An interventional study of Open Door intervention in Major Depression, sponsored by Weill Medical College of Cornell University. Completed at 1 site in United States. Open to participants aged 60 Years to 90 Years. Per ClinicalTrials.gov, last updated 2017-03-03.
Sponsored by Weill Medical College of Cornell University · Not applicable, Interventional, and Supportive care
The purpose of this study is to test the effectiveness of Open Door (previously known as the Treatment Initiation Program [TIP]), a brief psychosocial intervention to address the psychological barriers to care and improve the use of mental health services by depressed community elderly. The intervention is designed to help the older adult identify the barriers, problem-solve to find solutions and mobilize the motivation to seek help. Open Door was developed to work collaboratively with an older adult who is depressed to improve access and adherence to mental health treatment.
The primary aim of this research study did not change from the original application; it is to conduct a randomized controlled trial of the effectiveness of a brief, psychosocial intervention on engagement in mental health care among homebound depressed older adults. Engagement is defined as accepting a referral and attending a visit with a provider who could provide traditional mental health care (medication or psychotherapy). The intervention, now called Open Door, was developed to work collaboratively with an older adult who has depressive symptoms to address the barriers to care with the aim of helping them consider a referral and engage in mental health care. In prior research, this intervention has been found to improve treatment participation, reduce depressive symptoms and increase adherence to antidepressant therapy among depressed older adults in primary care and outpatient psychiatric settings. We propose that Open Door will improve the access to mental health care by reducing psychological barriers, providing education about care, and managing the resignation associated with the symptoms of depression among community dwelling depressed elders. Additionally, we believe that despite the heterogeneity of mental health care that may be received, Open Door will be associated with reduced depressive symptoms by empowering the older adult to initiate care for him/herself.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 161 is above the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Weill Medical College of Cornell University is the lead sponsor of 867 studies on the registry; 160 are open to participants now.
Of its 119 completed or terminated interventional studies of FDA-regulated products, 91 (76%) have results posted.
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Exclusion Criteria:
Subjects who receive the Open Door Intervention will work with the study counselor to identify barriers to participation in mental health treatment, set goals, and problem-solve, in addition to receiving a referral.
Behavioral: Open Door intervention
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.
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.
Also known as: West group
The Primary Outcome is Engagement Defined as at Least One Visit With a Mental Health Provider Who Can Offer Treatment of Depression.
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.
Time frame: 12 and 24 weeks
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.
| Milestone | Open Door Intervention | Services Referral (Control) |
|---|---|---|
| Started | 81 | 80 |
| Completed | 81 | 80 |
| Not completed | 0 | 0 |
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.
| percentage of participants | Open Door Intervention | Services Referral (Control) |
|---|---|---|
| The Primary Outcome is Engagement Defined as at Least One Visit With a Mental Health Provider Who Can Offer Treatment of Depression. | 74.1 | 56.3 |
Collected over Adverse data were collected throughout the entire study period (three years).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Open Door Intervention | — | 14/81 (17.3%) | 0/80 (0%) |
| Services Referral (Control) | — | 17/80 (21.3%) | 0/81 (0%) |
| Event | Open Door Intervention | Services Referral (Control) |
|---|---|---|
| HospitalizationInjury, poisoning and procedural complications | 9/20 | 15/24 |
| DeathGeneral disorders | 4/81 | 0/80 |
| Active Suicidal IdeationPsychiatric disorders | 1/81 | 2/80 |
| Age, Continuous(Years) | Open Door Intervention | Services Referral (Control) | Total |
|---|---|---|---|
| Mean | 82.9 ± 9.0 | 81.0 ± 9.5 | 81.9 ± 9.3 |
| Gender(Participants) | Open Door Intervention | Services Referral (Control) | Total |
|---|---|---|---|
| Female | 67 | 49 | 116 |
| Male | 14 | 31 | 45 |
| Ethnicity (NIH/OMB)(Participants) | Open Door Intervention | Services Referral (Control) | Total |
|---|---|---|---|
| Hispanic or Latino | 6 | 7 | 13 |
| Not Hispanic or Latino | 75 | 73 | 148 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Open Door Intervention | Services Referral (Control) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 17 | 25 | 42 |
| White | 64 | 53 | 117 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Open Door Intervention | Services Referral (Control) | Total |
|---|---|---|---|
| United States | 81 | 80 | 161 |
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Weill Medical College of Cornell University