Chronic PainNCT05174429
The Management of Work-Disability Associated With Co-Morbid Pain and Depression: A Feasibility Study
A study testing Risk-Targeted Behavioral Activation in people with Chronic Pain, run by McGill University.
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. Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Risk-Targeted Behavioral Activation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2016to 15 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Risk-Targeted Behavioral Activation for the Management of Work-Disability Associated With Co-Morbid Pain and Depression: A Feasibility Study
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.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- Risk-Targeted Behavioral Activation
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk-Targeted Behavioral ActivationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Risk-Targeted Behavioral Activation | Experimental | 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. Receives: Behavioral: Risk-Targeted Behavioral Activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return to work
Percentage of participants who resumed employment.
Measured: Assessed 6 months following termination of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2021
- Study start10 Jan 2016
- Primary completion20 Oct 2018
- Study completion15 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm.
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Collaborators
- l'Institut de recherche Robert-Sauvé en santé et en sécurité du travail (IRSST)
- Responsible party
- Sponsor
- Investigators
- Michael Sullivan, PhD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05174429
- Sponsor's protocol ID
- 2013-0024
- Status last verified
- Dec 2021
- First submitted
- 13 Dec 2021
- Last updated
- 30 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk-Targeted Behavioral Activation for the Management of Work-Disability Associated With Co-Morbid Pain and Depression: A Feasibility Study
- ClinicalTrials.gov ID
- NCT05174429
- Acronym / sponsor ID
- 2013-0024
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- l'Institut de recherche Robert-Sauvé en santé et en sécurité du travail (IRSST)
- Study start
- 10 Jan 2016 (actual)
- Primary completion
- 20 Oct 2018 (actual)
- Study completion
- 15 Dec 2018 (actual)
- First posted
- 30 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm.
| Arm | Type | Receives |
|---|---|---|
| Risk-Targeted Behavioral Activation | Experimental | Behavioral: Risk-Targeted Behavioral ActivationThe 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. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risk-Targeted Behavioral ActivationThe 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. | Behavioural | Risk-Targeted Behavioral Activation |
Primary outcome
Return to work
Time frame: Assessed 6 months following termination of treatment.
Percentage of participants who resumed employment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Sullivan, PhD principal investigator
McGill University
Questions about this trial
What is this clinical trial studying?
A study testing Risk-Targeted Behavioral Activation in people with Chronic Pain, run by McGill University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Return to work (time frame: Assessed 6 months following termination of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2021.