Comparing Engage to PST for Late Life Depression

NCT ID: NCT02086201

Last Updated: 2021-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 262 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2020-03-31

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.

Conditions

Major Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Problem Solving Therapy

Intervention Type: BEHAVIORAL

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

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.

Group Type: EXPERIMENTAL

Engage

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Pat Arean

Professor, Psychiatry and Behavioral Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patricia Arean, PhD

Role: PRINCIPAL_INVESTIGATOR

UW

George Alexopoulos, M.D.

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Weill Medical College of Cornell University

White Plains, New York, United States

University of Washington Department of Psychiatry and Behavioral Sciences

Seattle, Washington, United States

Countries

United States

Other Identifiers

STUDY00001739

Identifier Type: -

Identifier Source: org_study_id