Actively Recruiting
Developing an Integrated Psychotherapy With Cognitive-behavioral Therapy and Biofeedback Therapy for Somatic Symptom Disorder: a Randomized Controlled Trial
Led by National Taiwan University Hospital · Updated on 2025-12-19
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying somatic symptom disorder (SSD), a psychiatric condition characterized by distressing physical symptoms and related psychological issues. This study aims to develop and test an integrative psychotherapy combining cognitive-behavioral therapy (CBT) and biofeedback therapy to assess its effects on treating SSD. The research uses a randomized controlled design with a waiting list control group to compare outcomes like patient health and health anxiety. Participants in the experimental group will receive eight sessions of CBT and biofeedback therapy over three months. The control group will initially be on a waiting list without intervention, with data collected during this observation period. Afterward, they will also receive the same psychotherapy as the experimental group. Biofeedback therapy involves monitoring biological signals related to stress and relaxation to help patients understand their connection to physical and mental responses. Throughout the study, participants will be assessed using questionnaires such as the Patient Health Questionnaire-15 and Health Anxiety Questionnaire, along with other psychological and biological measures like depression, anxiety, cognition about health, heart rate variability, and skin conductance. The primary outcomes will be measured at week 12 compared to baseline. The study is sponsored by National Taiwan University Hospital and includes adults aged 20 to 70 years with confirmed SSD.
CONDITIONS
Brief Title
Developing an Integrated Psychotherapy With Cognitive-behavioral Therapy and Biofeedback Therapy for Somatic Symptom Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient with somatic symptom disorder (confirmed by psychiatrists)
You will not qualify if you...
- Younger than 20 years or older than 70 years
- Having psychotic symptoms or cognitive impairment
- Having a potentially lethal illness
- Cannot read the questionnaires by oneself
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Within 3 months
Participants complete eight sessions of integrated cognitive-behavioral therapy and biofeedback therapy.
8 therapy sessions
Duration - Up to Week 12 after treatment starts
Participants are assessed to evaluate treatment outcomes using questionnaires and biological measurements.
1 visit (in-person) for outcome assessments
Trial Site Locations
Total: 1 location
1
Department of Psychiatry, National Taiwan University Hospital Yunlin Branch
Yunlin, Taiwan, 640
Actively Recruiting
Research Team
W
Wei-Lieh Huang, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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