An interventional study of CM and P/T in Somatoform Disorders and Somatic Symptom Disorder, sponsored by National Taiwan University Hospital. Completed at 1 site in Taiwan. Open to participants aged 15 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-01-20.
Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment
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
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.
Exclusion Criteria:
Somatoform patients receiving case management, single group assignment, open label
Behavioral: CM
Somatoform patients receiving psychotherapy (based on cognitive-behavioral therapy and biofeedback therapy) vs treatment as usual, open label, non-randomized
Behavioral: P/T
Case management, a case manager will actively contact and follow the patient's physical and psychological conditions, and provide disease-specific psychoeducation
Psychotherapy, based on both cognitive-behavioral therapy and biofeedback therapy, structuralized, 6-10 sessions, performed by a psychiatrist or psychologist
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).
Time frame: 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).
Time frame: 3, 6 months after initiating psychotherapy (for psychotherapy); 3, 6, 12, 24 months after initiating case management (for case management)
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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 3, 6, 12, 24 months
Changes from baseline high-frequency power (HF)
HF component of HRV represents parasympathetic activity.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3, 6, 12, 24 months
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National Taiwan University Hospital