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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
McGill University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

25 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

    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)
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    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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