Comparing Engage to PST for Late Life Depression

NCT02086201 | Completed

• 1 other identifier: STUDY00001739
• Study Type: interventional
• Target: 262
• Locations: 1 country
• Sites: 2

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.

Conditions

Major Depression

Keywords

major depression; depression; depressive disorder; mental health; mental disorder

Outcome Measures

Primary Outcomes (1)

• 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.

  Measured at pretreatment and weeks 2,4,6,8,9,26 and 36

Study Arms (2)

Problem Solving Therapy

ACTIVE COMPARATOR

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

Engage

EXPERIMENTAL

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

Interventions

Problem Solving Therapy 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.

Problem Solving Therapy

Engage 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.

Engage

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• Weill Medical College of Cornell University: collaborator

Study Sites (2)

Weill Medical College of Cornell University

White Plains, New York, 10605, United States

Location

University of Washington Department of Psychiatry and Behavioral Sciences

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression; Depressive Disorder; Psychological Well-Being; Mental Disorders

Interventions

engage 8200

Condition Hierarchy (Ancestors)

Mood Disorders; Behavioral Symptoms; Behavior; Personal Satisfaction

Study Officials

• Patricia Arean, PhD

  UW

  PRINCIPAL INVESTIGATOR

• 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: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Psychiatry and Behavioral Sciences

Study Record Dates

• First Submitted: February 25, 2014
• First Posted: March 13, 2014
• Study Start: May 1, 2014
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: June 29, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share

Locations

US (2)