DepressionPhase 3NCT00511680
Beat the Blues: Treating Depression in African American Elders
A Phase 3 study testing Behavioral Based In-Home Intervention in people with Depression and Stress Reduction, run by Thomas Jefferson University at 1 site in United States.
Trial summary
The specific primary aims of the study are to: 1. Test the immediate effect of the intervention at 4-months on depression in urban African American older adults (primary trial outcome; between group comparison). Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Depression, Stress Reduction, Behavioral Activation Treatment
- What is being tested?
- Behavioral Based In-Home Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Jun 2012
- Phase
- Phase 3
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- African American
- ≥55 years of age
- English speaking
- Cognitively intact (MMSE >24)
- Depressed as measured by a score ≥5 on the PHQ-9
- Must have a telephone
- Planning to live in the area for 8 months
Who cannot join
- Not African American
- <55 years of age
- Does not speak English
- MMSE<24
- Not depressed as measures by a score of <5 on the PHQ-9
- Does not have a telephone
- Does not plan to live in the area for 8 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: Treating Depression in African American Elders: A Community-Academic Partnership
The specific primary aims of the study are to:
- Test the immediate effect of the intervention at 4-months on depression in urban African American older adults (primary trial outcome; between group comparison). Hypothesis: Participants in the intervention group will report fewer depressive symptoms in comparison to control group participants receiving usual care.
- Test the maintenance effect of the intervention at 8-months on depression (within group comparison). Hypothesis: Participants in the intervention group will maintain reduced symptom presentation from 4 to 8 months.
- Evaluate acceptability (social validity) of the intervention and extent of engagement in activities by study participants (both intervention and wait-list control subjects).
A secondary aim of this study is to assess the feasibility of conducting a clinical trial embedded in a community service setting and its dissemination using a community-academic partnership. We also propose three exploratory aims. First, we seek to evaluate the mechanisms of action, or pathways, by which treatment gains are obtained (Gitlin et al., 2000). Given that behavioral activation represents conceptually the key active ingredient of the proposed intervention, we plan to evaluate its mediational effect. Second, we seek to evaluate whether the intervention has a differential treatment effect based on a study participant's gender, age, and living arrangement (alone or with others). Given that previous research suggests that participant characteristics may moderate depressive symptoms and treatment outcomes, these exploratory analyses will provide insight as to whether this particular treatment benefits some groups more than others. Third, we seek to evaluate whether the intervention has short and long-term effects on quality of life, functional difficulty, and self-efficacy to manage day-to-day tasks. Previous research has shown that depressive symptoms exacerbate functional decline such that minimizing distress may have the added value of enhancing function and perceived efficacy for this group over time.
- Being tested
- Behavioral Based In-Home Intervention
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Based In-Home InterventionBehavioural
The 10 session intervention delivered by a social worker in the home includes five treatment components (education, referral, care management, stress reduction, behavioral activation). Each component has been shown to be effective in treating depression in previous research.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral based In-home Intervention | Experimental | This group will recieve up to 10 1-hour sessions over a 4 month period. Receives: Behavioral: Behavioral Based In-Home Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
Measured: Baseline, t2, t3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2007 (estimated)
- Study startSep 2008
- Primary completionJun 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- 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 3
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura N. Gitlin, Johns Hopkins University
- Investigators
- Laura N. Gitlin, Ph.D, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00511680
- Sponsor's protocol ID
- 1R01MH079814
- Status last verified
- Aug 2012
- First submitted
- 2 Aug 2007
- Last updated
- 8 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gitlin LN, Harris LF, McCoy MC, Hess E, Hauck WW. Delivery Characteristics, Acceptability, and Depression Outcomes of a Home-based Depression Intervention for Older African Americans: The Get Busy Get Better Program. Gerontologist. 2016 Oct;56(5):956-65. doi: 10.1093/geront/gnv117. Epub 2015 Nov 25.
PubMed 26608333Gitlin LN, Szanton SL, Huang J, Roth DL. Factors mediating the effects of a depression intervention on functional disability in older African Americans. J Am Geriatr Soc. 2014 Dec;62(12):2280-7. doi: 10.1111/jgs.13156.
PubMed 25516024Gitlin LN, Roth DL, Huang J. Mediators of the impact of a home-based intervention (beat the blues) on depressive symptoms among older African Americans. Psychol Aging. 2014 Sep;29(3):601-11. doi: 10.1037/a0036784.
PubMed 25244479Gitlin LN, Harris LF, McCoy MC, Chernett NL, Pizzi LT, Jutkowitz E, Hess E, Hauck WW. A home-based intervention to reduce depressive symptoms and improve quality of life in older African Americans: a randomized trial. Ann Intern Med. 2013 Aug 20;159(4):243-52. doi: 10.7326/0003-4819-159-4-201308200-00005.
PubMed 24026257Jutkowitz E, Pizzi L, Hess E, Suh DC, Gitlin LN. Comparison of three societally derived health-state classification values among older African Americans with depressive symptoms. Qual Life Res. 2013 Aug;22(6):1491-8. doi: 10.1007/s11136-012-0263-y. Epub 2012 Sep 13.
PubMed 22972437Gitlin LN, Harris LF, McCoy M, Chernett NL, Jutkowitz E, Pizzi LT; Beat the Blues Team. A community-integrated home based depression intervention for older African Americans: [corrected] description of the Beat the Blues randomized trial and intervention costs. BMC Geriatr. 2012 Feb 10;12:4. doi: 10.1186/1471-2318-12-4.
PubMed 22325065
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Depression in African American Elders: A Community-Academic Partnership
- ClinicalTrials.gov ID
- NCT00511680
- Acronym / sponsor ID
- 1R01MH079814
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 6 Aug 2007 (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 specific primary aims of the study are to:
- Test the immediate effect of the intervention at 4-months on depression in urban African American older adults (primary trial outcome; between group comparison). Hypothesis: Participants in the intervention group will report fewer depressive symptoms in comparison to control group participants receiving usual care.
- Test the maintenance effect of the intervention at 8-months on depression (within group comparison). Hypothesis: Participants in the intervention group will maintain reduced symptom presentation from 4 to 8 months.
- Evaluate acceptability (social validity) of the intervention and extent of engagement in activities by study participants (both intervention and wait-list control subjects).
A secondary aim of this study is to assess the feasibility of conducting a clinical trial embedded in a community service setting and its dissemination using a community-academic partnership. We also propose three exploratory aims. First, we seek to evaluate the mechanisms of action, or pathways, by which treatment gains are obtained (Gitlin et al., 2000). Given that behavioral activation represents conceptually the key active ingredient of the proposed intervention, we plan to evaluate its mediational effect. Second, we seek to evaluate whether the intervention has a differential treatment effect based on a study participant's gender, age, and living arrangement (alone or with others). Given that previous research suggests that participant characteristics may moderate depressive symptoms and treatment outcomes, these exploratory analyses will provide insight as to whether this particular treatment benefits some groups more than others. Third, we seek to evaluate whether the intervention has short and long-term effects on quality of life, functional difficulty, and self-efficacy to manage day-to-day tasks. Previous research has shown that depressive symptoms exacerbate functional decline such that minimizing distress may have the added value of enhancing function and perceived efficacy for this group over time.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Behavioral based In-home Intervention | Experimental | Behavioral: Behavioral Based In-Home InterventionThis group will recieve up to 10 1-hour sessions over a 4 month period. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- African American
- ≥55 years of age
- English speaking
- Cognitively intact (MMSE >24)
- Depressed as measured by a score ≥5 on the PHQ-9
Key exclusion criteria (7 listed)
- Not African American
- <55 years of age
- Does not speak English
- MMSE<24
- Not depressed as measures by a score of <5 on the PHQ-9
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 |
|---|---|---|
| Behavioral Based In-Home InterventionThe 10 session intervention delivered by a social worker in the home includes five treatment components (education, referral, care management, stress reduction, behavioral activation). Each component has been shown to be effective in treating depression in previous research. | Behavioural | Behavioral based In-home Intervention |
Primary outcome
Depression
Time frame: Baseline, t2, t3
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 Aug 2012.
- Derived from this study: PubMed 26608333Gitlin LN, Harris LF, McCoy MC, Hess E, Hauck WW. Delivery Characteristics, Acceptability, and Depression Outcomes of a Home-based Depression Intervention for Older African Americans: The Get Busy Get Better Program. Gerontologist. 2016 Oct;56(5):956-65. doi: 10.1093/geront/gnv117. Epub 2015 Nov 25.
- Derived from this study: PubMed 25516024Gitlin LN, Szanton SL, Huang J, Roth DL. Factors mediating the effects of a depression intervention on functional disability in older African Americans. J Am Geriatr Soc. 2014 Dec;62(12):2280-7. doi: 10.1111/jgs.13156.
- Derived from this study: PubMed 25244479Gitlin LN, Roth DL, Huang J. Mediators of the impact of a home-based intervention (beat the blues) on depressive symptoms among older African Americans. Psychol Aging. 2014 Sep;29(3):601-11. doi: 10.1037/a0036784.
- Derived from this study: PubMed 24026257Gitlin LN, Harris LF, McCoy MC, Chernett NL, Pizzi LT, Jutkowitz E, Hess E, Hauck WW. A home-based intervention to reduce depressive symptoms and improve quality of life in older African Americans: a randomized trial. Ann Intern Med. 2013 Aug 20;159(4):243-52. doi: 10.7326/0003-4819-159-4-201308200-00005.
- Derived from this study: PubMed 22972437Jutkowitz E, Pizzi L, Hess E, Suh DC, Gitlin LN. Comparison of three societally derived health-state classification values among older African Americans with depressive symptoms. Qual Life Res. 2013 Aug;22(6):1491-8. doi: 10.1007/s11136-012-0263-y. Epub 2012 Sep 13.
- Derived from this study: PubMed 22325065Gitlin LN, Harris LF, McCoy M, Chernett NL, Jutkowitz E, Pizzi LT; Beat the Blues Team. A community-integrated home based depression intervention for older African Americans: [corrected] description of the Beat the Blues randomized trial and intervention costs. BMC Geriatr. 2012 Feb 10;12:4. doi: 10.1186/1471-2318-12-4.
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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.
Laura N. Gitlin, Ph.D principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Behavioral Based In-Home Intervention in people with Depression and Stress Reduction, run by Thomas Jefferson University 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 7 inclusion and 7 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 Aug 2012. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Depression (time frame: Baseline, t2, t3). 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 NCT00511680, which also lists 6 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 8 Aug 2012.