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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-70
SponsorNational Taiwan University Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • cognitive-behavioral therapy and biofeedback therapy

    Behavioral

    Complete eight sessions of cognitive-behavioral therapy and biofeedback therapy within three months.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Experimental GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Week 12 (comparing with the data in week 0)
2

Scores of Health Anxiety Questionnaire (HAQ)

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)

Secondary outcomes

1

Scores of Beck Depression Inventory-II (BDI-II)

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)
2

Scores of Beck Anxiety Inventory (BAI)

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)
3

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

Time frame
Week 12 (comparing with the data in week 0)
4

Heart rate variability

Measurement of parasympathetic activity

Time frame
Week 12 (comparing with the data in week 0)

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Department of Psychiatry, National Taiwan University Hospital Yunlin BranchRecruiting640, YunlinTaiwanTaiwan

Sponsors and contacts

Click on the lead sponsor to view all of their trials.