Build a Research Clinic for Somatoform Patients

NCT04835103 | Completed

• 1 other identifier: 201812052RIND
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Somatoform Disorders; Somatic Symptom Disorder

Keywords

somatoform disorders; somatic symptom disorder; psychosomatic medicine; medically unexplained symptoms

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (13)

• Scores of Scale for the Assessment of Illness Behavior (SAIB)

  3, 6, 12, 24 months

• Scores of Cognition About Body and Health Questionnaire (CABAH)

  3, 6, 12, 24 months

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

  3, 6, 12, 24 months

• Scores of Beck Anxiety Inventory (BAI)

  3, 6, 12, 24 months

• Penn State Worry Questionnaire (PSWQ)

  3, 6, 12, 24 months

Study Arms (2)

Set a case management model for somatoform patients

OTHER

Somatoform patients receiving case management, single group assignment, open label

Behavioral: CM

Time-limited psychotherapy for somatoform patients

OTHER

Somatoform patients receiving psychotherapy (based on cognitive-behavioral therapy and biofeedback therapy) vs treatment as usual, open label, non-randomized

Behavioral: P/T

Interventions

CM BEHAVIORAL

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

Set a case management model for somatoform patients

P/T BEHAVIORAL

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

Time-limited psychotherapy for somatoform patients

Eligibility Criteria

• Age: 15 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. With psychotic symptoms (such as schizophrenia, bipolar disorder with psychotic symptoms) or cognitive impairment
• \. 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)
• \. Unable to read or understand the questionnaires

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Taiwan University Hospital, Yun-Lin Branch: collaborator

Study Sites (1)

Department of Psychiatry, National Taiwan University Hospital Yunlin Branch

Douliu, Taiwan

Location

MeSH Terms

Conditions

Somatoform Disorders; Medically Unexplained Symptoms

Condition Hierarchy (Ancestors)

Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: April 8, 2021
• Study Start: July 9, 2021
• Primary Completion: January 24, 2024
• Study Completion: March 14, 2024
• Last Updated: January 20, 2025

Record last verified: 2023-12

Locations

TW (1)