Integrated psychotherapy combining cognitive-behavioral therapy and biofeedback for somatic symptom disorder
Official title: Developing an Integrated Psychotherapy With Cognitive-behavioral Therapy and Biofeedback Therapy for Somatic Symptom Disorder: a Randomized Controlled Trial
Run by National Taiwan University Hospital · NCT05792930 · Data updated 2026-11-12
This study is testing a new therapy that combines cognitive-behavioral therapy and biofeedback to see if it helps people with somatic symptom disorder feel better.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 20 Years to 70 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 1 site (Yunlin) |
| Status | Recruiting |
| Started | July 11, 2023 |
| Main results expected | June 30, 2026 |
| Study ends | June 30, 2026 |
| Registry record updated | December 19, 2025 |
| Trial ID | NCT05792930 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 20 to 70 who have been diagnosed with somatic symptom disorder by a psychiatrist.
✕Probably not a fit
Patients with psychotic symptoms, cognitive impairment, or those with a potentially lethal illness may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This research program aims to develop an integrative psychotherapy that combines cognitive-behavioral therapy (CBT) and biofeedback therapy to treat somatic symptom disorder (SSD). The study employs a randomized controlled trial design with a waiting list control group to evaluate the efficacy of this combined approach. Primary endpoints include scores from the Patient Health Questionnaire-15 and the Health Anxiety Questionnaire, which will assess the impact of the intervention on somatic distress and health anxiety. The study builds on previous research into SSD, focusing on treatment strategies that have not been comprehensively explored.
Why it matters
Potential benefit: If successful, this approach could significantly improve the management of somatic symptom disorder, reducing distress and enhancing patients' quality of life.
How similar studies have gone: Previous studies have shown that cognitive-behavioral therapy is effective for somatic symptom disorder, but the combination with biofeedback therapy is a novel approach that has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient with somatic symptom disorder (confirmed by psychiatrists) Exclusion Criteria: * The age is younger than 20 or older than 70 years * Having psychotic symptoms or cognitive impairment * Having a potentially lethal illness * Cannot read the questionnaires by oneself
Where it's running
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Department of Psychiatry, National Taiwan University Hospital Yunlin Branch
Yunlin, Taiwan Recruiting
Study contacts
- Principal investigator: Wei-Lieh Huang, MD, PhD — National Taiwan University Hospital
- Study coordinator: Wei-Lieh Huang, MD, PhD
- Email: weiliehhuang@gmail.com
- Phone: 886-5-5323911
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.