Integrated psychotherapy combining cognitive-behavioral therapy and biofeedback for somatic symptom disorder
Developing an Integrated Psychotherapy With Cognitive-behavioral Therapy and Biofeedback Therapy for Somatic Symptom Disorder: a Randomized Controlled Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 20 Years to 70 Years |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 1 site (Yunlin) |
| Trial ID | NCT05792930 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 20 to 70 who have been diagnosed with somatic symptom disorder by a psychiatrist.
Not a fit: Patients with psychotic symptoms, cognitive impairment, or those with a potentially lethal illness may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Yunlin
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.