Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04835103
Other study ID # 201812052RIND
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT00276887 - Cognitive Behavior Therapy for Somatization Disorder Phase 2
Enrolling by invitation NCT05565352 - Observation of Ketamine Treatment Safety and Tolerability in Adult Psychiatry Clinic Medical University of GdaƄsk Inpatients
Active, not recruiting NCT04847310 - Cost-benefit Evaluation of a Transdiagnostic Psychological Treatment for Emotional Disorders in Primary Care N/A
Completed NCT05611606 - Welfare Benefits in Functional Somatic Disorders
Completed NCT05631860 - Psychological Risk Factors for Functional Somatic Disorders
Completed NCT02151500 - Stress and Health Interview for Primary Care Patients With Medically Unexplained Symptoms N/A
Completed NCT01590992 - Treatment of Globus Sensations With Psychotherapy N/A
Completed NCT00149799 - Effectiveness of Escitalopram in the Treatment of Body Dysmorphic Disorder Phase 3
Completed NCT00368212 - Integrated Treatment Program for Hypochondriasis in Primary Care Settings Phase 3
Terminated NCT02843932 - Subjective Perception of Motor Control During Psychogenic Disorders N/A
Terminated NCT03904784 - School Withdrawal in Adolescents
Recruiting NCT04807933 - Neurovegetative Decoupling in Somatoform Disorders : Biofeedback Interest N/A
Completed NCT01119469 - Comparing Cognitive Therapy and Exposure Therapy in Individuals With Hypochondriasis Phase 3
Recruiting NCT03188861 - Systematic Screening for Comorbid Psychological Conditions in Cardiac ACSC Patients With Multimorbidity in the ED
Completed NCT02346071 - Acceptance and Commitment Group Therapy for Adolescents With a Range of Functional Somatic Syndromes N/A
Completed NCT01518647 - Acceptance and Commitment Therapy for Patients With Multi-organ Bodily Distress Syndrome (Stress-4) N/A
Completed NCT01518634 - Imipramine Treatment for Patients With Multi-organ Bodily Distress Syndrome Phase 2
Recruiting NCT01391897 - Epigenetics of Posttraumatic Stress Disorder and Somatoform Disorders in the Course of Psychotherapy N/A
Completed NCT01924715 - Evaluating the Cost Effectiveness of ISTDP: A Quasi Experimental Study N/A
Completed NCT00130988 - DEPENAS: A Psychosocial Intervention for Patients With Medically Unexplained Symptoms Phase 3