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.
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).
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.
Parallel
Planned, systematic, exposure exercises
BehavioralExposure 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.
Response prevention
BehavioralResponse 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.
Somatic Symptom Disorder-B Criteria Scale (SSD-12)
Theoretical range: 0-48. A higher score indicates higher degree of reactivity to symptoms.
Somatic Symptom Scale 8 (SSS-8)
Theoretical range: 0-32. A higher score indicates a higher subjective somatic symptom burden.
GAD-7
Theoretical range: 0-21. A higher score indicates more general anxiety.
Patient Health Questionnaire 9 (PHQ-9)
Theoretical range: 0-27. A higher score indicates more symptoms of depression.
12-item WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
Theoretical range: 0-100. A higher score indicates more disability.
Credibility/Expectancy scale (C/E scale)
Theoretical range: 0-50. A higher score indicates higher credibility/expectancy.
Working Alliance Inventory (WAI)
Theoretical range: 6-42. A higher score indicates better relationship with the therapist.
Client Satisfaction Questionnaire (CSQ-8)
Theoretical range: 8-32. A higher score indicates higher satisfaction with treatment.
Negative Effects Questionnaire 20 (NEQ-20)
Scored as percentage scores over the following domains: increase in symptoms (range: 0-100), perceived insufficient quality of treatment (range: 0-100), dependency (range: 0-100), stigma (range: 0-100), and hopelessness (range: 0-100). Higher scores indicate more negative effects.
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