Clinical trial NCT03645759: Improving Quality of Life for Veterans With Stroke and Psychological Distress
Official title: Improving Quality of Life for Veterans With Stroke and Psychological Distress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Depression
Anxiety
Keywords: behavioral treatment
telehealth
stroke self-management
psychological distress
social integration
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2018-08-24
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Behavioral treatment intervention that focuses on enhancing stroke self-management, psychological distress and social functioning that will be provided to two groups (treatment and education plus usual care).
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Stroke Specific Quality of Life Scale Change
timeFrame: Absolute values at 12 weeks post-treatment are being reported
Secondary outcomes:
measure: Physical Activity and Disability Survey Change
timeFrame: The absolute values at 12 weeks post-treatment are being reported
measure: Community Integration Questionnaire Change
timeFrame: The absolute values at 12 weeks post-treatment are being reported
measure: Patient Health Questionnaire-8 Item Change
timeFrame: The absolute values at 12 weeks post-treatment are being reported
measure: General Anxiety Disorder-7 Change
timeFrame: The absolute values at 12 weeks post-treatment are being reported
Other outcomes:
Locations:
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center, Houston, TX
state: Texas
Study officials:
affiliation: Michael E. DeBakey VA Medical Center, Houston, TX
name: Gina L. Evans, PhD
role: PRINCIPAL_INVESTIGATOR
References: