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Completed

NCT Number: NCT04835103

Build a Research Clinic for Somatoform Patients

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

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Key information

Conditions

Somatoform Disorders Medically Unexplained Symptoms Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Somatic Symptom Disorder

Age range

15 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychiatry, National Taiwan University Hospital Yunlin Branch

Douliu, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CM

Behavioral

Case management, a case manager will actively contact and follow the patient's physical and psychological conditions, and provide disease-specific psychoeducation

P/T

Behavioral

Psychotherapy, based on both cognitive-behavioral therapy and biofeedback therapy, structuralized, 6-10 sessions, performed by a psychiatrist or psychologist

Primary outcomes

  1. 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)

    Time frame: 3, 6 months after initiating psychotherapy (for psychotherapy); 3, 6, 12, 24 months after initiating case management (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).

  2. 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)

    Time frame: 3, 6 months after initiating psychotherapy (for psychotherapy); 3, 6, 12, 24 months after initiating case management (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).

Secondary outcomes

  1. Scores of Scale for the Assessment of Illness Behavior (SAIB)

    Time frame: 3, 6, 12, 24 months

    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.

  2. Scores of Cognition About Body and Health Questionnaire (CABAH)

    Time frame: 3, 6, 12, 24 months

    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. Scores of Beck Depression Inventory-II (BDI- II)

    Time frame: 3, 6, 12, 24 months

    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).

  4. Scores of Beck Anxiety Inventory (BAI)

    Time frame: 3, 6, 12, 24 months

    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).

  5. Penn State Worry Questionnaire (PSWQ)

    Time frame: 3, 6, 12, 24 months

    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).

  6. Scores of WHOQOL-BREF

    Time frame: 3, 6, 12, 24 months

    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.

  7. Changes from baseline standard deviation of normal to normal RR intervals (SDNN)

    Time frame: 3, 6, 12, 24 months

    SDNN reflects all the cyclic components responsible for variability in the period of recording, therefore it represents total variability.

  8. Changes from baseline high-frequency power (HF)

    Time frame: 3, 6, 12, 24 months

    HF component of HRV represents parasympathetic activity.

  9. Changes from baseline ratio of low-frequency power to high-frequency power (LF/HF)

    Time frame: 3, 6, 12, 24 months

    LF/HF was considered to reflect sympathovagal balance by some scholars.

  10. Changes from baseline value of skin conductance.

    Time frame: 3, 6, 12, 24 months

    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.

  11. Changes from baseline value of Respiratory sinus arrhythmia

    Time frame: 3, 6, 12, 24 months

    Respiratory sinus arrhythmia is an index combining the heart rate and respiratory signal, it represents parasympathetic activity.

  12. Changes from baseline value of Finger temperature.

    Time frame: 3, 6, 12, 24 months

    Finger temperature is found to be related to emotional disturbance (such as depression and anxiety), and it is often used in biofeedback therapy.

  13. Changes from baseline value of electromyogram

    Time frame: 3, 6, 12, 24 months

    Electromyogram is found to be related to emotional disturbance (such as depression and anxiety), and it is often used in biofeedback therapy.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Collaborators

  • National Taiwan University Hospital, Yun-Lin Branch

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 8, 2021
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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