Clinical trial NCT02086201: Comparing Engage to PST for Late Life Depression
Official title: Stepped, Reward-exposure Based Therapy vs. PST in Late Life Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depression
Keywords: major depression
depression
depressive disorder
mental health
mental disorder
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Weill Medical College of Cornell University
First posted: 2014-03-13
Enrollment: 262
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Depression
timeFrame: Measured at pretreatment and weeks 2,4,6,8,9,26 and 36
Secondary outcomes:
Other outcomes:
Locations:
city: White Plains
country: United States
facility: Weill Medical College of Cornell University
state: New York
city: Seattle
country: United States
facility: University of Washington Department of Psychiatry and Behavioral Sciences
state: Washington
Study officials:
affiliation: UW
name: Patricia Arean, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Weill Medical College of Cornell University
name: George Alexopoulos, M.D.
role: PRINCIPAL_INVESTIGATOR
References: