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Ecosystem Focused Therapy in Post Stroke Depression

Primary Purpose

Depression, Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Education on Stroke and Depression (ESD)
Ecosystem Focused Therapy (EFT)
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • New York Presbyterian Hospital
  • Burke Rehabilitation Hospital
  • Institute of Geriatric Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ecosystem Focused Therapy (EFT)

Education on Stroke and Depression (ESD)

Arm Description

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.

Education on Stroke and Depression (ESD) is home-delivered and imparts education about depression, stroke, and the role of available treatments.

Outcomes

Primary Outcome Measures

Depression
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.

Secondary Outcome Measures

Full Information

First Posted
June 18, 2012
Last Updated
February 5, 2019
Sponsor
Weill Medical College of Cornell University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01624402
Brief Title
Ecosystem Focused Therapy in Post Stroke Depression
Official Title
Ecosystem Focused Therapy in Post Stroke Depression
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
March 2012 (Actual)
Primary Completion Date
January 31, 2019 (Actual)
Study Completion Date
January 31, 2019 (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

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
We propose to study the efficacy of "Ecosystem Focused Therapy" (EFT) in post-stroke depression (PSD), a disorder that afflicts a large number of stroke victims and increases mortality, cognitive impairment, and disability for years after stroke. EFT is a new, home-delivered intervention based on our integrative model of PSD, which originated from our clinical biology and treatment studies in late-life depression. It postulates two main paths to PSD. First, stroke and stroke-repair mechanisms contribute to metabolic changes mediating PSD. Second, a "psychosocial storm" stemming both from the patient's sudden disability and the change in the patient's needs and family life add a biological burden to this cascade of depressogenic events. EFT targets the "psychosocial storm" of PSD and focuses on the reciprocal interaction between the patient's abilities and the challenges of his/her "ecosystem" (family, specialized therapists). 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. Thus, EFT continuously "calibrates the environment" to the PSD patient's competence level and targets the PSD "psychosocial storm" through five integrated components: 1) It offers an action-oriented, "new perspective" about the patient's recovery. 2) It provides an "adherence enhancement structure". 3) It offers a "problem solving structure" to the patient focusing on problems, valued by the patient, and pertinent to daily function. 4) It helps the family "reengineer 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
151 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ecosystem Focused Therapy (EFT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Education on Stroke and Depression (ESD)
Arm Type
Active Comparator
Arm Description
Education on Stroke and Depression (ESD) is home-delivered and imparts education about depression, stroke, and the role of available treatments.
Intervention Type
Behavioral
Intervention Name(s)
Education on Stroke and Depression (ESD)
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Ecosystem Focused Therapy (EFT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Depression
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 50 years and older; Diagnosis of unipolar major depression; Montgomery Asberg Depression Rating Scale score ≥ 18; Capacity to provide written consent for both research assessment and treatment; Command of English sufficient to participate in assessments and talking therapy. Exclusion Criteria: Moderately severe to severe dementia (MMSE score < 20); Greater than mild to moderate aphasia (NIH Stroke Scale: Best Language > 1); Expectation to be discharged to a nursing home; Psychotic depression; Suicidal intent or plan.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George S. Alexopoulos, M.D.
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Burke Rehabilitation Hospital
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States
Facility Name
Institute of Geriatric Psychiatry
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Ecosystem Focused Therapy in Post Stroke Depression

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