Ecosystem Focused Therapy for Treating Older Depressed Stroke Survivors
Primary Purpose
Ischemic Stroke, Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ecosystem Focused Therapy (EFT)
Education in stroke and depression
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Stroke focused on measuring Stroke
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of unipolar major or minor depression, as assessed by the Structured Clinical Interview for Depression (SCID) for the Diagnostic and Statistical Manual-IV
- Montgomery-Asberg Depression Rating Scale (MADRS) score greater than or equal to 15
- Admitted to Burke Rehabilitation Hospital soon after ischemic stroke
- Mini Mental State Examination (MMSE) score greater than 17
- Command of English sufficient to comprehend study questionnaires and interventions
- Has family member or professional caregiver willing and able to participate in patient's treatment
Exclusion Criteria:
- Moderately severe to severe dementia, as defined by an MMSE score less than 17
- Moderate to severe aphasia
- Placed in a nursing home after discharge
- Diagnosis of psychotic depression
- High suicide risk (i.e., intent or plan to attempt suicide in near future)
- Presence of illnesses other than stroke (e.g., untreated thyroid or adrenal disease, pancreatic cancer, and lymphoma)
- Taking drugs known to cause depression (e.g., reserpine, alpha-methyl-dopa, steroids)
- Currently being treated for depression with psychotherapy
Sites / Locations
- The Burke Rehabilitation Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ecosystem Focused Therapy (EFT)
Education in stroke and depression
Arm Description
Participants will receive EFT.
Participants will receive education in stroke and depression.
Outcomes
Primary Outcome Measures
Depression
Secondary Outcome Measures
Disability
Full Information
NCT ID
NCT00944762
First Posted
July 22, 2009
Last Updated
February 17, 2017
Sponsor
Weill Medical College of Cornell University
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00944762
Brief Title
Ecosystem Focused Therapy for Treating Older Depressed Stroke Survivors
Official Title
Ecosystem Focused Therapy for Depressed Stroke Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
May 1, 2009 (Actual)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will determine the effectiveness of a specialized psychotherapy for treating elderly stroke survivors who are depressed.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke, Depression
Keywords
Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ecosystem Focused Therapy (EFT)
Arm Type
Experimental
Arm Description
Participants will receive EFT.
Arm Title
Education in stroke and depression
Arm Type
Active Comparator
Arm Description
Participants will receive education in stroke and depression.
Intervention Type
Behavioral
Intervention Name(s)
Ecosystem Focused Therapy (EFT)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Education in stroke and depression
Intervention Description
Information and resources on living with stroke and depression will be provided in 12 sessions over 25 weeks.
Primary Outcome Measure Information:
Title
Depression
Time Frame
Measured at baseline and after 2, 3, 6, 10, 14, 20, 26, and 52 weeks
Secondary Outcome Measure Information:
Title
Disability
Time Frame
Measured at baseline and after 2, 3, 6, 10, 14, 20, 26, and 52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of unipolar major or minor depression, as assessed by the Structured Clinical Interview for Depression (SCID) for the Diagnostic and Statistical Manual-IV
Montgomery-Asberg Depression Rating Scale (MADRS) score greater than or equal to 15
Admitted to Burke Rehabilitation Hospital soon after ischemic stroke
Mini Mental State Examination (MMSE) score greater than 17
Command of English sufficient to comprehend study questionnaires and interventions
Has family member or professional caregiver willing and able to participate in patient's treatment
Exclusion Criteria:
Moderately severe to severe dementia, as defined by an MMSE score less than 17
Moderate to severe aphasia
Placed in a nursing home after discharge
Diagnosis of psychotic depression
High suicide risk (i.e., intent or plan to attempt suicide in near future)
Presence of illnesses other than stroke (e.g., untreated thyroid or adrenal disease, pancreatic cancer, and lymphoma)
Taking drugs known to cause depression (e.g., reserpine, alpha-methyl-dopa, steroids)
Currently being treated for depression with psychotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victoria Wilkins, PhD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
George S. Alexopoulos, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Study Director
Facility Information:
Facility Name
The Burke Rehabilitation Hospital
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Ecosystem Focused Therapy for Treating Older Depressed Stroke Survivors
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