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Comparing Engage to PST for Late Life Depression (Engage)

Primary Purpose

Major Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Problem Solving Therapy
Engage
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depression focused on measuring major depression, depression, depressive disorder, mental health, mental disorder

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Weill Medical College of Cornell University
  • University of Washington Department of Psychiatry and Behavioral Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Problem Solving Therapy

Engage

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Depression
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.

Secondary Outcome Measures

Full Information

First Posted
February 25, 2014
Last Updated
June 25, 2021
Sponsor
University of Washington
Collaborators
Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT02086201
Brief Title
Comparing Engage to PST for Late Life Depression
Acronym
Engage
Official Title
Stepped, Reward-exposure Based Therapy vs. PST in Late Life Depression
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
March 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
Weill Medical College of Cornell University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression
Keywords
major depression, depression, depressive disorder, mental health, mental disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
262 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Problem Solving Therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Engage
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Problem Solving Therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Engage
Intervention Description
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 Measure Information:
Title
Depression
Description
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.
Time Frame
Measured at pretreatment and weeks 2,4,6,8,9,26 and 36

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Arean, PhD
Organizational Affiliation
UW
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
George Alexopoulos, M.D.
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Medical College of Cornell University
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States
Facility Name
University of Washington Department of Psychiatry and Behavioral Sciences
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We intend to share de-identified data once study is complete

Learn more about this trial

Comparing Engage to PST for Late Life Depression

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