Somatic Symptom DisordersNCT03773354
Somatic Symptom and Related Disorders: A Treatment Group and Mixed-Methods Investigation
A study testing Cognitive-behavioural therapy group for individuals with somatic symptom disorders in people with Somatic Symptom Disorders, run by St. Joseph's Healthcare Hamilton.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Somatic Symptom Disorders
- What is being tested?
- Cognitive-behavioural therapy group for individuals with somatic symptom disorders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2019to 3 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Somatic Symptom and Related Disorders: A Pilot Treatment Group and Mixed-Methods Investigation
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.
- Conditions
- Somatic Symptom Disorders
- Being tested
- Cognitive-behavioural therapy group for individuals with somatic symptom disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-behavioural therapy group for individuals with somatic symptom disordersBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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 Receives: Behavioral: Cognitive-behavioural therapy group for individuals with somatic symptom disorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 1 (prior to intervention), week 6 (post-intervention)
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 1 (prior to intervention), week 6 (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2018
- Study start1 May 2019 (estimated)
- Primary completion3 Dec 2019 (estimated)
- Study completion3 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Somatic Symptom DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emily MacKillop, St. Joseph's Healthcare Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03773354
- Sponsor's protocol ID
- 5498
- Status last verified
- Apr 2019
- First submitted
- 5 Dec 2018
- Last updated
- 4 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Somatic Symptom and Related Disorders: A Pilot Treatment Group and Mixed-Methods Investigation
- ClinicalTrials.gov ID
- NCT03773354
- Acronym / sponsor ID
- 5498
- Conditions
- Somatic Symptom Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Study start
- 1 May 2019 (estimated)
- Primary completion
- 3 Dec 2019 (estimated)
- Study completion
- 3 Feb 2020 (estimated)
- First posted
- 12 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Cognitive-behavioural therapy group for individuals with somatic symptom disordersThere 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive-behavioural therapy group for individuals with somatic symptom disordersThe 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. | Behavioural | Intervention |
Primary outcome
Change from baseline self-reported distress related to somatic symptoms at 6 weeks
Time frame: 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.
9 secondary outcomes
Baseline estimated level of intellectual ability
Time frame: Week 1 (prior to intervention)
Change from baseline intellectual functioning at 6 weeks
Time frame: Week 1 (prior to intervention), week 6 (post-intervention)
Baseline performance validity
Time frame: Week 1 (prior to intervention)
Performance validity at 6 weeks
Time frame: Week 6 (post-intervention)
Change from baseline auditory working memory at 6 weeks
Time frame: Week 1 (prior to intervention), week 6 (post-intervention)
Change from baseline visual attention and speed at 6 weeks
Time frame: Week 1 (prior to intervention), week 6 (post-intervention)
Change from baseline motor speed at 6 weeks
Time frame: Week 1 (prior to intervention), week 6 (post-intervention)
Change from baseline verbal fluency at 6 weeks
Time frame: Week 1 (prior to intervention), week 6 (post-intervention)
Change from baseline overall neurocognitive performance at 6 weeks
Time frame: Week 1 (prior to intervention), week 6 (post-intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-behavioural therapy group for individuals with somatic symptom disorders in people with Somatic Symptom Disorders, run by St. Joseph's Healthcare Hamilton.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katherine Jongsma, MA (905-522-1155 ext. 39365, kjongsma@stjoes.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline self-reported distress related to somatic symptoms at 6 weeks (time frame: Week 1 (prior to intervention), week 6 (post-intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2019.