Exposure Therapy vs. Standardized Education for Distress Related to Somatic Symptoms

Summary

The annual societal cost of medically unexplained symptoms in Sweden is approximately 40 billion SEK, i.e., similar to the annual cost of cancer. Prevalent chronic diseases like asthma and diabetes are also commonly associated with somatic symptoms that lead to significant distress and pervasive behavioral changes that result in functional impairment and place added strain on the health care system. Exposure-based treatment, where the patient willingly engages with stimuli that give rise to unwanted physical sensations or distress, has shown promise in reducing somatic symptom load and increasing quality of life in several conditions where patients commonly report substantial distress related to somatic symptoms, such as in asthma, musculoskeletal pain, and functional gastrointestinal syndromes. In routine care, however, access to such exposure-based treatment is limited. One reason for this is probably that there exists no flexible exposure-based treatment protocol that can be easily tailored to suit a wide spectrum of patient groups who suffer from distress related to recurrent somatic symptoms. In a recent single group feasibility trial (N=33) at Karolinska Institutet, Sweden, the investigators found that such a tailored exposure-based treatment delivered in an online text-based format can be acceptable, with high treatment adherence, adequate treatment satisfaction, large and lasting within-group improvement, and no serious adverse events. This is a randomized controlled trial (N=160) where the investigators aim to test if the same tailored internet-delivered exposure-based treatment is more efficacious than a standardized education control for adult patients with clinically significant distress related to somatic symptoms in a primary care setting. Primary outcome is change in self-rated somatic symptom burden as modelled using linear mixed models fitted on weekly Patient Health Questionnaire 15 sum scores over the treatment period. Long-term efficacy is assessed up to one year after treatment and cost-effectiveness is investigated based on the incremental cost-effectiveness ratio.

Conditions

• Somatic Symptom and Related Disorders
• Medically Unexplained Symptoms
• Psychological Factors Affecting Other Medical Conditions

Interventions

BEHAVIORAL

Exposure

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

BEHAVIORAL

Standardized education

Standardized routine care education for individuals suffering from distress related to somatic symptoms, primarily focusing on healthy lifestyle behaviors such as sleep, diet, and exercise

BEHAVIORAL

Prolonged assessment

Patients are encouraged to keep a rudimentary symptom diary to track if and how their symptoms interact with mood and lifestyle behaviors

Sponsors & Collaborators

• Karolinska Institutet

  collaborator OTHER

• Region Stockholm

  lead OTHER_GOV

Principal Investigators

• Erland Axelsson, PhD · Liljeholmen academic primary care clinic, Region Stockholm

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-10-07

Primary Completion

2025-01-02

Completion

2025-01-02

Countries

• Sweden

Study Locations