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

NCT ID: NCT03773354

Last Updated: 2019-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2020-02-03

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.

Detailed Description

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Conditions

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Somatic Symptom Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

Cognitive-behavioural therapy group for individuals with somatic symptom disorders

Intervention Type BEHAVIORAL

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.

Interventions

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Cognitive-behavioural therapy group for individuals with somatic symptom disorders

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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St. Joseph's Healthcare Hamilton

OTHER

Sponsor Role lead

Responsible Party

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Emily MacKillop

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Katherine Jongsma, MA

Role: CONTACT

905-522-1155 ext. 39365

Emily MacKillop, PhD C.Psych

Role: CONTACT

905-522-1155 ext. 35592

Other Identifiers

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5498

Identifier Type: -

Identifier Source: org_study_id

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