Clinical trial NCT01624402: Ecosystem Focused Therapy in Post Stroke Depression
Official title: Ecosystem Focused Therapy in Post Stroke Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Stroke
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2012-06-20
Enrollment: 151
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Depression
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Presbyterian Hospital
state: New York
city: White Plains
country: United States
facility: Burke Rehabilitation Hospital
state: New York
city: White Plains
country: United States
facility: Institute of Geriatric Psychiatry
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: George S. Alexopoulos, M.D.
role: PRINCIPAL_INVESTIGATOR
References: