Background Symptoms of depression and anxiety, suicidal ideation, and self-harm have escalated among adolescents to crisis levels during the COVID-19 pandemic. As a result, primary care providers (PCPs) are often called on to provide first-line care for these youth. Digital health interventions can extend mental health specialty care, but few are evidence based. We evaluated the feasibility of delivering an evidence-based mobile health (mHealth) app with an embedded conversational agent to deliver cognitive behavioral therapy (CBT) to symptomatic adolescents presenting in primary care settings during the pandemic. Objective In this 12-week pilot study, we evaluated the feasibility of delivering the app-based intervention to adolescents aged 13 to 17 years with moderate depressive symptoms who were treated in a practice-based research network (PBRN) of academically affiliated primary care clinics. We also obtained preliminary estimates of app acceptability, effectiveness, and usability. Methods This small, pilot randomized controlled trial (RCT) evaluated depressive symptom severity in adolescents randomized to the app or to a wait list control condition. The primary end point was depression severity at 4-weeks, measured by the 9-item Patient Health Questionnaire (PHQ-9). Data on acceptability, feasibility, and usability were collected from adolescents and their parent or legal guardian. Qualitative interviews were conducted with 13 PCPs from 11 PBRN clinics to identify facilitators and barriers to incorporating mental health apps in treatment planning for adolescents with depression and anxiety. Results The pilot randomized 18 participants to the app (n=10, 56%) or to a wait list control condition (n=8, 44%); 17 participants were included in the analysis, and 1 became ineligible upon chart review due to lack of eligibility based on documented diagnosis. The overall sample was predominantly female (15/17, 88%), White (15/17, 88%), and privately insured (15/17, 88%). Mean PHQ-9 scores at 4 weeks decreased by 3.3 points in the active treatment group (representing a shift in mean depression score from moderate to mild symptom severity categories) and 2 points in the wait list control group (no shift in symptom severity category). Teen- and parent-reported usability, feasibility, and acceptability of the app was high. PCPs reported preference for introducing mHealth interventions like the one in this study early in the course of care for individuals presenting with mild or moderate symptoms. Conclusions In this small study, we demonstrated the feasibility, acceptability, usability, and safety of using a CBT-based chatbot for adolescents presenting with moderate depressive symptoms in a network of PBRN-based primary care clinics. This pilot study could not establish effectiveness, but our results suggest that further study in a larger pediatric population is warranted. Future study inclusive of rural, socioeconomically disadvantaged, and underrepresented communities is needed to establish generalizability of effectiveness and identify implementation-related adaptations needed to promote broader uptake in pediatric primary care. Trial Registration ClinicalTrials.gov NCT04603053; https://clinicaltrials.gov/ct2/show/NCT04603053
BACKGROUND: Few adolescents with depression receive treatment in accordance with national guidelines. This quality improvement project took place in 11 primary care practices with the primary aim of increasing the percentage of teens with depression who received follow-up care within 6 weeks of diagnosis and within 3 months, once stable. METHODS: The primary strategy was external practice facilitation for 12 months. The change process used goal setting and plan-do-study-act cycles to identify and implement change ideas. A preanalysis and postanalysis was completed to evaluate process change, provider confidence, and patient improvement. RESULTS: Randomly selected samples of 199 and 217 charts of teens newly diagnosed with depression were reviewed before and after the intervention, respectively. Chart data for these measurements was provided by 10 and 9 practices, respectively. The percentage of patients with follow-up care within 6 weeks after diagnosis increased from 40% to 81% (P < .001), the percentage with a follow-up visit within 3 months once stable increased from 30% to 60% (P < .001), and the percentage in remission at 6 months increased from 7% to 21% (P < .001). Providers reported increased confidence to diagnose and manage depression, assess severity, provide pharmacotherapy, and educate families. CONCLUSIONS: Practices improved follow-up care for teens with depression. In addition, providers experienced an improvement in their confidence to diagnose and manage depression. Working with a facilitator, each practice implemented standardized systems to provide effective care in the medical home, increase providers’ confidence to address this common problem, and improve patient outcomes.
BACKGROUND Depression, anxiety and related suicidal ideation and self-harm are common among adolescents, and have increased in prevalence and severity during the pandemic to crisis levels, exacerbated by the long-standing workforce shortage of child mental health professionals. As a result, primary care providers are often called on to provide first-line care for these youth. Digital health interventions extend mental health specialty care to youth with moderately severe symptoms, but few are evidence-based. Here, we describe the feasibility of delivering an evidence-based intervention that utilizes a relational conversational agent embedded in a smartphone application (app) to deliver cognitive behavioral therapy (CBT) to adolescents presenting to their PCP for treatment of moderately severe depression and/or anxiety. OBJECTIVE In this 12-week pilot randomized controlled study, we evaluated the feasibility of the app-based intervention to adolescents ages 13-17 years with moderate depressive symptoms presenting in ambulatory pediatric primary care clinics. METHODS We evaluated change in depressive symptom severity as measured by the 9-item Patient Health Questionnaire (PHQ-9), anxiety symptoms via the 7-item Generalized Anxiety Disorder Questionnaire (GAD-7) and self-efficacy for mental health via the Mental Health Self-efficacy Scale (MHSES) at 4 and 12 weeks. Data on acceptability, feasibility and usability were collected from participants, and qualitative interviews were conducted with referring primary care providers (PCPs). RESULTS The pilot randomized 18 participants to treatment plus usual care (n=10) or usual care alone (n=8). There were no difference between groups on baseline characteristics, and all randomized participants completed the program. Although participants in the active treatment group experienced a greater reduction in depressive symptoms than the usual care group, mental health outcomes between groups was not statistically significant. Teen- and parent-reported usability, feasibility and acceptability of the app was high; PCPs reported preference for introducing the app early in the course of care for individuals presenting with mild or moderate symptoms. CONCLUSIONS In this small randomized study, we demonstrated the feasibility, acceptability, usability and safety of using a CBT-based chatbot for adolescents presenting with moderate depressive symptoms in real-world primary care settings. Further study is needed to fully determine effectiveness of both the intervention and implementation in primary care settings. CLINICALTRIAL NCT04603053 (https://clinicaltrials.gov/ct2/show/NCT04603053)
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