Psychotherapy for Late Life Depression (ENGAGE-II)
|ClinicalTrials.gov Identifier: NCT01698255|
Recruitment Status : Completed
First Posted : October 2, 2012
Last Update Posted : February 23, 2017
This randomized pilot study will test the feasibility of a behavioral intervention for late life depression. Enrolled participants will receive 9 weeks of a specialized form of psychotherapy we call "ENGAGE" or standard of care psychotherapy. ENGAGE is a stepped care psychotherapy based on what is currently known about older adults' response to depression interventions. Stepped care is a model of treatment that starts with the minimum effective therapeutic techniques first, and then based on how well people respond to treatment, additional therapeutic techniques are added until individuals recover from their depression. The treatment components of ENGAGE were selected to match the most common problems seen in older adults with depression. They include instructing the participant in basic problem solving techniques and encouraging re-engagement in rewarding activities.
Participants will be depressed, older adult clients of Westchester Jewish Community Services or outpatient research subjects recruited by the Cornell Institute of Geriatric Psychiatry. In addition to receiving therapy, study participants will also undergo research assessments at the beginning of the study and then at weeks 6 and 9.
|Condition or disease||Intervention/treatment||Phase|
|Depression||Behavioral: ENGAGE Behavioral: Standard of Care Psychotherapy||Not Applicable|
A concern about existing psychotherapies is that, while effective in depression, community clinicians find them difficult to implement in older people, particularly those with medical illnesses or disability. As a consequence evidence-based psychotherapies are utilized by a small number of specialized clinicians and offered to small number of select patients.
ENGAGE approaches these problems with a four prong strategy: 1) It developed a brief treatment program consisting of psychotherapeutic components of known efficacy. 2) Among them, ENGAGE selected components most pertinent to older adults. 3) ENGAGE distilled and simplified these components so that they can be accessible to most depressed older patients and taught to large numbers of clinicians. 4) To further simplify and personalize its administration, ENGAGE relies on a stepped approach focusing on engagement in rewarding social and physical activities (a form of behavioral activation), and when needed, adding techniques for management of emotionality (emotional control), negativity bias, and apathy. The self-correcting and least restrictive nature of stepped care approaches has appeal from patient cost/time efficiency and personalized treatment perspective. This project aims to further develop ENGAGE, to study the feasibility of training professionals (master's level social workers) offering care to depressed elderly patients in the community, to obtain preliminary data of its efficacy compared to community-based therapy (CT), and to prepare for an effectiveness (R01) study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Psychotherapy for Late Life Depression|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||April 2015|
ENGAGE is a stepped care psychotherapy based on what is known about how older adults respond to depression interventions. Stepped care is a model of treatment that starts with the minimum effective therapeutic techniques first, and then based on how well people respond to treatment, additional therapeutic techniques are added until people are recovered from their depression. The steps of ENGAGE are:
Active Comparator: Standard of Care Psychotherapy
The comparison group for this study will be the current standard of care psychotherapy offered by Westchester Jewish Community Services (WJCS) therapists. This type of psychotherapy is often supportive or eclectic in nature. Therapists will focus on helping the subject to express feelings and focus on strengths and abilities in working through current difficulties and transitions. Therapists assigned to provide standard psychotherapy to eligible participants will receive training and supervision from WJCS staff consistent with agency practice.
Behavioral: Standard of Care Psychotherapy
- Change in Depression [ Time Frame: 3 months ]To compare the effectiveness of the ENGAGE intervention in reducing depressive symptoms with that of the standard of care psychotherapy. We will assess severity of depression at Baseline. 6 weeks and 3 months using the Hamilton Depression Rating Scale as the primary measure.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01698255
|United States, New York|
|Westchester Jewish Community Services|
|Hartsdale, New York, United States, 10530|
|Weill Cornell Medical College|
|White Plains, New York, United States, 10605|
|Principal Investigator:||George Alexopoulos, M.D.||Weill Medical College of Cornell University|