The Management of Work-Disability Associated With Co-Morbid Pain and Depression: A Feasibility Study
Primary Purpose
Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Risk-Targeted Behavioral Activation
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain
Eligibility Criteria
Inclusion Criteria:
- 1) work-disability greater than 4 weeks associated with a musculoskeletal injury to the back or neck, 2) a score above clinical threshold on a self-report measure of depression, and 3) between 25 and 55 years of age.
Exclusion Criteria:
- 1) Clinical evidence of vertebral fracture, disk herniation, infectious disease, or rheumatoid arthritis: 2) Evidence of chronic pain pre-dating the current injury: 3) Evidence of loss of consciousness at the time of injury: 4) Previous musculoskeletal injury sustained within the past 12 months: 5) Evidence of any medical condition that might contraindicate participation in physical activity: 6) Illiteracy or severe cognitive impairment.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Risk-Targeted Behavioral Activation
Arm Description
The treatment program consisted of a 10-week standardized behavioral activation intervention supplemented by techniques to target two psychosocial risk-factors for delayed recovery, namely, catastrophic thinking and perceptions of injustice.
Outcomes
Primary Outcome Measures
Return to work
Percentage of participants who resumed employment.
Secondary Outcome Measures
Full Information
NCT ID
NCT05174429
First Posted
December 13, 2021
Last Updated
December 13, 2021
Sponsor
McGill University
Collaborators
l'Institut de recherche Robert-Sauvé en santé et en sécurité du travail (IRSST)
1. Study Identification
Unique Protocol Identification Number
NCT05174429
Brief Title
The Management of Work-Disability Associated With Co-Morbid Pain and Depression: A Feasibility Study
Official Title
Risk-Targeted Behavioral Activation for the Management of Work-Disability Associated With Co-Morbid Pain and Depression: A Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
January 10, 2016 (Actual)
Primary Completion Date
October 20, 2018 (Actual)
Study Completion Date
December 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McGill University
Collaborators
l'Institut de recherche Robert-Sauvé en santé et en sécurité du travail (IRSST)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the present study was to conduct a preliminary evaluation the feasibility and impact of a risk-targeted behavioral activation intervention for work-disabled individuals with co-morbid pain and depression.
Detailed Description
The design of the study was a single arm non-randomized trial. The sample consisted of 66 work-disabled individuals with co-morbid pain and depression. The treatment program consisted of a 10-week standardized behavioral activation intervention supplemented by techniques to target two psychosocial risk-factors for delayed recovery, namely, catastrophic thinking and perceptions of injustice.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single arm.
Masking
None (Open Label)
Allocation
N/A
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Risk-Targeted Behavioral Activation
Arm Type
Experimental
Arm Description
The treatment program consisted of a 10-week standardized behavioral activation intervention supplemented by techniques to target two psychosocial risk-factors for delayed recovery, namely, catastrophic thinking and perceptions of injustice.
Intervention Type
Behavioral
Intervention Name(s)
Risk-Targeted Behavioral Activation
Intervention Description
The behavioral activation component of the treatment program focused on goal setting, structuring and scheduling activities, increasing success and achievement experiences, and problem-solving. In order to maximize the impact of behavioral activation on disability reduction, goal setting and scheduling of activities focused primarily on resumption of discontinued activities as opposed to focusing on the scheduling of pleasant activities. One objective of goal setting and activity scheduling was to reduce the discrepancy between the client's pre-injury activity repertoire and the client's current activity repertoire.
Behavioral activation was supplemented by a collection of techniques designed to reduce catastrophic thinking and perceptions of injustice, two psychosocial risk factors that have been shown to contribute to prolonged work-absence.
Primary Outcome Measure Information:
Title
Return to work
Description
Percentage of participants who resumed employment.
Time Frame
Assessed 6 months following termination of treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1) work-disability greater than 4 weeks associated with a musculoskeletal injury to the back or neck, 2) a score above clinical threshold on a self-report measure of depression, and 3) between 25 and 55 years of age.
Exclusion Criteria:
1) Clinical evidence of vertebral fracture, disk herniation, infectious disease, or rheumatoid arthritis: 2) Evidence of chronic pain pre-dating the current injury: 3) Evidence of loss of consciousness at the time of injury: 4) Previous musculoskeletal injury sustained within the past 12 months: 5) Evidence of any medical condition that might contraindicate participation in physical activity: 6) Illiteracy or severe cognitive impairment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Sullivan, PhD
Organizational Affiliation
McGill University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Management of Work-Disability Associated With Co-Morbid Pain and Depression: A Feasibility Study
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