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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
- Study Primary Completion Date: March 2017
Interventions Used in this Clinical Trial
- Behavioral: Education on Stroke and Depression (ESD)
- 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).
- Behavioral: Ecosystem Focused Therapy (EFT)
- EFT offers an action-oriented, new perspective about the subject's recovery; It provides an adherence enhancement structure; It offers a problem solving structure to the subject focusing on problems, valued by the subject, and pertinent to daily function; It helps the family re-engineer its goals, involvement, and plans to accommodate the patient's disability; It coordinates care with specialized therapists with the goal to increase patient participation in rehabilitation and social activities.
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: Ecosystem Focused Therapy (EFT)
- Ecosystem 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.
- Active Comparator: Education on Stroke and Depression (ESD)
- Education on Stroke and Depression (ESD) is home-delivered and imparts education about depression, stroke, and the role of available treatments.
Outcome Measures for this Clinical Trial
- Time Frame: 12 months
Safety Issue?: No
- Time Frame: 12 months
Criteria for Participation in this Clinical Trial
1. Age 50 years and older;
2. Diagnosis of unipolar major depression;
3. MADRS score ≥ 18;
4. Capacity to provide written consent for both research assessment and treatment;
5. Command of English sufficient to participate in assessments and talking therapy.
1. Moderately severe to severe dementia (MMSE score < 20);
2. Greater than mild to moderate aphasia (NIH Stroke Scale: Best Language > 1);
3. Expectation to be discharged to a nursing home;
4. Psychotic depression;
5. Suicidal intent or plan.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 50 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial: No
Clinical Trial Investigator Information
- Lead Sponsor
- Weill Medical College of Cornell University
- National Institute of Mental Health (NIMH)
- Provider of Information About this Clinical Study
- Overall Official(s)
- George S. Alexopoulos, M.D., Principal Investigator, Weill Medical College of Cornell University
- Overall Contact(s)
- Tim Clark, MTS, firstname.lastname@example.org