Mental DisordersNCT00333658
A Behavioral Intervention to Improve Work Outcomes
A study testing Goal setting and work feedback group in people with Mental Disorders, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
This research has been designed to learn whether getting regular and specific feedback about work performance with small rewards for meeting goals helps people to improve their job performance and leads to better work outcomes, improved mental functioning, and better quality of life Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mental Disorders
- What is being tested?
- Goal setting and work feedback group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2003to Sep 2008
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Veterans participating in a work program at the VA Connecticut Healthcare System; English-speaking
Who cannot join
- No exclusion criteria based upon diagnosis, although VA work programs have pre-existing requirements such as a demonstrated need for services, a referral from a clinician, and an interest in work rehabilitation
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Connecticut Health Care System (West Haven)
West Haven, Connecticut, 06516
About this study
Official title: A Behavioral Intervention to Improve Outcomes in VA Work Programs
This research has been designed to learn whether getting regular and specific feedback about work performance with small rewards for meeting goals helps people to improve their job performance and leads to better work outcomes, improved mental functioning, and better quality of life
Read the detailed description
This study is designed to test whether systematic work performance feedback with weekly goal setting, combined with small rewards given for goal achievement, leads to improved vocational, health, and quality of life outcomes for veterans enrolled in the various work service programs at this medical center. The long-term goal of this project is to determine the effectiveness of these interventions at this medical center and to use this experience for a multi-site cooperative study proposal.
Research Design and Methods: One hundred and fifty subjects accepted into work services at this medical center will be randomly assigned to one of two conditions: Work Feedback with Small Rewards, or Usual Services. In the Work Feedback with Small Rewards condition, participants attend a weekly workers meeting where they receive specific feedback based upon the Work Behavior Inventory and set weekly goals. They also receive small rewards for goal achievement that equal $10 per month. Participants in the Usual Services condition do not get specific work feedback but receive all the usual work services normally provided. They also receive $10 per month for active participation. Assessments include baseline evaluations of mental and physical health, social function, cognitive function, and quality of life. Evaluations of mental health, quality of life, and job satisfaction will occur at two months and four months. Six-month and twelve month evaluations will repeat the baseline assessment. Outcome measures will include biweekly work performance assessments, vocational outcomes, mental and physical health status, social and cognitive function, and quality of life
- Conditions
- Mental Disorders
- Being tested
- Goal setting and work feedback group
- Keywords
- psychotherapy, group, rehabilitation, vocational, treatment outcome
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal setting and work feedback groupBehavioural
Goal setting and feedback using WBI
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Intervention Receives: Behavioral: Goal setting and work feedback group |
| 2 | No intervention | Work Services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Competitive employment-
Measured: 6 month and 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2006 (estimated)
- Study startDec 2003
- Primary completionOct 2007
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Investigators
- Morris D Bell, PhD, Principal investigator, VA Connecticut Health Care System (West Haven)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00333658
- Sponsor's protocol ID
- D3108R
- Other IDs
- MDB0007
- Status last verified
- Jun 2009
- First submitted
- 2 Jun 2006
- Last updated
- 25 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Bell MD, Bryson G. Work rehabilitation in schizophrenia: does cognitive impairment limit improvement? Schizophr Bull. 2001;27(2):269-79. doi: 10.1093/oxfordjournals.schbul.a006873.
PubMed 11354594Bryson G, Bell MD. Initial and final work performance in schizophrenia: cognitive and symptom predictors. J Nerv Ment Dis. 2003 Feb;191(2):87-92. doi: 10.1097/01.NMD.0000050937.06332.3C.
PubMed 12586961Bell MD, Fiszdon JM, Greig TC, Bryson GJ. Can older people with schizophrenia benefit from work rehabilitation? J Nerv Ment Dis. 2005 May;193(5):293-301. doi: 10.1097/01.nmd.0000161688.47164.71.
PubMed 15870612
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Behavioral Intervention to Improve Outcomes in VA Work Programs
- ClinicalTrials.gov ID
- NCT00333658
- Acronym / sponsor ID
- D3108R
- Conditions
- Mental Disorders
- Keywords
- psychotherapy, group, rehabilitation, vocational, treatment outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Dec 2003
- Primary completion
- Oct 2007 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 6 Jun 2006 (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.
This research has been designed to learn whether getting regular and specific feedback about work performance with small rewards for meeting goals helps people to improve their job performance and leads to better work outcomes, improved mental functioning, and better quality of life
Detailed description
This study is designed to test whether systematic work performance feedback with weekly goal setting, combined with small rewards given for goal achievement, leads to improved vocational, health, and quality of life outcomes for veterans enrolled in the various work service programs at this medical center. The long-term goal of this project is to determine the effectiveness of these interventions at this medical center and to use this experience for a multi-site cooperative study proposal.
Research Design and Methods: One hundred and fifty subjects accepted into work services at this medical center will be randomly assigned to one of two conditions: Work Feedback with Small Rewards, or Usual Services. In the Work Feedback with Small Rewards condition, participants attend a weekly workers meeting where they receive specific feedback based upon the Work Behavior Inventory and set weekly goals. They also receive small rewards for goal achievement that equal $10 per month. Participants in the Usual Services condition do not get specific work feedback but receive all the usual work services normally provided. They also receive $10 per month for active participation. Assessments include baseline evaluations of mental and physical health, social function, cognitive function, and quality of life. Evaluations of mental health, quality of life, and job satisfaction will occur at two months and four months. Six-month and twelve month evaluations will repeat the baseline assessment. Outcome measures will include biweekly work performance assessments, vocational outcomes, mental and physical health status, social and cognitive function, and quality of life
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Goal setting and work feedback groupIntervention |
| 2 | No intervention | –Work Services |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Veterans participating in a work program at the VA Connecticut Healthcare System; English-speaking
Key exclusion criteria (1 listed)
- No exclusion criteria based upon diagnosis, although VA work programs have pre-existing requirements such as a demonstrated need for services, a referral from a clinician, and an interest in work rehabilitation
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 |
|---|---|---|
| Goal setting and work feedback groupGoal setting and feedback using WBI | Behavioural | 1 |
Primary outcome
Competitive employment-
Time frame: 6 month and 12 month follow-up
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 25 Jun 2009.
- Results publication: PubMed 11354594Bell MD, Bryson G. Work rehabilitation in schizophrenia: does cognitive impairment limit improvement? Schizophr Bull. 2001;27(2):269-79. doi: 10.1093/oxfordjournals.schbul.a006873.
- Results publication: PubMed 12586961Bryson G, Bell MD. Initial and final work performance in schizophrenia: cognitive and symptom predictors. J Nerv Ment Dis. 2003 Feb;191(2):87-92. doi: 10.1097/01.NMD.0000050937.06332.3C.
- Results publication: PubMed 15870612Bell MD, Fiszdon JM, Greig TC, Bryson GJ. Can older people with schizophrenia benefit from work rehabilitation? J Nerv Ment Dis. 2005 May;193(5):293-301. doi: 10.1097/01.nmd.0000161688.47164.71.
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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.
Morris D Bell, PhD principal investigator
VA Connecticut Health Care System (West Haven)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goal setting and work feedback group in people with Mental Disorders, run by US Department of Veterans Affairs at 1 site 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 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 25 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Competitive employment- (time frame: 6 month and 12 month follow-up). 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 NCT00333658, which also lists 3 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 25 Jun 2009.