Article ; Online: Preliminary Efficacy of a Digital Intervention for Adolescent Depression: Randomized Controlled Trial.
Journal of medical Internet research
2024 Volume 26, Page(s) e48467
Abstract: Background: Adolescent depression is a significant public health concern; however, access to effective mental health care is limited. Digital therapeutics (DTx) can improve access to evidence-based interventions; however, their efficacy in adolescents ... ...
| Abstract | Background: Adolescent depression is a significant public health concern; however, access to effective mental health care is limited. Digital therapeutics (DTx) can improve access to evidence-based interventions; however, their efficacy in adolescents is sparsely documented. Objective: This study aims to examine the efficacy of a mobile app DTx versus an active control as an adjunct treatment for adolescent depression symptoms. Methods: An internet-based open-label randomized control trial was conducted nationwide with a partial crossover design, and 168 adolescents aged 13 to 21 years with symptoms of depression were recruited between November 2020 and September 2021. Participants were randomized (1:1) to the cognitive behavioral therapy-based treatment app (Spark) or to a psychoeducational control app (control), which they would use for a duration of 5 weeks. The primary outcome was a between-group (Spark vs control) difference in the change in depression symptoms from baseline to postintervention, as measured by the Patient Health Questionnaire-8 (PHQ-8) using a linear mixed-effects analysis. The PHQ-8 ranges from 0 to 24, with scores of 5 to 9 indicating mild depression symptoms, scores of 10 to 14 indicating moderate symptoms, scores of 15 to 19 indicating moderately severe symptoms, and scores of 20 to 24 indicating severe symptoms. A minimal clinically important difference (5-point reduction between baseline and postintervention) in the Spark arm and group differences in remission and treatment response rates based on the PHQ-8 at postintervention were also investigated. Results: A total of 160 participants were randomized, 80 in the Spark arm (mean age 16.89, SD 2.5 y) and 80 in the control arm (mean age 16.79, SD 2.59 y). Data from 121 participants (Spark: n=63; control: n=58) with moderate to severe (PHQ-8≥10) symptoms at baseline were included in the primary analyses following a modified intention-to-treat principle. A linear mixed-effect analysis revealed a nonsignificant difference between the study arms in depression symptom change over the intervention period. The Spark arm met a minimal clinically important difference threshold (mean -5.08, 95% CI -6.72 to -3.42). The remission rate in the Spark arm was significantly higher than that in the control arm (11/63, 17% vs 2/58, 3%; χ Conclusions: There is initial evidence that a self-guided, cognitive behavioral therapy-based DTx intervention may effectively treat mild to severe depression symptoms in adolescents. DTx may improve access to mental health care for adolescents or serve as an important adjunct to the standard of care. Trial registration: ClinicalTrials.gov NCT04524598; https://clinicaltrials.gov/study/NCT04524598. |
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| MeSH term(s) | Adolescent ; Humans ; Cognitive Behavioral Therapy ; Depression ; Depressive Disorder ; Intention ; Internet ; Young Adult |
| Language | English |
| Publishing date | 2024-02-07 |
| Publishing country | Canada |
| Document type | Randomized Controlled Trial ; Journal Article |
| ZDB-ID | 2028830-X |
| ISSN | 1438-8871 ; 1438-8871 |
| ISSN (online) | 1438-8871 |
| ISSN | 1438-8871 |
| DOI | 10.2196/48467 |
| Database | MEDical Literature Analysis and Retrieval System OnLINE |
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