Build a Research Clinic for Somatoform Patients

National Taiwan University

Status: Completed

Conditions: Somatic Symptom Disorder; Somatoform Disorders

Treatments: Behavioral: P/T; Behavioral: CM

Study type: Interventional

Funder types: Other

Identifiers

NCT04835103

201812052RIND

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,000 patients

Sex: All

Ages: 15 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,000 participants in 2 patient groups

Set a case management model for somatoform patients

Other group

Description:

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

Treatment:

Behavioral: CM

Time-limited psychotherapy for somatoform patients

Other group

Description:

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

Treatment:

Behavioral: P/T