Trial Outcomes & Findings for Increasing Use of Mental Health Services (NCT NCT00605358)
NCT ID: NCT00605358
Last Updated: 2017-03-03
Results Overview
Engagement was defined as at least one visit with a mental health provider, due to the fact that in some treatment settings, the initial evaluation and the onset of treatment both took place in the first visit. The primary outcome, engagement, was counted if the participant had engaged in mental health treatment by EITHER 12 weeks OR 24 weeks, based on research suggesting that older adults may take up to 6 months to follow through on a referral. Therefore, while there is only a single primary outcome (engaged or not), it could be fulfilled at either of the two follow-up time points, at 12 or 24 weeks.
COMPLETED
NA
161 participants
12 and 24 weeks
2017-03-03
Participant Flow
Older adults who were eligible for home-meals delivery were recruited into the study if they screened positive for depressive symptoms. Screens were completed by home meals staff, while all research interviews were completed by trained research assistants.
A number of participants were excluded from the trial after screening but prior to randomization, due to the following reasons: Non-English speaking, active suicidality, starting new antidepressant or therapy, cognitive impairment, substance abuse, psychosis.
Participant milestones
| Measure |
Open Door Intervention
Open Door intervention: Open Door intervention subjects will:
1. receive an evaluation
2. receive a referral to a local mental health provider
3. identify barriers, set goals and problem-solve to achieve a mental health evaluation using available resources.
|
Services Referral (Control)
Subjects who do not receive the Open Door intervention will receive:
1. an evaluation
2. referral to a local mental health provider
3. booklet information on depression and mental health care, and will complete an application for HEAP, a Westchester County service that provides reduced rates from oil companies on heating to seniors.
|
|---|---|---|
|
Overall Study
STARTED
|
81
|
80
|
|
Overall Study
COMPLETED
|
81
|
80
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Increasing Use of Mental Health Services
Baseline characteristics by cohort
| Measure |
Open Door Intervention
n=81 Participants
Open Door intervention: Open Door intervention subjects will:
1. receive an evaluation
2. receive a referral to a local mental health provider
3. identify barriers, set goals and problem-solve to achieve a mental health evaluation using available resources.
|
Services Referral (Control)
n=80 Participants
Subjects who do not receive the Open Door intervention will receive:
1. an evaluation
2. referral to a local mental health provider
3. booklet information on depression and mental health care, and will complete an application for HEAP, a Westchester County service that provides reduced rates from oil companies on heating to seniors.
|
Total
n=161 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
82.9 Years
STANDARD_DEVIATION 9.0 • n=39 Participants
|
81.0 Years
STANDARD_DEVIATION 9.5 • n=41 Participants
|
81.9 Years
STANDARD_DEVIATION 9.3 • n=35 Participants
|
|
Gender
Female
|
67 Participants
n=39 Participants
|
49 Participants
n=41 Participants
|
116 Participants
n=35 Participants
|
|
Gender
Male
|
14 Participants
n=39 Participants
|
31 Participants
n=41 Participants
|
45 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
13 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
75 Participants
n=39 Participants
|
73 Participants
n=41 Participants
|
148 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=39 Participants
|
25 Participants
n=41 Participants
|
42 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
64 Participants
n=39 Participants
|
53 Participants
n=41 Participants
|
117 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
81 participants
n=39 Participants
|
80 participants
n=41 Participants
|
161 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 12 and 24 weeksEngagement was defined as at least one visit with a mental health provider, due to the fact that in some treatment settings, the initial evaluation and the onset of treatment both took place in the first visit. The primary outcome, engagement, was counted if the participant had engaged in mental health treatment by EITHER 12 weeks OR 24 weeks, based on research suggesting that older adults may take up to 6 months to follow through on a referral. Therefore, while there is only a single primary outcome (engaged or not), it could be fulfilled at either of the two follow-up time points, at 12 or 24 weeks.
Outcome measures
| Measure |
Open Door Intervention
n=81 Participants
Open Door intervention: Open Door intervention subjects will:
1. receive an evaluation
2. receive a referral to a local mental health provider
3. identify barriers, set goals and problem-solve to achieve a mental health evaluation using available resources.
|
Services Referral (Control)
n=80 Participants
Subjects who do not receive the Open Door intervention will receive:
1. an evaluation
2. referral to a local mental health provider
3. booklet information on depression and mental health care, and will complete an application for HEAP, a Westchester County service that provides reduced rates from oil companies on heating to seniors.
|
|---|---|---|
|
The Primary Outcome is Engagement Defined as at Least One Visit With a Mental Health Provider Who Can Offer Treatment of Depression.
|
74.1 percentage of participants
|
56.3 percentage of participants
|
Adverse Events
Open Door Intervention
Services Referral (Control)
Serious adverse events
| Measure |
Open Door Intervention
n=80 participants at risk；n=81 participants at risk
Open Door intervention: Open Door intervention subjects will:
1. receive an evaluation
2. receive a referral to a local mental health provider
3. identify barriers, set goals and problem-solve to achieve a mental health evaluation using available resources.
|
Services Referral (Control)
n=81 participants at risk；n=80 participants at risk
Subjects who do not receive the Open Door intervention will receive:
1. an evaluation
2. referral to a local mental health provider
3. booklet information on depression and mental health care, and will complete an application for HEAP, a Westchester County service that provides reduced rates from oil companies on heating to seniors.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Hospitalization
|
45.0%
9/20 • Number of events 15 • Adverse data were collected throughout the entire study period (three years).
All participants were systematically asked if they had been hospitalized since the prior research visit. All participants were also assessed for depression and suicidality.
|
62.5%
15/24 • Number of events 16 • Adverse data were collected throughout the entire study period (three years).
All participants were systematically asked if they had been hospitalized since the prior research visit. All participants were also assessed for depression and suicidality.
|
|
Psychiatric disorders
Active Suicidal Ideation
|
1.2%
1/81 • Number of events 1 • Adverse data were collected throughout the entire study period (three years).
All participants were systematically asked if they had been hospitalized since the prior research visit. All participants were also assessed for depression and suicidality.
|
2.5%
2/80 • Number of events 3 • Adverse data were collected throughout the entire study period (three years).
All participants were systematically asked if they had been hospitalized since the prior research visit. All participants were also assessed for depression and suicidality.
|
|
General disorders
Death
|
4.9%
4/81 • Number of events 4 • Adverse data were collected throughout the entire study period (three years).
All participants were systematically asked if they had been hospitalized since the prior research visit. All participants were also assessed for depression and suicidality.
|
0.00%
0/80 • Adverse data were collected throughout the entire study period (three years).
All participants were systematically asked if they had been hospitalized since the prior research visit. All participants were also assessed for depression and suicidality.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place