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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05174429
Other study ID # 2013-0024
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 10, 2016
Est. completion date December 15, 2018

Study information

Verified date December 2021
Source McGill University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date December 15, 2018
Est. primary completion date October 20, 2018
Accepts healthy volunteers No
Gender All
Age group 25 Years to 55 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (2)

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

Outcome

Type Measure Description Time frame Safety issue
Primary Return to work Percentage of participants who resumed employment. Assessed 6 months following termination of treatment.
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