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OpenTrials
Completed

NCT Number: NCT03645759

Improving Quality of Life for Veterans With Stroke and Psychological Distress

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.

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Key information

Conditions

Stroke Anxiety Anxiety Disorders Behavior Behavioral Symptoms Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Depression Mental Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

I'm Whole

Behavioral

I'm whole will provide 6 behavioral health treatment sessions that focus on stroke self-management, psychological distress and social re-integration.

Education + usual care

Other

Will 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.

Primary outcomes

  1. Stroke Specific Quality of Life Scale Change

    Time frame: 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.

Secondary outcomes

  1. Physical Activity and Disability Survey Change

    Time frame: 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.

  2. Community Integration Questionnaire Change

    Time frame: 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.

  3. Patient Health Questionnaire-8 Item Change

    Time frame: 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.

  4. General Anxiety Disorder-7 Change

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 24, 2018
Registry last updated
Jul 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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