DepressionNCT02292849
Peer to Peer Delivery of Behavioral Activation
A study testing Peer to Peer and Standard Mental Health Referral in people with Depression, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The goal of this study is to test the feasibility, acceptability and preliminary impact of peer-delivered Behavioral Activation (BA) for depressed older adults (60+) who are Naturally Occurring Retirement Communities (NORC) residents or senior center participants. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Peer to Peer and Standard Mental Health Referral
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2013to 7 Oct 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 60 and older
- Member of Lenox Hill Senior Center, St. Peter's Senior Center, or Beth Abe
- Score of 10+ on Patient Health Questionnaire (PHQ-9)
Who cannot join
- Presence of alcohol abuse, substance abuse, psychotic disorder, or bipolar disorder as observed on the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (SCID)
- Inability to speak English
- Dementia: Mini Mental State Examination (MMSE) score below 24
- High suicide risk, i.e. intent or plan to attempt suicide
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College
White Plains, New York, 10605
About this study
The goal of this study is to test the feasibility, acceptability and preliminary impact of peer-delivered Behavioral Activation (BA) for depressed older adults (60+) who are Naturally Occurring Retirement Communities (NORC) residents or senior center participants.
Read the detailed description
This project focuses on helping to solve a growing problem in health care today. Through increased screening in the older adult population, detection of depression has increased which has established a growing need for mental health resources. Unfortunately, there are limited resources to keep up with the steady increase of individuals in need. Training peers to work with older depressed adults in techniques such as behavioral activation provides an alternative model to help moderate the increased need and provide a unique intervention of care. Developing an innovative peer facilitated program has the potential to enhance the delivery of quality health care.
The specific aims of the study are 1) to train peer coaches and implement Peer to Peer in the community 2) to examine depression ratings over time.
- Conditions
- Depression
- Being tested
- Peer to Peer, Standard Mental Health Referral
- Keywords
- Depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer to PeerBehavioural
12 weekly sessions of peer-delivered behavioral activation
Standard Mental Health ReferralOther
Standard mental health referral to a community agency
| Study group | Role | What they receive |
|---|---|---|
| Peer to Peer | Experimental | These individuals will receive a standard mental health referral to a community agency and in addition meet with a trained peer coach for 12 weekly meetings. Receives: Behavioral: Peer to Peer |
| Referral | Active comparator | These individuals will receive a standard mental health referral to a community agency. Receives: Other: Standard Mental Health Referral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Peer to Peer Coaches Who Undergo Behavioral Activation Training and Achieve Certification
Proportion of Peer to Peer coaches who undergo Behavioral Activation training and achieve certification
Measured: 4 weeks prior to Baseline
Number of Peer to Peer Clients Who Attend > 80% of Behavioral Activation Sessions
Number of Peer to Peer clients who attend > 80% of Behavioral Activation sessions
Measured: 12 weeks
Secondary outcomes (1)
Changes in Hamilton Depression Rating Scale Scores
Hamilton Depression Rating Scale mean change scores from baseline to 12 weeks. This scale measures severity of depressive symptoms (range=0-76), with higher scores indicating more sever depressive symptomatology.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2014 (estimated)
- Study start1 Nov 2013
- Primary completion7 Oct 2015
- Study completion7 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Patrick Raue, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02292849
- Sponsor's protocol ID
- 1307014080
- Other IDs
- P30MH085943
- Status last verified
- Aug 2017
- First submitted
- 12 Nov 2014
- Last updated
- 29 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Raue PJ, Sirey JA, Dawson A, Berman J, Bruce ML. Lay-delivered behavioral activation for depressed senior center clients: Pilot RCT. Int J Geriatr Psychiatry. 2019 Nov;34(11):1715-1723. doi: 10.1002/gps.5186. Epub 2019 Aug 8.
PubMed 31368583
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer to Peer Delivery of Behavioral Activation
- ClinicalTrials.gov ID
- NCT02292849
- Acronym / sponsor ID
- 1307014080
- Conditions
- Depression
- Keywords
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Nov 2013 (actual)
- Primary completion
- 7 Oct 2015 (actual)
- Study completion
- 7 Oct 2015 (actual)
- First posted
- 17 Nov 2014 (estimated)
- Results
- Posted 29 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to test the feasibility, acceptability and preliminary impact of peer-delivered Behavioral Activation (BA) for depressed older adults (60+) who are Naturally Occurring Retirement Communities (NORC) residents or senior center participants.
Detailed description
This project focuses on helping to solve a growing problem in health care today. Through increased screening in the older adult population, detection of depression has increased which has established a growing need for mental health resources. Unfortunately, there are limited resources to keep up with the steady increase of individuals in need. Training peers to work with older depressed adults in techniques such as behavioral activation provides an alternative model to help moderate the increased need and provide a unique intervention of care. Developing an innovative peer facilitated program has the potential to enhance the delivery of quality health care.
The specific aims of the study are 1) to train peer coaches and implement Peer to Peer in the community 2) to examine depression ratings over time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peer to Peer | Experimental | Behavioral: Peer to PeerThese individuals will receive a standard mental health referral to a community agency and in addition meet with a trained peer coach for 12 weekly meetings. |
| Referral | Active comparator | Other: Standard Mental Health ReferralThese individuals will receive a standard mental health referral to a community agency. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 60 and older
- Member of Lenox Hill Senior Center, St. Peter's Senior Center, or Beth Abe
- Score of 10+ on Patient Health Questionnaire (PHQ-9)
Key exclusion criteria (4 listed)
- Presence of alcohol abuse, substance abuse, psychotic disorder, or bipolar disorder as observed on the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (SCID)
- Inability to speak English
- Dementia: Mini Mental State Examination (MMSE) score below 24
- High suicide risk, i.e. intent or plan to attempt suicide
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 |
|---|---|---|
| Peer to Peer12 weekly sessions of peer-delivered behavioral activation | Behavioural | Peer to Peer |
| Standard Mental Health ReferralStandard mental health referral to a community agency | Other | Referral |
Primary outcome
Proportion of Peer to Peer Coaches Who Undergo Behavioral Activation Training and Achieve Certification
Time frame: 4 weeks prior to Baseline
Proportion of Peer to Peer coaches who undergo Behavioral Activation training and achieve certification
Number of Peer to Peer Clients Who Attend > 80% of Behavioral Activation Sessions
Time frame: 12 weeks
Number of Peer to Peer clients who attend > 80% of Behavioral Activation sessions
1 secondary outcome
Changes in Hamilton Depression Rating Scale Scores
Time frame: Baseline and 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31368583Raue PJ, Sirey JA, Dawson A, Berman J, Bruce ML. Lay-delivered behavioral activation for depressed senior center clients: Pilot RCT. Int J Geriatr Psychiatry. 2019 Nov;34(11):1715-1723. doi: 10.1002/gps.5186. Epub 2019 Aug 8.
- 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.
Patrick Raue, PhD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer to Peer and Standard Mental Health Referral in people with Depression, run by Weill Medical College of Cornell 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 3 inclusion and 4 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 29 Sep 2017. 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?
Yes. Results are posted in the registry (first posted 29 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Peer to Peer Coaches Who Undergo Behavioral Activation Training and Achieve Certification (time frame: 4 weeks prior to Baseline). 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 NCT02292849, 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 29 Sep 2017.