Common practices for sociodemographic data reporting in digital mental health intervention research: a scoping review.

BACKGROUND: The ability of digital mental health interventions (DMHIs) to reduce mental health disparities relies on the recruitment of research participants with diverse sociodemographic and self-identity characteristics. Despite its importance, sociodemographic reporting in research is often limited, and the state of reporting practices in DMHI research in particular has not been comprehensively reviewed. OBJECTIVES: To characterise the state of sociodemographic data reported in randomised controlled trials (RCTs) of app-based DMHIs published globally from 2007 to 2022. METHODS: A scoping review of RCTs of app-based DMHIs examined reporting frequency for 16 sociodemographic domains (eg, gender) and common category options within each domain (eg, woman). The search queried five electronic databases. 5079 records were screened and 299 articles were included. RESULTS: On average, studies reported 4.64 (SD=1.79; range 0-9) of 16 sociodemographic domains. The most common were age (97%) and education (67%). The least common were housing situation (6%), residency/location (5%), veteran status (4%), number of children (3%), sexual orientation (2%), disability status (2%) and food security (<1%). Gender or sex was reported in 98% of studies: gender only (51%), sex only (28%), both (<1%) and gender/sex reported but unspecified (18%). Race or ethnicity was reported in 48% of studies: race only (14%), ethnicity only (14%), both (10%) and race/ethnicity reported but unspecified (10%). CONCLUSIONS: This review describes the widespread underreporting of sociodemographic information in RCTs of app-based DMHIs published from 2007 to 2022. Reporting was often incomplete (eg, % female only), unclear (eg, the conflation of gender/sex) and limited (eg, only options representing majority groups were reported). Trends suggest reporting has somewhat improved in recent years. Diverse participant populations must be welcomed and described in DMHI research to broaden learning and the generalisability of results, a prerequisite of DMHI's potential to reduce disparities in mental healthcare.

Improvements in Work Productivity and Activity Impairment Among Adults With Anxiety or Depressive Symptoms Participating in a Relational Agent-Delivered Digital Mental Health Intervention.

OBJECTIVES: The study aimed to assess changes between baseline and end of treatment in work-related absenteeism, presenteeism, productivity, and nonwork-related activity impairment and estimate cost savings associated with observed improvements. METHODS: Data from 91 employed adult participants who enrolled in a single-arm, exploratory study of a relational agent-delivered digital mental health intervention and completed Work Productivity and Activity Impairment assessments were analyzed; overall work productivity improvement was multiplied by the overall and education-adjusted US median annual salary to arrive at potential cost savings estimates. RESULTS: Adjusted models indicated more than 20% improvements in presenteeism, work productivity impairment, and activity impairment, yielding cost-savings estimates between $14,000 and more than $18,000 annually. CONCLUSIONS: Relational agent-delivered digital mental health interventions may be associated with improvements in work productivity and activity impairment, which could result in a sizable cost savings.

Demographic and clinical characteristics associated with anxiety and depressive symptom outcomes in users of a digital mental health intervention incorporating a relational agent.

BACKGROUND: Digital mental health interventions (DMHIs) may reduce treatment access issues for those experiencing depressive and/or anxiety symptoms. DMHIs that incorporate relational agents may offer unique ways to engage and respond to users and to potentially help reduce provider burden. This study tested Woebot for Mood & Anxiety (W-MA-02), a DMHI that employs Woebot, a relational agent that incorporates elements of several evidence-based psychotherapies, among those with baseline clinical levels of depressive or anxiety symptoms. Changes in self-reported depressive and anxiety symptoms over 8 weeks were measured, along with the association between each of these outcomes and demographic and clinical characteristics. METHODS: This exploratory, single-arm, 8-week study of 256 adults yielded non-mutually exclusive subsamples with either clinical levels of depressive or anxiety symptoms at baseline. Week 8 Patient Health Questionnaire-8 (PHQ-8) changes were measured in the depressive subsample (PHQ-8 ≥ 10). Week 8 Generalized Anxiety Disorder-7 (GAD-7) changes were measured in the anxiety subsample (GAD-7 ≥ 10). Demographic and clinical characteristics were examined in association with symptom changes via bivariate and multiple regression models adjusted for W-MA-02 utilization. Characteristics included age, sex at birth, race/ethnicity, marital status, education, sexual orientation, employment status, health insurance, baseline levels of depressive and anxiety symptoms, and concurrent psychotherapeutic or psychotropic medication treatments during the study. RESULTS: Both the depressive and anxiety subsamples were predominantly female, educated, non-Hispanic white, and averaged 38 and 37 years of age, respectively. The depressive subsample had significant reductions in depressive symptoms at Week 8 (mean change =-7.28, SD = 5.91, Cohen's d = -1.23, p < 0.01); the anxiety subsample had significant reductions in anxiety symptoms at Week 8 (mean change = -7.45, SD = 5.99, Cohen's d = -1.24, p < 0.01). No significant associations were found between sex at birth, age, employment status, educational background and Week 8 symptom changes. Significant associations between depressive and anxiety symptom outcomes and sexual orientation, marital status, concurrent mental health treatment, and baseline symptom severity were found. CONCLUSIONS: The present study suggests early promise for W-MA-02 as an intervention for depression and/or anxiety symptoms. Although exploratory in nature, this study revealed potential user characteristics associated with outcomes that can be investigated in future studies. TRIAL REGISTRATION: This study was retrospectively registered on ClinicalTrials.gov (#NCT05672745) on January 5th, 2023.

Anatomy of a Woebot® (WB001): agent guided CBT for women with postpartum depression.

INTRODUCTION: Postpartum depression (PPD) is common, persistent, and stigmatized. There are insufficient trained professionals to deliver appropriate screening, diagnosis, and treatment. AREAS COVERED: WB001 is a Software as a Medical Device (SaMD) based Agent-Guided Cognitive-Behavioral Therapy (AGCBT) program for the treatment of PPD, for which Breakthrough Device Designation was recently granted by the US Food and Drug Administration. WB001 combines therapeutic alliance, human-centered design, machine learning techniques, and established principles from CBT and interpersonal therapy (IPT). We introduce AGCBT as a new model of service delivery, whilst describing Woebot, the agent technology that enables guidance through the replication of some elements of human relationships. The profile describes the device's design principles, enabling technology, risk handling, and efficacy data in PPD. EXPERT OPINION: WB001 is a dynamic and personalized tool with which patients may establish a therapeutic bond. Woebot is designed to augment (rather than replace) human healthcare providers, unlocking the therapeutic potency associated with guidance, whilst retaining the scalability and agency that characterizes self-help approaches. WB001 has the potential to improve both the quality and the scalability of care through providing support to patients on waiting lists, in between clinical encounters, and enabling automation of measurement-based-care.

Engagement, Satisfaction, and Mental Health Outcomes Across Different Residential Subgroup Users of a Digital Mental Health Relational Agent: Exploratory Single-Arm Study.

BACKGROUND: Mental illness is a pervasive worldwide public health issue. Residentially vulnerable populations, such as those living in rural medically underserved areas (MUAs) or mental health provider shortage areas (MHPSAs), face unique access barriers to mental health care. Despite the growth of digital mental health interventions using relational agent technology, little is known about their use patterns, efficacy, and favorability among residentially vulnerable populations. OBJECTIVE: This study aimed to explore differences in app use, therapeutic alliance, mental health outcomes, and satisfaction across residential subgroups (metropolitan, nonmetropolitan, or rural), MUAs (yes or no), and MHPSAs (yes or no) among users of a smartphone-based, digital mental health intervention, Woebot LIFE (WB-LIFE). WB-LIFE was designed to help users better understand and manage their moods and features a relational agent, Woebot, that converses through text-based messages. METHODS: We used an exploratory study that examined data from 255 adults enrolled in an 8-week, single-arm trial of WB-LIFE. Analyses compared levels of app use and therapeutic alliance total scores as well as subscales (goal, task, and bond), mental health outcomes (depressive and anxiety symptoms, stress, resilience, and burnout), and program satisfaction across residential subgroups. RESULTS: Few study participants resided in nonmetropolitan (25/255, 10%) or rural (3/255, 1%) areas, precluding estimates across this variable. Despite a largely metropolitan sample, nearly 39% (99/255) resided in an MUA and 55% (141/255) in an MHPSA. There were no significant differences in app use or satisfaction by MUA or MHPSA status. There also were no differences in depressive symptoms, anxiety, stress, resilience, or burnout, with the exception of MUA participants having higher baseline depressive symptoms among those starting in the moderate range or higher (Patient Health Questionnaire-8 item scale≥10) than non-MUA participants (mean 16.50 vs 14.41, respectively; P=.01). Although working alliance scores did not differ by MHPSA status, those who resided in an MUA had higher goal (2-tailed t203.47=2.21; P=.03), and bond (t203.47=1.94; P=.05) scores at day 3 (t192.98=2.15; P=.03), and higher goal scores at week 8 (t186.19=2.28; P=.02) as compared with those not living in an MUA. CONCLUSIONS: Despite the study not recruiting many participants from rural or nonmetropolitan populations, sizable proportions resided in an MUA or an MHPSA. Analyses revealed few differences in app use, therapeutic alliance, mental health outcomes (including baseline levels), or satisfaction across MUA or MHPSA status over the 8-week study. Findings suggest that vulnerable residential populations may benefit from using digital agent-guided cognitive behavioral therapy. TRIAL REGISTRATION: ClinicalTrials.gov NCT05672745; https://clinicaltrials.gov/study/NCT05672745.

Feasibility and impact of a mental health chatbot on postpartum mental health: a randomized controlled trial.

BACKGROUND: Perinatal mood disorders are common yet underdiagnosed and un- or undertreated. Barriers exist to accessing perinatal mental health services, including limited availability, time, and cost. Automated conversational agents (chatbots) can deliver evidence-based cognitive behavioral therapy content through text message-based conversations and reduce depression and anxiety symptoms in select populations. Such digital mental health technologies are poised to overcome barriers to mental health care access but need to be evaluated for efficacy, as well as for preliminary feasibility and acceptability among perinatal populations. OBJECTIVE: To evaluate the acceptability and preliminary efficacy of a mental health chatbot for mood management in a general postpartum population. STUDY DESIGN: An unblinded randomized controlled trial was conducted at a tertiary academic center. English-speaking postpartum women aged 18 years or above with a live birth and access to a smartphone were eligible for enrollment prior to discharge from delivery hospitalization. Baseline surveys were administered to all participants prior to randomization to a mental health chatbot intervention or to usual care only. The intervention group downloaded the mental health chatbot smartphone application with perinatal-specific content, in addition to continuing usual care. Usual care consisted of routine postpartum follow up and mental health care as dictated by the patient's obstetric provider. Surveys were administered during delivery hospitalization (baseline) and at 2-, 4-, and 6-weeks postpartum to assess depression and anxiety symptoms. The primary outcome was a change in depression symptoms at 6-weeks as measured using two depression screening tools: Patient Health Questionnaire-9 and Edinburgh Postnatal Depression Scale. Secondary outcomes included anxiety symptoms measured using Generalized Anxiety Disorder-7, and satisfaction and acceptability using validated scales. Based on a prior study, we estimated a sample size of 130 would have sufficient (80%) power to detect a moderate effect size (d=.4) in between group difference on the Patient Health Questionnaire-9. RESULTS: A total of 192 women were randomized equally 1:1 to the chatbot or usual care; of these, 152 women completed the 6-week survey (n=68 chatbot, n=84 usual care) and were included in the final analysis. Mean baseline mental health assessment scores were below positive screening thresholds. At 6-weeks, there was a greater decrease in Patient Health Questionnaire-9 scores among the chatbot group compared to the usual care group (mean decrease=1.32, standard deviation=3.4 vs mean decrease=0.13, standard deviation=3.01, respectively). 6-week mean Edinburgh Postnatal Depression Scale and Generalized Anxiety Disorder-7 scores did not differ between groups and were similar to baseline. 91% (n=62) of the chatbot users were satisfied or highly satisfied with the chatbot, and 74% (n=50) of the intervention group reported use of the chatbot at least once in 2 weeks prior to the 6-week survey. 80% of study participants reported being comfortable with the use of a mobile smartphone application for mood management. CONCLUSION: Use of a chatbot was acceptable to women in the early postpartum period. The sample did not screen positive for depression at baseline and thus the potential of the chatbot to reduce depressive symptoms in this population was limited. This study was conducted in a general obstetric population. Future studies of longer duration in high-risk postpartum populations who screen positive for depression are needed to further understand the utility and efficacy of such digital therapeutics for that population.

Changes in stress, burnout, and resilience associated with an 8-week intervention with relational agent "Woebot".

Background: Research investigating the potential for digital mental health interventions with integrated relational agents to improve mental health outcomes is in its infancy. By delivering evidence-based mental health interventions through tailored, empathic conversations, relational agents have the potential to help individuals manage their stress and mood, and increase positive mental health. Aims: The aims of this study were twofold: 1) to assess whether a smartphone app delivering mental health support through a relational agent, Woebot, is associated with changes in stress, burnout, and resilience over 8 weeks, and 2) to identify demographic and clinical factors associated with changes in these outcomes. Method: This exploratory, non-randomized, single-armed, open-labeled trial was conducted from May to July 2022. A total of 256 adults (mean age 39 ± 13.35; 72 % females) recruited through social media advertising enrolled in the study. Participants completed an 8-week intervention period during which they were invited to use a smartphone app called Woebot-LIFE that delivers cognitive behavioral therapy through a relational agent called "Woebot". Participant-reported measures of stress, burnout, and resilience were collected at Baseline, and Week 8. Changes in these outcomes during the study period were assessed. Bivariate and stepwise multiple regression modeling was used to identify sociodemographic and clinical factors associated with observed changes over the 8-week study period. Results: Exposure to Woebot-LIFE was associated with significant reductions in perceived stress and burnout and significantly increased resilience over the 8-week study period. A greater reduction in stress was observed among those with clinically elevated mood symptoms (i.e., Patient Health Questionnaire-8 or Generalized Anxiety Disorder 7-item scores ≥10) at baseline compared to those without; however, the differences in the improvements in resilience scores and burnout between the two groups were not statistically significant. Although a difference in the magnitude of change in stress was observed for participants with and without clinically elevated mood symptoms at baseline, significant improvements in stress, burnout, and resilience over the 8-week study period were observed for both groups. Bivariate analyses showed that race, insurance type, and baseline level of resilience were associated with changes in each of the outcomes, though baseline resilience was the only factor that remained significantly associated with changes in the outcomes in the stepwise multiple regression analyses. Conclusion: Results of this single-arm, exploratory study suggest that conversational agent-guided mental health interventions such as Woebot-LIFE may be associated with reduced stress and burnout and increased resilience in both clinical and non-clinical populations.

A Relational Agent Intervention for Adolescents Seeking Mental Health Treatment: Protocol for a Randomized Controlled Trial.

BACKGROUND: Unmet pediatric mental health (MH) needs are growing as rates of pediatric depression and anxiety dramatically increase. Access to care is limited by multiple factors, including a shortage of clinicians trained in developmentally specific, evidence-based services. Novel approaches to MH care delivery, including technology-leveraged and readily accessible options, need to be evaluated in service of expanding evidence-based services to youths and their families. Preliminary evidence supports the use of Woebot, a relational agent that digitally delivers guided cognitive behavioral therapy (CBT) through a mobile app, for adults with MH concerns. However, no studies have evaluated the feasibility and acceptability of such app-delivered relational agents specifically for adolescents with depression and/or anxiety within an outpatient MH clinic, nor compared them to other MH support services. OBJECTIVE: This paper describes the protocol for a randomized controlled trial evaluating the feasibility and acceptability of an investigational device, Woebot for Adolescents (W-GenZD), within an outpatient MH clinic for youths presenting with depression and/or anxiety. The study's secondary aim will compare the clinical outcomes of self-reported depressive symptoms with W-GenZD and a telehealth-delivered CBT-based skills group (CBT-group). Tertiary aims will evaluate additional clinical outcomes and therapeutic alliance between adolescents in W-GenZD and the CBT-group. METHODS: Participants include youths aged 13-17 years with depression and/or anxiety seeking care from an outpatient MH clinic at a children's hospital. Eligible youths will have no recent safety concerns or complex comorbid clinical diagnoses; have no concurrent individual therapy; and, if on medications, are on stable doses, based on clinical screening and as well as study-specific criteria. RESULTS: Recruitment began in May 2022. As of December 8, 2022, we have randomized 133 participants. CONCLUSIONS: Establishing the feasibility and acceptability of W-GenZD within an outpatient MH clinical setting will add to the field's current understanding of the utility and implementation considerations of this MH care service modality. The study will also evaluate the noninferiority of W-GenZD against the CBT-group. Findings may also have implications for patients, families, and providers looking for additional MH support options for adolescents seeking help for their depression and/or anxiety. Such options expand the menu of supports for youths with lower-intensity needs as well as possibly reduce waitlists and optimize clinician deployment toward more severe cases. TRIAL REGISTRATION: ClinicalTrials.gov NCT05372913; https://clinicaltrials.gov/ct2/show/NCT05372913. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/44940.

A relational agent for treating substance use in adults: Protocol for a randomized controlled trial with a psychoeducational comparator.

BACKGROUND: Substance use disorders (SUDs) are prevalent and compromise health and wellbeing. Scalable solutions, such as digital therapeutics, may offer a population-based strategy for addressing SUDs. Two formative studies supported the feasibility and acceptability of the relational agent Woebot, an animated screen-based social robot, for treating SUDs (W-SUDs) in adults. Participants randomized to W-SUDs reduced their substance use occasions from baseline to end-of-treatment (EOT) relative to a waitlist control. OBJECTIVE: To further develop the evidence base, the current randomized trial extends follow-up to 1-month post-treatment and will test the efficacy of W-SUDs relative to a psychoeducational control. METHODS: This study will recruit, screen, and consent 400 adults online reporting problematic substance use. Following baseline assessment, participants will be randomized to 8 weeks of W-SUDs or a psychoeducational control. Assessments will be conducted at weeks 4, 8 (EOT), and 12 (1-month post-treatment). Primary outcome is past-month number of substance use occasions, summed across all substances. Secondary outcomes are number of heavy drinking days, the percent of days abstinent from all substances, substance use problems, thoughts about abstinence, cravings, confidence to resist substance use, symptoms of depression and anxiety, and work productivity. If significant group differences are found, we will explore moderators and mediators of treatment effects. CONCLUSIONS: The current study builds upon emerging evidence of a digital therapeutic for reducing problematic substance use by examining sustained effects and testing against a psychoeducational control condition. If efficacious, the findings have implications for scalable mobile health interventions for reducing problematic substance use. TRIAL REGISTRATION: NCT04925570.

Anatomy of a Woebot® (WB001): agent guided CBT for women with postpartum depression.

INTRODUCTION: Postpartum Depression (PPD) is common, persistent, and stigmatized. There are insufficient trained professionals to deliver appropriate screening, diagnosis, and treatment. AREAS COVERED: WB001 is a Software as a Medical Device (SaMD) based Agent-Guided Cognitive Behavioral Therapy (AGCBT) program for the treatment of PPD, for which Breakthrough Device Designation was recently granted by the US Food and Drug Administration. WB001 combines therapeutic alliance, human-centered design, machine learning techniques, and established principles from CBT and interpersonal therapy (IPT). We introduce AGCBT as a new model of service delivery, whilst describing Woebot, the agent technology that enables guidance through the replication of some elements of human relationships. The profile describes the device's design principles, enabling technology, risk handling, and efficacy data in PPD. EXPERT OPINION: WB001 is a dynamic and personalized tool with which patients may establish a therapeutic bond. Woebot is designed to augment (rather than replace) human healthcare providers, unlocking the therapeutic potency associated with guidance, whilst retaining the scalability and agency that characterizes self-help approaches. WB001 has the potential to improve both the quality and the scalability of care through providing support to patients on waiting lists, in between clinical encounters, and enabling automation of measurement-based care.

Effectiveness of DBT skills training in outpatient men: A naturalistic study.

A plethora of research highlights the effectiveness of dialectical behavioral therapy (DBT) in improving emotion regulation and psychological functioning transdiagnostically. However, the majority of this research has focused on women, and the limited existing research on men has concentrated on high acuity patients in forensic and inpatient settings. The present study examined the effectiveness of DBT skills groups in reducing emotion regulation difficulties in a transdiagnostic sample of adult men in a university-based clinical outpatient setting using a naturalistic design. Sixteen adult male patients completed self-report measures examining emotion regulation difficulties (Difficulties in Emotion Regulation Scale) at intake and following one 12-week module of DBT skills group. Men showed a significant reduction in overall difficulty regulating emotions with a moderate effect size (d = 0.63, p < .05) following one module of DBT skills group, which were accounted for primarily by improvements on the impulse control difficulties subscale (d = 1.06, p < .01). In comparison, women (N = 82) showed significant improvements in global emotion regulation difficulties (d = 0.71, p < .01), with marked improvement across all six subscales. Implications of findings for the application of DBT for men in outpatient settings is discussed, limitations reviewed, and areas for future research suggested. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Associations Between Substance Use Problems and Stress During COVID-19.

OBJECTIVE: The COVID-19 pandemic has produced major life disruptions and increased stress. We explored associations between pandemic-related stress and substance use problems. METHOD: Adults (N = 180; 65% female) with problematic substance use (CAGE-AID > 1) were recruited online June-August 2020. Measures included the 15-item Short Inventory of Problems-Alcohol and Drugs (SIP-AD), Generalized Anxiety Disorder-7 (GAD-7) seven-item anxiety measure, Patient Health Questionnaire-8 (PHQ-8) eight-item depression measure, a three-item measure of pandemic life disruptions, a six-item measure of pandemic-related mental health effects, and a five-item measure of pandemic-related personal growth. Participants reported whether they frequented bars and attended large gatherings. Participants with children (<18 years of age) in the home completed a four-item measure of pandemic-related worry about children's well-being. Pandemic-related measures with significant bivariate associations with SIP-AD, GAD, and PHQ scores were tested in multivariable linear regression, adjusting for sex, age, and race/ethnicity. RESULTS: Participants who struggled with responsibilities at home, had greater mental health impacts, had greater personal growth, and frequented bars or large gatherings had higher SIPAD scores (all ps < .05). Participants who struggled with responsibilities at home, had difficulty getting necessities, had greater mental health impacts, and worried more about their children had higher GAD-7 and PHQ-8 scores (all ps < .05). Participants who lost a job or income during the pandemic had higher PHQ-8 scores (p = .015). In multivariable analyses, greater mental health impacts were associated with higher SIP-AD, PHQ-8, and GAD-7 scores (all ps < .05). CONCLUSIONS: Experiencing worsened mental health symptoms during COVID-19 was associated with more substance use problems and symptoms of depression and anxiety. Pandemic disruptions may exacerbate preexisting substance use problems.

A randomized controlled trial of a therapeutic relational agent for reducing substance misuse during the COVID-19 pandemic.

BACKGROUND: The COVID-19 pandemic disrupted access to treatment for substance use disorders (SUDs), while alcohol and cannabis retail sales increased. During the pandemic, we tested a tailored digital health solution, Woebot-SUDs (W-SUDs), for reducing substance misuse. METHODS: In a randomized controlled trial, we compared W-SUDs for 8 weeks to a waitlist control. U.S. adults (N = 180) who screened positive for substance misuse (CAGE-AID>1) were enrolled June-August 2020. The primary outcome was the change in past-month substance use occasions from baseline to end-of-treatment (EOT). Study retention was 84%. General linear models tested group differences in baseline-to-EOT change scores, adjusting for baseline differences and attrition. RESULTS: At baseline, the sample (age M = 40, SD = 12, 65% female, 68% non-Hispanic white) averaged 30.2 (SD = 18.6) substance occasions in the past month. Most (77%) reported alcohol problems, 28% cannabis, and 45% multiple substances; 46% reported moderate-to-severe depressive symptoms. Treatment participants averaged 920 in-app text messages (SD = 892, Median = 701); 96% of completed lessons were rated positively; and 88% would recommend W-SUDs. Relative to waitlist, W-SUDs participants significantly reduced past-month substance use occasions (M = -9.1, SE = 2.0 vs. M = -3.3, SE = 1.8; p = .039). Secondary substance use and mood outcomes did not change significantly by group; however, reductions in substance use occasions correlated significantly with increased confidence and fewer substance use problems, cravings, depression and anxiety symptoms, and pandemic-related mental health effects (p-value<.05). CONCLUSIONS: W-SUDs was associated with significant reductions in substance use occasions. Reduction in substance use occasions was associated with better outcomes, including improved mental health. W-SUDs satisfaction was high.

Evidence of Human-Level Bonds Established With a Digital Conversational Agent: Cross-sectional, Retrospective Observational Study.

BACKGROUND: There are far more patients in mental distress than there is time available for mental health professionals to support them. Although digital tools may help mitigate this issue, critics have suggested that technological solutions that lack human empathy will prevent a bond or therapeutic alliance from being formed, thereby narrowing these solutions' efficacy. OBJECTIVE: We aimed to investigate whether users of a cognitive behavioral therapy (CBT)-based conversational agent would report therapeutic bond levels that are similar to those in literature about other CBT modalities, including face-to-face therapy, group CBT, and other digital interventions that do not use a conversational agent. METHODS: A cross-sectional, retrospective study design was used to analyze aggregate, deidentified data from adult users who self-referred to a CBT-based, fully automated conversational agent (Woebot) between November 2019 and August 2020. Working alliance was measured with the Working Alliance Inventory-Short Revised (WAI-SR), and depression symptom status was assessed by using the 2-item Patient Health Questionnaire (PHQ-2). All measures were administered by the conversational agent in the mobile app. WAI-SR scores were compared to those in scientific literature abstracted from recent reviews. RESULTS: Data from 36,070 Woebot users were included in the analysis. Participants ranged in age from 18 to 78 years, and 57.48% (20,734/36,070) of participants reported that they were female. The mean PHQ-2 score was 3.03 (SD 1.79), and 54.67% (19,719/36,070) of users scored over the cutoff score of 3 for depression screening. Within 5 days of initial app use, the mean WAI-SR score was 3.36 (SD 0.8) and the mean bond subscale score was 3.8 (SD 1.0), which was comparable to those in recent studies from the literature on traditional, outpatient, individual CBT and group CBT (mean bond subscale scores of 4 and 3.8, respectively). PHQ-2 scores at baseline weakly correlated with bond scores (r=-0.04; P<.001); however, users with depression and those without depression had high bond scores of 3.45. CONCLUSIONS: Although bonds are often presumed to be the exclusive domain of human therapeutic relationships, our findings challenge the notion that digital therapeutics are incapable of establishing a therapeutic bond with users. Future research might investigate the role of bonds as mediators of clinical outcomes, since boosting the engagement and efficacy of digital therapeutics could have major public health benefits.

A Therapeutic Relational Agent for Reducing Problematic Substance Use (Woebot): Development and Usability Study.

BACKGROUND: Misuse of substances is common, can be serious and costly to society, and often goes untreated due to barriers to accessing care. Woebot is a mental health digital solution informed by cognitive behavioral therapy and built upon an artificial intelligence-driven platform to deliver tailored content to users. In a previous 2-week randomized controlled trial, Woebot alleviated depressive symptoms. OBJECTIVE: This study aims to adapt Woebot for the treatment of substance use disorders (W-SUDs) and examine its feasibility, acceptability, and preliminary efficacy. METHODS: American adults (aged 18-65 years) who screened positive for substance misuse without major health contraindications were recruited from online sources and flyers and enrolled between March 27 and May 6, 2020. In a single-group pre/postdesign, all participants received W-SUDs for 8 weeks. W-SUDs provided mood, craving, and pain tracking and modules (psychoeducational lessons and psychotherapeutic tools) using elements of dialectical behavior therapy and motivational interviewing. Paired samples t tests and McNemar nonparametric tests were used to examine within-subject changes from pre- to posttreatment on measures of substance use, confidence, cravings, mood, and pain. RESULTS: The sample (N=101) had a mean age of 36.8 years (SD 10.0), and 75.2% (76/101) of the participants were female, 78.2% (79/101) were non-Hispanic White, and 72.3% (73/101) were employed. Participants' W-SUDs use averaged 15.7 (SD 14.2) days, 12.1 (SD 8.3) modules, and 600.7 (SD 556.5) sent messages. About 94% (562/598) of all completed psychoeducational lessons were rated positively. From treatment start to end, in-app craving ratings were reduced by half (87/101, 86.1% reporting cravings in the app; odds ratio 0.48, 95% CI 0.32-0.73). Posttreatment assessment completion was 50.5% (51/101), with better retention among those who initially screened higher on substance misuse. From pre- to posttreatment, confidence to resist urges to use substances significantly increased (mean score change +16.9, SD 21.4; P<.001), whereas past month substance use occasions (mean change -9.3, SD 14.1; P<.001) and scores on the Alcohol Use Disorders Identification Test-Concise (mean change -1.3, SD 2.6; P<.001), 10-item Drug Abuse Screening Test (mean change -1.2, SD 2.0; P<.001), Patient Health Questionnaire-8 item (mean change 2.1, SD 5.2; P=.005), Generalized Anxiety Disorder-7 (mean change -2.3, SD 4.7; P=.001), and cravings scale (68.6% vs 47.1% moderate to extreme; P=.01) significantly decreased. Most participants would recommend W-SUDs to a friend (39/51, 76%) and reported receiving the service they desired (41/51, 80%). Fewer felt W-SUDs met most or all of their needs (22/51, 43%). CONCLUSIONS: W-SUDs was feasible to deliver, engaging, and acceptable and was associated with significant improvements in substance use, confidence, cravings, depression, and anxiety. Study attrition was high. Future research will evaluate W-SUDs in a randomized controlled trial with a more diverse sample and with the use of greater study retention strategies. TRIAL REGISTRATION: ClinicalTrials.gov NCT04096001; http://clinicaltrials.gov/ct2/show/NCT04096001.

Applying family-based treatment (FBT) to three clinical presentations of avoidant/restrictive food intake disorder: Similarities and differences from FBT for anorexia nervosa.

OBJECTIVE: This article uses three brief case reports to illustrate how family-based treatment (FBT) can be used to treat pre-adolescents with avoidant/restrictive food intake disorder (ARFID). METHOD: We present case material illustrating how FBT can be used in three different clinical presentations of ARFID: (1) low appetite and lack of interest; (2) sensory sensitive eaters; and (3) fear of aversive consequences eaters-all without shape or weight concerns. RESULTS: This case material illustrates that the main principles of FBT-agnosticism as to the cause of the illness, externalization, emphasizing the seriousness of ARFID, parental empowerment, behavioral consultation, and practical behavioral focus-are applicable for a range of ARFID clinical presentations. Common challenges in this patient group include (1) promoting urgency; (2) challenging long term behavioral accommodation; (3) lack of parental alignment, parental fatigue, (4) and co-morbid psychiatric problems in the patients. Strategies to address these problems are described. CONCLUSION: FBT can be adapted for children with ARFID using the main principles of the approach.

The Utility and Acceptability of a Self-Help Smartphone Application for Eating Disorder Behaviors.

OBJECTIVE: Smartphone applications (apps) for eating disorders are a promising approach to assist individuals who do not receive traditional treatment. This study examines usage characteristics, perceptions regarding the acceptability of a new self-help intervention developed for users with eating disorders, and associations between attitudes and use patterns. METHODS: 189 individuals pilot-tested a personalized app-based program, and 133 completed the required components of the pilot-test over an 8-day period. Of these, 64 individuals (49%) completed an exit survey pertaining to acceptability. RESULTS: Seventy percent of those who pilot-tested the app-based program completed the required components, i.e. a baseline review and then a 1-week assessment. Body mass index was associated with the total number of recorded meal logs. Study participants rated the app as highly suitable and acceptable, providing evidence of the feasibility and appropriateness of the program. CONCLUSION: The app-based program demonstrated feasibility of deploying the app across user groups and high acceptability.

Training models for implementing evidence-based psychological treatment for college mental health: A cluster randomized trial study protocol.

Mental disorders often emerge in adolescence and young adulthood, and these disorders can have lasting effects on students' health, social functioning, and education. Although evidence-based treatments have been established for many mental disorders, few community therapists use such treatments. What is needed is a practical, economically feasible means of training clinicians to implement evidence-based treatments suitable for widespread use. This cluster randomized trial will randomize 26 college counseling centers to one of two implementation strategies for training counselors to use interpersonal psychotherapy (IPT), an evidence-based treatment for depression and eating disorders: 1) an external expert consultation model comprising a workshop, therapy manual, and expert follow-up consultation (n = 13); or 2) a train-the-trainer model in which a staff member from the counseling center is coached to train other staff members to implement IPT (n = 13). The primary outcome is therapist adherence to IPT, with secondary outcomes of therapist competence in IPT and client outcomes for depression and eating disorders. Therapist and organizational characteristics will be explored as potential moderators and mediators of implementation outcomes. Implementation costs for each of the training methods will also be assessed. The present study involves partnering with college counseling centers to determine the most effective method to implement IPT for depression and eating disorders in these settings. The results of this study will inform future large-scale dissemination of clinical interventions to mental health service providers by providing evidence for the selection of training methods when an agency chooses to adopt new interventions.

Subgrouping the users of a specialized app for eating disorders.

Although mobile technologies for eating disorders (EDs) are burgeoning, there is limited data about the clinical characteristics of individuals using specialized smartphone applications (apps) without accompanying traditional forms of treatment. This study evaluated whether the users of an ED app cluster in clinically meaningful groups. Participants were 1,280 app users (91.3% female; mean age 27) who reported not being in a weekly treatment for their ED. A hierarchical cluster analysis distinguished five groups of participants, all approximating DSM-5 ED categories. One cluster comprised of non-female, ethnically diverse users with Bulimia Nervosa features. Findings suggest that app users resemble known patient classifications.