Developing an Integrated Psychotherapy With Cognitive-behavioral Therapy and Biofeedback Therapy for Somatic Symptom Disorder

Developing an Integrated Psychotherapy With Cognitive-behavioral Therapy and Biofeedback Therapy for Somatic Symptom Disorder: a Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Somatic Symptom Disorder
• Intervention / Treatment: Behavioral: cognitive-behavioral therapy and biofeedback therapy

Detailed Description

Somatic symptom disorder (SSD) is a psychiatric disorder featured with somatic distress and related psychological phenomena. In the past several years, our research team has investigated several aspects of SSD, including psychopathology, epidemiology, mechanism, and diagnostic biomarkers. But the aspect about treatment on SSD has not been comprehensively explored.

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wei-Lieh Huang, MD, PhD; Phone Number: 563700 886-5-5323911; Email: weiliehhuang@gmail.com

Study Locations

• Taiwan
  • Yunlin, Taiwan, 640
    • Recruiting
    • Department of Psychiatry, National Taiwan University Hospital Yunlin Branch
    • Contact: Huang Wei-Lieh, MD, MSc, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; The experimental group will receive cognitive-behavioral therapy (CBT) and biofeedback therapy.	Behavioral: cognitive-behavioral therapy and biofeedback therapy; Complete eight sessions of cognitive-behavioral therapy and biofeedback therapy within three months.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scores of Beck Depression Inventory-II (BDI-II)	Measurement of depression. Score range is 0 to 63; higher score means more severe depression	Week 12 (comparing with the data in week 0)
Scores of Beck Anxiety Inventory (BAI)	Measurement of anxiety. Score range is 0 to 63; higher score means more severe anxiety	Week 12 (comparing with the data in week 0)
Scores of Cognitions About Body and Health Questionnaire (CABAH)	Measurement of cognitions about health. Score range is 0 to 117; higher score means more severe cognitive distortion about health	Week 12 (comparing with the data in week 0)
Heart rate variability	Measurement of parasympathetic activity	Week 12 (comparing with the data in week 0)
Skin conductance	Measurement of sympathetic activity	Week 12 (comparing with the data in week 0)

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Wei-Lieh Huang, MD, PhD, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: March 20, 2023
• First Submitted That Met QC Criteria: March 20, 2023
• First Posted (Actual): March 31, 2023

Study Record Updates

• Last Update Posted (Actual): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: cognitive behavioral therapy; somatic symptom disorder; health anxiety; somatic distress; biofeedback therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Medically Unexplained Symptoms; Therapeutics; Mind-Body Therapies; Complementary Therapies; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological; Cognitive Behavioral Therapy; Biofeedback, Psychology
• Other Study ID Numbers: 202209093RIND

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No