Exposure Therapy for Reactivity to Symptoms

NCT07757854 | Not Yet Recruiting

• 1 other identifier: 2026-02486-01
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

It is unclear to what degree systematic exposure exercises contribute to the overall effects of exposure therapy (exposure and response prevention). This trial recruits individuals with high somatic symptom burden or reactivity to symptoms who, based on previous work, are likely to benefit specifically from exposure therapy. The aim of the study is to evaluate to what degree the effect of exposure therapy for this group is driven by the addition of structured exposure exercises to response prevention. This will be evaluated on the basis of a randomized controlled trial (N=360) where participants are enrolled either in response prevention (n=180), or exposure and response prevention (n=180). Primary outcome will be the between-group differences in the reduction in reactivity to symptoms, as measured week-by-week using the somatic symptom disorder B-criteria scale (SSD-12). Results from this project will be informative for exposure-based and various multicomponent behavioral treatments for individuals with persistent physical symptoms worldwide.

Conditions

Psychological Factors Affecting Other Medical Conditions; Somatic Symptom and Related Disorders; Bodily Distress Disorder

Keywords

exposure therapy; primary care; dismantling trial; persistent physical symptoms

Outcome Measures

Primary Outcomes (1)

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

  Theoretical range: 0-48. A higher score indicates higher degree of reactivity to symptoms.

  Change over the main phase, as modeled 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.

Secondary Outcomes (10)

• Somatic Symptom Scale 8 (SSS-8)

  Change over the main phase, as modeled 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.

• 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 9 (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 modeled using data from the baseline assessment and primary endpoint (≤45 days after treatment). Additional analyses incorporate 6- and 12-months follow-up assessments.

• Seven questions probing into basic emotions related to somatic symptoms

  Change over the main phase, as modeled using data from the baseline assessment and primary endpoint (≤45 days after treatment).

Other Outcomes (15)

• Credibility/Expectancy scale (C/E scale)

  Week 2 of main phase

• Working Alliance Inventory (WAI)

  Week 2 of main phase

• Client Satisfaction Questionnaire (CSQ-8)

  Primary endpoint assessment (≤45 days after treatment)

Study Arms (2)

Exposure with response prevention

EXPERIMENTAL

Full exposure therapy, i.e., exposure with response prevention.

Behavioral: Planned, systematic, exposure exercises; Behavioral: Response prevention

Response prevention

ACTIVE COMPARATOR

Response prevention without conventional, planned, exposure exercises.

Behavioral: Response prevention

Interventions

Planned, systematic, exposure exercises BEHAVIORAL

Exposure exercises, planned on the basis of functional analysis. Participants are encouraged to evaluate the relevance of-, and if so work continuously with-, interceptive, in vivo, and imaginal exposure exercises which are planned at specific timepoints.

Exposure with response prevention

Response prevention BEHAVIORAL

Response prevention, planned on the basis of functional analysis. Participants make a plan to reduce presumably negatively reinforced behavior contingent on somatic symptoms and distress related to somatic symptoms.

Exposure with response prevention; Response prevention

Eligibility Criteria

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

You may qualify if:

• Bothered by at least one somatic symptom for at least 4 months.
• High symptom burden, defined as a PHQ-15≥15 or SSD-12≥25.
• Adult (≥18 years old).
• Living in Stockholm County (catchment area of the clinic).
• Sufficient technical knowledge with web-enabled device and fluent in Swedish.
• Complete pre-treatment assessment.

You may not qualify if:

• A maximum of half the sample (180 participants) will be included with health anxiety, i.e., a fear of or preoccupation with serious illness, as their principal clinical problem.
• Clinical picture dominated by non-somatoform psychiatric disorder such as depression, panic disorder, or primary insomnia. Comorbidities are allowed.
• Severe psychiatric condition (e.g., ongoing manic episode, psychotic disorder, severe depression) or markers for suicidality beyond sporadic ideation.
• Clear medical risk in taking part in exposure-based treatment (e.g., pregnancy), or somatic condition, or treatment for somatic condition, makes treatment unfeasible.
• Continuous psychotropic medication (antidepressants, anticonvulsants, mood-stabilizers, antipsychotics) is present and has either not been stable for at least 4 weeks, or is not expected to remain stable.
• Other psychotherapy or planned absence \>1 week during intended main phase.

Sponsors & Collaborators

• Region Stockholm: lead
• Karolinska Institutet: collaborator
• Stockholm University: collaborator

Study Sites (1)

Liljeholmen University Primary Health Care Centre

Stockholm, 117 63, Sweden

Location

Related Publications (1)

• Hybelius J, Af Winklerfelt Hammarberg S, Salomonsson S, Wachtler C, Epstein M, Olsson A, Strand E, Soderstrom Winter L, Akerlund T, Bjorkander D, Kosic A, Chahin G, Wallert J, Toth-Pal E, Nordin S, Axelsson E. Effect of internet-delivered exposure therapy versus healthy lifestyle promotion for patients with persistent physical symptoms (SOMEX1): a randomized controlled trial with planned moderator analysis. Psychol Med. 2025 Aug 8;55:e226. doi: 10.1017/S0033291725101244.

  PMID: 40776412 BACKGROUND

MeSH Terms

Conditions

Medically Unexplained Symptoms; Neurasthenia

Condition Hierarchy (Ancestors)

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

Study Officials

• Erland Axelsson, PhD

  Region Stockholm and Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erland Axelsson, PhD

CONTACT

+46852483930; erland.axelsson@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Blinding to trial design, but not assigned intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: August 11, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): December 1, 2031
• Last Updated: August 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)