Somatic Symptom and Related Disorders: A Treatment Group and Mixed-Methods Investigation

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effectiveness of a new cognitive behavioural therapy (CBT) group for individuals with a somatic symptom disorder (i.e., Somatic Symptom and Related Disorders from the DSM-5). Patients with somatic symptom and related disorders are underserved by the medical system. Further, there is currently a paucity of research aimed at evaluating treatments for patients with somatic symptom disorders. The limited existing research literature supports CBT as an efficacious treatment in this population, but a standardized means of modifying CBT for somatic symptom disorders has not been developed, and it is unclear if group CBT is effective. In this study, the investigators will evaluate the effectives of a new six session CBT group designed specifically to address commonly-reported difficulties among individuals with somatic symptom disorders, such as somatic symptoms, psychological distress, and related cognitive interference. This study will allow us to validate a new intervention for somatic symptom disorders, and will help to fill the current void of evidence-supported evaluation and treatment protocols to better serve patients with somatic symptom disorders.

Official Title
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Somatic Symptom and Related Disorders: A Pilot Treatment Group and Mixed-Methods Investigation

Conditions
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Somatic Symptom Disorders

Intervention / Treatment
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* Behavioral: Cognitive-behavioural therapy group for individuals with somatic symptom disorders


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older, formally diagnosed with a somatic symptom or related disorder, registered patients of St. Joseph's Healthcare Hamilton, and subjective psychological complaints and somatic complaints causing distress and/or functional impairment. Exclusion Criteria: individuals with acute and severe depression/suicidal ideation, severe PTSD symptoms, current psychosis, current substance use disorder, or severe cognitive impairment will be excluded from the study and referred to a more appropriate intervention.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>There is no control group for this study, and all participants receive the intervention. Although a few participants will be asked to give additional information during the intake and after the study concludes for quality improvement purposes. Effects of these additional interview questions will be considered during analysis | Behavioral: Cognitive-behavioural therapy group for individuals with somatic symptom disorders<br>* The intervention is a cognitive-behavioural therapy group for designed for individuals with a formal diagnosis of a somatic symptom disorder (i.e., Somatic Symptom and Related Disorders from the DSM-5) who are interested in learning self-management skills to cope with somatic symptoms and reduce emotional dysregulation, increasing their understanding of factors that contribute to somatic symptoms, and learning relaxation skills to help reduce stress.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline self-reported distress related to somatic symptoms at 6 weeks | Will be measured with the Patient Health Questionnaire 15-Item (PHQ-15) Somatic Symptom Severity. Scores are added to form a total score ranging from 0-30 with higher values indicating more severe distress related to somatic symptoms. | Week 1 (prior to intervention), week 6 (post-intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline estimated level of intellectual ability | Will be measured with the Advanced Clinical Solutions - Test of Premorbid Functioning (copyrighted), which results in a total raw score ranging from 0-70, and is normatively scored based on respondents' age resulting in standard scores (mean = 100). Higher values indicate a higher premorbid level of intellect. | Week 1 (prior to intervention) | 
| Change from baseline intellectual functioning at 6 weeks | Will be measured with the Wechsler Abbreviated Scale of Intelligence - 2nd Edition (copyrighted), which results in a total raw score (full scale intellectual quotient) ranging from 0-205, and is normatively scored based on respondents' age resulting in standard scores (mean = 100). Higher values indicate a higher level of intellect. | Week 1 (prior to intervention), week 6 (post-intervention) | 
| Baseline performance validity | Measured with the Victoria Symptom Validity Test (copyrighted), which has two subtests of Easy Items (raw scores ranging from 0-24) and Hard Items (raw scores ranging from 0-24), which higher scores indicating better performance. | Week 1 (prior to intervention) | 
| Performance validity at 6 weeks | Measured with the Victoria Symptom Validity Test (copyrighted), which has two subtests of Easy Items (raw scores ranging from 0-24) and Hard Items (raw scores ranging from 0-24), which higher scores indicating better performance. | Week 6 (post-intervention) | 
| Change from baseline auditory working memory at 6 weeks | Measured with the Digit Span subtest of the Wechsler Adult Intelligence Scale - 4th Edition (copyrighted), which results in three subtests (Digit Span Forward, Digit Span Backward, and Digit Span Sequencing), each ranging from a raw score of 0-16 and scored normatively resulting in scaled score (mean = 10). Higher scores indicate better performance. | Week 1 (prior to intervention), week 6 (post-intervention) | 
| Change from baseline visual attention and speed at 6 weeks | Will be measured with Trails A & B. The participants' response time on each of the two tasks is scored normatively resulting in a t-score (mean = 50). Higher t-scores indicate better performance. | Week 1 (prior to intervention), week 6 (post-intervention) | 
| Change from baseline motor speed at 6 weeks | Will be measured on Grooved Pegboard. The time taken to complete the task with each hand will be normatively scored, resulting in a t-score. Higher t-scores are indicative of better performance. | Week 1 (prior to intervention), week 6 (post-intervention) | 
| Change from baseline verbal fluency at 6 weeks | Will be measured with phonemic fluency (FAS) and semantic fluency (animals) tasks. The number of words they provide is normatively scored resulting in t-scores. Higher t-scores are indicative of better performance. | Week 1 (prior to intervention), week 6 (post-intervention) | 
| Change from baseline overall neurocognitive performance at 6 weeks | Will be measured with the Repeatable Battery for the Assessment of Neuropsychological Status Update (copyrighted), which results in 12 subtests that are normatively scored, summed together, and normatively scored to result in a index score (mean = 100) with higher values indicating better performance. | Week 1 (prior to intervention), week 6 (post-intervention) |