Ecosystem Focused Therapy in Post Stroke Depression
1 other identifier
interventional
151
1 country
3
Brief Summary
Older adults who are stroke survivors can experience many challenges, including depression, cognitive dysfunction, and physical disability. Family members and other caregivers may struggle with helping stroke survivors adjust to life after stroke. This research study involves testing a modified form of problem-solving therapy called Ecosystem Focused Therapy (EFT) to help treat depression in older adult stroke survivors. EFT teaches problem-solving skills to patients to help them cope with problems related to stroke and depression, alters their physical environment to accommodate new needs resulting from stroke, and helps the family or caregiver to assist in the patient's adaptation. In addition this study will compare EFT to an education intervention to see which is more effective in treating depressed stroke survivors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable depression
Started Mar 2012
Longer than P75 for not_applicable depression
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 18, 2012
CompletedFirst Posted
Study publicly available on registry
June 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2019
CompletedFebruary 6, 2019
February 1, 2019
6.9 years
June 18, 2012
February 5, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Depression
This research study involves testing a modified form of problem-solving therapy called Ecosystem Focused Therapy (EFT) in reducing depression in older adult stroke survivors.
12 months
Study Arms (2)
Ecosystem Focused Therapy (EFT)
EXPERIMENTALEcosystem Focused Therapy (EFT) follows a structured personalization approach based on the model of adaptive functioning, in which behavior is a function of the person's competence and the demands of the environment.
Education on Stroke and Depression (ESD)
ACTIVE COMPARATOREducation on Stroke and Depression (ESD) is home-delivered and imparts education about depression, stroke, and the role of available treatments.
Interventions
* Each session begins by assessing the subject's and his/her family's level of information in a given area and by identifying misconceptions, thus guiding the selection of educational material. * Comprehending illness-related information is a process contaminated by pessimism, denial, misconceptions, and stigma. The role of the ESD therapist is to impart valuable information, despite these complexities. * Conveying information is a process. The ESD therapist needs to be aware of where the subject and family are in each session and offer information for which they have readiness to accept. * ESD therapists do not engage in additional interventions (e.g., cognitive behavioral therapy, interpersonal therapy, problem solving therapy).
1. EFT offers an action-oriented, new perspective about the subject's recovery; 2. It provides an adherence enhancement structure; 3. It offers a problem solving structure to the subject focusing on problems, valued by the subject, and pertinent to daily function; 4. It helps the family re-engineer its goals, involvement, and plans to accommodate the patient's disability; 5. It coordinates care with specialized therapists with the goal to increase patient participation in rehabilitation and social activities.
Eligibility Criteria
You may qualify if:
- Age 50 years and older;
- Diagnosis of unipolar major depression;
- Montgomery Asberg Depression Rating Scale score ≥ 18;
- Capacity to provide written consent for both research assessment and treatment;
- Command of English sufficient to participate in assessments and talking therapy.
You may not qualify if:
- Moderately severe to severe dementia (MMSE score \< 20);
- Greater than mild to moderate aphasia (NIH Stroke Scale: Best Language \> 1);
- Expectation to be discharged to a nursing home;
- Psychotic depression;
- Suicidal intent or plan.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
New York Presbyterian Hospital
New York, New York, 10065, United States
Burke Rehabilitation Hospital
White Plains, New York, 10605, United States
Institute of Geriatric Psychiatry
White Plains, New York, 10605, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
George S. Alexopoulos, M.D.
Weill Medical College of Cornell University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2012
First Posted
June 20, 2012
Study Start
March 1, 2012
Primary Completion
January 31, 2019
Study Completion
January 31, 2019
Last Updated
February 6, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share