Developing an Integrated Psychotherapy With Cognitive-behavioral Therapy and Biofeedback Therapy for Somatic Symptom Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: cognitive-behavioral therapy and biofeedback therapy.
- Who it may be relevant to
- Registry conditions: Somatic Symptom Disorder. Basic parameters: 20 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Developing an Integrated Psychotherapy With Cognitive-behavioral Therapy and Biofeedback Therapy for Somatic Symptom Disorder: a Randomized Controlled Trial
Overview
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
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.
Interventions
- Behavioral cognitive-behavioral therapy and biofeedback therapy
Complete eight sessions of cognitive-behavioral therapy and biofeedback therapy within three months.
Primary outcome measures
- Scores of Patient Health Questionnaire-15 (PHQ-15) [Time frame: Week 12 (comparing with the data in week 0)]
- Scores of Health Anxiety Questionnaire (HAQ) [Time frame: Week 12 (comparing with the data in week 0)]
Secondary outcome measures (5)
- Scores of Beck Depression Inventory-II (BDI-II) [Time frame: Week 12 (comparing with the data in week 0)]
- Scores of Beck Anxiety Inventory (BAI) [Time frame: Week 12 (comparing with the data in week 0)]
- Scores of Cognitions About Body and Health Questionnaire (CABAH) [Time frame: Week 12 (comparing with the data in week 0)]
- Heart rate variability [Time frame: Week 12 (comparing with the data in week 0)]
- Skin conductance [Time frame: Week 12 (comparing with the data in week 0)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- Department of Psychiatry, National Taiwan University Hospital Yunlin Branch — Yunlin
Identifiers
NCT: NCT05792930 · 202209093RIND