Tokyo, Aug. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062235) titled 'Brief Cognitive Behavioral Therapy for Patients with Somatic Symptom Disorder in General Practice' on Aug. 1.

Study Type: Interventional

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

Primary Sponsor: Institute - Jichi Medical University

Condition: Condition - Somatic Symptom Disorder Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to evaluate the effectiveness of brief cognitive behavioral therapy (CBT) delivered by general practitioners during outpatient care for patients with somatic symptom disorder (SSD), to develop practical tools such as a handbook for delivering CBT in SSD care, and to examine the feasibility of applying these tools in real-world clinical settings. Specifically, this study aims to evaluate symptom improvement resulting from brief CBT delivered by general practitioners to patients with SSD, to develop practical support tools such as a handbook for delivering CBT for patients with SSD in outpatient settings, and to examine barriers and facilitators among general practitioners in order to assess the applicability of the developed tools to real-world clinical practice. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - In the usual care group, patients with somatic symptom disorder or persistent somatic symptoms will receive routine outpatient care. The content, interval, and number of consultations will be determined according to each patient's condition and the physician's clinical judgment. This group will be used as a historical control without the brief handbook-based psychological intervention. Interventions/Control_2 - In the handbook-assisted care group, general practitioners will provide a brief psychological intervention using a handbook during routine outpatient consultations for patients with somatic symptom disorder or persistent somatic symptoms. The program incorporates elements of cognitive behavioral therapy, acceptance and commitment therapy, and mindfulness. The intervention will consist of three sessions, each lasting approximately 15 minutes. If necessary, the physician will first confirm the program purpose, procedure, safety considerations, and the patient's agreement to participate. The sessions will include reviewing symptoms, impact on daily life, mood, personal values, and a 3-month short-term goal; introducing body scan practice; planning and reviewing behavioral experiments; and discussing coping strategies. Patients will complete homework such as body scan practice and behavioral experiments between sessions.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - (a) Aged 18 years or older and able to communicate sufficiently in Japanese. (b) Able to provide written informed consent to participate in the study. (c) Assessed by the attending physician in clinical practice as having somatic symptom disorder (SSD) or suspected SSD, and meeting the following diagnostic concept used in this study: A. At least one of the following: (1) Disproportionate and persistent thoughts about the seriousness of one's symptoms. (2) Persistently high level of anxiety about health or symptoms. (3) Excessive time and energy devoted to these symptoms or health concerns. B. Although any one somatic symptom need not be continuously present, the state of being symptomatic has persisted for at least 3 months. Key exclusion criteria - (a) Those with the following psychiatric disorders or conditions: depressive disorders, bipolar disorder, suicidal tendency, eating disorders, substance use disorders, acute psychosis, brain injury, personality disorders, or similar conditions.

(b) Those who pose a risk of harm to others or themselves, or who require urgent medical care.

(c) Those who have received inpatient psychiatric treatment within the past 5 years or psychotherapy for SSD within the past 2 years. Target Size - 23

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 06 Month 22 Day Date of IRB - 2026 Year 06 Month 22 Day Anticipated trial start date - 2026 Year 08 Month 01 Day Last follow-up date - 2028 Year 03 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071215

Disclaimer: Curated by HT Syndication.