Exposure-Based Treatment for Undifferentiated Somatic Symptom Disorder

NCT04511286 | Completed Results

• 1 other identifier: 2020-01740
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Somatic Symptom Disorder

Keywords

Exposure; Feasibility

Outcome Measures

Primary Outcomes (10)

• Feasibility 1: Distribution of Physical Symptoms

  According to the Patient Health Questionnaire-15 (PHQ-15, theoretical range: 0-30, higher score indicates more distressing physical symptoms)

  Pre-treatment assessment (within 2 weeks before treatment)

• Feasibility 2: Credibility/Expectancy Based on the Credibility/Expectancy Scale

  Theoretical range: 0-50, higher score indicates higher credibility/expectancy

  Week 3 of treatment

• Feasibility 3: Adherence to the Protocol #1: Percentage Completed Modules in the Sample as a Whole

  Preregistered target: at least 60% completed modules in the sample as a whole. In this study, all participants were enrolled in the same type of treatment and were thus offered to work with the same treatment modules. This outcome was the proportion of modules completed in total by all participants, out of the total modules available to all participants.

  Adherence data collected over the entire course of the treatment, up to 8 weeks.

• Feasibility 4: Patient-reported Adequacy of Rationale as Assessed Using a Questionnaire Developed Specifically for This Purpose (Theoretical Range: 0-10)

  From 0 ("not at all relevant") to 10 ("extremely relevant"). Was originally intended to be administered at week 3, but was administered post-treatment due to an administrative error

  Post-treatment assessment (immediately after treatment, completed within 45 days)

• Feasibility 5: Adequacy of the Measurement Strategy

  Preregistered target: less than 30% missing data at post-treatment, and at least 75% finding the measurement strategy acceptable (less than 7 on a scale from 0 \["Not at all stressful/bothering"\] to 10 \["Extremely stressful/bothering"\])

  Post-treatment assessment (immediately after treatment, completed within 45 days)

• Feasibility 6: Satisfaction With Treatment as Indicated by a Mean Client Satisfaction Questionnaire (CSQ-8) Score of at Least 22

  Theoretical range: 8-32, higher score indicates higher satisfaction. This sum score is based on 8 items, each scored 1-4.

  Post-treatment assessment (immediately after treatment, completed within 45 days)

• Feasibility 7a: Adverse Events Measured Using Free-text Items #1: Total Number of Reported Events

  The respondent was instructed to describe up to three adverse events.

  Post-treatment assessment (immediately after treatment, completed within 45 days)

• Feasibility 7b: Adverse Events Measured Using the 20-item Negative Effects Questionnaire (NEQ-20)

  Theoretical range: 0-80, higher score indicates more severe adverse events

  Post-treatment assessment (immediately after treatment, completed within 45 days)

• Feasibility 3: Adherence to the Protocol #2: Percentage of Participants Completing at Least 2 Exposure Exercises

  Preregistered target: at least 50% of participants completing at least 2 exposure exercises

  Adherence data collected over the entire course of the treatment, up to 8 weeks.

• Feasibility 7a: Adverse Events Measured Using Free-text Items #2: Number of Participants Who Reported at Least One Adverse Event

  The respondent was instructed to describe up to three adverse events.

  Post-treatment assessment (immediately after treatment, completed within 45 days)

Secondary Outcomes (11)

• Patient Health Questionnaire-15 (PHQ-15)

  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

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

  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

• Symptom Preoccupation Scale (Preliminary Scale)

  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

• 14-item Health Anxiety Inventory (HAI-14)

  Screening, pre-treatment assessment (within 2 weeks before treatment), Post-treatment assessment (immediately after treatment, completed within 45 days), 3 months after treatment

• Anxiety Sensitivity Index (ASI)

  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

Study Arms (1)

Internet-delivered exposure-based treatment

EXPERIMENTAL

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

Behavioral: Exposure

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

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska Institutet

Stockholm, 17165, Sweden

Location

Related Publications (1)

• 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.

  PMID: 35854392 DERIVED

Limitations and Caveats

The lack of a control group implies that we cannot determine if change in the efficacy outcomes were caused by participants engaging in exposure. Within-group effects were probably on the conservative side, considering the covid-19 restrictions. Another limitation is that, for pragmatic reasons, the participants were self-selected, which could indicate a highly motivated sample. Moreover, the participants were highly educated with a low average level of functional impairment.

Results Point of Contact

• Title: Dr. Erland Axelsson
• Organization: Karolinska Institutet

erland.axelsson@ki.se

0706171039

Study Officials

• Erland Axelsson, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Psychological intervention, patient-reported outcomes
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective single-group cohort study

Study Record Dates

• First Submitted: July 18, 2020
• First Posted: August 13, 2020
• Study Start: September 11, 2020
• Primary Completion: February 24, 2021
• Study Completion: February 24, 2021
• Last Updated: March 19, 2025
• Results First Posted: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)