Build a Research Clinic for Somatoform Patients

Somatoform Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04835103
• Other study ID #: 201812052RIND
• Status: Recruiting
• Phase: N/A
• Start date: July 9, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: December 2023
• Source: National Taiwan University Hospital
• Contact: Wei-Lieh Huang
• Phone: +886 5 532 3911
• Email: weiliehhuang[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Medically Unexplained Symptoms
• Somatic Symptom Disorder
• Somatoform Disorders

Intervention

Behavioral:
• CM
Case management, a case manager will actively contact and follow the patient's physical and psychological conditions, and provide disease-specific psychoeducation
• P/T
Psychotherapy, based on both cognitive-behavioral therapy and biofeedback therapy, structuralized, 6-10 sessions, performed by a psychiatrist or psychologist

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	National Taiwan University Hospital, Yun-Lin Branch

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Changes from baseline high-frequency power (HF)	HF component of HRV represents parasympathetic activity.	3, 6, 12, 24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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