Improving Quality of Life for Veterans With Stroke and Psychological Distress

VA Office of Research and Development

Status: Completed

Conditions: Stroke; Depression; Anxiety

Treatments: Other: Education + usual care; Behavioral: I'm Whole

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT03645759

I21RX002898-01A1 (U.S. NIH Grant/Contract)

D2898-P

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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38 participants in 2 patient groups

I'm Whole

Experimental group

Description:

This arm will receive 6 behavioral health treatment sessions that focus on stroke self-management, psychological distress and social re-integration. Treatments will occur weekly. They will also receive 3 assessments at 0, 6, and 12 weeks.

Treatment:

Behavioral: I'm Whole

Education + usual care

Active Comparator group

Description:

This arm will only receive the standard usual care for stroke self-management provided by the Michael E. Debakey VA Medical facility and will receive 6 brief health education calls unrelated to stroke or psychological distress.

Treatment:

Other: Education + usual care