Ecosystem Focused Therapy in Post Stroke Depression

Stroke Clinical Trial

Official title:

Ecosystem Focused Therapy in Post Stroke Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01624402
• Other study ID #: R01MH096685
• Secondary ID: R01MH096685
• Status: Completed
• Phase: N/A
• Start date: March 2012
• Est. completion date: January 31, 2019

Study information

• Verified date: February 2019
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: January 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Stroke

Intervention

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).
• 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.

Locations

Country	Name	City	State
United States	New York Presbyterian Hospital	New York	New York
United States	Burke Rehabilitation Hospital	White Plains	New York
United States	Institute of Geriatric Psychiatry	White Plains	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months