Adding smartphone cognitive-behavior therapy to pharmacotherapy for major depression: A randomized control trial
- Conditions
- Major depressive disorder
- Registration Number
- JPRN-UMIN000013693
- Lead Sponsor
- Japan Foundation of Neuroscience and Mental Health
- Brief Summary
Please see: Mantani A, Kato T, Furukawa TA, Horikoshi M, Imai H, Hiroe T, Chino B, Funayama T, Yonemoto N, Zhou Q & Kawanishi N (2017) Smartphone Cognitive Behavioral Therapy as an Adjunct to Pharmacotherapy for Refractory Depression: Randomized Controlled Trial. Journal of Medical Internet Research, 19, e373.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 164
Not provided
1) Treatment with monoamine oxidase inhibitors, electroconvulsive therapy , repetitive transcranial magnetic stimulation, escitalopram/sertraline or individual face-to-face cognitive-behavior or interpersonal therapy during the index episode 2) Psychiatric omorbidities 2-1) Lifetime diagnosis of schizophrenia, schizoaffective disorder or bipolar disorder 2-2) Current diagnosis of neurocognitive disorder, eating disorder, substance dependence or borderline personality disorder 3) Imminent risk of suicide 4) Physical comorbidities that interfere with escitalopram treatment 4-1) prolonged QTc (>450 ms for men, and >470 for women) 4-2) co-administration of drugs known to cause QTc prolongation as judged by treating physician 5) Pregnant or breast-feeding women 6) Current participation in another clinical intervention research
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Slope of Patient Health Questionnaire-9 (PHQ-9) scores at 0, 1, 5 and 9 weeks
- Secondary Outcome Measures
Name Time Method Slope of Beck Depression Inventory-II (BDI-II) scores at 0, 1, 5 and 9 weeks, Response rate at 9 weeks (defined as 4 or less on PHQ-9) Treatment satisfaction at 9 weeks Continuation of antidepressant pharmacotherapy through 9 weeks Slope of Frequency, Intensity, and Burden of Side Effects Ratings (FIBSER) scores at 0, 1, 5 and 9 weeks