Trial Outcomes & Findings for Peer to Peer Delivery of Behavioral Activation (NCT NCT02292849)
NCT ID: NCT02292849
Last Updated: 2017-09-29
Results Overview
Proportion of Peer to Peer coaches who undergo Behavioral Activation training and achieve certification
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
29 participants
Primary outcome timeframe
4 weeks prior to Baseline
Results posted on
2017-09-29
Participant Flow
Participant milestones
| Measure |
Peer to Peer Coaches
Peer coaches who were eligible to provide the Behavioral Activation intervention
|
Peer to Peer Clients
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.
Peer to Peer: 12 weekly sessions of peer-delivered behavioral activation
|
Referral Clients
These individuals will receive a standard mental health referral to a community agency.
Standard Mental Health Referral: Standard mental health referral to a community agency
|
|---|---|---|---|
|
Overall Study
STARTED
|
11
|
8
|
10
|
|
Overall Study
COMPLETED
|
7
|
6
|
8
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
2
|
Reasons for withdrawal
| Measure |
Peer to Peer Coaches
Peer coaches who were eligible to provide the Behavioral Activation intervention
|
Peer to Peer Clients
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.
Peer to Peer: 12 weekly sessions of peer-delivered behavioral activation
|
Referral Clients
These individuals will receive a standard mental health referral to a community agency.
Standard Mental Health Referral: Standard mental health referral to a community agency
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
2
|
|
Overall Study
Physician Decision
|
4
|
0
|
0
|
Baseline Characteristics
Peer to Peer Delivery of Behavioral Activation
Baseline characteristics by cohort
| Measure |
Peer to Peer Coaches
n=11 Participants
These individuals were eligible to provide the Behavioral Activation intervention.
|
Peer to Peer Clients
n=8 Participants
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.
Peer to Peer: 12 weekly sessions of peer-delivered behavioral activation
|
Referral Clients
n=10 Participants
These individuals will receive a standard mental health referral to a community agency.
Standard Mental Health Referral: Standard mental health referral to a community agency
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
29 Participants
n=483 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
24 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
27 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
23 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
29 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 4 weeks prior to BaselinePopulation: This outcome analyzed Peer to Peer coaches who were eligible to provide the Behavioral Activation intervention
Proportion of Peer to Peer coaches who undergo Behavioral Activation training and achieve certification
Outcome measures
| Measure |
Peer to Peer Coaches
n=11 Participants
Peer coaches who were eligible to provide the Behavioral Activation intervention
|
Referral Clients
These individuals will receive a standard mental health referral to a community agency.
Standard Mental Health Referral: Standard mental health referral to a community agency
|
|---|---|---|
|
Proportion of Peer to Peer Coaches Who Undergo Behavioral Activation Training and Achieve Certification
|
7 Participants
|
—
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Clients assigned to receive Peer BA
Number of Peer to Peer clients who attend \> 80% of Behavioral Activation sessions
Outcome measures
| Measure |
Peer to Peer Coaches
n=8 Participants
Peer coaches who were eligible to provide the Behavioral Activation intervention
|
Referral Clients
These individuals will receive a standard mental health referral to a community agency.
Standard Mental Health Referral: Standard mental health referral to a community agency
|
|---|---|---|
|
Number of Peer to Peer Clients Who Attend > 80% of Behavioral Activation Sessions
|
8 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Randomized clients
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.
Outcome measures
| Measure |
Peer to Peer Coaches
n=6 Participants
Peer coaches who were eligible to provide the Behavioral Activation intervention
|
Referral Clients
n=8 Participants
These individuals will receive a standard mental health referral to a community agency.
Standard Mental Health Referral: Standard mental health referral to a community agency
|
|---|---|---|
|
Changes in Hamilton Depression Rating Scale Scores
|
-8.0 units on a scale
Standard Deviation 4.3
|
0.0 units on a scale
Standard Deviation 7.5
|
Adverse Events
Peer to Peer Clients
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Referral Clients
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Peer to Peer Clients
n=8 participants at risk
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.
Peer to Peer: 12 weekly sessions of peer-delivered behavioral activation
|
Referral Clients
n=10 participants at risk
These individuals will receive a standard mental health referral to a community agency.
Standard Mental Health Referral: Standard mental health referral to a community agency
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
ER visit for respiratory disorder
|
0.00%
0/8 • 12 weeks
|
10.0%
1/10 • Number of events 1 • 12 weeks
|
|
Injury, poisoning and procedural complications
ER visit for injury
|
12.5%
1/8 • Number of events 1 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
|
General disorders
ER visit for general disorder
|
12.5%
1/8 • Number of events 1 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place