Somatic Symptom and Related Disorders: A Treatment Group and Mixed-Methods Investigation
- Conditions
- Somatic Symptom Disorders
- Interventions
- Behavioral: Cognitive-behavioural therapy group for individuals with somatic symptom disorders
- Registration Number
- NCT03773354
- Lead Sponsor
- St. Joseph's Healthcare Hamilton
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
- 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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention Cognitive-behavioural therapy group for individuals with somatic symptom disorders 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
- Primary Outcome Measures
Name Time Method Change from baseline self-reported distress related to somatic symptoms at 6 weeks Week 1 (prior to intervention), week 6 (post-intervention) 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.
- Secondary Outcome Measures
Name Time Method Baseline performance validity Week 1 (prior to intervention) 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.
Performance validity at 6 weeks Week 6 (post-intervention) 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.
Baseline estimated level of intellectual ability Week 1 (prior to intervention) 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.
Change from baseline visual attention and speed at 6 weeks Week 1 (prior to intervention), week 6 (post-intervention) 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.
Change from baseline intellectual functioning at 6 weeks Week 1 (prior to intervention), week 6 (post-intervention) 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.
Change from baseline verbal fluency at 6 weeks Week 1 (prior to intervention), week 6 (post-intervention) 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.
Change from baseline overall neurocognitive performance at 6 weeks Week 1 (prior to intervention), week 6 (post-intervention) 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.
Change from baseline auditory working memory at 6 weeks Week 1 (prior to intervention), week 6 (post-intervention) 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.
Change from baseline motor speed at 6 weeks Week 1 (prior to intervention), week 6 (post-intervention) 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.