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

NCT04942028 | Completed

• 1 other identifier: 2021-01400
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

exposure; primary care

Outcome Measures

Primary Outcomes (1)

• Patient Health Questionnaire-15 (PHQ-15)

  Theoretical range: 0-30. A higher score indicates a higher subjective somatic symptom burden.

  Change over the main phase, as modelled using data from all 11 assessments from the baseline assessment to the primary endpoint (≤45 days after treatment). Secondary analyses incorporate 6- and 12-months follow-up assessments.

Secondary Outcomes (15)

• Somatic Symptom Disorder-B Criteria Scale (SSD-12)

  Change over the main phase, as modelled using data from all 11 assessments from the baseline assessment to the primary endpoint (≤45 days after treatment). Additional analyses incorporate 6- and 12-months follow-up assessments.

• Symptom Preoccupation Scale (preliminary scale)

  Change over the main phase, as modelled using data from all 11 assessments from the baseline assessment to the primary endpoint (≤45 days after treatment). Additional analyses incorporate 6- and 12-months follow-up assessments.

• GAD-7

  Change over the main phase, as modelled using data from the baseline assessment and primary endpoint (≤45 days after treatment). Additional analyses incorporate 6- and 12-months follow-up assessments.

• Patient Health Questionnaire (PHQ-9)

  Change over the main phase, as modelled using data from the baseline assessment and primary endpoint (≤45 days after treatment). Additional analyses incorporate 6- and 12-months follow-up assessments.

• 12-item WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)

  Change over the main phase, as modelled using data from the baseline assessment and primary endpoint (≤45 days after treatment). Additional analyses incorporate 6- and 12-months follow-up assessments.

Study Arms (2)

Internet-delivered exposure-based treatment

EXPERIMENTAL

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

Behavioral: Exposure

Internet-delivered standardized education and prolonged assessment

ACTIVE COMPARATOR

10 weeks of therapist-guided intervention based on prolonged assessment and routine care educational material delivered via the Internet.

Behavioral: Standardized education; Behavioral: Prolonged assessment

Interventions

Exposure BEHAVIORAL

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

Internet-delivered exposure-based treatment

Standardized education BEHAVIORAL

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

Internet-delivered standardized education and prolonged assessment

Prolonged assessment BEHAVIORAL

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

Internet-delivered standardized education and prolonged assessment

Eligibility Criteria

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

You may qualify if:

• (i) Either much bothered by at least one somatic symptom (2 points on at least one item of the PHQ-15) or at least a moderate overall somatic symptom burden (PHQ-15 sum ≥10), with (ii) recurrent distress related to somatic symptoms ≥4 months
• Interested in completing an intense psychological treatment with the aim of reducing distress associated with physical symptoms
• Adult (≥18 years old)
• Living in Stockholm County
• Can read and write in Swedish
• Complete baseline assessment

You may not qualify if:

• Symptoms best explained by, or clinical picture dominated by, severe health anxiety or a non-somatoform psychiatric disorder such as depression, panic disorder, primary insomnia, a chronic stress disorder, or an acute stress disorder
• Severe psychiatric condition or suicidal ideation
• Clear medical risk in taking part in exposure-based treatment (e.g., pregnancy) or somatic condition (e.g., recent cancer diagnosis), or treatment for somatic condition (e.g., recent chemotherapy), makes treatment unfeasible
• Continuous psychotropic medication (antidepressants, anticonvulsants, mood-stabilizers, antipsychotics) not stable in past 4 weeks, or not expected to remain stable over the main phase of the trial
• Severe alcohol or substance use disorder likely to interfere with treatment
• Planned absence for more than 1 week during the intended main phase

Sponsors & Collaborators

• Region Stockholm: lead
• Karolinska Institutet: collaborator

Study Sites (1)

Liljeholmen academic primary care clinic

Stockholm, 11763, Sweden

Location

Related Links

• Simple exposure protocol administered over 10 weeks

MeSH Terms

Conditions

Medically Unexplained Symptoms

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Erland Axelsson, PhD

  Liljeholmen academic primary care clinic, Region Stockholm

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 17, 2021
• First Posted: June 28, 2021
• Study Start: October 7, 2021
• Primary Completion: January 2, 2025
• Study Completion: January 2, 2025
• Last Updated: April 23, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)