Clinical trial NCT04511286: Exposure-Based Treatment for Undifferentiated Somatic Symptom Disorder
Official title: Single-Arm Feasibility Study of Exposure-Based Treatment for Undifferentiated Somatic Symptom Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Somatic Symptom Disorder
Keywords: Exposure
Feasibility
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2020-08-13
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective single-group cohort study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Feasibility 1: Distribution of Physical Symptoms
timeFrame: Pre-treatment assessment (within 2 weeks before treatment)
measure: Feasibility 2: Credibility/Expectancy Based on the Credibility/Expectancy Scale
timeFrame: Week 3 of treatment
measure: Feasibility 3: Adherence to the Protocol #1: Percentage Completed Modules in the Sample as a Whole
timeFrame: Adherence data collected over the entire course of the treatment, up to 8 weeks.
measure: Feasibility 4: Patient-reported Adequacy of Rationale as Assessed Using a Questionnaire Developed Specifically for This Purpose (Theoretical Range: 0-10)
timeFrame: Post-treatment assessment (immediately after treatment, completed within 45 days)
measure: Feasibility 5: Adequacy of the Measurement Strategy
timeFrame: Post-treatment assessment (immediately after treatment, completed within 45 days)
measure: Feasibility 6: Satisfaction With Treatment as Indicated by a Mean Client Satisfaction Questionnaire (CSQ-8) Score of at Least 22
timeFrame: Post-treatment assessment (immediately after treatment, completed within 45 days)
measure: Feasibility 7a: Adverse Events Measured Using Free-text Items #1: Total Number of Reported Events
timeFrame: Post-treatment assessment (immediately after treatment, completed within 45 days)
measure: Feasibility 7b: Adverse Events Measured Using the 20-item Negative Effects Questionnaire (NEQ-20)
timeFrame: Post-treatment assessment (immediately after treatment, completed within 45 days)
measure: Feasibility 3: Adherence to the Protocol #2: Percentage of Participants Completing at Least 2 Exposure Exercises
timeFrame: Adherence data collected over the entire course of the treatment, up to 8 weeks.
measure: Feasibility 7a: Adverse Events Measured Using Free-text Items #2: Number of Participants Who Reported at Least One Adverse Event
timeFrame: Post-treatment assessment (immediately after treatment, completed within 45 days)
Secondary outcomes:
measure: Patient Health Questionnaire-15 (PHQ-15)
timeFrame: Screening, pre-treatment assessment (within 2 weeks before treatment), weekly during treatment, Post-treatment assessment (immediately after treatment, completed within 45 days), 3 months after treatment
measure: Somatic Symptom Disorder-B Criteria Scale (SSD-12)
timeFrame: Screening, pre-treatment assessment (within 2 weeks before treatment), weekly during treatment, Post-treatment assessment (immediately after treatment, completed within 45 days), 3 months after treatment
measure: Symptom Preoccupation Scale (Preliminary Scale)
timeFrame: Screening, pre-treatment assessment (within 2 weeks before treatment), weekly during treatment, Post-treatment assessment (immediately after treatment, completed within 45 days), 3 months after treatment
measure: 14-item Health Anxiety Inventory (HAI-14)
timeFrame: Screening, pre-treatment assessment (within 2 weeks before treatment), Post-treatment assessment (immediately after treatment, completed within 45 days), 3 months after treatment
measure: Anxiety Sensitivity Index (ASI)
timeFrame: Screening, pre-treatment assessment (within 2 weeks before treatment), post-treatment assessment Post-treatment assessment (immediately after treatment, completed within 45 days), 3 months after treatment
measure: GAD-7
timeFrame: Pre-treatment assessment (within 2 weeks before treatment), post-treatment assessment Post-treatment assessment (immediately after treatment, completed within 45 days), 3 months after treatment
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Screening, pre-treatment assessment (within 2 weeks before treatment), weekly during treatments (suicidality), post-treatment assesment (immediately after treatment, completed within 45 days), 3 months after treatment
measure: 12-item WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
timeFrame: Screening, pre-treatment assessment (within 2 weeks before treatment), post-treatment assessment (immediately after treatment, completed within 45 days), 3 months after treatment
measure: Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: Screening only
measure: Drug Use Disorders Identification Test (DUDIT)
timeFrame: Screening only
measure: Working Alliance Inventory (WAI)
timeFrame: Week 3 of treatment
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Erland Axelsson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.