Clinical trial NCT05792930: Developing an Integrated Psychotherapy With Cognitive-behavioral Therapy and Biofeedback Therapy for Somatic Symptom Disorder
Official title: Developing an Integrated Psychotherapy With Cognitive-behavioral Therapy and Biofeedback Therapy for Somatic Symptom Disorder: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Somatic Symptom Disorder
Keywords: somatic symptom disorder
cognitive behavioral therapy
biofeedback therapy
somatic distress
health anxiety
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-03-31
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

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

Primary outcomes:
measure: Scores of Patient Health Questionnaire-15 (PHQ-15)
timeFrame: Week 12 (comparing with the data in week 0)
measure: Scores of Health Anxiety Questionnaire (HAQ)
timeFrame: Week 12 (comparing with the data in week 0)
Secondary outcomes:
measure: Scores of Beck Depression Inventory-II (BDI-II)
timeFrame: Week 12 (comparing with the data in week 0)
measure: Scores of Beck Anxiety Inventory (BAI)
timeFrame: Week 12 (comparing with the data in week 0)
measure: Scores of Cognitions About Body and Health Questionnaire (CABAH)
timeFrame: Week 12 (comparing with the data in week 0)
measure: Heart rate variability
timeFrame: Week 12 (comparing with the data in week 0)
measure: Skin conductance
timeFrame: Week 12 (comparing with the data in week 0)
Other outcomes:
Locations:
city: Yunlin
country: Taiwan
facility: Department of Psychiatry, National Taiwan University Hospital Yunlin Branch
Study officials:
affiliation: National Taiwan University Hospital Yunlin Branch
name: Wei-Lieh Huang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: