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Somatoform DisordersNCT04835103

Build a Research Clinic for Somatoform Patients

A study testing CM and P/T in people with Somatoform Disorders and Somatic Symptom Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 15 to 80 years
What is being tested?
CM and P/T
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,000 participants
Where
1 siteTaiwan
Study dates
9 Jul 2021to 14 Mar 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 1. Between 15 and 80 years old
  • 2. Meet the diagnosis of DSM-5 somatic symptom disorder

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Department of Psychiatry, National Taiwan University Hospital Yunlin Branch

    Douliu

Other trials in Taiwan

About this study

Official title: Build a Psychosomatic Research Clinic for Providing Comprehensive Managements to 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

Read the 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.

Being tested
CM, P/T
Keywords
somatoform disorders, somatic symptom disorder, psychosomatic medicine, medically unexplained symptoms
Medical subject headings
Somatoform Disorders, Medically Unexplained Symptoms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CMBehavioural

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

  • P/TBehavioural

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

Study groups in NCT04835103
Study groupRoleWhat they receive
Set a case management model for somatoform patientsOtherSomatoform patients receiving case management, single group assignment, open label
Receives: Behavioral: CM
Time-limited psychotherapy for somatoform patientsOtherSomatoform patients receiving psychotherapy (based on cognitive-behavioral therapy and biofeedback therapy) vs treatment as usual, open label, non-randomized
Receives: Behavioral: P/T

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    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).

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

  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)

    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).

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

Secondary outcomes (13)

  1. 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.

    Measured: 3, 6, 12, 24 months

  2. 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.

    Measured: 3, 6, 12, 24 months

  3. 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).

    Measured: 3, 6, 12, 24 months

  4. 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).

    Measured: 3, 6, 12, 24 months

  5. 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).

    Measured: 3, 6, 12, 24 months

  6. 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.

    Measured: 3, 6, 12, 24 months

  7. 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.

    Measured: 3, 6, 12, 24 months

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

    HF component of HRV represents parasympathetic activity.

    Measured: 3, 6, 12, 24 months

  9. 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.

    Measured: 3, 6, 12, 24 months

  10. 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.

    Measured: 3, 6, 12, 24 months

  11. 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.

    Measured: 3, 6, 12, 24 months

  12. 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.

    Measured: 3, 6, 12, 24 months

  13. 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.

    Measured: 3, 6, 12, 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2021
  2. Study start9 Jul 2021
  3. Primary completion24 Jan 2024
  4. Study completion14 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
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)
Masking
None (open label)
Enrolment
1,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04835103
Sponsor's protocol ID
201812052RIND
Status last verified
Dec 2023
First submitted
29 Jan 2021
Last updated
20 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing CM and P/T in people with Somatoform Disorders and Somatic Symptom Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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) (time frame: 3, 6 months after initiating psychotherapy (for psychotherapy); 3, 6, 12, 24 months after initiating case management (for case management)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04835103.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2025.

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