Mental DisordersPGAP for VetsNCT01565863
Progressive Goal Attainment Program for Veterans
A study testing Progressive Goal Attainment Program in people with Mental Disorders and Worries; Pain or Disability, run by MDRC at 2 sites in United States.
Trial summary
The purpose of this study is to test the effectiveness of the Progressive Goal Attainment Program (PGAP) in improving employment outcomes and community engagement among U.S. veterans with disabilities. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Disorders, Worries; Pain or Disability
- What is being tested?
- Progressive Goal Attainment Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2012to Nov 2013
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Self-reporting a disability.
- Unemployed or under-employed.
- Likely to benefit from PGAP (i.e. unengaged in social and community activities, difficulty attaining work due to motivational factors).
Who cannot join
- Does not consent to be in the study.
- Significant barriers: serious substance abuse, significant psychotic disorders and cognitive disabilities that would preclude them from active participation in PGAP.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030
VA Connecticut Health Care Center
West Haven, Connecticut, 06516
About this study
Official title: The Progressive Goal Attainment Program for Veterans Project
The purpose of this study is to test the effectiveness of the Progressive Goal Attainment Program (PGAP) in improving employment outcomes and community engagement among U.S. veterans with disabilities.
Read the detailed description
Veterans with disabilities often have low self-esteem and motivation, significant depression and a belief that their disability precludes them from gainful employment. The Progressive Goal Attainment Program (PGAP) is specifically designed to target these psycho-social risk factors of disability. PGAP is a structured, 10-week intervention that focuses on helping clients develop a planned activity schedule to assist them in resuming desirable life activities, including employment. The PGAP for Veterans Project will test the feasibility of delivering PGAP to U.S. military veterans. The research will focus on the best means of service delivery, staffing needs and how to coordinate PGAP in a larger veteran service system. MDRC will also gather information on the target population, recruitment methods, the feasibility of scaling and replication, and employment outcomes among the sample. Two hundred veterans will be enrolled and randomly assigned into the study across two sites: Errera Community Care Center within (part of the VA Connecticut Health Care System) and the Michael DeBakey VA Medical Center in Houston, Texas.
- Conditions
- Mental Disorders, Worries; Pain or Disability
- Being tested
- Progressive Goal Attainment Program
- Keywords
- Perceived Disability, Mental Wellness, Employment, Social Integration and Engagement, Goal Achievement
- Medical subject headings
- Mental Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Goal Attainment ProgramBehavioural
Also called PGAP
The Progressive Goal Attainment Program (PGAP) is a behavioral intervention originally developed in Canada at McGill University in order to increase return to work and community integration for individuals who receive worker's compensation. PGAP is the first disability program that is specifically designed to target the psycho-social risk factors of disability. The premise behind PGAP is that inactivity and attitudinal barriers increase work disability, and these issues are a primary cause of unemployment for individuals with physical and mental disabilities. PGAP is a structured, 10-week intervention that focuses upon helping clients develop a planned activity schedule to assist them in resuming desirable life activities.
| Study group | Role | What they receive |
|---|---|---|
| Progressive Goal Attainment Program | Experimental | Not described Receives: Behavioral: Progressive Goal Attainment Program |
| VA employment services | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Employment
Measured: 6 months
Secondary outcomes (2)
Quality of Life
Lehman Quality of Life Interview: Participants to rate their level of satisfaction with several domains of their lives (e.g. daily activities, social relations etc.) and their feelings about their lives as a whole on a 1-7 ("delighted" to "terrible") scale.
Measured: 6 months
Citizenship
Citizenship Measure: 42-item scale that asks about the person's involvement in community and social activities and their ability to act and make choices on their own behalf on a 1-5 ("not at all/never" to "a lot/very often") scale
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionJun 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Mental DisordersStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- MDRC
- Sponsor type
- University, hospital or other
- Collaborators
- VA Connecticut Healthcare System, Michael E. DeBakey VA Medical Center, The Boeing Company, Bristol-Myers Squibb, The Community Foundation for Greater New Haven, Disabled American Veterans
- Responsible party
- Sponsor
- Investigators
- Peter Baird, Study director, MDRCJack Tsai, Principal investigator, VA Connecticut Healthcare SystemAnthony Kerrigan, Principal investigator, Michael E. DeBakey VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01565863
- Sponsor's protocol ID
- PGAP for Vets 1166.01.410.10
- Acronym
- PGAP for Vets
- Status last verified
- Jun 2020
- First submitted
- 23 Mar 2012
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Adams H, Ellis T, Stanish WD, Sullivan MJ. Psychosocial factors related to return to work following rehabilitation of whiplash injuries. J Occup Rehabil. 2007 Jun;17(2):305-15. doi: 10.1007/s10926-007-9082-3. Epub 2007 May 8.
PubMed 17486435Sullivan MJ, Adams H, Rhodenizer T, Stanish WD. A psychosocial risk factor--targeted intervention for the prevention of chronic pain and disability following whiplash injury. Phys Ther. 2006 Jan;86(1):8-18. doi: 10.1093/ptj/86.1.8.
PubMed 16386058Sullivan MJ, Feuerstein M, Gatchel R, Linton SJ, Pransky G. Integrating psychosocial and behavioral interventions to achieve optimal rehabilitation outcomes. J Occup Rehabil. 2005 Dec;15(4):475-89. doi: 10.1007/s10926-005-8029-9.
PubMed 16254750Hossain F, Baird P, and Pardoe R. Improving employment outcomes and community integration for veterans with disabilities: Early implementation of the Progressive Goal Attainment Program (PGAP) for Veterans Demonstration. April 2013. New York: MDRC.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Progressive Goal Attainment Program for Veterans Project
- ClinicalTrials.gov ID
- NCT01565863
- Acronym / sponsor ID
- PGAP for Vets / PGAP for Vets 1166.01.410.10
- Conditions
- Mental Disorders, Worries; Pain or Disability
- Keywords
- Perceived Disability, Mental Wellness, Employment, Social Integration and Engagement, Goal Achievement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- MDRCUniversity, hospital or other
- Collaborators
- VA Connecticut Healthcare System, Michael E. DeBakey VA Medical Center, The Boeing Company, Bristol-Myers Squibb, The Community Foundation for Greater New Haven, Disabled American Veterans
- Study start
- Feb 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 29 Mar 2012 (estimated)
- 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 this study is to test the effectiveness of the Progressive Goal Attainment Program (PGAP) in improving employment outcomes and community engagement among U.S. veterans with disabilities.
Detailed description
Veterans with disabilities often have low self-esteem and motivation, significant depression and a belief that their disability precludes them from gainful employment. The Progressive Goal Attainment Program (PGAP) is specifically designed to target these psycho-social risk factors of disability. PGAP is a structured, 10-week intervention that focuses on helping clients develop a planned activity schedule to assist them in resuming desirable life activities, including employment. The PGAP for Veterans Project will test the feasibility of delivering PGAP to U.S. military veterans. The research will focus on the best means of service delivery, staffing needs and how to coordinate PGAP in a larger veteran service system. MDRC will also gather information on the target population, recruitment methods, the feasibility of scaling and replication, and employment outcomes among the sample. Two hundred veterans will be enrolled and randomly assigned into the study across two sites: Errera Community Care Center within (part of the VA Connecticut Health Care System) and the Michael DeBakey VA Medical Center in Houston, Texas.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progressive Goal Attainment Program | Experimental | Behavioral: Progressive Goal Attainment Program |
| VA employment services | No intervention | – |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Self-reporting a disability.
- Unemployed or under-employed.
- Likely to benefit from PGAP (i.e. unengaged in social and community activities, difficulty attaining work due to motivational factors).
Key exclusion criteria (2 listed)
- Does not consent to be in the study.
- Significant barriers: serious substance abuse, significant psychotic disorders and cognitive disabilities that would preclude them from active participation in PGAP.
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 |
|---|---|---|
| Progressive Goal Attainment ProgramAlso: PGAPThe Progressive Goal Attainment Program (PGAP) is a behavioral intervention originally developed in Canada at McGill University in order to increase return to work and community integration for individuals who receive worker's compensation. PGAP is the first disability program that is specifically designed to target the psycho-social risk factors of disability. The premise behind PGAP is that inactivity and attitudinal barriers increase work disability, and these issues are a primary cause of unemployment for individuals with physical and mental disabilities. PGAP is a structured, 10-week intervention that focuses upon helping clients develop a planned activity schedule to assist them in resuming desirable life activities. | Behavioural | Progressive Goal Attainment Program |
Primary outcome
Employment
Time frame: 6 months
2 secondary outcomes
Quality of Life
Time frame: 6 months
Citizenship
Time frame: 6 months
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 11 Jun 2020.
- Background: PubMed 17486435Adams H, Ellis T, Stanish WD, Sullivan MJ. Psychosocial factors related to return to work following rehabilitation of whiplash injuries. J Occup Rehabil. 2007 Jun;17(2):305-15. doi: 10.1007/s10926-007-9082-3. Epub 2007 May 8.
- Background: PubMed 16386058Sullivan MJ, Adams H, Rhodenizer T, Stanish WD. A psychosocial risk factor--targeted intervention for the prevention of chronic pain and disability following whiplash injury. Phys Ther. 2006 Jan;86(1):8-18. doi: 10.1093/ptj/86.1.8.
- Background: PubMed 16254750Sullivan MJ, Feuerstein M, Gatchel R, Linton SJ, Pransky G. Integrating psychosocial and behavioral interventions to achieve optimal rehabilitation outcomes. J Occup Rehabil. 2005 Dec;15(4):475-89. doi: 10.1007/s10926-005-8029-9.
- BackgroundHossain F, Baird P, and Pardoe R. Improving employment outcomes and community integration for veterans with disabilities: Early implementation of the Progressive Goal Attainment Program (PGAP) for Veterans Demonstration. April 2013. New York: MDRC.
- The Progressive Goal Attainment Program (PGAP)Link provided by the sponsor.
- Link to working paper with results cited aboveLink provided by the sponsor.
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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.
Peter Baird study director
MDRC
Jack Tsai principal investigator
VA Connecticut Healthcare System
Anthony Kerrigan principal investigator
Michael E. DeBakey VA Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive Goal Attainment Program in people with Mental Disorders and Worries; Pain or Disability, run by MDRC at 2 sites in United States.
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 3 inclusion and 2 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 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Employment (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01565863, which also lists 4 linked publications.
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 11 Jun 2020.