Ecosystem Focused Therapy for Treating Older Depressed Stroke Survivors
|Ischemic Stroke Depression||Behavioral: Ecosystem Focused Therapy (EFT) Behavioral: Education in stroke and depression|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||Ecosystem Focused Therapy for Depressed Stroke Survivors|
- Depression [ Time Frame: Measured at baseline and after 2, 3, 6, 10, 14, 20, 26, and 52 weeks ]
- Disability [ Time Frame: Measured at baseline and after 2, 3, 6, 10, 14, 20, 26, and 52 weeks ]
|Actual Study Start Date:||May 1, 2009|
|Study Completion Date:||April 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
Experimental: Ecosystem Focused Therapy (EFT)
Participants will receive EFT.
Behavioral: Ecosystem Focused Therapy (EFT)
12 therapist-led sessions over 25 weeks, in which a participant will learn problem-solving skills, the participant's physical environment will be modified, and the family or caregiver will facilitate the participant's adaptation. Active participation in treatment and rehabilitation for stroke will also be targeted by EFT's problem-solving approach, creating synergy among treatments.
Active Comparator: Education in stroke and depression
Participants will receive education in stroke and depression.
Behavioral: Education in stroke and depression
Information and resources on living with stroke and depression will be provided in 12 sessions over 25 weeks.
A stroke occurs when blood cannot reach part of the brain, either because of a blocked blood vessel (ischemic stroke) or because of a burst blood vessel (hemorrhagic stroke). When a part of the brain is deprived of blood, brain cells in that part often die or are at risk of dying. In addition to physical difficulties, older adults who survive strokes can also suffer from depression and cognitive dysfunction. Effective psychotherapy treatments that provide rehabilitation for problems in emotions and thinking are still needed. Ecosystem focused therapy (EFT) is a specialized psychotherapy that helps patients learn problem-solving skills and make adjustments in their environment. This study will determine the effectiveness of EFT in reducing depression and improving functioning and quality of life in older adults who experienced an ischemic stroke and are now depressed.
Participation in this study will last 1 year. Participants will be randomly assigned to receive one of two treatments: EFT or education in stroke and depression (ESD). Both treatments will be led by therapists and will involve 12 sessions over 25 weeks, with sessions occurring weekly for the first month, every other week for the second 2 months, and monthly for the last 3 months. EFT will involve the following: teaching the participant skills for solving problems related to adjusting to a stroke, altering the participant's physical environment to accommodate new needs, and helping the family or caregiver to assist in the participant's adaptation. ESD will involve providing the participant with education on living with a stroke and depression. Study assessments will include interviews and will occur at nine time points: at baseline and after 2, 3, 6, 10, 14, 20, 26, and 52 weeks. These assessments will measure participants' mood, thinking, and functioning. A family member or caregiver of the older adult participant must also be able to participate in the study, in order both to complete assessments and effectively implement EFT.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00944762
|United States, New York|
|The Burke Rehabilitation Hospital|
|White Plains, New York, United States, 10605|
|Principal Investigator:||Victoria Wilkins, PhD||Weill Medical College of Cornell University|
|Study Director:||George S. Alexopoulos, MD||Weill Medical College of Cornell University|