The Management of Work-Disability Associated With Co-Morbid Pain and Depression: A Feasibility Study

Sponsor

McGill University (Other)

Overall Status

Completed

CT.gov ID

NCT05174429

Collaborator

l'Institut de recherche Robert-Sauvé en santé et en sécurité du travail (IRSST) (Other)

Enrollment

Arm

35.2

Actual Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain	Behavioral: Risk-Targeted Behavioral Activation	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

66 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Single arm.Single arm.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Risk-Targeted Behavioral Activation for the Management of Work-Disability Associated With Co-Morbid Pain and Depression: A Feasibility Study

Actual Study Start Date :

Jan 10, 2016

Actual Primary Completion Date :

Oct 20, 2018

Actual Study Completion Date :

Dec 15, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Risk-Targeted Behavioral Activation 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.	Behavioral: Risk-Targeted Behavioral Activation 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.

Arm

Intervention/Treatment

Experimental: Risk-Targeted Behavioral Activation

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.

Behavioral: Risk-Targeted Behavioral Activation

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.

Outcome Measures

Primary Outcome Measures

Return to work [Assessed 6 months following termination of treatment.]
Percentage of participants who resumed employment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 55 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

McGill University
l'Institut de recherche Robert-Sauvé en santé et en sécurité du travail (IRSST)

Investigators

Principal Investigator: Michael Sullivan, PhD, McGill University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

McGill University

ClinicalTrials.gov Identifier:

NCT05174429

Other Study ID Numbers:

2013-0024

First Posted:

Dec 30, 2021

Last Update Posted:

Dec 30, 2021

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Chronic Pain

Study Results

No Results Posted as of Dec 30, 2021