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

Somatic Symptom Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05792930
• Other study ID #: 202209093RIND
• Status: Recruiting
• Phase: N/A
• Start date: July 11, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2023
• Source: National Taiwan University Hospital
• Contact: Wei-Lieh Huang, MD, PhD
• Phone: 886-5-5323911
• Email: weiliehhuang[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Medically Unexplained Symptoms
• Somatic Symptom Disorder

Intervention

Behavioral:
• cognitive-behavioral therapy and biofeedback therapy
Complete eight sessions of cognitive-behavioral therapy and biofeedback therapy within three months.

Locations

Country	Name	City	State
Taiwan	Department of Psychiatry, National Taiwan University Hospital Yunlin Branch	Yunlin

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	Heart rate variability	Measurement of parasympathetic activity	Week 12 (comparing with the data in week 0)
Secondary	Skin conductance	Measurement of sympathetic activity	Week 12 (comparing with the data in week 0)