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.

Predicting response to a smartphone-based cognitive-behavioral therapy for body dysmorphic disorder.

BACKGROUND: Body dysmorphic disorder (BDD) is a severe, chronic disorder if untreated. Smartphone cognitive behavioral therapy (CBT) for BDD is efficacious and can reduce key treatment barriers (e.g., lack of clinicians, cost, stigma). While promising, little is known about who is more or less likely to benefit from this approach. METHODS: This is a secondary data analysis of a randomized, waitlist-controlled trial of smartphone CBT for BDD. Participants (N = 80) were recruited nationally and randomized to receive a 12-week, coach-guided CBT for BDD app, either immediately or after a 12-week waitlist. The main outcome for this analysis was BDD severity (BDD-YBOCS) over time (baseline, week 6, week 12) during the active app use phase in each randomized group (n = 74). Secondary outcomes included treatment response (≥30 % reduction in BDD-YBOCS) and remission (total BDD-YBOCS ≤16) at end-of-treatment. RESULTS: Immediate (vs. delayed) CBT predicted better outcomes (symptom improvement), as did gender identity (symptom improvement), higher baseline treatment credibility and expectancy (response, remission), lower baseline BDD severity (remission), and sexual minority status (vs. heterosexual; response, remission). LIMITATIONS: Limitations include the relatively small sample, drop-out rate of 22 %, and limited gender and racial-ethnic diversity. CONCLUSIONS: These results highlight a potential advantage of smartphone CBT in historically marginalized populations, and the importance of efforts to hasten treatment access, bolster confidence in the treatment at treatment onset, and develop stratified care models to optimize treatment allocation and efficacy.

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.

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.

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.

Identifying sex-specific anthropometric measures and thresholds for dysglycemia screening in an HIV-endemic rural South African population.

Valid screening and diagnostic algorithms are needed to achieve 2030 targets proposed by the WHO's Global Diabetes Compact. We explored anthropometric thresholds to optimally screen and refer individuals for diabetes testing in rural South Africa. We evaluated screening thresholds for waist circumference (WC), body mass index (BMI), and waist-hip ratio (WHR) to detect dysglycemia based on a glycated hemoglobin (HbA1C) ≥6.5% among adults in a population-based study in South Africa using weighted, non-parametric ROC regression analyses. We then assessed the diagnostic validity of traditional obesity thresholds, explored optimal thresholds for this population, and fit models stratified by sex, age, and HIV status. The prevalence of dysglycemia in the total study population (n = 17,846) was 7.7%. WC had greater discriminatory capacity than WHR to detect dysglycemia in men (p-value<0.001) and women (p<0.001). WC had greater discriminatory capacity than BMI to detect dysglycemia in women (p<0.001). However, BMI and WC performed similarly for men (p = 0.589). Whereas traditional WC thresholds for women (>81cm) performed well (sensitivity 91%, positive predictive value [PPV] 14.9%), substantially lower thresholds were needed to achieve acceptable sensitivity and PPV among men (traditional >94cm, derived >79.5cm). WC outperforms BMI as an anthropometric screening measure for dysglycemia in rural South Africa. Whereas WC guideline thresholds are appropriate for women, male-derived WC cutoffs performed better at lower thresholds. In this rural South African population, thresholds that maximize specificity and PPV for efficient resource allocation may be preferred.

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.

Association between prior tuberculosis disease and dysglycemia within an HIV-endemic, rural South African population.

OBJECTIVE: Tuberculosis (TB) may predispose individuals to the development of diabetes. Such a relationship could have an outsized impact in high-prevalence TB settings. However, few studies have explored this relationship in populations heavily burdened by diabetes and TB. METHODS: We analyzed data from a community-based population cohort that enrolled adults in rural South Africa. Individuals were considered to have prior TB if they self-reported a history of TB treatment. We fitted sex-specific logistic regression models, adjusted for potential clinical and demographic confounders, to estimate relationships between dysglycemia (HBA1c ≥6.5%) and prior TB. Propensity score-matched cohorts accounted for the differential age distributions between comparator groups. We examined the interactions between sex, prior TB, and HIV status. RESULTS: In the analytic cohort (n = 17,593), the prevalence of prior TB was 13.8% among men and 10.7% among women. Dysglycemia was found in 9.1% of the population, and HIV prevalence was 34.0%. We found no difference in dysglycemia prevalence by prior TB (men OR 0.96, 95% CI 0.60-1.56: women OR 1.05, 95% CI 0.79-1.39). However, there was a qualitative interaction by HIV serostatus, such that among men without HIV, those with a history of TB had a greater prevalence of dysglycemia than those without prior TB (10.1% vs. 4.6%, p = 0.0077). An inverse relationship was observed among men living with HIV (prior TB 3.3% vs. no TB 7.3%, p = 0.0073). CONCLUSIONS: Treated TB disease was not associated with dysglycemia in an HIV-endemic, rural South African population. However, we found a significant interaction between prior TB and HIV status among men, suggesting distinct pathophysiological mechanisms between the two infections that may impact glucose metabolism. Longitudinal studies are needed to better establish a causal effect and underlying mechanisms related to resolved TB, HIV, and diabetes.

Characterizing observed and effective behavioral engagement with smartphone cognitive behavioral therapy for body dysmorphic disorder: A methods roadmap and use case.

Smartphone psychotherapies are growing in popularity, yet little is understood about (1) how people prefer to engage with psychotherapy apps, or (2) which engagement patterns constitute effective engagement. The present study uses secondary data from a 12-week randomized waitlist-controlled trial of smartphone-delivered cognitive behavioral therapy (CBT) for body dysmorphic disorder (BDD) (N = 77) to address these aims. Additionally, using the present study as a use-case, we seek to provide a roadmap for how researchers may improve upon methodological limitations of existing smartphone psychotherapy engagement research. We measured behavioral engagement via 19 objective variables derived from phone analytics data, which we reduced via factor analysis into two factors: 1) use volume and frequency, and 2) session duration. Cluster analysis based on engagement factors yielded three engager types, which mapped onto "deep" users, "samplers," and "light" users. The clusters did not differ significantly in improvement in BDD severity across treatment, although deep users improved more than light users at a marginally significant level. Results suggest that varying patterns of preferred engagement may be efficacious. Moreover, the study's methods provide an example of how researchers can measure and study behavioral engagement comprehensively and objectively. Trial Registration: ClinicalTrials.gov Identifier: NCT04034693.

Testing the Outcomes of a Smoking Cessation Smartphone App for Nondaily Smokers: Protocol for a Proof-of-concept Randomized Controlled Trial.

BACKGROUND: Nondaily smoking is a widespread, increasingly prevalent pattern of smoking, particularly in ethnic minority and vulnerable populations. To date, no effective treatment approach for this type of smokers has been identified. OBJECTIVE: This study aims to use a randomized controlled trial to evaluate proof-of-concept markers of the Smiling instead of Smoking (SiS) app, a smoking cessation smartphone app designed specifically for nondaily smokers. This app was developed iteratively and is now in its third version. Previous studies have demonstrated acceptability and feasibility when participants were onboarded in person (study 1) and remotely (study 2) and showed within-person changes in line with hypothesized mechanisms of change. This is the first randomized test of this app. METHODS: In total, 225 adult nondaily smokers will be asked to undertake a quit attempt while using smoking cessation support materials for a period of 7 weeks. Participants will be randomized to use the SiS smartphone app, the National Cancer Institute smartphone app QuitGuide, or the National Cancer Institute smoking cessation brochure "Clearing the Air." Participants will take part in a 15-minute scripted onboarding phone call during which study staff will introduce participants to their support materials. Survey links will be sent 2, 6, 12, and 24 weeks after the participants' initially chosen quit date. The primary outcome is self-efficacy to remain abstinent from smoking at treatment end, measured using the Smoking Self-Efficacy Questionnaire. Secondary outcomes cover several domains relevant to treatment development and implementation: treatment acceptability (eg, satisfaction with smoking cessation support, measured using the Client Satisfaction Questionnaire, and app usability, measured using the System Usability Scale); treatment feasibility (eg, measured using the number of days participants used the SiS or QuitGuide app during the prescribed treatment period); and, in an exploratory way, treatment efficacy assessed using self-reported 30-day point prevalence abstinence. RESULTS: Recruitment began in January 2021 and ended June 2022. The final 24-week follow-up was completed in January 2023. This trial is funded by the American Cancer Society. CONCLUSIONS: This study is designed to test whether the prescribed use of the SiS app results in greater self-efficacy to abstain from smoking in nondaily smokers than commonly recommended alternative treatments and whether the SiS app treatment is acceptable and feasible. Positive results will mean that the SiS app warrants testing in a large-scale randomized controlled trial to test its effectiveness in supporting smoking cessation in nondaily smokers. The design of this study also provides insights into issues pertinent to smoking cessation smartphone app treatment development and implementation by measuring, in a randomized design, markers of treatment satisfaction, engagement with the technology and content of the treatment, and adherence to the treatment plan. TRIAL REGISTRATION: ClinicalTrials.gov NCT04672239; https://clinicaltrials.gov/ct2/show/NCT04672239. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/40867.

Associations of the COVID-19 pandemic with quality of life: A cross-sectional study of older-age people with and without HIV in rural Uganda.

Background: COVID-19-related lockdowns and other public health measures may have differentially affected the quality of life (QOL) of older people with and without human immunodeficiency virus (HIV) in rural Uganda. Methods: The Quality of Life and Aging with HIV in Rural Uganda study enrolled people with and without HIV aged over 49 from October 2020 to October 2021. We collected data on COVID-19-related stressors (behavior changes, concerns, interruptions in health care, income, and food) and the participants' QOL. We used linear regression to estimate the associations between COVID-19-related stressors and QOL, adjusting for demographic characteristics, mental and physical health, and time before vs after the lockdown during the second COVID-19 wave in Uganda. Interaction between HIV and COVID-19-related stressors evaluated effect modification. Results: We analyzed complete data from 562 participants. Mean age was 58 (standard deviation (SD) = 7); 265 (47%) participants were female, 386 (69%) were married, 279 (50%) had HIV, and 400 (71%) were farmers. Those making ≥5 COVID-19-related behavior changes compared to those making ≤2 had worse general QOL (estimated linear regression coefficient (b) = - 4.77; 95% confidence interval (CI) = -6.61, -2.94) and health-related QOL (b = -4.60; 95% CI = -8.69, -0.51). Having access to sufficient food after the start of the COVID-19 pandemic (b = 3.10, 95% CI = 1.54, 4.66) and being interviewed after the start of the second lockdown (b = 2.79, 95% CI = 1.30, 4.28) were associated with better general QOL. Having HIV was associated with better health-related QOL (b = 5.67, 95% CI = 2.91,8.42). HIV was not associated with, nor did it modify the association of COVID-19-related stressors with general QOL. Conclusions: In the context of the COVID-19 pandemic in an HIV-endemic, low-resource setting, there was reduced QOL among older Ugandans making multiple COVID-19 related behavioral changes. Nonetheless, good QOL during the second COVID-19 wave may suggest resilience among older Ugandans.

Mechanisms of cognitive behavioral therapy vs. supportive psychotherapy in body dysmorphic disorder: An exploratory mediation analysis.

Body dysmorphic disorder (BDD) is common, severe, and often chronic. Cognitive behavioral therapy (CBT) is the first-line psychosocial treatment for BDD, with well-established efficacy. However, some patients do not improve with CBT, and little is known about how CBT confers its effects. Neurocognitive processes have been implicated in the etiology and maintenance of BDD and are targeted by CBT-BDD treatment components. Yet, the malleability of these factors in BDD, and their potential role in mediating symptom improvement, are not well understood. Understanding how treatment works could help optimize treatment outcomes. In this secondary data analysis of a randomized clinical trial of CBT vs. supportive psychotherapy (SPT) in BDD (n = 120), we examined whether treatment-related changes in detail processing (Rey-Osterrieth Complex Figure test), maladaptive appearance beliefs (Appearance Schemas Inventory-Revised), and emotion recognition (Emotion Recognition Task) mediated treatment outcome. All constructs improved over time and were associated with symptom improvement. CBT was associated with greater improvements in maladaptive beliefs than SPT. None of the variables examined mediated symptom improvement. Findings suggest that with successful treatment, individuals with BDD demonstrate reduced neurocognitive deficits (detail processing, emotion recognition, maladaptive beliefs) and that CBT is more likely than SPT to improve maladaptive appearance beliefs. More work is needed to understand mechanisms of change and thus maximize treatment outcomes.

Credibility and expectancy of smartphone-based cognitive behavioral therapy among adults with body dysmorphic disorder.

BACKGROUND: Few patients receive cognitive behavioral therapy, the gold-standard for body dysmorphic disorder (CBT-BDD). Smartphones can make evidence-based interventions, like CBT-BDD, more accessible and scalable. A key question is: how do patients view it? Low credibility and expectancy would likely translate to low uptake and engagement outside of research settings, diminishing the impact. Thus, it is important to understand patients' beliefs about digital CBT-BDD. METHODS: We compared credibility and expectancy in a coach-guided app-based CBT-BDD trial (N=75) to a previous in-person CBT-BDD trial (N = 55). We further examined the relationship of perceptions of digital CBT-BDD to baseline clinical and demographic factors and dropout. RESULTS: Credibility did not differ between the in-person (M=19.3) and digital (M=18.3) trials, p=.24. Expectancy for improvement was moderately higher for in-person (M=58.4) than digital (M=48.3) treatment, p=.005. In the digital trial, no demographic variables were associated with credibility or expectancy. Better BDD-related insight and past non-CBT BDD therapy were associated with greater expectancy. Credibility was associated with lower likelihood of dropout. DISCUSSION: Digital CBT-BDD was regarded as similarly credible to in-person CBT-BDD but with lower expectancy. Tailored expectancy-enhancing strategies could strengthen this novel approach, particularly among those with poorer insight and without prior BDD treatment.

A secondary analysis examining the performance of the State Optimism Measure (SOM) compared to the Life Orientation Test-Revised (LOT-R) in measuring optimism over time.

Objective: Optimism is an important factor impacting health and human functioning. Originally conceptualized as a trait, increasing evidence indicates that optimism can change over time and could be an intervention target. Measures are needed that can capture changes in optimism.Design: In this secondary analysis, we compared the performance of a newly developed state measure, the State Optimism Measure (SOM), to the widely used trait measure, the Life Orientation Test-Revised (LOT-R), in detecting changes over time during a disruptive life event: the onset of the COVID-19 pandemic in the United States.Main Outcome Measures: Participants (n = 81) were nondaily smokers participating in a smoking cessation intervention, who completed the SOM and LOT-R before and after the initial COVID-19 outbreak.Results: Optimism declined from pre- to post-COVID-19 outbreak, as assessed by both scales (LOT-R: p=.0147,gav=0.23; SOM: p<.0001,gav=0.56). The change detected was greater when measured by the SOM (p<.0001). Changes in optimism were correlated with concurrent changes in perceived stress, positive affect, and negative affect.Conclusion: Our results suggest that the SOM has a greater sensitivity to detect within-person changes in optimism than the LOT-R and highlight the SOM's utility for longitudinal studies assessing changes in optimism.

Feature-Level Analysis of a Smoking Cessation Smartphone App Based on a Positive Psychology Approach: Prospective Observational Study.

BACKGROUND: Smoking cessation smartphone apps have emerged as highly accessible tools to support smoking cessation efforts. It is unknown how specific app features contribute to user engagement over time and relate to smoking outcomes. OBJECTIVE: To provide a feature-level analysis of the Smiling Instead of Smoking app (version 2) and to link feature use to subsequent smoking cessation. METHODS: Nondaily smokers (N=100) used the app for a period of 49 days (1 week before quitting and 6 weeks after quitting). Participants self-reported 30-day point-prevalence abstinence at the end of this period and at a 6-month follow up (the survey response rate was 94% and 89% at these points, respectively). Self-reported 30-day point prevalence abstinence rates were 40% at the end of treatment and 56% at the 6-month follow up. The app engaged users in both positive psychology content and traditional behavioral smoking cessation content. The app sent push notifications to prompt participants to complete prescribed content (ie, a "happiness exercise" every day and a "behavioral challenge" to use the app's smoking cessation tools on 15 out of 49 days). Actions that participants took within the app were timestamped and recorded. RESULTS: Participants used the app on 24.7 (SD 13.8) days out of the 49 prescribed days, interacting with the happiness content on more days than the smoking content (23.8, SD 13.8 days vs 17.8, SD 10.3 days; t99=9.28 [2-tailed]; P<.001). The prescribed content was frequently completed (45% of happiness exercises; 57% of behavioral challenges) and ad libitum tools were used on ≤7 days. Most participants used each ad libitum smoking cessation tool at least once, with higher use of personalized content (≥92% used "strategies," "cigarette log," "smoke alarms," and "personal reasons") than purely didactic content (79% viewed "benefits of quitting smoking"). The number of days participants used the app significantly predicted 30-day point-prevalence abstinence at the end of treatment (odds ratio [OR] 1.05, 95% CI 1.02-1.09; P=.002) and at the 6-month follow up (OR 1.04, 95% CI 1.008-1.07; P=.01). The number of days participants engaged with the happiness content significantly predicted smoking abstinence at the end of treatment (OR 1.05, 95% CI 1.02-1.08; P=.002) and at the 6-month follow up (OR 1.04, 95% CI 1.007-1.07; P=.02). This effect was not significant for the number of days participants engaged with the smoking cessation content of the app, either at the end of treatment (OR 1.04, 95% CI 0.996-1.08, P=.08) or at the 6-month follow up (OR 1.02, 95% CI 0.98-1.06; P=.29). CONCLUSIONS: Greater app usage predicted greater odds of self-reported 30-day point-prevalence abstinence at both the end of treatment and over the long term, suggesting that the app had a therapeutic benefit. Positive psychology content and prescriptive clarity may promote sustained app engagement over time. TRIAL REGISTRATION: ClinicalTrials.gov NCT03951766; https://clinicaltrials.gov/ct2/show/NCT03951766.

Impact of preference for yoga or cognitive behavioral therapy in patients with generalized anxiety disorder on treatment outcomes and engagement.

There is some, but inconsistent, evidence to suggest that matching patient treatment preference enhances treatment engagement and outcome. The current study examined differential preferences and factors associated with treatment preference for 12-week group cognitive behavioral therapy (CBT), yoga, or stress education in 226 adults with generalized anxiety disorder (GAD; 70% female, Mean age = 33 ± 13.5). In a subsample of 165 patients who reported an intervention preference and were randomized to yoga or CBT, we further examined whether match to preferred intervention improved the primary treatment outcome (responder status on Clinical Global Impressions Scale) and engagement (dropout, homework compliance). Preferences for CBT (44%) and yoga (40%) were similar among patients. Women tended to prefer yoga (OR = 2.75, p = .01) and CBT preference was associated with higher baseline perceived stress (OR = 0.92, p = .04) and self-consciousness meta-cognitions (OR = 0.90, p = .02). Among those not matched to their preference, treatment response was higher for those receiving CBT than yoga (OR = 11.73, p = .013); there were no group differences for those matched to their treatment preference. In yoga, those who received their preference were more likely to drop than those who did not (OR = 3.02, 95% CI = [1.20, 7.58], p = .037). This was not the case for CBT (OR = 0.37, 95% CI = [0.13, 1.03], p = .076). Preference match did not predict homework compliance. Overall, results suggest that treatment preference may be important to consider to optimize outcome and engagement; however, it may vary by treatment modality. Future research incorporating preference, especially with yoga for anxiety, is aligned with personalized medicine. TRIAL REGISTRATION: clinicaltrials.gov: NCT01912287; https://clinicaltrials.gov/ct2/show/NCT01912287.

Early response to cognitive behavioral therapy for body dysmorphic disorder as a predictor of outcomes.

Individuals with body dysmorphic disorder (BDD) suffer from distressing or impairing preoccupations with perceived imperfections in their appearance. This often-chronic condition is associated with significant functional impairment and elevated rates of psychiatric comorbidity and morbidity, including depression, substance use disorders, and suicidality. Cognitive behavioral therapy (CBT) for BDD has been shown to be efficacious. However, this intervention is long (up to 24 weeks) relative to many manualized approaches for other related conditions, there is a significant shortage of clinicians trained in CBT for BDD, and some patients drop out of treatment and/or do not respond. Thus, there is great interest in understanding and predicting who is most likely to respond, to better allocate clinical resources. This secondary data analysis of participants enrolled in prior uncontrolled and controlled studies of CBT for BDD explored whether early response to CBT, operationalized as percentage change in symptom severity within the first four weeks and the first 12 weeks of this 24-week treatment, predicts clinical outcomes for patients with BDD (n = 90). The findings indicated that minimal early symptom change was not indicative of eventual non-response. This suggests that patients and clinicians should not be discouraged by limited early improvement but should instead continue with a full course of treatment before reevaluating progress and alternative interventions. Overall, the results support the view that treatment success is more likely if a longer CBT protocol is followed. More work is needed to understand mechanisms of change and thus match optimal interventions to patient characteristics.

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.

COVID-19 and obsessive-compulsive symptoms in a large multi-site college sample.

The COVID-19 pandemic poses unique risks to college students' mental health, and specifically to symptoms of obsessive-compulsive disorder (OCD). To better understand the relationship between COVID-19 impact and OC symptoms in this population, six colleges from across the US administered a battery of questionnaires and an emotion differentiation paradigm to eligible students (N = 841). We examined whether degree of pandemic-related disruption was associated with OC severity, and if so, whether this relationship was explained by trait (poor emotion regulation and differentiation) and state risk factors (poor sleep quality, less exercise frequency, less social support, thwarted sense of belongingness, and greater loneliness). Results indicated that the positive relationship between COVID-19 impact and OC severity was mediated by trait emotion-related processes (e.g., emotion regulation and differentiation), but no state risk factors emerged as significant mediators. Our findings contribute to the literature demonstrating a significant relationship between COVID-19 impact and OC severity, and highlight that emotion regulation difficulties may help explain this association. Our findings can inform evidence-based interventions on college campuses; however, the cross-sectional design precludes causal inferences. Future research should evaluate these relationships longitudinally and incorporate other psychosocial factors that may operate as mechanisms.

An Evaluation of the Body Dysmorphic Disorder Symptom Scale as a Measure of Treatment Response and Remission in Psychotherapy and Medication Trials.

The Body Dysmorphic Disorder Symptom Scale (BDD-SS) is a self-report tool that captures an array of representative behavioral and cognitive symptoms commonly displayed by individuals with BDD. The BDD-SS is regularly used among experts in the field, though its utility as a measure of treatment response has not yet been formally evaluated. Results from two clinical trials of BDD treatment were pooled from an archived database to create a sample of 220 BDD participants who received either psychosocial or medication-based interventions for BDD. We used baseline BDD-SS scores to describe psychometric properties, baseline correlations with other scales to examine the content validity of the BDD-SS, and longitudinal symptom data to evaluate capacity to detect clinically relevant change. Results indicated that the BDD-SS has good psychometric properties and is able to detect symptom change over time, although it showed lower rates of reliable change with treatment relative to the gold standard rater-administered Yale-Brown Obsessive-Compulsive Scale Modified for BDD (BDD-YBOCS). The BDD-SS offers meaningful information about treatment response in a self-report format and may be particularly useful to employ in clinical practice settings as a means of gathering symptom and treatment response data via self-report when rater-administered interviews are not feasible, although it may underestimate the extent of improvement with treatment.