Tokyo, Feb. 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060595) titled 'A Preliminary Study on the Efficacy of the Group Cognitive Behavioral Therapy Based on the Unified Protocol' on Feb. 5.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - National Center of Neurology and Psychiatry

Condition: Condition - Major Depressive Disorder, Persistent Depressive Disorder, Panic Disorder, Agoraphobia, Social Anxiety Disorder, Obsessive-Compulsive Disorder, Generalized Anxiety Disorder Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The present study aims to examine the feasibility and efficacy of the group-based Unified Protocol (UP) among patients with major depressive disorder, persistent depressive disorder, panic disorder, agoraphobia, social anxiety disorder, obsessive-compulsive disorder, and generalized anxiety disorder as defined in DSM-5. Additionally, interviews will be conducted with study participants to explore group CBT processes in Japan, focusing on the content of a measure assessing group cohesion and their experiences with group CBT. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - The Group Cognitive Behavioral Therapy Based on the Unified Protocol

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - 1) Individuals who meet the DSM-5 diagnostic criteria at the pre-intervention assessment for one of the following: major depressive disorder, persistent depressive disorder, panic disorder, agoraphobia, social anxiety disorder, obsessive-compulsive disorder, or generalized anxiety disorder 2) Moderate or greater symptom severity (Clinical Global Impressions-Severity of Illness: CGI-S >= 4) is present at the pre-intervention assessment, as assessed by the CGI-S 3) Age between 18 and 70 years 4) Individuals who are deemed by the treating psychiatrist to be suitable for CBT 5) Individuals who provided written informed consent after understanding the purpose and procedures of the study and agreeing to participate voluntarily Key exclusion criteria - 1) Individuals with alcohol use disorder or substance use disorder at the pre-intervention assessment 2) Individuals with hypomanic episodes, manic episodes, or psychotic disorders at the pre-intervention assessment 3) Individuals who exhibit marked suicidal ideation (rated as severe on the Suicide module of the GRID-HAMD) at the pre-intervention assessment 4) Individuals who are known in advance to have difficulty attending six or more sessions during the intervention period 5) Individuals who are receiving other structured psychotherapies (excluding supportive therapy and psychoeducation) during the intervention period 6) Individuals who, at the pre-intervention assessment, have physical illnesses or severe cognitive impairment to a degree that would make it difficult to carry out the group-based UP 7) Individuals deemed unsuitable for participation in this study by the principal investigator Target Size - 16

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2025 Year 08 Month 15 Day Date of IRB - 2025 Year 08 Month 18 Day Anticipated trial start date - 2026 Year 02 Month 06 Day Last follow-up date - 2030 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069309

Disclaimer: Curated by HT Syndication.