Exposure-Based Treatment for Undifferentiated Somatic Symptom Disorder

NCT ID: NCT04511286

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-11
• Study Completion Date: 2021-02-24

Brief 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.

Detailed 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.

Conditions

Somatic Symptom Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Internet-delivered exposure-based treatment

Eight weeks of therapist-guided exposure-based treatment delivered via the Internet.

Group Type: EXPERIMENTAL

Exposure

Intervention Type: BEHAVIORAL

Systematic confrontation with stimuli associated with symptom-related distress, to achieve therapeutic changes in cognitions or behavior

Interventions

Exposure

Systematic confrontation with stimuli associated with symptom-related distress, to achieve therapeutic changes in cognitions or behavior

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• DSM-5 somatic symptom disorder
• Interest in 8-week intensive psychological treatment to reduce distress and the impact of physical symptoms
• At least 18 years old
• Living in Sweden
• Fluent in Swedish
• Complete pre-treatment assessment

Exclusion Criteria

• Preoccupation with physical symptoms better explained by another psychiatric condition such as illness anxiety disorder, panic disorder, or obsessive-compulsive disorder
• Severe psychiatric condition, such as bipolar disorder, suicidal ideation, or psychosis
• Medical risks associated with participating in exposure-based treatment, or somatic condition - or treatment for somatic condition - that is an obstacle to participating in exposure-based treatment
• Non-stable continuous pharmacotherapy (dosage changed during the past 4 weeks) and the drug is likely to affect outcome measures (primarily: antidepressants, anticonvulsants, benzodiazepines, nonbenzodiazepines, opioids)
• Alcohol or substance use that is a clear obstacle to therapy
• Planned absence for more than 1 week of the treatment period

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Erland Axelsson

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Erland Axelsson, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Karolinska Institutet

Stockholm, , Sweden

Countries

Sweden

References

Hybelius J, Gustavsson A, Af Winklerfelt Hammarberg S, Toth-Pal E, Johansson R, Ljotsson B, Axelsson E. A unified Internet-delivered exposure treatment for undifferentiated somatic symptom disorder: single-group prospective feasibility trial. Pilot Feasibility Stud. 2022 Jul 19;8(1):149. doi: 10.1186/s40814-022-01105-0.

Reference Type: DERIVED

PMID: 35854392 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2020-01740

Identifier Type: -

Identifier Source: org_study_id