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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05792930
Other study ID # 202209093RIND
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 11, 2023
Est. completion date December 31, 2025

Study information

Verified date January 2023
Source National Taiwan University Hospital
Contact Wei-Lieh Huang, MD, PhD
Phone 886-5-5323911
Email weiliehhuang@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Intervention

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

Locations

Country Name City State
Taiwan Department of Psychiatry, National Taiwan University Hospital Yunlin Branch Yunlin

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Week 12 (comparing with the data in week 0)
Primary Scores of Health Anxiety Questionnaire (HAQ) Measurement of health anxiety. Score range is 0 to 63; higher score means more severe health anxiety Week 12 (comparing with the data in week 0)
Secondary Scores of Beck Depression Inventory-II (BDI-II) Measurement of depression. Score range is 0 to 63; higher score means more severe depression Week 12 (comparing with the data in week 0)
Secondary Scores of Beck Anxiety Inventory (BAI) Measurement of anxiety. Score range is 0 to 63; higher score means more severe anxiety Week 12 (comparing with the data in week 0)
Secondary 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 Week 12 (comparing with the data in week 0)
Secondary Heart rate variability Measurement of parasympathetic activity Week 12 (comparing with the data in week 0)
Secondary Skin conductance Measurement of sympathetic activity Week 12 (comparing with the data in week 0)
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