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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00605358
Other study ID # R01MH079265-01A1
Secondary ID
Status Active, not recruiting
Phase N/A
First received January 18, 2008
Last updated December 16, 2014
Start date August 2007
Est. completion date January 2016

Study information

Verified date January 2011
Source Weill Medical College of Cornell University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 200
Est. completion date January 2016
Est. primary completion date January 2014
Accepts healthy volunteers No
Gender Both
Age group 60 Years to 90 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care


Intervention

Behavioral:
Open Door intervention
Open Door intervention subjects will: receive an evaluation receive a referral to a local mental health provider identify barriers, set goals and problem-solve to achieve a mental health evaluation using available resources.

Locations

Country Name City State
United States Weill Cornell Medical College White Plains New York

Sponsors (1)

Lead Sponsor Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The primary outcome is engagement defined as at least two visits with a mental health provider who can offer treatment of depression. 12 and 24 weeks No
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