Ecosystem Focused Therapy in Post Stroke Depression

Not Applicable

Completed

• Conditions: Depression; Stroke
• Interventions: Behavioral: Education on Stroke and Depression (ESD); Behavioral: Ecosystem Focused Therapy (EFT)

• Registration Number: NCT01624402
• Lead Sponsor: Weill Medical College of Cornell University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-06-18
• Study First Submitted QC: 2012-06-18
• Study First Posted: 2012-06-20
• Primary Completion: 2019-01-31
• Study Completion: 2019-01-31
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-05
• Last Update Posted: 2019-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Education on Stroke and Depression (ESD)	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.
Ecosystem Focused Therapy (EFT)	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.

Primary Outcome Measures

Name	Time	Method
Depression	12 months	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.

Trial Locations

Locations (3)

Burke Rehabilitation Hospital; 🇺🇸 White Plains, New York, United States

New York Presbyterian Hospital; 🇺🇸 New York, New York, United States

Institute of Geriatric Psychiatry; 🇺🇸 White Plains, New York, United States