NCT00944762

Brief Summary

This study will determine the effectiveness of a specialized psychotherapy for treating elderly stroke survivors who are depressed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 23, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

2.8 years

First QC Date

July 22, 2009

Last Update Submit

February 17, 2017

Conditions

Ischemic StrokeDepression

Keywords

Stroke

Outcome Measures

Primary Outcomes (1)

  • Depression

    Measured at baseline and after 2, 3, 6, 10, 14, 20, 26, and 52 weeks

Secondary Outcomes (1)

  • Disability

    Measured at baseline and after 2, 3, 6, 10, 14, 20, 26, and 52 weeks

Study Arms (2)

Ecosystem Focused Therapy (EFT)

EXPERIMENTAL

Participants will receive EFT.

Behavioral: Ecosystem Focused Therapy (EFT)

Education in stroke and depression

ACTIVE COMPARATOR

Participants will receive education in stroke and depression.

Behavioral: Education in stroke and depression

Interventions

Ecosystem Focused Therapy (EFT)BEHAVIORAL

12 therapist-led sessions over 25 weeks, in which a participant will learn problem-solving skills, the participant's physical environment will be modified, and the family or caregiver will facilitate the participant's adaptation. Active participation in treatment and rehabilitation for stroke will also be targeted by EFT's problem-solving approach, creating synergy among treatments.

Ecosystem Focused Therapy (EFT)
Education in stroke and depressionBEHAVIORAL

Information and resources on living with stroke and depression will be provided in 12 sessions over 25 weeks.

Education in stroke and depression

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of unipolar major or minor depression, as assessed by the Structured Clinical Interview for Depression (SCID) for the Diagnostic and Statistical Manual-IV
  • Montgomery-Asberg Depression Rating Scale (MADRS) score greater than or equal to 15
  • Admitted to Burke Rehabilitation Hospital soon after ischemic stroke
  • Mini Mental State Examination (MMSE) score greater than 17
  • Command of English sufficient to comprehend study questionnaires and interventions
  • Has family member or professional caregiver willing and able to participate in patient's treatment

You may not qualify if:

  • Moderately severe to severe dementia, as defined by an MMSE score less than 17
  • Moderate to severe aphasia
  • Placed in a nursing home after discharge
  • Diagnosis of psychotic depression
  • High suicide risk (i.e., intent or plan to attempt suicide in near future)
  • Presence of illnesses other than stroke (e.g., untreated thyroid or adrenal disease, pancreatic cancer, and lymphoma)
  • Taking drugs known to cause depression (e.g., reserpine, alpha-methyl-dopa, steroids)
  • Currently being treated for depression with psychotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Burke Rehabilitation Hospital

White Plains, New York, 10605, United States

Location

MeSH Terms

Conditions

Ischemic StrokeDepressionStroke

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Victoria Wilkins, PhD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

  • George S. Alexopoulos, MD

    Weill Medical College of Cornell University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2009

First Posted

July 23, 2009

Study Start

May 1, 2009

Primary Completion

February 1, 2012

Study Completion

April 1, 2012

Last Updated

February 23, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)