Comparing Engage to PST for Late Life Depression

Major Depression Clinical Trial

— Engage  

Official title:

Stepped, Reward-exposure Based Therapy vs. PST in Late Life Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02086201
• Other study ID #: STUDY00001739
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: March 31, 2020

Study information

• Verified date: June 2021
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 262
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression

Intervention

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
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.

Locations

Country	Name	City	State
United States	University of Washington Department of Psychiatry and Behavioral Sciences	Seattle	Washington
United States	Weill Medical College of Cornell University	White Plains	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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