N/A N=38 Randomized Double-blind Treatment

Improving Quality of Life for Veterans With Stroke and Psychological Distress

Stroke · Depression · Anxiety

Bottom Line

View on ClinicalTrials.gov: NCT03645759 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2024

Primary outcome: Primary: Stroke Specific Quality of Life Scale Change — 41.24; 41.67 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: I'm Whole (Behavioral); Education + usual care (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: VA Office of Research and Development
Primary completion: Aug 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Stroke Specific Quality of Life Scale Change	41.24; 41.67	—
SECONDARY Physical Activity and Disability Survey Change	602; 60	—
SECONDARY Community Integration Questionnaire Change	16.8; 13.8	—
SECONDARY Patient Health Questionnaire-8 Item Change	4.00; 8.21	—
SECONDARY General Anxiety Disorder-7 Change	2.80; 3.91	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03645759). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.