Improving Quality of Life for Veterans With Stroke and Psychological Distress
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Anxiety
- Depression
- Stroke
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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).Masking: Double (Participant, Investigator)Masking Description: No other parties will be maskedPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 cl...
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.
Tracking Information
- NCT #
- NCT03645759
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Gina L. Evans, PhD Michael E. DeBakey VA Medical Center, Houston, TX
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