Developing an Integrated Psychotherapy With Cognitive-behavioral Therapy and Biofeedback Therapy for Somatic Symptom Disorder
1 other identifier
interventional
60
1 country
1
Brief Summary
This research program is aimed to develop a integrative psychotherapy (including CBT and biofeedback therapy) and to examine its efficacy on treatment of somatic symptom disorder. The study design is a randomized controlled trial with waiting list control. Scores of Patient Health Questionniare-15 and Health Anxiety Questionnaire are the primary endpoints.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2023
CompletedFirst Posted
Study publicly available on registry
March 31, 2023
CompletedStudy Start
First participant enrolled
July 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
December 19, 2025
December 1, 2025
3 years
March 20, 2023
December 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Scores of Patient Health Questionnaire-15 (PHQ-15)
Measurement of somatic distress. Score range is 0 to 30; higher score means more severe somatic distress
Week 12 (comparing with the data in week 0)
Scores of Health Anxiety Questionnaire (HAQ)
Measurement of health anxiety. Score range is 0 to 63; higher score means more severe health anxiety
Week 12 (comparing with the data in week 0)
Secondary Outcomes (5)
Scores of Beck Depression Inventory-II (BDI-II)
Week 12 (comparing with the data in week 0)
Scores of Beck Anxiety Inventory (BAI)
Week 12 (comparing with the data in week 0)
Scores of Cognitions About Body and Health Questionnaire (CABAH)
Week 12 (comparing with the data in week 0)
Heart rate variability
Week 12 (comparing with the data in week 0)
Skin conductance
Week 12 (comparing with the data in week 0)
Study Arms (2)
Experimental Group
EXPERIMENTALThe experimental group will receive cognitive-behavioral therapy (CBT) and biofeedback therapy.
Control Group
NO INTERVENTIONThe design of control group is waiting list control; their data will be collected without intervention during the observation period. After the observation period, psychotherapy (CBT and biofeedback, the same as intervention) will be arranged.
Interventions
Complete eight sessions of cognitive-behavioral therapy and biofeedback therapy within three months.
Eligibility Criteria
You may qualify if:
- Patient with somatic symptom disorder (confirmed by psychiatrists)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Psychiatry, National Taiwan University Hospital Yunlin Branch
Yunlin, 640, Taiwan
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wei-Lieh Huang, MD, PhD
National Taiwan University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2023
First Posted
March 31, 2023
Study Start
July 11, 2023
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
December 19, 2025
Record last verified: 2025-12