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Published on: June 12, 2020
A Relational Agent Intervention for Adolescents Seeking Mental Health Treatment: Outcomes From a Randomized
Mary Margaret Gleason1, Megan Flom2, Stephanie Rapoport2
1Children's Hospital of The King's Daughters and Eastern Virginia Medical School, Norfolk, Virginia.
Objective:
Despite steady increases in the prevalence of depression and anxiety, many adolescents remain undertreated. Digital mental health interventions (DMHI) may address some barriers to care. This study is the first to examine the prospective noninferiority of a smartphone-based, self-guided relational agent (W-GenZD) DMHI to address adolescent depressive symptoms compared to group-based telehealth cognitive-behavioral therapy (CBT).
Method:
Adolescents 13 to 17 years of age who were seeking treatment for depression and/or anxiety at a children's hospital outpatient mental health program and who met study inclusion criteria were randomized to either W-GenZD (n = 71) or CBT Group (n = 70). The primary aim was to examine feasibility and acceptability. The secondary aim was to test the noninferiority of W-GenZD compared to CBT Group on the 8-item Patient Health Questionnaire (PHQ-8) at 4 weeks (end of treatment [EOT]). The study also examined the trajectory of working alliance, anxiety, general mood, and safety in each intervention group.
Results:
W-GenZD was noninferior to CBT Group in reducing depressive symptoms, with a mean between-group PHQ-8 EOT score difference of -0.67, 95% CI = - 2.30, 0.82 in intent-to-treat analysis (N = 141) using multiple imputation for missing values. Four different sensitivity analyses confirmed noninferiority, including per protocol analysis (-1.38, -3.61, 0.86, n = 82). Feasibility, acceptability, and tertiary aims were similar in both groups, and data support the safety of W-GenZD in a mental health outpatient setting.
Conclusion:
Results suggest that W-GenZD is a feasible and efficacious intervention for adolescents presenting with depression and/or anxiety in a real-world setting. W-GenZD could help expand the capacity of mental health clinicians to support the many youth and families in need of mental health care.
Clinical Trial Registration Information:
Feasibility and Acceptability of W-GenZD vs CBT-light Teletherapy for Adolescents Seeking Mental Health Services; https://clinicaltrials.gov/study/NCT05372913.
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