Major Depression
Conditions
Keywords
major depression, depression, depressive disorder, mental health, mental disorder
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.
Interventions
BEHAVIORALProblem 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.
BEHAVIORALEngage
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.
Sponsors
Weill Medical College of Cornell University
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression | Measured at pretreatment and weeks 2,4,6,8,9,26 and 36 | 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. |
Countries
United States
Outcome results
None listed