Developing an Integrated Psychotherapy With Cognitive-behavioral Therapy and Biofeedback Therapy for Somatic Symptom Disorder
NCT ID: NCT05792930
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2023-07-11
2026-06-30
Brief Summary
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Detailed Description
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In literature, the treatment of SSD can be separated into physical and psychological approaches. The physical approach includes pharmacotherapy and magnetic/electrical neuromodulation. Among several types of psychotherapies, cognitive behavioral therapy (CBT) has the most evidence. Previous studies have disclosed SSD patients to have following cognitive or behavioral features: selective attention on somatic distress; memory bias on the severe health conditions; all-or-none cognition about health; organic attribution style; catastrophizing cognitive pattern about health; high motivation of concerning issues about health; inadequate reassurance-seeking behavior; the assumption about the connection between rest and somatic distress, etc.
Biofeedback therapy works by measuring several biological signals related with stress and relaxation (such as heart rate, skin conductance, electromyography, electroencephalography, and finger temperature); feedback of these signals to the subjects can help them more clearly understand the association between their behavior/cognition and relaxation. Biofeedback therapy has been extensively applied in the psychosomatic field.
This research program is aimed to develop a integrative psychotherapy (including CBT and biofeedback therapy) and to examine its efficacy. The study design is a randomized controlled trial with waiting list control. Scores of Patient Health Questionniare-15 (PHQ-15) and Health Anxiety Questionnaire (HAQ) are the primary endpoints; the changes of other psychological and biological measurements are viewed as secondary endpoints.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental Group
The experimental group will receive cognitive-behavioral therapy (CBT) and biofeedback therapy.
cognitive-behavioral therapy and biofeedback therapy
Complete eight sessions of cognitive-behavioral therapy and biofeedback therapy within three months.
Control Group
The 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.
No interventions assigned to this group
Interventions
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cognitive-behavioral therapy and biofeedback therapy
Complete eight sessions of cognitive-behavioral therapy and biofeedback therapy within three months.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Having psychotic symptoms or cognitive impairment
* Having a potentially lethal illness
* Cannot read the questionnaires by oneself
20 Years
70 Years
ALL
No
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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Principal Investigators
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Wei-Lieh Huang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University Hospital
Locations
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Department of Psychiatry, National Taiwan University Hospital Yunlin Branch
Yunlin, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Huang Wei-Lieh, MD, MSc, PhD
Role: primary
Other Identifiers
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202209093RIND
Identifier Type: -
Identifier Source: org_study_id