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Comparing Engage to PST for Late Life Depression (Engage)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02086201
Recruitment Status : Recruiting
First Posted : March 13, 2014
Last Update Posted : January 15, 2019
Weill Medical College of Cornell University
Information provided by (Responsible Party):
Pat Arean, University of Washington

Brief Summary:
This is a non-inferiority trial of Engage, a new intervention for late-life depression, and problem solving therapy (PST). Patient participants will be randomized to either Engage or PST and receive 9 weeks of either intervention. Interview assessments will be collected at baseline and weeks 2, 4, 6, 8, 9, 26, and 36. Clinician participants, social workers from mental health agencies, will be randomized to receive training and certification in either Engage or PST.

Condition or disease Intervention/treatment Phase
Major Depression Behavioral: Problem Solving Therapy Behavioral: Engage Not Applicable

Detailed Description:

Policy reports document that evidence-based psychotherapies are rarely employed and sustained in the community. Several causes of this science to service gap have been identified. One cause, specific to behavioral interventions, is the complexity of interventions and the competencies community clinicians must acquire and sustain over time in order to deliver them. A realistic solution is to streamline behavioral interventions and tailor them to the settings and therapist skill level available in the community. In response to this need, we have developed Engage, which: 1) is streamlined on the basis of concepts and findings on the neurobiology of depression; 2) consists of psychotherapeutic and ecosystem management components of known efficacy; 3) has distilled and simplified these components so as they can be accessible to most depressed older patients and taught to larger numbers of clinicians than available therapies, e.g., Problem Solving Therapy (PST); and 4) is personalized through a structured stepped approach focusing on "reward exposure". Problem Solving Therapy is an evidenced-based intervention shown to be effective in treating late-life depression.

Three hundred (150 per site) patient participants will be randomly assigned to receive 9 sessions of either Engage or PST. Forty-two clinician participants will be randomly assigned to receive training and certification in either Engage or PST. Once certified, clinicians will be assigned a patient participant and administer their assigned intervention.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 342 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stepped, Reward-exposure Based Therapy vs. PST in Late Life Depression
Study Start Date : May 2014
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Problem Solving Therapy
Problem solving therapy is an evidence based psychotherapy for depression, with 30 years of research supporting its efficacy. PST focuses on the patients themselves and helps them develop skills in identifying, prioritizing, and solving problems, and thereby creates a sense of empowerment.
Behavioral: Problem Solving Therapy
PST is a behavioral intervention for depression that is delivered by trained therapists over a 9 week period. It consists of a process to help patients understand and then solve the problems in their lives they feel is contributing to their depression.

Experimental: Engage
Engage utilizes reward exposure consisting of the reintroduction of activities that patients once found rewarding and enjoyed, but have abandoned after they developed depression. Engage uses basic problem solving through which patients learn how to form "action plans" for pursuing rewarding activities of their choice.
Behavioral: Engage
Engage is a weekly behavioral intervention that is delivered over a 9 week period of time by trained therapists. The focus of Engage is to help patient reconnect with activities that they have lost interest in pursuing due to depression.

Primary Outcome Measures :
  1. Depression [ Time Frame: Measured at pretreatment and weeks 2,4,6,8,9,26 and 36 ]
    Depression will be assessed using the Hamilton Depression Rating Scale, a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery.

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria (Patient participants):

  • Age ≥ 60 years
  • unipolar, non-psychotic major depression (by SCID, DSM-IV)
  • MADRS ≥ 20
  • MMSE ≥ 24
  • off antidepressants or have been on a stable dose of an antidepressant for 12 weeks and do not intend to change the dose in the next 10 weeks
  • English speaking
  • capacity to provide written consent

Exclusion Criteria (Patient participants):

  • Presence of psychiatric diagnoses other than unipolar, non-psychotic major depression or generalized anxiety disorder
  • Newly started use of psychotropic drugs (<12wks) or cholinesterase inhibitors other than mild doses of benzodiazepines
  • Current active suicidal intent/plan
  • Current substance abuse

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02086201

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Contact: Jaden Duffy, B.A. 206-616-4947
Contact: Brittany Mosser, M.S.W. 206-543-3350

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United States, New York
Weill Medical College of Cornell University Recruiting
White Plains, New York, United States, 10605
Principal Investigator: George Alexopoulos, M.D.         
United States, Washington
University of Washington Department of Psychiatry and Behavioral Sciences Recruiting
Seattle, Washington, United States, 98195
Contact: Brittany Mosser, MSW    206-543-3350   
Principal Investigator: Patricia A. Arean, Ph.D.         
Sponsors and Collaborators
University of Washington
Weill Medical College of Cornell University
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Principal Investigator: Patricia Arean, PhD UW
Principal Investigator: George Alexopoulos, M.D. Weill Medical College of Cornell University

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Responsible Party: Pat Arean, Professor, Psychiatry and Behavioral Sciences, University of Washington Identifier: NCT02086201     History of Changes
Other Study ID Numbers: STUDY00001739
First Posted: March 13, 2014    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We intend to share de-identified data once study is complete
Keywords provided by Pat Arean, University of Washington:
major depression
depressive disorder
mental health
mental disorder
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders