NCT02292849

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 12, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 17, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 7, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2015

Completed
2 years until next milestone

Results Posted

Study results publicly available

September 29, 2017

Completed
Last Updated

September 29, 2017

Status Verified

August 1, 2017

Enrollment Period

1.9 years

First QC Date

November 12, 2014

Results QC Date

January 27, 2017

Last Update Submit

August 3, 2017

Conditions

Depression

Keywords

Depression

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    12 weeks

Secondary Outcomes (1)

  • Changes in Hamilton Depression Rating Scale Scores

    Baseline and 12 weeks

Study Arms (2)

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.

Behavioral: Peer to Peer

Referral

ACTIVE COMPARATOR

These individuals will receive a standard mental health referral to a community agency.

Other: Standard Mental Health Referral

Interventions

Peer to PeerBEHAVIORAL

12 weekly sessions of peer-delivered behavioral activation

Peer to Peer
Standard Mental Health ReferralOTHER

Standard mental health referral to a community agency

Referral

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Cornell Medical College

White Plains, New York, 10605, United States

Location

Related Publications (1)

  • 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.

    PMID: 31368583DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Results Point of Contact

Title
Patrick Raue, Ph.D.
Organization
Weill Cornell Medical College
praue@uw.edu
206-543-3807

Study Officials

  • Patrick Raue, PhD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2014

First Posted

November 17, 2014

Study Start

November 1, 2013

Primary Completion

October 7, 2015

Study Completion

October 7, 2015

Last Updated

September 29, 2017

Results First Posted

September 29, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)