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Build a Research Clinic for Somatoform Patients

Primary Purpose

Somatoform Disorders, Somatic Symptom Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
CM
P/T
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Somatoform Disorders focused on measuring somatoform disorders, somatic symptom disorder, psychosomatic medicine, medically unexplained symptoms

Eligibility Criteria

15 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 1. Between 15 and 80 years old
  • 2. Meet the diagnosis of DSM-5 somatic symptom disorder

Exclusion Criteria:

  • 1. With psychotic symptoms (such as schizophrenia, bipolar disorder with psychotic symptoms) or cognitive impairment
  • 2. Having potentially lethal physical diseases (such as cancer, coronary artery diseases, cerebrovascular diseases; because under this condition, high health anxiety is quite rational. Patients with common physical diseases can still enter this trial)
  • 3. Unable to read or understand the questionnaires

Sites / Locations

  • Department of Psychiatry, National Taiwan University Hospital Yunlin BranchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Set a case management model for somatoform patients

Time-limited psychotherapy for somatoform patients

Arm Description

Somatoform patients receiving case management, single group assignment, open label

Somatoform patients receiving psychotherapy (based on cognitive-behavioral therapy and biofeedback therapy) vs treatment as usual, open label, non-randomized

Outcomes

Primary Outcome Measures

Changes from baseline Patient Health Questionnaire-15 (PHQ-15) score at 3 months and 6 months (for psychotherapy); changes from baseline PHQ-15 score at 3, 6, 12, 24 months (for case management)
PHQ-15 is a scale rating the severity of somatic distress. It is a 3-point Likert scale with 15 items. The scores range from 0 (lowest level of somatic distress) to 30 (highest level of somatic distress).
Changes from baseline Health Anxiety Questionnaire (HAQ) score at 3 months and 6 months (for psychotherapy); changes from baseline HAQ score at 3, 6, 12, 24 months (for case management)
HAQ is a scale rating the severity of health anxiety. It is a 4-point Likert scale with 21 items. The scores range from 0 (lowest level of health anxiety) to 63 (highest level of health anxiety).

Secondary Outcome Measures

Scores of Scale for the Assessment of Illness Behavior (SAIB)
SAIB is a scale rating the illness behavior. It is a 4-point Likert scale with 25 items. The scores range from 0 to 75.
Scores of Cognition About Body and Health Questionnaire (CABAH)
CABAH is a scale rating the cognition about health anxiety. It is a 4-point Likert scale with 39 items. The scores range from 0 to 117.
Scores of Beck Depression Inventory-II (BDI- II)
BDI- II is a scale rating the severity of depression. It is a 4-point Likert scale with 21 items. The scores range from 0 (lowest level of depression) to 63 (highest level of depression).
Scores of Beck Anxiety Inventory (BAI)
BAI- II is a scale rating the severity of anxiety. It is a 4-point Likert scale with 21 items. The scores range from 0 (lowest level of anxiety) to 63 (highest level of anxiety).
Penn State Worry Questionnaire (PSWQ)
PSWQ-16 is a scale rating the severity of worry. It is 5-point Likert scale with 16 items. The scores range from 1 (lowest level of worry) to 80 (highest level of worry).
Scores of WHOQOL-BREF
It is a self-report questionnaire measuring health-related quality of life. It is a 4-point Likert scale with 28 items, which belong to 5 domains (the overall, physical, psychological, social and environmental domains). The scores of each domain are usually normalized with 0-20 or 0-100.
Changes from baseline standard deviation of normal to normal RR intervals (SDNN)
SDNN reflects all the cyclic components responsible for variability in the period of recording, therefore it represents total variability.
Changes from baseline high-frequency power (HF)
HF component of HRV represents parasympathetic activity.
Changes from baseline ratio of low-frequency power to high-frequency power (LF/HF)
LF/HF was considered to reflect sympathovagal balance by some scholars.
Changes from baseline value of skin conductance.
In skin conductance, an electrodermograph imposes an imperceptible current across the skin and measures how easily it travels through the skin. Skin conductance is usually considered as a biomarker of sympathetic activity.
Changes from baseline value of Respiratory sinus arrhythmia
Respiratory sinus arrhythmia is an index combining the heart rate and respiratory signal, it represents parasympathetic activity.
Changes from baseline value of Finger temperature.
Finger temperature is found to be related to emotional disturbance (such as depression and anxiety), and it is often used in biofeedback therapy.
Changes from baseline value of electromyogram
Electromyogram is found to be related to emotional disturbance (such as depression and anxiety), and it is often used in biofeedback therapy.

Full Information

First Posted
January 29, 2021
Last Updated
November 25, 2022
Sponsor
National Taiwan University Hospital
Collaborators
National Taiwan University Hospital, Yun-Lin Branch
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1. Study Identification

Unique Protocol Identification Number
NCT04835103
Brief Title
Build a Research Clinic for Somatoform Patients
Official Title
Build a Psychosomatic Research Clinic for Providing Comprehensive Managements to Somatoform Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 9, 2021 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
Collaborators
National Taiwan University Hospital, Yun-Lin Branch

4. Oversight

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

5. Study Description

Brief Summary
To investigate the effects of the two following interventions on somatoform patients:1. case management model2. psychotherapy, based on cognitive-behavioral therapy and biofeedback therapy
Detailed Description
Patients with presentations of somatic symptoms and associated psychological features are named as "somatoform disorders" in psychiatric field. Because the patients' concerns are somatic distress, they often seek help in non-psychiatric clinics. However, the symptoms are usually medically unexplained. This group of diagnoses can be managed from the psychiatric perspective, including medications and psychotherapies. However, many patients do not receive psychiatric management in current medical practice. The goal of this project is to establish an association named "psychosomatic center" for providing comprehensive evaluations and treatments to the somatoform patients. Besides the psychiatrist, a case manager, a clinical psychologist, and a research assistant will be included in this association for the purposes of connection, performing psychotherapy and examinations. After entering the psychosomatic clinic, the investigators will routinely perform diagnostic interview, measure psychological and physiological features, and arrange individualized treatment program. The investigators will follow the important psychological and biological indexes every 3-6 months for building a cohort. At the same time, the case manager will connect with non-psychiatric clinics for ensuring the patients physical problems to be managed. The investigators expect this project to enhance the quality of treatment on the patients, to reduce the excessive examinations for the frequent attenders, and to improve the emotional burden of medical staffs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Somatoform Disorders, Somatic Symptom Disorder
Keywords
somatoform disorders, somatic symptom disorder, psychosomatic medicine, medically unexplained symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Case management, a case manager will actively contact and follow the patient's physical and psychological conditions, and provide disease-specific psychoeducation; psychotherapy for patients with somatoform disorders (combined cognitive-behavioral treatment and biofeedback therapy)
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Set a case management model for somatoform patients
Arm Type
Other
Arm Description
Somatoform patients receiving case management, single group assignment, open label
Arm Title
Time-limited psychotherapy for somatoform patients
Arm Type
Other
Arm Description
Somatoform patients receiving psychotherapy (based on cognitive-behavioral therapy and biofeedback therapy) vs treatment as usual, open label, non-randomized
Intervention Type
Behavioral
Intervention Name(s)
CM
Intervention Description
Case management, a case manager will actively contact and follow the patient's physical and psychological conditions, and provide disease-specific psychoeducation
Intervention Type
Behavioral
Intervention Name(s)
P/T
Intervention Description
Psychotherapy, based on both cognitive-behavioral therapy and biofeedback therapy, structuralized, 6-10 sessions, performed by a psychiatrist or psychologist
Primary Outcome Measure Information:
Title
Changes from baseline Patient Health Questionnaire-15 (PHQ-15) score at 3 months and 6 months (for psychotherapy); changes from baseline PHQ-15 score at 3, 6, 12, 24 months (for case management)
Description
PHQ-15 is a scale rating the severity of somatic distress. It is a 3-point Likert scale with 15 items. The scores range from 0 (lowest level of somatic distress) to 30 (highest level of somatic distress).
Time Frame
3, 6 months after initiating psychotherapy (for psychotherapy); 3, 6, 12, 24 months after initiating case management (for case management)
Title
Changes from baseline Health Anxiety Questionnaire (HAQ) score at 3 months and 6 months (for psychotherapy); changes from baseline HAQ score at 3, 6, 12, 24 months (for case management)
Description
HAQ is a scale rating the severity of health anxiety. It is a 4-point Likert scale with 21 items. The scores range from 0 (lowest level of health anxiety) to 63 (highest level of health anxiety).
Time Frame
3, 6 months after initiating psychotherapy (for psychotherapy); 3, 6, 12, 24 months after initiating case management (for case management)
Secondary Outcome Measure Information:
Title
Scores of Scale for the Assessment of Illness Behavior (SAIB)
Description
SAIB is a scale rating the illness behavior. It is a 4-point Likert scale with 25 items. The scores range from 0 to 75.
Time Frame
3, 6, 12, 24 months
Title
Scores of Cognition About Body and Health Questionnaire (CABAH)
Description
CABAH is a scale rating the cognition about health anxiety. It is a 4-point Likert scale with 39 items. The scores range from 0 to 117.
Time Frame
3, 6, 12, 24 months
Title
Scores of Beck Depression Inventory-II (BDI- II)
Description
BDI- II is a scale rating the severity of depression. It is a 4-point Likert scale with 21 items. The scores range from 0 (lowest level of depression) to 63 (highest level of depression).
Time Frame
3, 6, 12, 24 months
Title
Scores of Beck Anxiety Inventory (BAI)
Description
BAI- II is a scale rating the severity of anxiety. It is a 4-point Likert scale with 21 items. The scores range from 0 (lowest level of anxiety) to 63 (highest level of anxiety).
Time Frame
3, 6, 12, 24 months
Title
Penn State Worry Questionnaire (PSWQ)
Description
PSWQ-16 is a scale rating the severity of worry. It is 5-point Likert scale with 16 items. The scores range from 1 (lowest level of worry) to 80 (highest level of worry).
Time Frame
3, 6, 12, 24 months
Title
Scores of WHOQOL-BREF
Description
It is a self-report questionnaire measuring health-related quality of life. It is a 4-point Likert scale with 28 items, which belong to 5 domains (the overall, physical, psychological, social and environmental domains). The scores of each domain are usually normalized with 0-20 or 0-100.
Time Frame
3, 6, 12, 24 months
Title
Changes from baseline standard deviation of normal to normal RR intervals (SDNN)
Description
SDNN reflects all the cyclic components responsible for variability in the period of recording, therefore it represents total variability.
Time Frame
3, 6, 12, 24 months
Title
Changes from baseline high-frequency power (HF)
Description
HF component of HRV represents parasympathetic activity.
Time Frame
3, 6, 12, 24 months
Title
Changes from baseline ratio of low-frequency power to high-frequency power (LF/HF)
Description
LF/HF was considered to reflect sympathovagal balance by some scholars.
Time Frame
3, 6, 12, 24 months
Title
Changes from baseline value of skin conductance.
Description
In skin conductance, an electrodermograph imposes an imperceptible current across the skin and measures how easily it travels through the skin. Skin conductance is usually considered as a biomarker of sympathetic activity.
Time Frame
3, 6, 12, 24 months
Title
Changes from baseline value of Respiratory sinus arrhythmia
Description
Respiratory sinus arrhythmia is an index combining the heart rate and respiratory signal, it represents parasympathetic activity.
Time Frame
3, 6, 12, 24 months
Title
Changes from baseline value of Finger temperature.
Description
Finger temperature is found to be related to emotional disturbance (such as depression and anxiety), and it is often used in biofeedback therapy.
Time Frame
3, 6, 12, 24 months
Title
Changes from baseline value of electromyogram
Description
Electromyogram is found to be related to emotional disturbance (such as depression and anxiety), and it is often used in biofeedback therapy.
Time Frame
3, 6, 12, 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Between 15 and 80 years old 2. Meet the diagnosis of DSM-5 somatic symptom disorder Exclusion Criteria: 1. With psychotic symptoms (such as schizophrenia, bipolar disorder with psychotic symptoms) or cognitive impairment 2. Having potentially lethal physical diseases (such as cancer, coronary artery diseases, cerebrovascular diseases; because under this condition, high health anxiety is quite rational. Patients with common physical diseases can still enter this trial) 3. Unable to read or understand the questionnaires
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei-Lieh Huang
Phone
+886 5 532 3911
Ext
7101
Email
weiliehhuang@gmail.com
Facility Information:
Facility Name
Department of Psychiatry, National Taiwan University Hospital Yunlin Branch
City
Douliu
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei-Lieh Huang, MD
Phone
+886 5 532 3911
Ext
7101
Email
weiliehhuang@gmail.com
First Name & Middle Initial & Last Name & Degree
Wei-Lieh Huang

12. IPD Sharing Statement

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