Ecosystem Focused Therapy for Treating Older Depressed Stroke Survivors

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Weill Medical College of Cornell University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00944762
First received: July 22, 2009
Last updated: September 12, 2013
Last verified: September 2013
  Purpose

This study will determine the effectiveness of a specialized psychotherapy for treating elderly stroke survivors who are depressed.


Condition Intervention
Ischemic Stroke
Depression
Behavioral: Ecosystem Focused Therapy (EFT)
Behavioral: Education in stroke and depression

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ecosystem Focused Therapy for Depressed Stroke Survivors

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Depression [ Time Frame: Measured at baseline and after 2, 3, 6, 10, 14, 20, 26, and 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disability [ Time Frame: Measured at baseline and after 2, 3, 6, 10, 14, 20, 26, and 52 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: May 2009
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00944762

Contacts
Contact: Kaitlin Dyroff 914-682-9100 ext 2464 kad2026@med.cornell.edu

Locations
United States, New York
The Burke Rehabilitation Hospital Recruiting
White Plains, New York, United States, 10605
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Victoria Wilkins, PhD Weill Medical College of Cornell University
Study Director: George S. Alexopoulos, MD Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00944762     History of Changes
Other Study ID Numbers: P30 MH085943, P30MH085943, ACISR, 1 P30 MH085943-01, DATR A4-GPC
Study First Received: July 22, 2009
Last Updated: September 12, 2013
Health Authority: United States: Federal Government

Keywords provided by Weill Medical College of Cornell University:
Stroke

Additional relevant MeSH terms:
Cerebral Infarction
Depression
Stroke
Behavioral Symptoms
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014