NCT00605358

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
161

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 31, 2008

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

March 3, 2017

Completed
Last Updated

March 3, 2017

Status Verified

January 1, 2017

Enrollment Period

6.4 years

First QC Date

January 18, 2008

Results QC Date

April 26, 2016

Last Update Submit

January 12, 2017

Conditions

Keywords

geriatric depression

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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.

Behavioral: Open Door intervention

Services Referral

NO 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.

Interventions

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
Open Door Intervention

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 60 years and older
  • Homebound
  • Endorse depressive symptoms

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Cornell Medical College

White Plains, New York, 10605, United States

Location

Related 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. doi: 10.1176/appi.ajp.162.1.184.

    PMID: 15625220BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Results Point of Contact

Title
Dr. Jo Anne Sirey
Organization
Weill Cornell Medicine

Study Officials

  • Jo Anne Sirey, Ph.D.

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 18, 2008

First Posted

January 31, 2008

Study Start

August 1, 2007

Primary Completion

January 1, 2014

Study Completion

January 1, 2015

Last Updated

March 3, 2017

Results First Posted

March 3, 2017

Record last verified: 2017-01

Locations