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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Door Intervention | Active Comparator | 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. |
|
| Services Referral | No Intervention | Subjects who do not receive the Open Door intervention will receive:
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open Door intervention | Behavioral | Open Door intervention subjects will:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 and 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jo Anne Sirey, Ph.D. | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medical College | White Plains | New York | 10605 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15625220 | Background | Sirey JA, Bruce ML, Alexopoulos GS. The Treatment Initiation Program: an intervention to improve depression outcomes in older adults. Am J Psychiatry. 2005 Jan;162(1):184-6. doi: 10.1176/appi.ajp.162.1.184. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Open Door Intervention | Open Door intervention: Open Door intervention subjects will:
|
| FG001 | Services Referral (Control) | Subjects who do not receive the Open Door intervention will receive:
|
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Open Door Intervention | Open Door intervention: Open Door intervention subjects will:
|
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | percentage of participants | 12 and 24 weeks |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Open Door Intervention | Open Door intervention: Open Door intervention subjects will:
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Injury, poisoning and procedural complications | Systematic Assessment | Hospitalizations occurred due to medical emergencies and falls |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jo Anne Sirey | Weill Cornell Medicine | 9149974333 | jsirey@med.cornell.edu |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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|
| Services Referral (Control) |
Subjects who do not receive the Open Door intervention will receive:
|
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Gender | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Services Referral (Control) | Subjects who do not receive the Open Door intervention will receive:
|
|
|
|
| 14 |
| 81 |
| 0 |
| 80 |
| EG001 | Services Referral (Control) | Subjects who do not receive the Open Door intervention will receive:
| 17 | 80 | 0 | 81 |
|
| Active Suicidal Ideation | Psychiatric disorders | Systematic Assessment |
|
| Death | General disorders | Systematic Assessment | Death was either natural or expected, NOT related to the study. |
|
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