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.|
|ClinicalTrials.gov Identifier: NCT02086201|
Recruitment Status : Recruiting
First Posted : March 13, 2014
Last Update Posted : May 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Major Depression||Behavioral: Problem Solving Therapy Behavioral: Engage||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||342 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
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.
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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT02086201
|Contact: Jaden Duffy, B.A.||email@example.com|
|Contact: Kathy Ringwood, M.S.W.||firstname.lastname@example.org|
|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: Kathy Ringwood, MSW 206-221-8692 email@example.com|
|Principal Investigator: Patricia A. Arean, Ph.D.|
|Principal Investigator:||Patricia Arean, PhD||UW|
|Principal Investigator:||George Alexopoulos, M.D.||Weill Medical College of Cornell University|