Adding smartphone-based cognitive-behavior therapy to pharmacotherapy for major depression (FLATT project): study...

Area of Science:

• Psychiatry
• Digital Health
• Clinical Psychology

Background:

• Major depression significantly impacts quality of life, with many patients not achieving remission with standard antidepressant treatment.
• Cognitive-behavioral therapy (CBT) is effective but limited by therapist availability and time commitment.
• Treatment-resistant depression necessitates innovative and accessible therapeutic strategies.

Purpose of the Study:

• To evaluate the effectiveness of combining a smartphone-based CBT program with antidepressant switching versus antidepressant switching alone.
• To assess the additive value of a digital CBT intervention for patients with persistent depressive symptoms.

Main Methods:

• A multi-center randomized trial involving 164 patients with DSM-5 major depressive disorder.
• Participants were allocated to either a smartphone-based CBT (Kokoro-App) plus antidepressant switching group or antidepressant switching alone.
• Primary outcome: change in Patient Health Questionnaire score over 9 weeks, assessed by blinded raters.

Main Results:

• The study is ongoing, and results are pending.
• The Kokoro-App has demonstrated feasibility in a prior open study.
• Secondary outcomes include Beck Depression Inventory-II scores, side effect burden, and treatment satisfaction.

Conclusions:

• An accessible intervention like smartphone-based CBT could improve mental health and reduce societal burden.
• This trial investigates the potential benefits of integrating digital CBT into treatment-resistant depression management.