Psychotherapy for Late Life Depression (ENGAGE-II)

This study is currently recruiting participants.

Verified September 2012 by Weill Medical College of Cornell University

Sponsor:

Collaborator:

National Institute of Mental Health (NIMH)

Information provided by (Responsible Party):

Weill Medical College of Cornell University

ClinicalTrials.gov Identifier:

NCT01698255

First received: August 2, 2012

Last updated: September 27, 2012

Last verified: September 2012

History of Changes

Purpose

This randomized pilot study will test the feasibility of a behavioral intervention for late life depression. Enrolled participants will receive 9 weeks of a specialized form of psychotherapy we call "ENGAGE" or standard of care psychotherapy. ENGAGE is a stepped care psychotherapy based on what is currently known about older adults' response to depression interventions. Stepped care is a model of treatment that starts with the minimum effective therapeutic techniques first, and then based on how well people respond to treatment, additional therapeutic techniques are added until individuals recover from their depression. The treatment components of ENGAGE were selected to match the most common problems seen in older adults with depression. They include instructing the participant in basic problem solving techniques and encouraging re-engagement in rewarding activities.

Participants will be depressed, older adult clients of Westchester Jewish Community Services or outpatient research subjects recruited by the Cornell Institute of Geriatric Psychiatry. In addition to receiving therapy, study participants will also undergo research assessments at the beginning of the study and then at weeks 6 and 9.

Condition	Intervention
Depression	Behavioral: ENGAGE Behavioral: Standard of Care Psychotherapy

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Psychotherapy for Late Life Depression

Resource links provided by NLM:

MedlinePlus related topics: Depression

U.S. FDA Resources

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:

Change in Depression [ Time Frame: 3 months ] [ Designated as safety issue: No ]
To compare the effectiveness of the ENGAGE intervention in reducing depressive symptoms with that of the standard of care psychotherapy. We will assess severity of depression at Baseline. 6 weeks and 3 months using the Hamilton Depression Rating Scale as the primary measure.

Estimated Enrollment:	40
Study Start Date:	March 2012
Estimated Study Completion Date:	April 2014
Estimated Primary Completion Date:	April 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: ENGAGE ENGAGE is a stepped care psychotherapy based on what is known about how older adults respond to depression interventions. Stepped care is a model of treatment that starts with the minimum effective therapeutic techniques first, and then based on how well people respond to treatment, additional therapeutic techniques are added until people are recovered from their depression. The steps of ENGAGE are: basic social and physical engagement, which has been found to be a very effective depression strategy for most older adults; the addition of strategies to address clinical features of depression interfering with treatment engagement, namely affect regulation, pessimism, and disorganization.	Behavioral: ENGAGE
Active Comparator: Standard of Care Psychotherapy The comparison group for this study will be the current standard of care psychotherapy offered by Westchester Jewish Community Services (WJCS) therapists. This type of psychotherapy is often supportive or eclectic in nature. Therapists will focus on helping the subject to express feelings and focus on strengths and abilities in working through current difficulties and transitions. Therapists assigned to provide standard psychotherapy to eligible participants will receive training and supervision from WJCS staff consistent with agency practice.	Behavioral: Standard of Care Psychotherapy

Arms

Assigned Interventions

Experimental: ENGAGE

ENGAGE is a stepped care psychotherapy based on what is known about how older adults respond to depression interventions. Stepped care is a model of treatment that starts with the minimum effective therapeutic techniques first, and then based on how well people respond to treatment, additional therapeutic techniques are added until people are recovered from their depression. The steps of ENGAGE are:

basic social and physical engagement, which has been found to be a very effective depression strategy for most older adults;
the addition of strategies to address clinical features of depression interfering with treatment engagement, namely affect regulation, pessimism, and disorganization.

Behavioral: ENGAGE

Active Comparator: Standard of Care Psychotherapy

The comparison group for this study will be the current standard of care psychotherapy offered by Westchester Jewish Community Services (WJCS) therapists. This type of psychotherapy is often supportive or eclectic in nature. Therapists will focus on helping the subject to express feelings and focus on strengths and abilities in working through current difficulties and transitions. Therapists assigned to provide standard psychotherapy to eligible participants will receive training and supervision from WJCS staff consistent with agency practice.

Behavioral: Standard of Care Psychotherapy

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria (WJCS Participants):

Current client of Westchester Jewish Community Services;
Age 60 years or older;
Diagnosis of depression as determined by WJCS therapists;
Command of English sufficient to participate in talking therapy;

Inclusion Criteria (Cornell Participants):

Age 60 years or older;
Depression as determined by a PHQ-9 score of 6 or higher (with at least one item being "depressed mood" or "loss of interest/pleasure");
Command of English sufficient to participate in talking therapy;

Exclusion Criteria:

Dementia: Mini Mental State Exam score below 24 or clinical diagnosis of dementia by DSM-IV;
High suicide risk, i.e. intent or plan to attempt suicide in near future;
History of psychiatric diagnoses other than major depressive disorder or generalized anxiety disorder (including bi-polar depression, psychotic depression, schizoaffective disorders).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01698255

Contacts

Contact: Patrick J Raue, Ph.D.

914-997-8384

praue@med.cornell.edu

Locations

United States, New York
Westchester Jewish Community Services	Recruiting
Hartsdale, New York, United States, 10530
Contact: Patrick J Raue, Ph.D. 914-997-8684 praue@med.cornell.edu
Principal Investigator: George S Alexopoulos, M.D.
Weill Cornell Medical College	Recruiting
White Plains, New York, United States, 10605
Contact: Patrick J Raue, Ph.D. 914-997-8684 praue@med.cornell.edu
Principal Investigator: George S Alexopoulos, M.D.

Sponsors and Collaborators

Weill Medical College of Cornell University

National Institute of Mental Health (NIMH)

More Information

No publications provided

Responsible Party:	Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:	NCT01698255 History of Changes
Other Study ID Numbers:	P30 MH085943-05, 11108011880
Study First Received:	August 2, 2012
Last Updated:	September 27, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:

Depression
Geriatrics

Additional relevant MeSH terms:

Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013

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