Psychotherapy for Late Life Depression

NCT01698255 | Completed DMC

• 3 other identifiers: 110801188011108011880P30MH085943-05
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Depression

Keywords

Depression; Geriatrics

Outcome Measures

Primary Outcomes (1)

• Change in Depression

  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.

  3 months

Study Arms (2)

ENGAGE

EXPERIMENTAL

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: 1. basic social and physical engagement, which has been found to be a very effective depression strategy for most older adults; 2. the addition of strategies to address clinical features of depression interfering with treatment engagement, namely affect regulation, pessimism, and disorganization.

Behavioral: ENGAGE

Standard of Care Psychotherapy

ACTIVE COMPARATOR

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

Interventions

ENGAGE BEHAVIORAL

ENGAGE

Standard of Care Psychotherapy BEHAVIORAL

Standard of Care Psychotherapy

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Age 60 years or older;
• Depression as determined by a Patient Health Questionnaire-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;

You may not qualify if:

• Dementia: Mini Mental State Exam score below 24 or clinical diagnosis of dementia by Diagnostic and Statistical Manual 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).

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

Westchester Jewish Community Services

Hartsdale, New York, 10530, United States

Location

Weill Cornell Medical College

White Plains, New York, 10605, United States

Location

Related Publications (2)

• Alexopoulos GS, O'Neil R, Banerjee S, Raue PJ, Victoria LW, Bress JN, Pollari C, Arean PA. "Engage" therapy: Prediction of change of late-life major depression. J Affect Disord. 2017 Oct 15;221:192-197. doi: 10.1016/j.jad.2017.06.037. Epub 2017 Jun 19.

  PMID: 28647669 DERIVED

• Alexopoulos GS, Raue PJ, Kiosses DN, Seirup JK, Banerjee S, Arean PA. Comparing engage with PST in late-life major depression: a preliminary report. Am J Geriatr Psychiatry. 2015 May;23(5):506-13. doi: 10.1016/j.jagp.2014.06.008. Epub 2014 Jun 26.

  PMID: 25081818 DERIVED

MeSH Terms

Conditions

Depression

Interventions

engage 8200

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• George Alexopoulos, M.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2012
• First Posted: October 2, 2012
• Study Start: March 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: February 23, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)