Exposure-Based Treatment for Undifferentiated Somatic Symptom Disorder — SOMEX0  

Somatic Symptom Disorder Clinical Trial

Official title: Single-Arm Feasibility Study of Exposure-Based Treatment for Undifferentiated Somatic Symptom Disorder

Status Completed

Clinical Trial Summary

This study investigates the feasibility of a general exposure-based treatment protocol that is intended to work for a large variety of patient groups with a clinically significant preoccupation with physical symptoms. This is a prospective single-group study based at Karolinska Institutet, Stockholm, Sweden, where 40 adults with DSM-5 somatic symptom disorder are enrolled in 8 weeks of therapist-guided exposure-based treatment via the Internet. Exposure is based on general principles but tailored to suit the needs of each patient. Outcomes include patient-reported credibility and expectancy, adherence to the treatment protocol, client satisfaction, and negative events. Within-group effects will also be quantified and discussed in relation to the existing literature.

Clinical Trial Description

Background:

A substantial portion of patients in routine care suffer from a recurrent preoccupation with physical symptoms, which often leads to substantial suffering and impairment. Exposure-based treatment - where the patient systematically seeks out that which gives rise to unwanted sensations, cognitions, or behavior - has been found to lead to beneficial effects in several types of symptom preoccupation. Yet, this form of treatment is rarely offered in routine care. This may be partially because existing treatment protocols have been developed for specific symptom clusters (e.g., functional somatic syndromes such as irritable bowel syndrome and fibromyalgia) or specific unwanted responses to symptoms (e.g., the fear of having a severe illness), and that many clinics do not have the resources to offer all these specialized protocols in parallel. An alternative approach could be to base exposure treatment on a more general protocol that may be tailored to suit a larger variety of patient groups who suffer from a recurrent preoccupation with physical symptoms. However, it is yet unclear if the use of such a general treatment protocol for symptom preoccupation would be feasible, for example in terms of patient-reported credibility, adherence, identification with the rationale, and general client satisfaction.

Aim:

To investigate the feasibility of delivering exposure-based treatment using a general protocol for clinically significant symptom preoccupation, without selecting patients based on any specific symptom cluster (such as a functional somatic syndrome) or specific unwanted response to physical symptoms (such as a frequent fear of illness).

Design:

This is a prospective single-group feasibility study based at Karolinska Institutet, Stockholm, Sweden, where 40 adults with somatic symptom disorder according to the Diagnostic and statistical manual of mental disorders 5 (DSM-5) are enrolled in 8 weeks of therapist-guided exposure-based treatment that is delivered via the Internet. Various aspects of feasibility are assessed; most notably: patient-reported credibility and expectancy, adherence to the treatment protocol, client satisfaction, and negative events. Within-group effects are also quantified. ;

Related Conditions & MeSH terms

• Medically Unexplained Symptoms
• Somatic Symptom Disorder

• NCT number: NCT04511286
• Study type: Interventional
• Source: Karolinska Institutet
• Status: Completed
• Phase: N/A
• Start date: September 11, 2020
• Completion date: February 24, 2021