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BACKGROUND Mental illness is a pervasive worldwide public health issue. Residentially vulnerable populations such as those living in rural, medically underserved, or mental health provider shortage areas face unique access barriers to mental health care. Despite the growth of digital mental health interventions utilizing relational agent technology, little is known about their use patterns, efficacy, and favorability in residentially vulnerable populations. OBJECTIVE To explore differences in application (app) utilization, therapeutic alliance, mental health outcomes, and satisfaction across residential subgroups (metropolitan/nonmetropolitan/rural, medically underserved area (MUA) (yes/no), and mental health provider shortage areas (MHPSA) (yes/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 This exploratory study examined data from 255 adults enrolled in an 8-week, single-arm trial of WB-LIFE. Analyses compared levels of app utilization and therapeutic alliance Total scores as well as subscales Goal, Task, and Bond, mental health outcomes (depressive and anxiety symptoms, stress, resilience, burnout), and program satisfaction across residential subgroups. RESULTS Few study participants resided in non-metropolitan (n=25, 10%) or rural (n=3, 1%) areas, precluding estimates across this variable. Despite a largely metropolitan sample, nearly 39% (n=99) resided in an MUA and 55% (n=141) in an MHPSA. There were no significant differences in app utilization or satisfaction by MUA or MHPSA status. There also were no differences in depression, 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 ([PHQ-8]≥10) than non-MUA participants (mean=16.50 versus 14.41, respectively, p=0.01). Although working alliance scores did not differ by MHPSA status, those who resided in an MUA had higher Goal (t=2.21, p=0.03), Bond (t=1.94, p=0.05) and Total therapeutic alliance scores at Day 3 (t=2.15, p=0.03), and higher Goal scores at Week 8 (t=2.28, p=0.02) as compared to 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 utilization, 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.

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 WB-LIFE, a DMHI that employs Woebot, a relational agent that delivers evidence-based psychotherapies, among those with baseline clinical levels of depressive or anxiety symptoms. Self-reported depressive and anxiety symptom changes between baseline and end of 8-week intervention, as well as the association between demographic and clinical characteristics and each outcome, were measured 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 WB-LIFE 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, pConclusions The present study suggests early promise for WB-LIFE 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 05/01/2023.

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. CLINICALTRIAL ClinicalTrials.gov NCT05372913; https://clinicaltrials.gov/ct2/show/NCT05372913 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/44940

Postpartum Depression (PPD) is common, persistent, and stigmatized. There are insufficient trained professionals to deliver appropriate screening, diagnosis, and treatment.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.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 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 (

ObjectiveThe COVID-19 pandemic has produced major life disruptions and increased stress. We explored associations between pandemic-related stress and substance use problems.MethodAdults (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 (

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 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.

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 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.

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; PPPPP=.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. CLINICALTRIAL ClinicalTrials.gov NCT04096001; http://clinicaltrials.gov/ct2/show/NCT04096001.

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.

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.

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.

Author(s): Prochaska, Judith J; Vogel, Erin A; Chieng, Amy; Baiocchi, Michael; Maglalang, Dale Dagar; Pajarito, Sarah; Weingardt, Kenneth R; Darcy, Alison; Robinson, Athena | Abstract: BackgroundThe 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.MethodsIn 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-AIDg1) 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.ResultsAt 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-valuel.05).ConclusionsW-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.

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. 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. 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

Current bariatric literature on postoperative interventions that prevent or remediate suboptimal weight loss outcomes is limited. In response, Early Adherence Targeted Therapy (EATT), an efficient early postoperative intervention to target patients at high risk for suboptimal postoperative weight loss outcomes was developed. The rationale for and a detailed description of EATT is provided, including sample session transcripts. Preliminary findings from a pilot designed to explore EATT’s feasibility and acceptability are reported. EATT is a principle driven, skills-based intervention that addresses psychological skill deficits that underlie poor dietary adherence and maladaptive eating behaviors associated with suboptimal weight loss outcomes. Of 22 postoperative patients who consented to participate, 13 screened positive for poor dietary adherence and thus received EATT (77% female, 69% White, 23% Hispanic; mean age = 42.9 years; mean BMI = 45.4 ± 12.8 kg/m2). The majority had undergone gastric bypass surgery (54%) and 76.9% had a psychiatric diagnosis, with 61% on psychotropic medications. Patient retention was high, with 11/13 (85%) completing treatment. Treatment was delivered efficiently, with an average of only 4.5 sessions (out of a possible 12) required to significantly increase dietary adherence (p

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 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.

To examine if implicit emotion regulation (occurring outside of awareness) is related to binge eating disorder (BED) symptomatology and explicit emotion regulation (occurring within awareness), and can be altered via intervention.Implicit emotion regulation was assessed via the Emotion Conflict Task (ECT) among a group of adults with BED. Study 1 correlated BED symptomatology and explicit emotion regulation with ECT performance at baseline (BL) and after receiving BED treatment (PT). Study 2 generated effect sizes comparing ECT performance at BL and PT with healthy (non-eating disordered) controls (HC).Study 1 yielded significant correlations (p.05) between both BED symptomatology and explicit emotion regulation with ECT performance. Study 2 found that compared to BL ECT performance, PT shifted (d=-.27), closer to HC. Preliminary results suggest a) BED symptomatology and explicit emotion regulation are associated with ECT performance, and b) PT ECT performance normalized after BED treatment.Implicit emotion regulation may be a BED treatment mechanism because psychotherapy, directly or indirectly, decreased sensitivity to implicit emotional conflict. Further understanding implicit emotion regulation may refine conceptualizations and effective BED treatments.

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.

This chapter reflects on core themes raised within this Handbook, which collectively reflect the state of the science in the eating disorder field. Such themes include the growing recognition of the complexity of eating disorders including their etiological underpinnings and the contributions of basic sciences to an understanding of processes underlying the expression of maladaptive eating patterns. The status of the prevention and treatment of these disorders as reflected in the literature to date is considered with questions raised about future progress. Looking toward the future, new technologies may offer opportunities to bring cost-effective evidence-based treatments to underserved populations. However, such opportunities bring with them new ethical and practical considerations. Also highlighted are potential areas for further research.

This chapter provides a brief introduction to and overview of the contents of the Handbook. Several issues are highlighted, including changes since the previous edition of this volume, namely, the revised Diagnostic and Statistical Manual (DSM-5); the research domain criteria (RDoC), and recent technological innovations such as Internet treatment and the use of virtual reality related to eating disorders. Chapters on selective eating, bariatric surgery, and cognitive remediation have also been added. Themes carried forward from the previous edition of the Handbook are presented in updated chapters reviewing etiological, maintenance, assessment, comorbidity, medical complications, and pharmacotherapy, as well as evidence-based prevention and treatment considerations.

Binge Eating Disorder (BED), a chronic condition characterized by eating disorder psychopathology and physical and social disability, represents a significant public health problem. Guided Self Help (GSH) treatments for BED appear promising and may be more readily disseminable to mental health care providers, accessible to patients, and cost-effective than existing, efficacious BED specialty treatments which are limited in public health utility and impact given their time and expense demands. No existing BED GSH treatment has incorporated affect regulation models of binge eating, which appears warranted given research linking negative affect and binge eating. Integrative Response Therapy (IRT), a new group-based guided self-help treatment, based on the affect regulation model of binge eating, that has shown initial promise in a pilot sample of adults meeting DSM IV criteria for BED, is described. Fifty-four% and 67% of participants were abstinent at post-treatment and three month follow-up respectively. There was a significant reduction in the number of binge days over the previous 28 days from baseline to post-treatment [14.44 (±7.16) to 3.15 (±5.70); t=7.71, p

Objective: Investigate moderators of a randomized clinical trial of group Dialectical Behavior Therapy for Binge Eating Disorder (DBT-BED) compared to an active comparison group control (ACGT) on the post-treatment outcome of binge frequency after twenty 2-h weekly sessions. Method: Moderation analyses. Results: Participants were 101 adults with BED [mean (SD) age, 52.2 (10.6) years and BMI, 36.4 (8.6)]. Analyses identified two moderators of post-treatment outcome. Participants with (1) Avoidant Personality Disorder or (2) an earlier onset of overweight and dieting (

Dialectical Behavior Therapy for Binge Eating Disorder (DBT-BED) aims to reduce binge eating by improving adaptive emotion-regulation skills. Preliminary findings have been promising but have only compared DBT-BED to a wait-list. To control for the hypothesized specific effects of DBT-BED, the present study compared DBT-BED to an active comparison group therapy (ACGT). Men and women (n = 101) meeting DSM-IV BED research criteria were randomly assigned to 20 group sessions of DBT-BED (n = 50) or ACGT (n = 51). DBT-BED had a significantly lower dropout rate (4%) than ACGT (33.3%). Linear Mixed Models revealed that posttreatment binge abstinence and reductions in binge frequency were achieved more quickly for DBT-BED than for ACGT (posttreatment abstinence rate = 64% for DBT-BED vs. 36% for ACGT) though differences did not persist over the 3-, 6-, and 12-month follow-up assessments (e.g., 12-month follow-up abstinence rate = 64% for DBT-BED vs. 56% for ACGT). Secondary outcome measures revealed no sustained impact on emotion regulation. Although both DBT-BED and ACGT reduced binge eating, DBT-BED showed significantly fewer dropouts and greater initial efficacy (e.g., at posttreatment) than ACGT. The lack of differential findings over follow-up suggests that the hypothesized specific effects of DBT-BED do not show long-term impact beyond those attributable to nonspecific common therapeutic factors.

Phone and Internet-based interventions can improve the management of depression in primary care, and interventions using these communication channels are increasingly used to improve behaviors such as diet and physical activity. Increased physical activity has been shown to improve depressive symptoms, but to date there are no reports of the effects of a phone and Internet diet and exercise intervention on symptoms of depression in patients seen in primary care. This study assessed depressive symptoms in 401 participants in a randomized control trial of a 12-month primary care, phone and Internet-based behavioral intervention for overweight women. A one-way analysis of variance examining the mean change in Center for Epidemiological Studies Depression (CESD) score from baseline to 12 months, controlling for age, education, marital status, and employment showed that those receiving the intervention significantly decreased their CESD scores (P=.03) more than those receiving standard care. Although the intervention did not target depressed individuals or present material relating to mood management, those with probable depression (27% of the whole sample) showed clinically important improvements-a mean five-point change on the CESD short form. Participants who engaged more readily with the intervention were more likely to reduce their depression scores. A 1-year primary care based phone and Internet diet and exercise intervention can improve depressive symptoms in overweight women. Given the promise of phone and Internet-based interventions to improve both depression and lifestyle-related behaviors, and given that such interventions could extend the reach of primary care to many individuals at relatively low cost, these results suggest the need for further research, including the effects of additional mood management components.

This paper reviews progress in the treatment of the eating disorders between 1968 and 2008. In 1968, no evidence-based treatments were available for any of the eating disorders, and binge eating disorder had not yet been described. In 2008, there are still no evidence-based treatments for anorexia nervosa, although a specific form of family therapy (based on the Maudsley model) appears promising. Both psychotherapeutic and psychopharmacological evidence-based treatments are now available for bulimia nervosa and binge eating disorder. Therapist-assisted self-help is a promising approach to treatment because it may reduce the costs of treatment, allow for more adequate dissemination to areas lacking specialty resources and also provide a basis for algorithm-driven approaches to treatment.

Prior evidence indicates that predictors of weight loss outcomes after gastric bypass surgery fall within 5 domains: 1) presurgical factors, 2) postsurgical psychosocial variables (e.g., support group attendance), 3) postsurgical eating patterns, 4) postsurgical physical activity, and 5) follow-up at postsurgical clinic. However, little data exist on which specific behavioral predictors are most associated with successful outcomes (e.g.,≥ 50% excess weight loss) when considering the 5 domains simultaneously. The objective of this study was to specify the behavioral variables, and their respective cutoff points, most associated with successful weight loss outcomes.Signal detection analysis evaluated associations between 84 pre- and postsurgical behavioral variables (within the 5 domains) and successful weight loss at ≥ 1 year in 274 postgastric bypass surgery patients.Successful weight loss was highest (92.6%) among those reporting dietary adherence of3 on a 9-point scale (median = 5) who grazed no more than once-per-day. Among participants reporting dietary adherence3 and grazing daily or less, success rates more than doubled when highest lifetime body mass index was53.7 kg/m(2). Success rates also doubled for participants with dietary adherence = 3 if attending support groups. No variables from the physical activity or postsurgical follow-up domains were significant, nor were years since surgery. The overall model's sensitivity = .62, specificity = .92.To our knowledge, this is the first study to simultaneously consider the relative contribution of behavioral variables within 5 domains and offer clinicians an assessment algorithm identifying cut-off points for behaviors most associated with successful postsurgical weight loss. Such data may inform prospective study designs and postsurgical interventions.

This chapter reviews the literature to date on the prevalence of disordered eating behaviors among ethnic minorities. Empirical studies from the past decade indicate that disordered eating behaviors among adults and adolescents from various minority groups are more prevalent than previously thought. Preliminary conclusions are that Anorexia Nervosa is rare among blacks, data are mixed on whether rates of Bulimia Nervosa among ethnic minority and white females differ, and rates of binge eating among ethnic minorities are higher than other forms of disordered eating. Primary care physicians are often the first viable line of eating disorder assessment and referral. It is therefore imperative that primary care physicians are aware of disordered eating presentations in minority groups in order to provide needed evaluation and intervention. Areas for future research of disordered eating among minority groups include assessment of variation in risk factors, the relationship between overweight/obesity and binge eating disorder, level of acculturation impacting eating disorder severity, access to and engagement in treatment, and response to treatment.

To investigate the construct, concurrent and predictive validity of stage of change measures for physical activity (PA), and intakes of fruit and vegetables (FVs), dietary fiber (FB) and dietary fat (DF) among a sample of overweight women.Subjects were 401 women (mean age=41, s.d.=8.7 years; mean body mass index=32.35, s.d.=4.6) recruited to participate in a 12-month weight loss intervention trial. Concurrent validity tests included (1) self-report of current behavior, (2) decisional balance (for example, pros and cons of behavior change), (3) self-efficacy, (4) the MTI Actigraph accelerometer (for the PA staging measure), and (5) a food-frequency questionnaire (for all dietary staging measures). Predictive validity was assessed through tests of the relationship between the baseline stage of change measures and their corresponding behavior 1-year later.Coefficient alpha-tests of internal consistency exceeded 0.70 on the majority of scales. Concurrent validity tests indicated strong validity evidence for three staging measures and little validity for the DF staging measure (eta(2) range, 0.02-0.18). All staging algorithms demonstrated predictive validity (eta(2) range, 0.04-0.126).Staging measures can determine motivational readiness for overweight women, contribute to the standardization of stage of change assessment and facilitate cross-study comparisons.