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Ecosystem Focused Therapy in Post Stroke Depression

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:
NCT01624402
First received: June 18, 2012
Last updated: September 12, 2013
Last verified: September 2013

June 18, 2012
September 12, 2013
March 2012
March 2017   (final data collection date for primary outcome measure)
Depression [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01624402 on ClinicalTrials.gov Archive Site
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Ecosystem Focused Therapy in Post Stroke Depression
Not Provided

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.

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Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Depression
  • Stroke
  • 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)
    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.
  • 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.
    Intervention: Behavioral: Ecosystem Focused Therapy (EFT)
  • 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.
    Intervention: Behavioral: Education on Stroke and Depression (ESD)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
160
March 2017
March 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age 50 years and older;
  2. Diagnosis of unipolar major depression;
  3. Montgomery Asberg Depression Rating Scale 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.

Exclusion Criteria:

  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.
Both
50 Years and older
No
Contact: Kaitlin Dyroff 914-682-9100 ext 2462 kad2026@med.cornell.edu
United States
 
NCT01624402
R01 MH096685
Yes
Weill Medical College of Cornell University
Weill Medical College of Cornell University
National Institute of Mental Health (NIMH)
Principal Investigator: George S. Alexopoulos, M.D. Weill Medical College of Cornell University
Weill Medical College of Cornell University
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP