18 and older, any sex, with Stroke or Depression. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Stroke Specific Quality of Life Scale ChangePrimary· Absolute values at 12 weeks post-treatment are being reported
The Stroke Specific Quality of Life Scale assesses change in energy, language, vision, mobility, fine motor tasks, mood, personality and thinking, social roles, family roles and work productivity. Scores are reported for the energy, language, mobility, personality, mood, family roles, thinking, and social roles. The score range for each item 1= strongly disagree to 5=strongly agree with a higher score indicating greater disability and worst outcomes. A total score range is 14-70.
Group
Value
95% CI
I'm Whole
41.24
± 6.30
Education + Usual Care
41.67
± 5.80
Physical Activity and Disability Survey ChangeSecondary· The absolute values at 12 weeks post-treatment are being reported
The Physical Activity and Disability Survey measures change in exercise, leisure time physical activity, indoor and outdoor household activity, wheelchair ambulation, employment-related activity and rehabilitation therapy-related activity. Scores were reported for each 6 areas of exercise/activity. The subscale score is based on the self-reported amount of time an individual states they spend performing each exercise. Higher values represent a better outcome and more time spent engaging in the activity. The range of scores are 0-1440 minutes per day.
Group
Value
95% CI
I'm Whole
602
± 48
Education + Usual Care
60
± 22
Community Integration Questionnaire ChangeSecondary· The absolute values at 12 weeks post-treatment are being reported
The Community Integration Questionnaire measures change in home integration (i.e., market, meal preparation, household activities, finance), social integration (i.e., shopping, avocation, going out), and productive activity (i.e., work, school, volunteer activity). The score range is 1=you yourself alone 3=someone else. Total score range is 13-39. Lower values represent a better outcome and greater integration into the community.
Group
Value
95% CI
I'm Whole
16.8
± 4.21
Education + Usual Care
13.8
± 4.23
Patient Health Questionnaire-8 Item ChangeSecondary· The absolute values at 12 weeks post-treatment are being reported
The Patient Health Questionnaire-8 assesses change in severity of depression symptoms over the last two weeks. The score range is 0=Not at all to 3=Nearly every day. Total score range is 0-24. Lower values represent a better outcome and less symptoms of depression.
Group
Value
95% CI
I'm Whole
4.00
± 1.10
Education + Usual Care
8.21
± 0.80
General Anxiety Disorder-7 ChangeSecondary· The absolute values at 12 weeks post-treatment are being reported
The General Anxiety Disorder-7 assesses change in severity of anxiety symptoms over the last two weeks. The total score is reported. The score range is 0=Not at all to 3=Nearly every day. Total score range is 0-21. Lower values represent a better outcome and less symptoms of anxiety.
Group
Value
95% CI
I'm Whole
2.80
± 0.82
Education + Usual Care
3.91
± 1.03
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by VA Office of Research and Development
Last refreshed: 18 July 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03645759.