Exposure-Based Treatment for Undifferentiated Somatic Symptom Disorder

Somatic Symptom Disorder Clinical Trial

— SOMEX0  

Official title:

Single-Arm Feasibility Study of Exposure-Based Treatment for Undifferentiated Somatic Symptom Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04511286
• Other study ID #: 2020-01740
• Status: Completed
• Phase: N/A
• Start date: September 11, 2020
• Est. completion date: February 24, 2021

Study information

• Verified date: July 2021
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: February 24, 2021
• Est. primary completion date: February 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Medically Unexplained Symptoms
• Somatic Symptom Disorder

Intervention

Behavioral:
• Exposure
Systematic confrontation with stimuli associated with symptom-related distress, to achieve therapeutic changes in cognitions or behavior

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility 1: distribution of physical symptoms	Primarily 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)
Primary	Feasibility 2: credibility/expectancy based on the Credibility/Expectancy scale	Theoretical range: 0-50, higher score indicates higher credibility/expectancy	Week 3 of treatment
Primary	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		Post-treatment assessment (immediately after treatment, completed within 45 days)
Primary	Feasibility 4: patient-reported adequacy of rationale as assessed using a questionnaire developed specifically for this purpose (theoretical range: 0-10)	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)
Primary	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		Post-treatment assessment (immediately after treatment, completed within 45 days)
Primary	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. The original preregistered range of 7-28 was an erratum.	Post-treatment assessment (immediately after treatment, completed within 45 days)
Primary	Feasibility 7a: adverse events measured using free-text items, primarily reported as the total number of reported events		Post-treatment assessment (immediately after treatment, completed within 45 days)
Primary	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)
Secondary	Patient Health Questionnaire-15 (PHQ-15)	Theoretical range: 0-30, higher score indicates more distressing physical symptoms	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
Secondary	Somatic Symptom Disorder-B Criteria Scale (SSD-12)	Theoretical range: 0-48, higher score indicates higher degree of preoccupation with symptoms	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
Secondary	Symptom Preoccupation Scale (preliminary scale)	Under development, higher score indicates higher degree of preoccupation with symptoms	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
Secondary	14-item Health Anxiety Inventory (HAI-14)	Theoretical range: 0-42, higher score indicates more health anxiety	Screening, pre-treatment assessment (within 2 weeks before treatment), Post-treatment assessment (immediately after treatment, completed within 45 days), 3 months after treatment
Secondary	Anxiety Sensitivity Index (ASI)	Theoretical range: 0-64, higher score indicates more anxiety sensitivity	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
Secondary	GAD-7	Theoretical range: 0-21, higher score indicates more general anxiety	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
Secondary	Patient Health Questionnaire (PHQ-9)	Theoretical range: 0-27, higher score indicates more symptoms of depression	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
Secondary	12-item WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)	Theoretical range: 0-100, higher score indicates more disability	Screening, pre-treatment assessment (within 2 weeks before treatment), post-treatment assessment (immediately after treatment, completed within 45 days), 3 months after treatment
Secondary	Alcohol Use Disorders Identification Test (AUDIT)	Theoretical range: 0-40, higher score indicates more problematic alcohol use	Screening only
Secondary	Drug Use Disorders Identification Test (DUDIT)	Theoretical range: 0-44, higher score indicates more problematic substance use	Screening only
Secondary	Working Alliance Inventory (WAI)	Theoretical range: 6-42, higher score indicates better relationship with the therapist	Week 3 of treatment