- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02292849
Peer to Peer Delivery of Behavioral Activation
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
White Plains, New York, United States, 10605
- Weill Cornell Medical College
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Peer to Peer
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.
|
12 weekly sessions of peer-delivered behavioral activation
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Active Comparator: Referral
These individuals will receive a standard mental health referral to a community agency.
|
Standard mental health referral to a community agency
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
4 weeks prior to Baseline
|
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
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Hamilton Depression Rating Scale Scores
Time Frame: Baseline and 12 weeks
|
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.
|
Baseline and 12 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Patrick Raue, PhD, Weill Medical College of Cornell University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1307014080
- P30MH085943 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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