About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient with somatic symptom disorder (confirmed by psychiatrists)
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
cognitive-behavioral therapy and biofeedback therapy
BehavioralComplete eight sessions of cognitive-behavioral therapy and biofeedback therapy within three months.
Treatment groups
Trial outcomes
Primary outcomes
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
Scores of Health Anxiety Questionnaire (HAQ)
Measurement of health anxiety. Score range is 0 to 63; higher score means more severe health anxiety
Secondary outcomes
Scores of Beck Depression Inventory-II (BDI-II)
Measurement of depression. Score range is 0 to 63; higher score means more severe depression
Scores of Beck Anxiety Inventory (BAI)
Measurement of anxiety. Score range is 0 to 63; higher score means more severe anxiety
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
Heart rate variability
Measurement of parasympathetic activity
Locations
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Sponsors and contacts
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