Improving Quality of Life for Veterans With Stroke and Psychological Distress
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Anxiety, Anxiety, Depression, Neurology |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/9/2019 |
| Start Date: | April 8, 2019 |
| End Date: | December 21, 2020 |
| Contact: | Gina L Evans, PhD |
| Email: | Gina.Evans@va.gov |
| Phone: | (713) 794-8662 |
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.
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.
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.
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.
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
We found this trial at
1
site
Houston, Texas 77030
Principal Investigator: Gina L. Evans, PhD
Phone: 713-794-8662
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