Clinical trial NCT03773354: Somatic Symptom and Related Disorders: A Treatment Group and Mixed-Methods Investigation
Official title: Somatic Symptom and Related Disorders: A Pilot Treatment Group and Mixed-Methods Investigation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Somatic Symptom Disorders
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
First posted: 2018-12-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. 18 years or older,
2. formally diagnosed with a somatic symptom or related disorder,
3. registered patients of St. Joseph's Healthcare Hamilton, and
4. subjective psychological complaints and somatic complaints causing distress and/or functional impairment.

Exclusion Criteria: individuals with

1. acute and severe depression/suicidal ideation,
2. severe PTSD symptoms,
3. current psychosis,
4. current substance use disorder, or
5. severe cognitive impairment will be excluded from the study and referred to a more appropriate intervention.

Primary outcomes:
measure: Change from baseline self-reported distress related to somatic symptoms at 6 weeks
timeFrame: Week 1 (prior to intervention), week 6 (post-intervention)
Secondary outcomes:
measure: Baseline estimated level of intellectual ability
timeFrame: Week 1 (prior to intervention)
measure: Change from baseline intellectual functioning at 6 weeks
timeFrame: Week 1 (prior to intervention), week 6 (post-intervention)
measure: Baseline performance validity
timeFrame: Week 1 (prior to intervention)
measure: Performance validity at 6 weeks
timeFrame: Week 6 (post-intervention)
measure: Change from baseline auditory working memory at 6 weeks
timeFrame: Week 1 (prior to intervention), week 6 (post-intervention)
measure: Change from baseline visual attention and speed at 6 weeks
timeFrame: Week 1 (prior to intervention), week 6 (post-intervention)
measure: Change from baseline motor speed at 6 weeks
timeFrame: Week 1 (prior to intervention), week 6 (post-intervention)
measure: Change from baseline verbal fluency at 6 weeks
timeFrame: Week 1 (prior to intervention), week 6 (post-intervention)
measure: Change from baseline overall neurocognitive performance at 6 weeks
timeFrame: Week 1 (prior to intervention), week 6 (post-intervention)
Other outcomes:
measure: Baseline personality traits
timeFrame: Week 1 (prior to intervention)
measure: Change from baseline alcohol consumption at 6 weeks
timeFrame: Week 1 (prior to intervention), week 6 (post-intervention)
measure: Change from baseline cannabis consumption at 6 weeks
timeFrame: Week 1 (prior to intervention), week 6 (post-intervention)
measure: Change from baseline drug use at 6 weeks
timeFrame: Week 1 (prior to intervention), week 6 (post-intervention)
measure: Change from baseline nicotine dependence at 6 weeks
timeFrame: Week 1 (prior to intervention), week 6 (post-intervention)
measure: Change from baseline substance use at 6 weeks
timeFrame: Week 1 (prior to intervention), week 6 (post-intervention)
measure: Change from baseline readiness for change at 6 weeks
timeFrame: Week 1 (prior to intervention), week 6 (post-intervention)
measure: Change from baseline problem gambling at 6 weeks
timeFrame: Week 1 (prior to intervention), week 6 (post-intervention)
measure: Change from baseline symptoms of attention deficit/hyperactivity disorder at 6 weeks
timeFrame: Week 1 (prior to intervention), week 6 (post-intervention)
measure: Change from baseline depressive symptoms at 6 weeks
timeFrame: Week 1 (prior to intervention), week 6 (post-intervention)
measure: Change from baseline symptoms of anxiety at 6 weeks
timeFrame: Week 1 (prior to intervention), week 6 (post-intervention)
measure: Change from baseline symptoms of disordered eating at 6 weeks
timeFrame: Week 1 (prior to intervention), week 6 (post-intervention)
measure: Change from baseline traits of borderline personality disorder at 6 weeks
timeFrame: Week 1 (prior to intervention), week 6 (post-intervention)
measure: Change from baseline prodromal symptoms at 6 weeks
timeFrame: Week 1 (prior to intervention), week 6 (post-intervention)
measure: Change from baseline traumatic experiences at 6 weeks
timeFrame: Week 1 (prior to intervention), week 6 (post-intervention)
measure: Change from baseline post-traumatic stress disorder (PTSD) symptoms at 6 weeks
timeFrame: Week 1 (prior to intervention), week 6 (post-intervention)
measure: Change from baseline indicators of traumatic brain injury at 6 weeks
timeFrame: Week 1 (prior to intervention), week 6 (post-intervention)
measure: Change from baseline perceived stress at 6 weeks
timeFrame: Week 1 (prior to intervention), week 6 (post-intervention)
measure: Change from baseline delay discounting ability at 6 weeks
timeFrame: Week 1 (prior to intervention), week 6 (post-intervention)
measure: Change from baseline distress tolerance at 6 weeks
timeFrame: Week 1 (prior to intervention), week 6 (post-intervention)
measure: Change from baseline impulsive behaviour at 6 weeks
timeFrame: Week 1 (prior to intervention), week 6 (post-intervention)
measure: Change from baseline mindfulness at 6 weeks
timeFrame: Week 1 (prior to intervention), week 6 (post-intervention)
measure: Change from baseline somatic symptom severity at 6 weeks
timeFrame: Week 1 (prior to intervention), week 6 (post-intervention)
measure: Change from baseline level of disability at 6 weeks
timeFrame: Week 1 (prior to intervention), week 6 (post-intervention)
measure: Change from baseline pain disability at 6 weeks
timeFrame: Week 1 (prior to intervention), week 6 (post-intervention)
measure: Change from baseline pain self-efficacy at 6 weeks
timeFrame: Week 1 (prior to intervention), week 6 (post-intervention)
measure: Change from baseline resilience at 6 weeks
timeFrame: Week 1 (prior to intervention), week 6 (post-intervention)
measure: Change from baseline illness perception at 6 weeks
timeFrame: Week 1 (prior to intervention), week 6 (post-intervention)
measure: Change from baseline recent life events at 6 weeks
timeFrame: Week 1 (prior to intervention), week 6 (post-intervention)
Locations:
Study officials:
References: