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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Somatic Symptom Disorder

Intervention / Treatment
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* Behavioral: cognitive-behavioral therapy and biofeedback therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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somatic symptom disorder, cognitive behavioral therapy, biofeedback therapy, somatic distress, health anxiety