Clinical Trial: Therapeutic Mechanisms and Neural Substrates of Transdiagnostic Cognitive Behavioral Therapy for Emotional Disorders (Continuation of an Ancillary Study to an Existing Trial) (Japan)

Tokyo, July 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058549) titled 'Therapeutic Mechanisms and Neural Substrates of Transdiagnostic Cognitive Behavioral Therapy for Emotional Disorders (Continuation of an Ancillary Study to an Existing Trial)' on July 22.

Study Type: Interventional

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

Primary Sponsor: Institute - National Center of Neurology and Psychiatry, Japan

Condition: Condition - Anxiety Disorders Depressive Disorders Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - In the primary outcome paper, the hypothesis was supported that a combination of cognitive behavioral therapy (CBT) and treatment as usual (TAU) was more effective than a waitlist condition for CBT alongside TAU in reducing depressive and anxiety symptoms, as measured by the GRID-HAMD, in patients with depressive and anxiety disorders (Ito et al., 2023). However, the average change in GRID-HAMD scores following the Unified Protocol (UP) was approximately five points, and some patients showed no clear improvement. These findings suggest that the UP is not universally effective for all patients within its target population. Therefore, the present study aims to examine the therapeutic mechanisms and neural substrates that underlie variability in treatment response. Basic objectives2 - Others

Intervention: Interventions/Control_1 - Unified Protocol with Treatment As Usual Unified Protocol is designed to help patients learn how to confront and experience uncomfortable emotions and learn how to respond to their emotions in more adaptive ways. Individual treatment sessions will be conducted by experienced clinicians who will be trained in the administration of this protocol. A workbook will be provided to each patient as part of this manualized treatment. During this treatment period, the participants continue the Treatment As Usual.

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - a) DSM-IV or DSM-5 diagnosis of Major Depressive Disorder, Dysthymia, Depressive Disorder Not Otherwise Specified, Panic Disorder With Agoraphobia, Panic Disorder Without Agoraphobia, Agoraphobia Without History of Panic Disorder, Social Phobia(Social Anxiety Disorder), Obsessive-Compulsive Disorder, Posttraumatic Stress Disorder, Generalized Anxiety Disorder, Anxiety Disorder Not Otherwise Specified assessed by SCID or M.I.N.I.. b) Depressive and anxiety symptoms is mild or more severe (GRID-HAMD >= 8). c) Ages 20 years or older, and 65 years or younger at screening. d) Subjects who give full consent in the participation of the study. Key exclusion criteria - a) No alcohol or substance use disorder in 6 months prior to the screening assessed by SCID or M.I.N.I.. b) No current manic episode or current schizophrenia and other psychotic disorders at baseline assessed by SCID or M.I.N.I.. c) No serious suicidal ideation at baseline (GRID-HAMD Item3 severity is 3 or higher.) d) No life-threatening, severe or unstable physical disorders or major cognitive deficits at baseline. e) Evidence of unable to participate half or more of the intervention phase. f) No structured psychotherapy during at baseline. g) Other relevant reason decided by the investigators. Target Size - 200

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2023 Year 05 Month 17 Day Date of IRB - 2023 Year 06 Month 09 Day Anticipated trial start date - 2023 Year 06 Month 09 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=R000066868

Disclaimer: Curated by HT Syndication.