Build a Research Clinic for Somatoform Patients

Not Applicable

Recruiting

• Conditions: Somatic Symptom Disorder; Somatoform Disorders
• Interventions: Behavioral: CM; Behavioral: P/T

• Registration Number: NCT04835103
• Lead Sponsor: National Taiwan University Hospital

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.

Study Timeline

• Study First Submitted: 2021-01-29
• Study First Submitted QC: 2021-04-05
• Study First Posted: 2021-04-08
• Study Start: 2021-07-09
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-22
• Last Update Posted: 2023-12-26
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Set a case management model for somatoform patients	CM	Somatoform patients receiving case management, single group assignment, open label
Time-limited psychotherapy for somatoform patients	P/T	Somatoform patients receiving psychotherapy (based on cognitive-behavioral therapy and biofeedback therapy) vs treatment as usual, open label, non-randomized

Primary Outcome Measures

Name	Time	Method
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)	3, 6 months after initiating psychotherapy (for psychotherapy); 3, 6, 12, 24 months after initiating case management (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).
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)	3, 6 months after initiating psychotherapy (for psychotherapy); 3, 6, 12, 24 months after initiating case management (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).

Secondary Outcome Measures

Name	Time	Method
Changes from baseline value of electromyogram	3, 6, 12, 24 months	Electromyogram is found to be related to emotional disturbance (such as depression and anxiety), and it is often used in biofeedback therapy.
Penn State Worry Questionnaire (PSWQ)	3, 6, 12, 24 months	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 Beck Depression Inventory-II (BDI- II)	3, 6, 12, 24 months	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 WHOQOL-BREF	3, 6, 12, 24 months	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 value of Respiratory sinus arrhythmia	3, 6, 12, 24 months	Respiratory sinus arrhythmia is an index combining the heart rate and respiratory signal, it represents parasympathetic activity.
Scores of Beck Anxiety Inventory (BAI)	3, 6, 12, 24 months	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).
Changes from baseline standard deviation of normal to normal RR intervals (SDNN)	3, 6, 12, 24 months	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)	3, 6, 12, 24 months	HF component of HRV represents parasympathetic activity.
Changes from baseline ratio of low-frequency power to high-frequency power (LF/HF)	3, 6, 12, 24 months	LF/HF was considered to reflect sympathovagal balance by some scholars.
Changes from baseline value of skin conductance.	3, 6, 12, 24 months	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 Finger temperature.	3, 6, 12, 24 months	Finger temperature is found to be related to emotional disturbance (such as depression and anxiety), and it is often used in biofeedback therapy.
Scores of Scale for the Assessment of Illness Behavior (SAIB)	3, 6, 12, 24 months	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)	3, 6, 12, 24 months	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.

Trial Locations

Locations (1)

Department of Psychiatry, National Taiwan University Hospital Yunlin Branch; 🇨🇳 Douliu, Taiwan