search
Back to results

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

Primary Purpose

Somatic Symptom Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
cognitive-behavioral therapy and biofeedback therapy
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Somatic Symptom Disorder focused on measuring somatic symptom disorder, cognitive behavioral therapy, biofeedback therapy, somatic distress, health anxiety

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Psychiatry, National Taiwan University Hospital Yunlin BranchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental Group

Control Group

Arm Description

The experimental group will receive cognitive-behavioral therapy (CBT) and biofeedback therapy.

The design of control group is waiting list control; their data will be collected without intervention during the observation period. After the observation period, psychotherapy (CBT and biofeedback, the same as intervention) will be arranged.

Outcomes

Primary Outcome Measures

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 Outcome Measures

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
Skin conductance
Measurement of sympathetic activity

Full Information

First Posted
March 20, 2023
Last Updated
July 11, 2023
Sponsor
National Taiwan University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05792930
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 11, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Somatic Symptom Disorder
Keywords
somatic symptom disorder, cognitive behavioral therapy, biofeedback therapy, somatic distress, health anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
The experimental group will receive cognitive-behavioral therapy (CBT) and biofeedback therapy.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The design of control group is waiting list control; their data will be collected without intervention during the observation period. After the observation period, psychotherapy (CBT and biofeedback, the same as intervention) will be arranged.
Intervention Type
Behavioral
Intervention Name(s)
cognitive-behavioral therapy and biofeedback therapy
Intervention Description
Complete eight sessions of cognitive-behavioral therapy and biofeedback therapy within three months.
Primary Outcome Measure Information:
Title
Scores of Patient Health Questionnaire-15 (PHQ-15)
Description
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)
Title
Scores of Health Anxiety Questionnaire (HAQ)
Description
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 Outcome Measure Information:
Title
Scores of Beck Depression Inventory-II (BDI-II)
Description
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)
Title
Scores of Beck Anxiety Inventory (BAI)
Description
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)
Title
Scores of Cognitions About Body and Health Questionnaire (CABAH)
Description
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)
Title
Heart rate variability
Description
Measurement of parasympathetic activity
Time Frame
Week 12 (comparing with the data in week 0)
Title
Skin conductance
Description
Measurement of sympathetic activity
Time Frame
Week 12 (comparing with the data in week 0)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei-Lieh Huang, MD, PhD
Phone
886-5-5323911
Ext
563700
Email
weiliehhuang@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei-Lieh Huang, MD, PhD
Organizational Affiliation
National Taiwan University Hospital Yunlin Branch
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry, National Taiwan University Hospital Yunlin Branch
City
Yunlin
ZIP/Postal Code
640
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huang Wei-Lieh, MD, MSc, PhD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs