Ecosystem Focused Therapy in Post Stroke Depression

This study is currently recruiting participants.

Verified June 2012 by Weill Medical College of Cornell University

Sponsor:

Collaborator:

National Institute of Mental Health (NIMH)

Information provided by (Responsible Party):

Weill Medical College of Cornell University

ClinicalTrials.gov Identifier:

NCT01624402

First received: June 18, 2012

Last updated: NA

Last verified: June 2012

History: No changes posted

Purpose

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.

Condition	Intervention
Depression Stroke	Behavioral: Education on Stroke and Depression (ESD) Behavioral: Ecosystem Focused Therapy (EFT)

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Depression

U.S. FDA Resources

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

Primary Outcome Measures:

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.

Estimated Enrollment:	160
Study Start Date:	March 2012
Estimated Study Completion Date:	March 2017
Estimated Primary Completion Date:	March 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	Behavioral: Ecosystem Focused Therapy (EFT) 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.
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.	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).

Arms

Assigned Interventions

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.

Behavioral: Ecosystem Focused Therapy (EFT)

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.

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.

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).

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 50 years and older;
Diagnosis of unipolar major depression;
MADRS 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01624402

Contacts

Contact: Tim Clark, MTS

tec2004@med.cornell.edu

Locations

United States, New York
New York Presbyterian Hospital	Recruiting
New York, New York, United States, 10065
Principal Investigator: Michael O'Dell, M.D.
Institute of Geriatric Psychiatry	Recruiting
White Plains, New York, United States, 10605
Principal Investigator: George S. Alexopoulos, M.D.
Burke Rehabilitation Hospital	Recruiting
White Plains, New York, United States, 10605
Principal Investigator: Michael Redding, M.D.

Sponsors and Collaborators

Weill Medical College of Cornell University

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

George S. Alexopoulos, M.D.

Weill Medical College of Cornell University

More Information

No publications provided

Responsible Party:	Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:	NCT01624402 History of Changes
Other Study ID Numbers:	R01 MH096685
Study First Received:	June 18, 2012
Last Updated:	June 18, 2012
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Depression
Depressive Disorder
Stroke
Cerebral Infarction
Behavioral Symptoms
Mood Disorders
Mental Disorders
Cerebrovascular Disorders

Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on May 16, 2013

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