Expired Study
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Houston, Texas 77030


Purpose:

The study will create a treatment to improves mobility, physical activity, engagement in activities with family and friends and overall satisfaction with life for Veterans who have depression and anxiety after having a stroke. The treatment will then be tested to ensure it makes the desired improvements in the Veterans.


Study summary:

The study has three aims. The first aim is to develop a client-centered, behavioral stroke self-management program (I'm Whole) for Veterans with stroke and psychological distress (e.g., symptoms of anxiety and/or depression). This will be done using expert input from a multidisciplinary team of a clinical psychologist, nurse practitioner, exercise physiologist and social role functioning expert will be used to create the I'm Whole patient workbook and clinician manual. The second aim is to pilot the I'm Whole treatment by delivering the intervention to 5 Veterans suffering from stroke and comorbid depression and/or anxiety symptoms. The feasibility (barriers and facilitators to completing I'm Whole and acceptability of the intervention) will be assessed through qualitative interviews posttreatment. Veterans' feedback about ways to improve I'm Whole will be analyzed and used to improve treatment. The third aim is to test the feasibility and preliminary efficacy of I'm Whole on quality of life (primary outcome) physical functioning, physical activity, social role functioning, psychological distress, and satisfaction with I'm Whole (secondary outcomes). To test the feasibility and efficacy, a small randomized controlled trial (RCT) with 30 Veterans (15 I'm Whole and 15 education+usual care) with stroke and psychological distress will be conducted.


Criteria:

Inclusion Criteria: - a documented history of stroke and/or transient ischemic attack within the last 30 days - a modified Rankin score of > 3) - regular access to a computer or tablet with internet and a camera - ability to give appropriate informed consent - score > 5 on a measure of depression (Patient Health Questionnaire [PHQ-8]) and/or >17 on a measure of anxiety (Generalized Anxiety Disorder-7 [GAD-7]) assessments - ability to ambulate with or without assistance of a cane or walker Exclusion Criteria: - cognitive impairment, as evidenced by a score of >3 on a brief cognitive screener - documented diagnosis of psychotic disorder or schizophrenia - documented severe depression, anxiety (based on PHQ-8 or GAD-7 score of > 20), or hospitalization for psychiatric illness within the past 30 days


NCT ID:

NCT03645759


Primary Contact:

Principal Investigator
Gina L. Evans, PhD
Michael E. DeBakey VA Medical Center, Houston, TX

Gina L Evans, PhD
Phone: (713) 794-8662
Email: Gina.Evans@va.gov


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States

Gina L Evans, PhD
Phone: 713-794-8662
Email: Gina.Evans@va.gov

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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