UNASSIGNED: Treatment-resistant depression (TRD) presents a significant challenge, affecting approximately 30% of individuals diagnosed with major depressive disorder and leading to poor treatment responses. Innovations in digital mental health, especially online mindfulness-based cognitive therapy (eMBCT), offer promising avenues for enhancing access to effective mental health care for individuals with TRD in a clinical setting.
UNASSIGNED: The aim of this study was to examine the feasibility of eMBCT in an individual clinical context to decrease depressive symptoms for TRD.
UNASSIGNED: Conducted at the Institute of Psychiatry of the Federal University of Rio de Janeiro, Brazil, this parallel-arm, randomized controlled feasibility trial involved outpatients diagnosed with TRD, aged 18 and above. Of the 39 outpatients invited, 28 were randomized into two groups: an intervention group receiving the eMBCT program (n = 15) and a control group (n = 13). The intervention, consisting of an 8-week course, was delivered via live video sessions. Following the assessment period, participants in the control group were offered the eMBCT intervention. Assessments using standardized questionnaires were conducted at the start and end of the study.
UNASSIGNED: Within the eMBCT group, improvements were observed in depression symptoms (Z = -3.423; p = 0.001; effect size r = 0.78), anxiety symptoms (Z = -3.361; p = 0.001; effect size r = 0.77), with no significant changes in the control group. Comparatively, the eMBCT group showed significant reductions in depression symptoms and improvements in clinical global impressions over the control group (BDI2: U = 30.5; p = 0.015; effect size r = 0.47, CGI1: U = 21.0; p = 0.004; effect size r = 0.56).
UNASSIGNED: eMBCT in an individual format combined with medication, appears to be a feasible treatment for TRD, decreasing symptoms of depression. In a future trial the control group may have a manualized intervention.
UNASSIGNED: The Brazilian Clinical Trials Registry: (https://ensaiosclinicos.gov.br/rg/RBR-6zndpbv) and RBR-6zndpbv.

BACKGROUND: Although adolescents report high levels of stress, they report engaging in few stress management techniques. Consequently, developing effective and targeted programs to help address this transdiagnostic risk factor in adolescence is particularly important. Most stress management programs for adolescents are delivered within schools, and the evidence for these programs is mixed, suggesting a need for alternative options for stress management among adolescents.
OBJECTIVE: The aim of the study is to test the short-term effects of a self-guided digital mental health intervention (DMHI) designed for adolescents on perceived stress and rumination (ie, brooding).
METHODS: This was a 12-week, 2-arm decentralized randomized controlled trial of adolescents aged 13 to 17 years who presented with elevated levels of perceived stress and brooding. Participants were randomly assigned to engage with a self-guided DMHI (Happify for Teens) or to a waitlist control. Participants assigned to the intervention group were given access to the program for 12 weeks. Happify for Teens consists of various evidence-based activities drawn from therapeutic modalities such as cognitive behavioral therapy, positive psychology, and mindfulness, which are then organized into several programs targeting specific areas of concern (eg, Stress Buster 101). Participants in the waitlist control received access to this product for 12 weeks upon completing the study. Participants in both groups completed measures of perceived stress, brooding, optimism, sleep disturbance, and loneliness at baseline, 4 weeks, 8 weeks, and 12 weeks. Changes in outcomes between the intervention and waitlist control groups were assessed using repeated-measures multilevel models.
RESULTS: Of the 303 participants included in data analyses, 132 were assigned to the intervention and 171 to the waitlist. There were significantly greater improvements in the intervention condition for perceived stress (intervention: B=-1.50; 95% CI -1.82 to -1.19; P<.001 and control: B=-0.09; 95% CI -0.44 to 0.26; P=.61), brooding (intervention: B=-0.84; 95% CI -1.00 to -0.68; P<.001 and control: B=-0.30; 95% CI -0.47 to -0.12; P=.001), and loneliness (intervention: B=-0.96; 95% CI -1.2 to -0.73; P<.001 and control: B=-0.38; 95% CI: -0.64 to -0.12; P=.005) over the 12-week study period. Changes in optimism and sleep disturbance were not significantly different across groups (Ps≥.096).
CONCLUSIONS: Happify for Teens was effective at reducing perceived stress, rumination, and loneliness among adolescents over 12 weeks when compared to a waitlist control group. Our data reveal the potential benefits of DMHIs for adolescents, which may present a more scalable, destigmatized, and cost-effective alternative to school-based programs.
BACKGROUND: ClinicalTrials.gov NCT04567888; https://clinicaltrials.gov/ct2/show/NCT04567888.
UNASSIGNED: RR2-10.2196/25545.

BACKGROUND: Young people today are exhibiting increasing rates of disordered eating behaviors, as well as eating disorders (EDs), alongside other mental and behavioral problems such as anxiety and depression. However, limited access to mental health care means that EDs, disordered eating behaviors, and comorbid mental health problems are often underdiagnosed and undertreated. Digital mental health interventions (DMHIs) offer accessible and scalable alternatives to traditional treatment modalities, but their effectiveness has not been well established among adolescents with EDs and disordered eating behaviors.
OBJECTIVE: This study uses data from a collaborative care pediatric DMHI to determine whether participation in a DMHI is associated with a reduction in adolescents\' disordered eating behaviors.
METHODS: Adolescent members in care with Bend Health Inc completed the SCOFF questionnaire at baseline (before the start of care) and approximately every month during care to assess disordered eating behaviors. They also completed assessments of mental health symptoms at baseline. Member characteristics, mental health symptoms, and disordered eating behaviors of adolescents with elevated SCOFF scores at baseline (before the start of care) were compared to those of adolescents with nonelevated SCOFF scores at baseline. Members participated in web-based coaching or therapy sessions throughout the duration of mental health care.
RESULTS: Compared to adolescents with nonelevated SCOFF scores (n=520), adolescents with elevated SCOFF scores (n=169) were predominantly female and exhibited higher rates of elevated anxiety and depressive symptoms. SCOFF scores decreased over time in care with the DMHI for 61.4% (n=70) of adolescents with elevated SCOFF scores, and each additional month of participation was associated with greater improvements in disordered eating behaviors (F1,233=72.82; P<.001).
CONCLUSIONS: Our findings offer promising preliminary evidence that participation in mental health care with a collaborative care DMHI may be beneficial in the reduction of disordered eating symptoms in adolescents, including those who are experiencing comorbid anxiety and depressive symptoms.

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.
BACKGROUND: This study was retrospectively registered on ClinicalTrials.gov (#NCT05672745) on January 5th, 2023.

Digital health technology has been widely applied to mental health interventions worldwide. Using digital phenotyping to identify an individual\'s mental health status has become particularly important. However, many technologies other than digital phenotyping are expected to become more prevalent in the future. The systematization of these technologies is necessary to accurately identify trends in mental health interventions. However, no consensus on the technical classification of digital health technologies for mental health interventions has emerged. Thus, we conducted a review of systematic review articles on the application of digital health technologies in mental health while attempting to systematize the technology using the Delphi method. To identify technologies used in digital phenotyping and other digital technologies, we included 4 systematic review articles that met the inclusion criteria, and an additional 8 review articles, using a snowballing approach, were incorporated into the comprehensive review. Based on the review results, experts from various disciplines participated in the Delphi process and agreed on the following 11 technical categories for mental health interventions: heart rate estimation, exercise or physical activity, sleep estimation, contactless heart rate/pulse wave estimation, voice and emotion analysis, self-care/cognitive behavioral therapy/mindfulness, dietary management, psychological safety, communication robots, avatar/metaverse devices, and brain wave devices. The categories we defined intentionally included technologies that are expected to become widely used in the future. Therefore, we believe these 11 categories are socially implementable and useful for mental health interventions.

Precision medicine methods (machine learning; ML) can identify which clients with generalized anxiety disorder (GAD) benefit from mindfulness ecological momentary intervention (MEMI) vs. self-monitoring app (SM). We used randomized controlled trial data of MEMI vs. SM for GAD (N = 110) and tested three ML models to predict one-month follow-up reliable improvement in GAD severity, perseverative cognitions (PC), trait mindfulness (TM), and executive function (EF). Eleven baseline predictors were tested regarding differential reliable change from MEMI vs. SM (age, sex, race, EF errors, inhibitory dyscontrol, set-shifting deficits, verbal fluency, working memory, GAD severity, TM, PC). The final top five prescriptive predictor models of all outcomes performed well (AUC = .752 .886). The following variables predicted better outcome from MEMI vs. SM: Higher GAD severity predicted more GAD improvement but less EF improvement. Elevated PC, inhibitory dyscontrol, and verbal dysfluency predicted better improvement in most outcomes. Greater set-shifting and TM predicted stronger improvements in GAD symptoms and TM. Older age predicted more alleviation of GAD and PC symptoms. Women exhibited more enhancements in trait mindfulness and EF than men. White individuals benefitted more than non-White. PC, TM, EF, and sociodemographic data might help predictive models optimize intervention selection for GAD.

BACKGROUND: Rates of anxiety and depression have been increasing among children and adolescents for the past decade; however, many young people do not receive adequate mental health care. Digital mental health interventions (DMHIs) that include web-based behavioral health coaching are widely accessible and can confer significant improvements in youth anxiety and depressive symptoms. However, more research is necessary to determine the number of web-based coaching sessions that confer clinically significant improvements in anxiety and depressive symptoms in youth.
OBJECTIVE: This study uses data from a pediatric DMHI to explore the number of web-based coaching sessions required to confer symptom improvements among children and adolescents with moderate or moderately severe symptoms of anxiety and depression.
METHODS: We used retrospective data from a pediatric DMHI that offered web-based behavioral health coaching in tandem with self-guided access to asynchronous chat with practitioners, digital mental health resources, and web-based mental health symptom assessments. Children and adolescents who engaged in 3 or more sessions of exclusive behavioral health coaching for moderate to moderately severe symptoms of anxiety (n=66) and depression (n=59) were included in the analyses. Analyses explored whether participants showed reliable change (a decrease in symptom scores that exceeds a clinically established threshold) and stable reliable change (at least 2 successive assessments of reliable change). Kaplan-Meier survival analyses were performed to determine the median number of coaching sessions when the first reliable change and stable reliable change occurred for anxiety and depressive symptoms.
RESULTS: Reliable change in anxiety symptoms was observed after a median of 2 (95% CI 2-3) sessions, and stable reliable change in anxiety symptoms was observed after a median of 6 (95% CI 5-8) sessions. A reliable change in depressive symptoms was observed after a median of 2 (95% CI 1-3) sessions, and a stable reliable change in depressive symptoms was observed after a median of 6 (95% CI 5-7) sessions. Children improved 1-2 sessions earlier than adolescents.
CONCLUSIONS: Findings from this study will inform caregivers and youth seeking mental health care by characterizing the typical time frame in which current participants show improvements in symptoms. Moreover, by suggesting that meaningful symptom improvement can occur within a relatively short time frame, these results bolster the growing body of research that indicates web-based behavioral health coaching is an effective form of mental health care for young people.

BACKGROUND: Mental illness has become a prevalent issue impacting adolescents worldwide. Many barriers, including stigma and poor health literacy, prevent this population group from accessing reliable mental health care services. Synchronous text-therapy counseling is an underused therapeutic approach in combating adolescent mental illness. Phone-based text therapy is uniquely placed to offer personalized counseling to adolescents through a familiar and engaging treatment modality.
OBJECTIVE: This rapid review aims to understand the clinical effectiveness, usability, and accessibility of phone-based text therapy for youth mental health.
METHODS: Cochrane CENTRAL, Embase, PubMed, and PsycINFO were used to search for suitable literature. Five groups of keywords were used: those related to (1) \"therapy,\" (2) \"text,\" (3) \"phone,\" (4) \"youth,\" and (5) \"mental health.\" Eligibility criteria were formed through the PICO (Population, Intervention, Control, and Outcome) framework. Studies were included if a synchronous phone-based text therapy intervention was used in an adolescent population, with an age range of 12-24 years. Only literature available in full-text, English, and a peer-reviewed journal was considered. Furthermore, a date limit of 5 years was set to reflect the recent development of digital interventions for mental health. Pertinent information from each study was tabulated, and a narrative synthesis was used to assess, describe, and organize the included studies comprehensively and concisely.
RESULTS: Of the 771 studies dual screened, 7 studies were included in this rapid review. Most of the exclusions occurred due to the use of the wrong intervention, such as asynchronous messaging. The selected studies had a low risk of bias and were suitable for the review. All interventional trials demonstrated reductions in mental health symptoms, primarily depression and anxiety. Most studies displayed high usability among participants, while data were unclear regarding accessibility.
CONCLUSIONS: This review reveals the high potential of phone-based text therapy as an intervention for adolescents experiencing mental illness. We hope that this review promotes further refinement of text-based phone therapies and encourages future research on this subject matter.

BACKGROUND: Adolescents with disabilities experience alarmingly higher rates of depression and isolation than peers without disabilities. There is a need to identify interventions that can improve mental health and isolation among this underserved population. Innovations in virtual reality (VR) gaming \"standalone\" headsets allow greater access to immersive high-quality digital experiences, due to their relatively low cost.
OBJECTIVE: This study had three purposes, which were to (1) examine the preliminary effects of a low-cost, home-based VR multiplayer recreation and socialization on depression, socialization, and loneliness; (2) quantify the acceptability of the program as measured by participant adherence, total play time, and exercise time; and (3) identify and describe behavioral mechanisms that affected participant engagement.
METHODS: This was a single-group, pre- to postdesign trial. The intervention was conducted at home. Participants were recruited from a children\'s hospital. The intervention lasted 4 weeks and included 2×1-hour sessions per week of supervised peer-to-peer gaming. Participants used the Meta Quest 2 headset to meet peers and 2 coaches in a private party held digitally. Aim 1 was evaluated with the Children\'s Depression Inventory 2 Short Form and the University of California, Los Angeles Loneliness Scale 20 items, which are measures of social isolation and loneliness, respectively. Aim 2 was evaluated through the following metrics: participant adherence, the types of games played, friendship building and playtime, and program satisfaction and enjoyment.
RESULTS: In total, 12 people enrolled (mean age 16.6, SD 1.8 years; male: n=9 and female: n=3), and 8 people completed the program. Mean attendance for the 8 participants was 77% (49 sessions of 64 total possible sessions; mean 6, SD 2 sessions). A trend was observed for improved Children\'s Depression Inventory 2 Short Form scores (mean preintervention score 7.25, SD 4.2; mean postintervention score 5.38, SD 4.1; P=.06; effect size=0.45, 95% CI -0.15 to 3.9), but this was not statistically significant; no difference was observed for University of California, Los Angeles Loneliness Scale 20 items scores. Most participants (7/8, 88%) stated that they became friends with a peer in class; 50% (4/8) reported that they played with other people. Participants reported high levels of enjoyment and satisfaction with how the program was implemented. Qualitative analysis resulted in 4 qualitative themes that explained behavioral mechanisms that determined engagement in the program.
CONCLUSIONS: The study findings demonstrated that a brief VR group program could be valuable for potentially improving mental health among adolescents with physical disabilities. Participants built friendships with peers and other players on the web, using low-cost consumer equipment that provided easy access and strong scale-up potential. Study findings identified factors that can be addressed to enhance the program within a larger clinical trial.
BACKGROUND: ClinicalTrials.gov NCT05259462; https://clinicaltrials.gov/study/NCT05259462.
UNASSIGNED: RR2-10.2196/42651.

BACKGROUND: Preliminary evidence suggests that digital mental health intervention (Wysa for Chronic Pain) can improve mental and physical health in people with chronic musculoskeletal pain and coexisting symptoms of depression or anxiety. However, the behavioral mechanisms through which this intervention acts are not fully understood.
OBJECTIVE: The purpose of this study was to identify behavioral mechanisms that may mediate changes in mental and physical health associated with use of Wysa for Chronic Pain during orthopedic management of chronic musculoskeletal pain. We hypothesized that improved behavioral activation, pain acceptance, and sleep quality mediate improvements in self-reported mental and physical health.
METHODS: In this prospective cohort, pilot mediation analysis, adults with chronic (≥3 months) neck or back pain received the Wysa for Chronic Pain digital intervention, which uses a conversational agent and text-based access to human counselors to deliver cognitive behavioral therapy and related therapeutic content. Patient-reported outcomes and proposed mediators were collected at baseline and 1 month. The exposure of interest was participants\' engagement (ie, total interactions) with the digital intervention. Proposed mediators were assessed using the Behavioral Activation for Depression Scale-Short Form, Chronic Pain Acceptance Questionnaire, and Athens Insomnia Scale. Outcomes included Patient-Reported Outcomes Measurement Information System Anxiety, Depression, Pain Interference, and Physical Function scores. A mediation analysis was conducted using the Baron and Kenny method, adjusting for age, sex, and baseline mediators and outcome values. P<.20 was considered significant for this pilot study.
RESULTS: Among 30 patients (mean age 59, SD 14, years; 21 [70%] female), the mediation effect of behavioral activation on the relationship between increased intervention engagement and improved anxiety symptoms met predefined statistical significance thresholds (indirect effect -0.4, 80% CI -0.7 to -0.1; P=.13, 45% of the total effect). The direction of mediation effect was generally consistent with our hypothesis for all other proposed mediator or outcome relationships, as well.
CONCLUSIONS: In a full-sized randomized controlled trial of patients with chronic musculoskeletal pain, behavioral activation, pain acceptance, and sleep quality may play an important role in mediating the relationship between use of a digital mental health intervention (Wysa for Chronic Pain) and improved mental and physical health.
BACKGROUND: ClinicalTrials.gov NCT05194722; https://clinicaltrials.gov/ct2/show/NCT05194722.