Clinical trial NCT04835103: Build a Research Clinic for Somatoform Patients
Official title: Build a Psychosomatic Research Clinic for Providing Comprehensive Managements to Somatoform Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Somatoform Disorders
Somatic Symptom Disorder
Keywords: somatoform disorders
somatic symptom disorder
psychosomatic medicine
medically unexplained symptoms
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Taiwan University Hospital, Yun-Lin Branch
First posted: 2021-04-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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)
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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)
timeFrame: 3, 6 months after initiating psychotherapy (for psychotherapy); 3, 6, 12, 24 months after initiating case management (for case management)
measure: 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)
timeFrame: 3, 6 months after initiating psychotherapy (for psychotherapy); 3, 6, 12, 24 months after initiating case management (for case management)
Secondary outcomes:
measure: Scores of Scale for the Assessment of Illness Behavior (SAIB)
timeFrame: 3, 6, 12, 24 months
measure: Scores of Cognition About Body and Health Questionnaire (CABAH)
timeFrame: 3, 6, 12, 24 months
measure: Scores of Beck Depression Inventory-II (BDI- II)
timeFrame: 3, 6, 12, 24 months
measure: Scores of Beck Anxiety Inventory (BAI)
timeFrame: 3, 6, 12, 24 months
measure: Penn State Worry Questionnaire (PSWQ)
timeFrame: 3, 6, 12, 24 months
measure: Scores of WHOQOL-BREF
timeFrame: 3, 6, 12, 24 months
measure: Changes from baseline standard deviation of normal to normal RR intervals (SDNN)
timeFrame: 3, 6, 12, 24 months
measure: Changes from baseline high-frequency power (HF)
timeFrame: 3, 6, 12, 24 months
measure: Changes from baseline ratio of low-frequency power to high-frequency power (LF/HF)
timeFrame: 3, 6, 12, 24 months
measure: Changes from baseline value of skin conductance.
timeFrame: 3, 6, 12, 24 months
measure: Changes from baseline value of Respiratory sinus arrhythmia
timeFrame: 3, 6, 12, 24 months
measure: Changes from baseline value of Finger temperature.
timeFrame: 3, 6, 12, 24 months
measure: Changes from baseline value of electromyogram
timeFrame: 3, 6, 12, 24 months
Other outcomes:
Locations:
city: Douliu
country: Taiwan
facility: Department of Psychiatry, National Taiwan University Hospital Yunlin Branch
Study officials:
References: