life in recovery more rewarding and therefore more reinforcing. Our objective was to determine PRJ's feasibility, acceptability, and impact on a set of strengths-based, multidimensional aspects of recovery, including satisfaction with life, happiness with recovery, and commitment to sobriety. METHODS: The study randomized adults in substance-use disorder treatment (N = 81) to PRJ or control. Those in PRJ were asked to practice PRJ daily and complete online surveys for four weeks; those in the control group completed online surveys for four weeks. We used multi-level modelling to determine intercept and slope for feasibility and acceptability outcomes as well as to compare differences in recovery indicators between treatment and control at baseline and Weeks 2, 4, and 8. We conducted intention-to-treat and per-protocol analyses for each recovery indicator. RESULTS: Participants were 53 % female, and 26 % Black, Indigenous, People of Color (BIPOC) and mean age of 39 years. PRJ participants attended 71 % of groups and completed 56 % of the daily PRJ entries. Treatment and control groups rated their study tasks (PRJ for the treatment group, surveys for the control group) as equally easy; however, the PRJ group rated PRJ as significantly more satisfying, helpful, and pleasant. Treatment and control were not significantly different on any recovery indicator. In post hoc analyses, we found that for those with <90 days sobriety at baseline (51 %), PRJ had a statistically significant beneficial effect for satisfaction with life, happiness with recovery, and numerous secondary recovery indicators. DISCUSSION: Results suggest a positive impact of PRJ on numerous recovery indices for those in earliest recovery. Integrating PRJ into support services among those with <90 days sobriety could reinforce what is going well in recovery to encourage its continued maintenance and thereby improve treatment outcomes.

Time to Response in Therapy for Body Dysmorphic Disorder: A Comparison of Cognitive Behavioral Therapy and Supportive Psychotherapy.

Psychotherapy has been shown to be effective for individuals with body dysmorphic disorder (BDD); however, time to treatment response for different treatments have not yet been examined. We randomized 120 patients to either weekly cognitive behavioral therapy (CBT) or supportive psychotherapy (SPT) at two academic medical research centers. In this secondary data analysis, we aimed to determine the time to first response (30% or greater reduction in BDD symptom severity) in both treatment conditions among those who attended at least one post-baseline assessment (n = 109). As previously reported, CBT for BDD was associated with more consistent improvement in symptom severity and quality of life than SPT. In a pooled analysis combining both sites, the median time to first response was shorter for CBT (76 days [10.9 weeks], 95% CI: 76-107 days) than for SPT (88 days [12.6 weeks], 95% CI: 88-nonestimable days; Χ2df=1 = 3.85, p = .0498). For CBT, the estimated 75th percentile response times were 148 days [21.1 weeks] at site 1 and 134 days [19.1 weeks] at site 2. Response times were not estimable for SPT at either site because the response rate was too low. Thus, therapy clients seeking treatment for BDD and clinicians should be aware that an initial treatment response requires more than 11 therapy sessions for the majority of clients, and that 21 or even more sessions may be required. Treatment response is likely to occur earlier with CBT for BDD (the first-line therapy for BDD) than with supportive psychotherapy.

Impact of sleep disruption on BDD symptoms and treatment response.

BACKGROUND: Body dysmorphic disorder (BDD) is severe, undertreated, and relatively common. Although gold-standard cognitive behavioral therapy (CBT) for BDD has strong empirical support, a significant number of patients do not respond. More work is needed to understand BDD's etiology and modifiable barriers to treatment response. Given its high prevalence and impact on the development, maintenance, and treatment of related, frequently comorbid disorders, sleep disruption is a compelling, but not-yet studied factor. METHODS: Data were drawn from a randomized controlled trial of guided smartphone app-based CBT for BDD. Included participants were offered 12-weeks of treatment, immediately (n = 40) or after a 12-week waitlist (n = 37). Sleep disruption and BDD symptom severity were assessed at baseline, week-6, and week-12. RESULTS: Hypotheses and analysis plan were pre-registered. Two-thirds of patients reported significant insomnia symptoms at baseline. Baseline severity of sleep disruption and BDD symptoms were not related (r = 0.02). Pre-treatment sleep disruption did not predict BDD symptom reduction across treatment, nor did early sleep improvements predict greater BDD symptom improvement. Early BDD symptom improvement also did not predict later improvements in sleep. LIMITATIONS: Limitations include the small sample, restricted ranges of BDD symptom severity and treatment response, and few metrics of sleep disruption. CONCLUSIONS: Although insomnia was disproportionately high in this sample and both BDD symptoms and sleep improved in treatment, results suggest sleep and BDD symptoms may function largely independent of one another. More work is encouraged to replicate and better understand findings as well as potential challenges and benefits of addressing sleep in BDD.

Feasibility, Acceptability, and Preliminary Efficacy of a Smartphone App-Led Cognitive Behavioral Therapy for Depression Under Therapist Supervision: Open Trial.

BACKGROUND: Major depressive disorder affects approximately 1 in 5 adults during their lifetime and is the leading cause of disability worldwide. Yet, a minority receive adequate treatment due to person-level (eg, geographical distance to providers) and systems-level (eg, shortage of trained providers) barriers. Digital tools could improve this treatment gap by reducing the time and frequency of therapy sessions needed for effective treatment through the provision of flexible, automated support. OBJECTIVE: This study aimed to examine the feasibility, acceptability, and preliminary clinical effect of Mindset for Depression, a deployment-ready 8-week smartphone-based cognitive behavioral therapy (CBT) supported by brief teletherapy appointments with a therapist. METHODS: This 8-week, single-arm open trial tested the Mindset for Depression app when combined with 8 brief (16-25 minutes) video conferencing visits with a licensed doctoral-level CBT therapist (n=28 participants). The app offers flexible, accessible psychoeducation, CBT skills practice, and support to patients as well as clinician guidance to promote sustained engagement, monitor safety, and tailor treatment to individual patient needs. To increase accessibility and thus generalizability, all study procedures were conducted remotely. Feasibility and acceptability were assessed via attrition, patient expectations and feedback, and treatment utilization. The primary clinical outcome measure was the clinician-rated Hamilton Depression Rating Scale, administered at pretreatment, midpoint, and posttreatment. Secondary measures of functional impairment and quality of life as well as maintenance of gains (3-month follow-up) were also collected. RESULTS: Treatment credibility (week 4), expectancy (week 4), and satisfaction (week 8) were moderate to high, and attrition was low (n=2, 7%). Participants self-reported using the app or practicing (either on or off the app) the CBT skills taught in the app for a median of 50 (IQR 30-60; week 4) or 60 (IQR 30-90; week 8) minutes per week; participants accessed the app on an average 36.8 (SD 10.0) days and completed a median of 7 of 8 (IQR 6-8) steps by the week 8 assessment. The app was rated positively across domains of engagement, functionality, aesthetics, and information. Participants' depression severity scores decreased from an average Hamilton Depression Rating Scale score indicating moderate depression (mean 19.1, SD 5.0) at baseline to a week 8 mean score indicating mild depression (mean 10.8, SD 6.1; d=1.47; P<.001). Improvement was also observed for functional impairment and quality of life. Gains were maintained at 3-month follow-up. CONCLUSIONS: The results show that Mindset for Depression is a feasible and acceptable treatment option for individuals with major depressive disorder. This smartphone-led treatment holds promise to be an efficacious, scalable, and cost-effective treatment option. The next steps include testing Mindset for Depression in a fully powered randomized controlled trial and real-world clinical settings. TRIAL REGISTRATION: ClinicalTrials.gov NCT05386329; https://clinicaltrials.gov/study/NCT05386329?term=NCT05386329.