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NCT Number: NCT05792930

Developing an Integrated Psychotherapy With Cognitive-behavioral Therapy and Biofeedback Therapy for Somatic Symptom Disorder

This research program is aimed to develop a integrative psychotherapy (including CBT and biofeedback therapy) and to examine its efficacy on treatment of somatic symptom disorder. The study design is a randomized controlled trial with waiting list control. Scores of Patient Health Questionniare-15 and Health Anxiety Questionnaire are the primary endpoints.

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychiatry, National Taiwan University Hospital Yunlin Branch

Yunlin, 640, Taiwan

Location status: Recruiting

Location contact

Huang Wei-Lieh, MD, MSc, PhD

CONTACT

About this study

Somatic symptom disorder (SSD) is a psychiatric disorder featured with somatic distress and related psychological phenomena. In the past several years, our research team has investigated several aspects of SSD, including psychopathology, epidemiology, mechanism, and diagnostic biomarkers. But the aspect about treatment on SSD has not been comprehensively explored.

In literature, the treatment of SSD can be separated into physical and psychological approaches. The physical approach includes pharmacotherapy and magnetic/electrical neuromodulation. Among several types of psychotherapies, cognitive behavioral therapy (CBT) has the most evidence. Previous studies have disclosed SSD patients to have following cognitive or behavioral features: selective attention on somatic distress; memory bias on the severe health conditions; all-or-none cognition about health; organic attribution style; catastrophizing cognitive pattern about health; high motivation of concerning issues about health; inadequate reassurance-seeking behavior; the assumption about the connection between rest and somatic distress, etc.

Biofeedback therapy works by measuring several biological signals related with stress and relaxation (such as heart rate, skin conductance, electromyography, electroencephalography, and finger temperature); feedback of these signals to the subjects can help them more clearly understand the association between their behavior/cognition and relaxation. Biofeedback therapy has been extensively applied in the psychosomatic field.

This research program is aimed to develop a integrative psychotherapy (including CBT and biofeedback therapy) and to examine its efficacy. The study design is a randomized controlled trial with waiting list control. Scores of Patient Health Questionniare-15 (PHQ-15) and Health Anxiety Questionnaire (HAQ) are the primary endpoints; the changes of other psychological and biological measurements are viewed as secondary endpoints.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient with somatic symptom disorder (confirmed by psychiatrists)

Exclusion criteria

  • The age is younger than 20 or older than 70 years
  • Having psychotic symptoms or cognitive impairment
  • Having a potentially lethal illness
  • Cannot read the questionnaires by oneself

Treatment and study plan

cognitive-behavioral therapy and biofeedback therapy

Behavioral

Complete eight sessions of cognitive-behavioral therapy and biofeedback therapy within three months.

Primary outcomes

  1. Scores of Patient Health Questionnaire-15 (PHQ-15)

    Time frame: Week 12 (comparing with the data in week 0)

    Measurement of somatic distress. Score range is 0 to 30; higher score means more severe somatic distress

  2. Scores of Health Anxiety Questionnaire (HAQ)

    Time frame: Week 12 (comparing with the data in week 0)

    Measurement of health anxiety. Score range is 0 to 63; higher score means more severe health anxiety

Secondary outcomes

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

    Time frame: Week 12 (comparing with the data in week 0)

    Measurement of depression. Score range is 0 to 63; higher score means more severe depression

  2. Scores of Beck Anxiety Inventory (BAI)

    Time frame: Week 12 (comparing with the data in week 0)

    Measurement of anxiety. Score range is 0 to 63; higher score means more severe anxiety

  3. Scores of Cognitions About Body and Health Questionnaire (CABAH)

    Time frame: Week 12 (comparing with the data in week 0)

    Measurement of cognitions about health. Score range is 0 to 117; higher score means more severe cognitive distortion about health

  4. Heart rate variability

    Time frame: Week 12 (comparing with the data in week 0)

    Measurement of parasympathetic activity

  5. Skin conductance

    Time frame: Week 12 (comparing with the data in week 0)

    Measurement of sympathetic activity

Study contacts

Contact information is provided by the study sponsor or research team.

Wei-Lieh Huang, MD, PhD

CONTACT

[email protected]

886-5-5323911 ext. 563700

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

Developing an Integrated Psychotherapy With Cognitive-behavioral Therapy and Biofeedback Therapy for Somatic Symptom Disorder: a Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 31, 2023
Registry last updated
Dec 19, 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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