Tokyo, Nov. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059046) titled 'Evaluation of the efficacy of smartphone-based cognitive behavioral therapy for preventing relapse in treatment-resistant depression after a successful course of repetitive transcranial magnetic stimulation: a randomized controlled trial' on Nov. 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Fujita Health University

Condition: Condition - Major depressive disorder Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To determine whether combined therapy with smartphone-based cognitive behavioral therapy (sCBT) and pharmacotherapy is more effective than pharmacotherapy alone in preventing relapse among adult patients with moderate-to-severe depression, characterized by non-response to antidepressant pharmacotherapy and subsequent response or remission with acute-phase rTMS therapy Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Combination of smartphone-based cognitive behavioral therapy and pharmacotherapy Interventions/Control_2 - pharmacotherapy alone

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients who have provided written informed consent after receiving sufficient explanation about the study and fully understanding it, based on their own free will Adult patients (aged 18 years or older) with depression who did not achieve the expected therapeutic effect despite adequate pharmacotherapy with existing antidepressants and were judged to be eligible for rTMS therapy Patients who, after 3 to 6 weeks of rTMS therapy, demonstrated response, defined as a reduction of 50% or more in HAMD-17 total score from baseline, or remission, defined as a HAMD-17 total score of 7 or lower, and with a PHQ-9 score of less than 10 Patients capable of verbal and written communication in Japanese Patients who own a smartphone and are familiar with its operation Key exclusion criteria - Patients with suicidal ideation Patients with a history of schizophrenia, schizoaffective disorder, or bipolar disorder, as clinically diagnosed by the attending physician Patients with a current diagnosis of dementia, eating disorder, substance dependence, or borderline personality disorder, as clinically diagnosed by the attending physician Patients judged by the investigators to have difficulty using the smartphone application Any other patients deemed inappropriate for participation by the principal investigator or co-investigators Target Size - 156

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 05 Month 29 Day Anticipated trial start date - 2025 Year 11 Month 01 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067531

Disclaimer: Curated by HT Syndication.