Exposure-Based Treatment for Undifferentiated Somatic Symptom Disorder (SOMEX0)

• ClinicalTrials.gov Identifier: NCT04511286
• Recruitment Status: Completed
• First Posted: August 13, 2020
• Last Update Posted: July 26, 2021
• Sponsor: Karolinska Institutet
• Information provided by (Responsible Party): Erland Axelsson, Karolinska Institutet

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Somatic Symptom Disorder	Behavioral: Exposure	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 33 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Prospective single-group cohort study
• Masking: None (Open Label)
• Masking Description: Psychological intervention, patient-reported outcomes
• Primary Purpose: Treatment
• Official Title: Single-Arm Feasibility Study of Exposure-Based Treatment for Undifferentiated Somatic Symptom Disorder
• Actual Study Start Date: September 11, 2020
• Actual Primary Completion Date: February 24, 2021
• Actual Study Completion Date: February 24, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Internet-delivered exposure-based treatment; Eight weeks of therapist-guided exposure-based treatment delivered via the Internet.	Behavioral: Exposure; Systematic confrontation with stimuli associated with symptom-related distress, to achieve therapeutic changes in cognitions or behavior

Outcome Measures

Primary Outcome Measures :

1. Feasibility 1: distribution of physical symptoms [ Time Frame: Pre-treatment assessment (within 2 weeks before treatment) ]
   Primarily according to the Patient Health Questionnaire-15 (PHQ-15, theoretical range: 0-30, higher score indicates more distressing physical symptoms)
2. Feasibility 2: credibility/expectancy based on the Credibility/Expectancy scale [ Time Frame: Week 3 of treatment ]
   Theoretical range: 0-50, higher score indicates higher credibility/expectancy
3. Feasibility 3: adherence to the protocol in terms of at least 60% completed modules and at least 50% of participants completing at least 2 exposure exercises [ Time Frame: Post-treatment assessment (immediately after treatment, completed within 45 days) ]
4. Feasibility 4: patient-reported adequacy of rationale as assessed using a questionnaire developed specifically for this purpose (theoretical range: 0-10) [ Time Frame: Post-treatment assessment (immediately after treatment, completed within 45 days) ]
   Was originally intended to be administered at week 3, but was administered post-treatment due to an administrative error
5. Feasibility 5: adequacy of the measurement strategy in terms of less than 30% missing data at post-treatment, and at least 75% finding the measurement strategy acceptable [ Time Frame: Post-treatment assessment (immediately after treatment, completed within 45 days) ]
6. Feasibility 6: satisfaction with treatment as indicated by a mean Client Satisfaction Questionnaire (CSQ-8) score of at least 22 [ Time Frame: Post-treatment assessment (immediately after treatment, completed within 45 days) ]
   Theoretical range: 8-32, higher score indicates higher satisfaction. This sum score is based on 8 items, each scored 1-4. The original preregistered range of 7-28 was an erratum.
7. Feasibility 7a: adverse events measured using free-text items, primarily reported as the total number of reported events [ Time Frame: Post-treatment assessment (immediately after treatment, completed within 45 days) ]
8. Feasibility 7b: adverse events measured using the 20-item Negative Effects Questionnaire (NEQ-20) [ Time Frame: Post-treatment assessment (immediately after treatment, completed within 45 days) ]
   Theoretical range: 0-80, higher score indicates more severe adverse events

Secondary Outcome Measures :

1. Patient Health Questionnaire-15 (PHQ-15) [ Time Frame: 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 ]
   Theoretical range: 0-30, higher score indicates more distressing physical symptoms
2. Somatic Symptom Disorder-B Criteria Scale (SSD-12) [ Time Frame: 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 ]
   Theoretical range: 0-48, higher score indicates higher degree of preoccupation with symptoms
3. Symptom Preoccupation Scale (preliminary scale) [ Time Frame: 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 ]
   Under development, higher score indicates higher degree of preoccupation with symptoms
4. 14-item Health Anxiety Inventory (HAI-14) [ Time Frame: Screening, pre-treatment assessment (within 2 weeks before treatment), Post-treatment assessment (immediately after treatment, completed within 45 days), 3 months after treatment ]
   Theoretical range: 0-42, higher score indicates more health anxiety
5. Anxiety Sensitivity Index (ASI) [ Time Frame: 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 ]
   Theoretical range: 0-64, higher score indicates more anxiety sensitivity
6. GAD-7 [ Time Frame: 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 ]
   Theoretical range: 0-21, higher score indicates more general anxiety
7. Patient Health Questionnaire (PHQ-9) [ Time Frame: 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 ]
   Theoretical range: 0-27, higher score indicates more symptoms of depression
8. 12-item WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) [ Time Frame: Screening, pre-treatment assessment (within 2 weeks before treatment), post-treatment assessment (immediately after treatment, completed within 45 days), 3 months after treatment ]
   Theoretical range: 0-100, higher score indicates more disability
9. Alcohol Use Disorders Identification Test (AUDIT) [ Time Frame: Screening only ]
   Theoretical range: 0-40, higher score indicates more problematic alcohol use
10. Drug Use Disorders Identification Test (DUDIT) [ Time Frame: Screening only ]
    Theoretical range: 0-44, higher score indicates more problematic substance use
11. Working Alliance Inventory (WAI) [ Time Frame: Week 3 of treatment ]
    Theoretical range: 6-42, higher score indicates better relationship with the therapist

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Sweden

Karolinska Institutet

Stockholm, Sweden, 17165

Sponsors and Collaborators

Karolinska Institutet

Investigators

• Principal Investigator: Erland Axelsson, PhD; Karolinska Institutet

  Study Documents (Full-Text)

Documents provided by Erland Axelsson, Karolinska Institutet:

Study Protocol and Statistical Analysis Plan  [PDF] May 20, 2020

More Information

• Responsible Party: Erland Axelsson, Principal Investigator, Karolinska Institutet
• ClinicalTrials.gov Identifier: NCT04511286
• Other Study ID Numbers: 2020-01740
• First Posted: August 13, 2020
• Last Update Posted: July 26, 2021
• Last Verified: July 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: We are willing to consider reasonable requests for individual participant data (IPD) and to consult the responsible parties accordingly. However, we do not expect to be granted permission to share IPD as long as, under Swedish and European Union (EU) data protection and privacy legislation, the IPD constitutes personal data meaning that it is possible to, using the study database, link the IPD to an identifiable living natural person.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Erland Axelsson, Karolinska Institutet:

Exposure; Feasibility

Additional relevant MeSH terms:

Medically Unexplained Symptoms