Build a Research Clinic for Somatoform Patients

Build a Psychosomatic Research Clinic for Providing Comprehensive Managements to Somatoform Patients

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

Study Overview

• Status: Recruiting
• Conditions: Somatoform Disorders; Somatic Symptom Disorder
• Intervention / Treatment: Behavioral: CM; Behavioral: P/T

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.

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wei-Lieh Huang; Phone Number: 7101 +886 5 532 3911; Email: weiliehhuang@gmail.com

Study Locations

• Taiwan
  • Douliu, Taiwan
    • Recruiting
    • Department of Psychiatry, National Taiwan University Hospital Yunlin Branch
    • Contact: Wei-Lieh Huang, MD; Phone Number: 7101 +886 5 532 3911; Email: weiliehhuang@gmail.com
    • Principal Investigator: Wei-Lieh Huang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Set a case management model for somatoform patients; Somatoform patients receiving case management, single group assignment, open label	Behavioral: CM; Case management, a case manager will actively contact and follow the patient's physical and psychological conditions, and provide disease-specific psychoeducation
Other: Time-limited psychotherapy for somatoform patients; Somatoform patients receiving psychotherapy (based on cognitive-behavioral therapy and biofeedback therapy) vs treatment as usual, open label, non-randomized	Behavioral: P/T; Psychotherapy, based on both cognitive-behavioral therapy and biofeedback therapy, structuralized, 6-10 sessions, performed by a psychiatrist or psychologist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	3, 6 months after initiating psychotherapy (for psychotherapy); 3, 6, 12, 24 months after initiating case management (for case management)
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).	3, 6 months after initiating psychotherapy (for psychotherapy); 3, 6, 12, 24 months after initiating case management (for case management)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3, 6, 12, 24 months
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.	3, 6, 12, 24 months
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).	3, 6, 12, 24 months
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).	3, 6, 12, 24 months
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).	3, 6, 12, 24 months
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.	3, 6, 12, 24 months
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.	3, 6, 12, 24 months
Changes from baseline high-frequency power (HF)	HF component of HRV represents parasympathetic activity.	3, 6, 12, 24 months
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.	3, 6, 12, 24 months
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.	3, 6, 12, 24 months
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.	3, 6, 12, 24 months
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.	3, 6, 12, 24 months
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.	3, 6, 12, 24 months

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: National Taiwan University Hospital, Yun-Lin Branch

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2021
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: January 29, 2021
• First Submitted That Met QC Criteria: April 5, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): December 26, 2023
• Last Update Submitted That Met QC Criteria: December 22, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: somatoform disorders; somatic symptom disorder; psychosomatic medicine; medically unexplained symptoms
• Additional Relevant MeSH Terms: Mental Disorders; Somatoform Disorders; Medically Unexplained Symptoms
• Other Study ID Numbers: 201812052RIND

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No