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.

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.

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.

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.

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.

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.

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.

Correlates of Dietary Adherence and Maladaptive Eating Patterns Following Roux-en-Y Bariatric Surgery.

BACKGROUND: Self-reported poor dietary adherence following bariatric surgery is associated with less successful weight loss outcomes. Poor dietary adherence is a global construct lacking specificity regarding its underlying, clinically targetable, maladaptive eating behaviors. METHODS: Comprehensive online survey data were obtained from a sample of 274 adults who underwent Roux-en-Y surgery in the prior 1-12 years. Correlations between dietary adherence and six eating-related behaviors were calculated, with the frequency of each behavior reported on a 7-point scale. Linear regression modeling was applied. RESULTS: All six maladaptive eating behaviors were highly correlated with dietary adherence (Pearson's r > 0.5): grazing (r = - 0.565), mindless eating (r = - 0.572), loss of control eating (r = - 0.517), eating "more than is best" after dinner (r = - 0.518), eating foods off of one's plan (r = - 0.557), and "when I eat something off-plan, I feel like I have blown it and I give up and eat more" (r = - 0.574). The estimated regression coefficients in the linear model was statistically significant, [F(5, 261) = 60.006, p < 0.001] and accounted for approximately 54% of the variance of global dietary adherence (R 2 = 0.535, adjusted R 2 = 0.526). CONCLUSION: Six maladaptive eating behaviors accounted for a highly significant portion of post-Roux-en-Y patients' poor self- reported dietary adherence. Prospective studies are needed to investigate the relationship between targetable maladaptive eating behaviors and bariatric surgery outcomes.

Delivering Cognitive Behavior Therapy to Young Adults With Symptoms of Depression and Anxiety Using a Fully Automated Conversational Agent (Woebot): A Randomized Controlled Trial.

BACKGROUND: Web-based cognitive-behavioral therapeutic (CBT) apps have demonstrated efficacy but are characterized by poor adherence. Conversational agents may offer a convenient, engaging way of getting support at any time. OBJECTIVE: The objective of the study was to determine the feasibility, acceptability, and preliminary efficacy of a fully automated conversational agent to deliver a self-help program for college students who self-identify as having symptoms of anxiety and depression. METHODS: In an unblinded trial, 70 individuals age 18-28 years were recruited online from a university community social media site and were randomized to receive either 2 weeks (up to 20 sessions) of self-help content derived from CBT principles in a conversational format with a text-based conversational agent (Woebot) (n=34) or were directed to the National Institute of Mental Health ebook, "Depression in College Students," as an information-only control group (n=36). All participants completed Web-based versions of the 9-item Patient Health Questionnaire (PHQ-9), the 7-item Generalized Anxiety Disorder scale (GAD-7), and the Positive and Negative Affect Scale at baseline and 2-3 weeks later (T2). RESULTS: Participants were on average 22.2 years old (SD 2.33), 67% female (47/70), mostly non-Hispanic (93%, 54/58), and Caucasian (79%, 46/58). Participants in the Woebot group engaged with the conversational agent an average of 12.14 (SD 2.23) times over the study period. No significant differences existed between the groups at baseline, and 83% (58/70) of participants provided data at T2 (17% attrition). Intent-to-treat univariate analysis of covariance revealed a significant group difference on depression such that those in the Woebot group significantly reduced their symptoms of depression over the study period as measured by the PHQ-9 (F=6.47; P=.01) while those in the information control group did not. In an analysis of completers, participants in both groups significantly reduced anxiety as measured by the GAD-7 (F1,54= 9.24; P=.004). Participants' comments suggest that process factors were more influential on their acceptability of the program than content factors mirroring traditional therapy. CONCLUSIONS: Conversational agents appear to be a feasible, engaging, and effective way to deliver CBT.

Parental guided self-help family based treatment for adolescents with anorexia nervosa: A feasibility study.

OBJECTIVE: Family-based treatment (FBT) is an evidence-based treatment for adolescent anorexia nervosa (AN), but many families cannot access it. This study evaluated feasibility, acceptability, and preliminary treatment effects of a parental guided self-help (GSH) version of FBT for adolescent AN. METHOD: This was a case-series design. Parents of medically stable adolescents (11-18 years) with DSM-5 AN were recruited over 12 months. Parents received online training in parental GSH FBT and 12 20-30 min GSH sessions by phone or online over 6 months. Recruitment, dropout, changes in weight, and eating-related psychopathology were assessed. Analyses used mixed modeling that included all data for all participants. RESULTS: Of the 19 families that participated, most were white (94%) and from intact families (88%). Baseline median BMI (mBMI) percent was 85.01% (SD = 4.31). Participants' mBMI percent increased to 97.31% (SD ± 7.48) at the end of treatment (EOT) (ES = 2.06; CI= 0.13-3.99). Eating-related psychopathology improved by EOT (ES = 0.58; CI=.04-1.21). Dropout rate was 21% during treatment and 33% during follow-up. DISCUSSION: Parental GSH-FBT is feasible and acceptable to families willing to undertake online treatment. Follow-up data was only available for nine families (47%); thus further systematic evaluation is required before reaching conclusions about the efficacy of this approach.

A qualitative analysis of male eating disorder symptoms.

Insights into how males experience eating disorder symptoms early in the course of illness are important to improve detection efforts and may also provide valuable information for treatment. In this qualitative study, 10 adolescent males and 10 matched female patients completed standardized questionnaires and were interviewed. Results indicated that although there were many similarities between the genders, females were more likely to describe the involvement of family systems and males were more likely to describe involvement in sports as being catalysts for their disorders. Males in this study were more positive about being in treatment.

Using Technology to Improve Treatment Outcomes for Children and Adolescents with Eating Disorders.

Dissemination and implementation of evidence-based treatments are among the biggest challenges facing clinical psychiatry. Developing scalable evidence-based treatments is a major priority and fraught with challenges. This article describes the development of 3 technology-based innovations. It discusses the use of massive open online courses (MOOCs) and mobile applications. Three projects are presented: (1) the modification of a MOOC methodology for psychotherapy training clinicians in manualized family-based therapy (FBT) for adolescents with anorexia nervosa; (2) a modified MOOC platform for the delivery of FBT; and (3) the development of mobile applications for treatment augmentation and delivery.

Cognitive remediation therapy and cognitive behavioral therapy with an older adult with anorexia nervosa: A brief case report.

Cognitive remediation therapy represents a new approach to the treatment of anorexia nervosa (AN) emerging from research, suggesting that adults with chronic AN have specific neurocognitive inefficiencies. Specifically, adults with AN demonstrate an overly detailed cognitive processing bias (Roberts, Tchanturia, & Treasure, 2013) and difficulties shifting set quickly and efficiently (Roberts, Tchanturia, Stahl, Southgate, & Treasure, 2007). These characteristics manifest as rigid, rule-bound, and detail-focused cognitions, beliefs, and behaviors. Versions of these problems appear to persist after weight restoration (Tchanturia et al., 2004) and are observable in patient's healthy sisters (Roberts et al., 2013). Thus, central coherence difficulties and set-shifting problems have been proposed as endophenotypes and maintaining factors of AN (Roberts et al., 2013). (PsycINFO Database Record

Development of a smartphone application for eating disorder self-monitoring.

OBJECTIVE: This case report aims to (1) describe the development and refinement of a smartphone application for eating disorder self-monitoring; (2) characterize its users in terms of demographic and clinical characteristics; and (3) explore its feasibility and utilization as a self-monitoring tool. METHOD: We developed a mobile phone application through which people with eating disorders can self-monitor meals, emotions, behaviors, and thoughts. The application also included positive reinforcement, coping skill suggestions, social support, and feedback components. The app was made available on two Internet app stores. Data include number of downloads and subsequent usage statistics, consumer ratings on app-stores are used as indicators of satisfaction, anonymous aggregate demographic data and Eating Disorder Examination Questionnaire scores from 57,940 individuals collected over a two-year period. RESULTS: The app demonstrated population-level utilization with over 100,000 users over a two-year period. Almost 50% percent of users stated that they are not currently receiving clinical treatment and 33% reported they had not told anyone about their eating disorder. A surprising number of people with severe problems are using the app. DISCUSSION: Smartphone apps have the capacity to reach and engage traditionally underserved individuals with eating disorders at a large scale. Additional work is indicated for the evaluation of the clinical effectiveness of applications for specific user groups and in clinical treatment contexts.

Development and evaluation of a treatment fidelity instrument for family-based treatment of adolescent anorexia nervosa.

OBJECTIVE: This study provides data on the psychometric properties of a newly developed measure of treatment fidelity in Family-Based Treatment (FBT) for adolescent anorexia nervosa (AN). The Family Therapy Fidelity and Adherence Check (FBT-FACT) was created to evaluate therapist adherence and competency on the core interventions in FBT. METHOD: Participants were 45 adolescents and their families sampled from three randomized clinical trials evaluating treatment for AN. Trained fidelity raters evaluated 19 therapists across 90 early session recordings using the FBT-FACT. They also rated an additional 15 session 1 recordings of an alternate form of family therapy-Systemic Family Therapy for the purpose of evaluating discriminant validity of the FBT-FACT. The process of development and the psychometric properties of the FBT-FACT are presented. RESULTS: Overall fidelity ratings for each session demonstrated moderate to strong inter-rater agreement. Internal consistency of the measure was strong for sessions 1 and 2 and poor for session 3. Principal components analysis suggests sessions 1 and 2 are distinct interventions. DISCUSSION: The FBT-FACT demonstrates good reliability and validity as a measure of treatment fidelity in the early phase of FBT.