Department of Psychiatry, National Taiwan University Hospital Yunlin Branch
Yunlin, 640, Taiwan
Location status: Recruiting
Location contact
Huang Wei-Lieh, MD, MSc, PhD
CONTACT
NCT Number: NCT05792930
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.
Interested in participating?
Request Info20 year–70 year
All sexes
Interventional
Not applicable
Yunlin, 640, Taiwan
Location status: Recruiting
Huang Wei-Lieh, MD, MSc, PhD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Complete eight sessions of cognitive-behavioral therapy and biofeedback therapy within three months.
Time frame: Week 12 (comparing with the data in week 0)
Measurement of somatic distress. Score range is 0 to 30; higher score means more severe somatic distress
Time frame: Week 12 (comparing with the data in week 0)
Measurement of health anxiety. Score range is 0 to 63; higher score means more severe health anxiety
Time frame: Week 12 (comparing with the data in week 0)
Measurement of depression. Score range is 0 to 63; higher score means more severe depression
Time frame: Week 12 (comparing with the data in week 0)
Measurement of anxiety. Score range is 0 to 63; higher score means more severe anxiety
Time frame: Week 12 (comparing with the data in week 0)
Measurement of cognitions about health. Score range is 0 to 117; higher score means more severe cognitive distortion about health
Time frame: Week 12 (comparing with the data in week 0)
Measurement of parasympathetic activity
Time frame: Week 12 (comparing with the data in week 0)
Measurement of sympathetic activity
Contact information is provided by the study sponsor or research team.
National Taiwan University Hospital
Other
Developing an Integrated Psychotherapy With Cognitive-behavioral Therapy and Biofeedback Therapy for Somatic Symptom Disorder: a Randomized Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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