Major Depression
Conditions
Keywords
geriatric depression
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALOpen 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.
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
60 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Age 60 years and older * Homebound * Endorse depressive symptoms
Exclusion criteria
* Presence of significant alcohol or substance abuse or psychotic disorder * High suicide risk, i.e. intent or plan to attempt suicide * Cognitive impairment * Inability to speak English * Aphasia interfering with communication. * Current use of antidepressants or psychotherapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Primary Outcome is Engagement Defined as at Least One Visit With a Mental Health Provider Who Can Offer Treatment of Depression. | 12 and 24 weeks | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 81 |
| 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. | 80 |
| Total | 161 |
Baseline characteristics
| Characteristic | Open Door Intervention | Services Referral (Control) | Total |
|---|---|---|---|
| Age, Continuous | 82.9 Years STANDARD_DEVIATION 9 | 81.0 Years STANDARD_DEVIATION 9.5 | 81.9 Years STANDARD_DEVIATION 9.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 7 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 75 Participants | 73 Participants | 148 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Gender Female | 67 Participants | 49 Participants | 116 Participants |
| Gender Male | 14 Participants | 31 Participants | 45 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants | 25 Participants | 42 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 64 Participants | 53 Participants | 117 Participants |
| Region of Enrollment United States | 81 participants | 80 participants | 161 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 80 | 0 / 81 |
| serious Total, serious adverse events | 14 / 81 | 17 / 80 |
Outcome results
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.
Time frame: 12 and 24 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Open Door Intervention | 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 |
| 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. | 56.3 percentage of participants |
Comparison: Participants in the Open Door Intervention and the Services Referral condition were compared on rates of engagement in mental health services over the study follow-up period.p-value: 0.01895% CI: [1.17, 4.93]Chi-squared