DepressionNCT01163890
Preventing Mid- and Later-Life Work Limitations
A study testing Work and Health Initiative and Usual Medical or Behavioral Intervention in people with Depression, run by Tufts Medical Center at 1 site in United States.
Trial summary
The Work and Health Initiative (WHI) trial is testing an innovative, community-based program that provides mental health and vocational services to workers 50 years or older to improve functioning and reduce productivity loss. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Work and Health Initiative and Usual Medical or Behavioral Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 431 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Jun 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 45 years
- working ≥ 15 hours/week
- DSM-IV current major depression and/or dysthymia
- Work limitations: at-work productivity loss score ≥ 5%
Who cannot join
- severe physical health deficits
- non-English speaking or reading
- positive current alcoholism screening
- psychosis
- mania
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preventing Mid- and Later-Life Work Limitations: Community-Based Depression Care
The Work and Health Initiative (WHI) trial is testing an innovative, community-based program that provides mental health and vocational services to workers 50 years or older to improve functioning and reduce productivity loss. The purpose of this study is to test the hypothesis that relative to usual care, the WHI improves the work outcomes of depression and reduces depression-related productivity loss.
Read the detailed description
National demographic, economic and cultural trends are creating a need for hiring and retaining older workers. However, while many older people will prefer and/or need to work, chronic health problems occurring in mid-life or later can severely disrupt employment. This study will conduct a randomized controlled trial (RCT) of the Work and Health Initiative (WHI). The WHI is an innovative community-based program that provides mental health and vocational services to workers with depression to improve functioning and reduce productivity loss. This study will focus on workers 50 years of age and older. This study will test the hypothesis that relative to usual care, the WHI improves the work outcomes of depression. Study results potentially will result in a new multi-disciplinary method for addressing a serious public health and employment issue.
- Conditions
- Depression
- Being tested
- Work and Health Initiative, Usual Medical or Behavioral Intervention
- Keywords
- Depression, Work Performance and Productivity, Worksite Intervention
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Work and Health InitiativeBehavioural
Telephone-based multi-modal intervention, consisting of: vocational coaching, cognitive-behavioral therapy strategies and care coordination strategies provided by specially-trained EAP counselors
Usual Medical or Behavioral InterventionBehavioural
Referral to treatment as usual through personal physician, mental health professional, behavioral health program, and/or Employee Assistance Program
| Study group | Role | What they receive |
|---|---|---|
| WHI | Experimental | Not described Receives: Behavioral: Work and Health Initiative |
| Usual Care | Active comparator | Not described Receives: Behavioral: Usual Medical or Behavioral Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
At-work performance deficits and productivity loss as measured by the Work Limitations Questionnaire
Measured: 4 months post-randomization
Absenteeism and productivity loss as measured by the Work Limitations Questionnaire Absence Module
Measured: 4 months post-randomization
Secondary outcomes (1)
Depression symptom severity as measured by the Patient Health Questionnaire (PHQ-9)
Measured: 4 months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2010 (estimated)
- Study startSep 2009
- Primary completionMay 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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
- 431 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- OptumHealth Behavioral Solutions
- Responsible party
- Sponsor
- Investigators
- Debra Lerner, MS, PhD, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01163890
- Sponsor's protocol ID
- 1R01AG033125-01A1
- Status last verified
- Apr 2014
- First submitted
- 14 Jul 2010
- Last updated
- 8 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Adler DA, Lerner D, Visco ZL, Greenhill A, Chang H, Cymerman E, Azocar F, Rogers WH. Improving work outcomes of dysthymia (persistent depressive disorder) in an employed population. Gen Hosp Psychiatry. 2015 Jul-Aug;37(4):352-9. doi: 10.1016/j.genhosppsych.2015.04.001. Epub 2015 Apr 8.
PubMed 25892151
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Mid- and Later-Life Work Limitations: Community-Based Depression Care
- ClinicalTrials.gov ID
- NCT01163890
- Acronym / sponsor ID
- 1R01AG033125-01A1
- Conditions
- Depression
- Keywords
- Depression, Work Performance and Productivity, Worksite Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 431 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Collaborators
- OptumHealth Behavioral Solutions
- Study start
- Sep 2009
- Primary completion
- May 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 16 Jul 2010 (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 Work and Health Initiative (WHI) trial is testing an innovative, community-based program that provides mental health and vocational services to workers 50 years or older to improve functioning and reduce productivity loss. The purpose of this study is to test the hypothesis that relative to usual care, the WHI improves the work outcomes of depression and reduces depression-related productivity loss.
Detailed description
National demographic, economic and cultural trends are creating a need for hiring and retaining older workers. However, while many older people will prefer and/or need to work, chronic health problems occurring in mid-life or later can severely disrupt employment. This study will conduct a randomized controlled trial (RCT) of the Work and Health Initiative (WHI). The WHI is an innovative community-based program that provides mental health and vocational services to workers with depression to improve functioning and reduce productivity loss. This study will focus on workers 50 years of age and older. This study will test the hypothesis that relative to usual care, the WHI improves the work outcomes of depression. Study results potentially will result in a new multi-disciplinary method for addressing a serious public health and employment issue.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WHI | Experimental | Behavioral: Work and Health Initiative |
| Usual Care | Active comparator | Behavioral: Usual Medical or Behavioral Intervention |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age ≥ 45 years
- working ≥ 15 hours/week
- DSM-IV current major depression and/or dysthymia
- Work limitations: at-work productivity loss score ≥ 5%
Key exclusion criteria (5 listed)
- severe physical health deficits
- non-English speaking or reading
- positive current alcoholism screening
- psychosis
- mania
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 |
|---|---|---|
| Work and Health InitiativeTelephone-based multi-modal intervention, consisting of: vocational coaching, cognitive-behavioral therapy strategies and care coordination strategies provided by specially-trained EAP counselors | Behavioural | WHI |
| Usual Medical or Behavioral InterventionReferral to treatment as usual through personal physician, mental health professional, behavioral health program, and/or Employee Assistance Program | Behavioural | Usual Care |
Primary outcome
At-work performance deficits and productivity loss as measured by the Work Limitations Questionnaire
Time frame: 4 months post-randomization
Absenteeism and productivity loss as measured by the Work Limitations Questionnaire Absence Module
Time frame: 4 months post-randomization
1 secondary outcome
Depression symptom severity as measured by the Patient Health Questionnaire (PHQ-9)
Time frame: 4 months post-randomization
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 8 Apr 2014.
- Derived from this study: PubMed 25892151Adler DA, Lerner D, Visco ZL, Greenhill A, Chang H, Cymerman E, Azocar F, Rogers WH. Improving work outcomes of dysthymia (persistent depressive disorder) in an employed population. Gen Hosp Psychiatry. 2015 Jul-Aug;37(4):352-9. doi: 10.1016/j.genhosppsych.2015.04.001. Epub 2015 Apr 8.
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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.
Debra Lerner, MS, PhD principal investigator
Tufts Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Work and Health Initiative and Usual Medical or Behavioral Intervention in people with Depression, run by Tufts Medical Center 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 4 inclusion and 5 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 8 Apr 2014. 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?
At-work performance deficits and productivity loss as measured by the Work Limitations Questionnaire (time frame: 4 months post-randomization). The study lists 2 primary outcomes in all. 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 NCT01163890, which also lists 1 linked publication.
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 8 Apr 2014.