Anxiety, Depression, Stroke
Conditions
Keywords
behavioral treatment, telehealth, stroke self-management, psychological distress, social integration
Brief 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.
Detailed 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.
Interventions
BEHAVIORALI'm Whole
I'm whole will provide 6 behavioral health treatment sessions that focus on stroke self-management, psychological distress and social re-integration.
OTHEREducation + usual care
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.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
No other parties will be masked
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stroke Specific Quality of Life Scale Change | 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
| Measure | Time frame | Description |
|---|---|---|
| Physical Activity and Disability Survey Change | 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. |
| Community Integration Questionnaire Change | 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. |
| Patient Health Questionnaire-8 Item Change | 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. |
| General Anxiety Disorder-7 Change | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| I'm Whole 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.
I'm Whole: I'm whole will provide 6 behavioral health treatment sessions that focus on stroke self-management, psychological distress and social re-integration. | 19 |
| Education + Usual Care 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.
Education + usual care: 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. | 19 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 2 |
Baseline characteristics
| Characteristic | I'm Whole | Education + Usual Care | Total |
|---|---|---|---|
| 36-Item Short Form Survey | 40.23 units on a scale STANDARD_DEVIATION 9.15 | 51.39 units on a scale STANDARD_DEVIATION 10.96 | 45.81 units on a scale STANDARD_DEVIATION 10.06 |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 6 Participants | 15 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 13 Participants | 23 Participants |
| Age, Continuous | 65.44 years STANDARD_DEVIATION 3.77 | 63.44 years STANDARD_DEVIATION 4.27 | 64.44 years STANDARD_DEVIATION 2.87 |
| Community Integration Questionnaire | 18.60 units on a scale STANDARD_DEVIATION 4.6 | 29.70 units on a scale STANDARD_DEVIATION 4.41 | 24.15 units on a scale STANDARD_DEVIATION 4.51 |
| Generalized Anxiety Disorder-7 items | 4.80 units on a scale STANDARD_DEVIATION 0.7 | 4.52 units on a scale STANDARD_DEVIATION 1.01 | 4.65 units on a scale STANDARD_DEVIATION 0.85 |
| International physical activity questionnaire | 203 MET Minutes per day STANDARD_DEVIATION 284 | 143 MET Minutes per day STANDARD_DEVIATION 233.9 | 173 MET Minutes per day STANDARD_DEVIATION 258.8 |
| Patient Health Questionnaire | 11.01 units on a scale STANDARD_DEVIATION 0.91 | 10.10 units on a scale STANDARD_DEVIATION 0.7 | 10.55 units on a scale STANDARD_DEVIATION 0.81 |
| Patient-Reported Outcomes Measurement Information System | 64.04 units on a scale STANDARD_DEVIATION 5.32 | 61.01 units on a scale STANDARD_DEVIATION 9.1 | 62.53 units on a scale STANDARD_DEVIATION 7.21 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 9 Participants | 24 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 10 Participants | 14 Participants |
| Region of Enrollment United States | 19 Participants | 19 Participants | 38 Participants |
| Sedentary Behaviors Questionnaire | 5.73 hours spent in sedentary behaviors STANDARD_DEVIATION 9.49 | 4.51 hours spent in sedentary behaviors STANDARD_DEVIATION 1.4 | 5.12 hours spent in sedentary behaviors STANDARD_DEVIATION 5.45 |
| Sex: Female, Male Female | 2 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Male | 17 Participants | 19 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 19 |
| other Total, other adverse events | 0 / 19 | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 | 0 / 19 |
Outcome results
Primary
Stroke Specific Quality of Life Scale Change
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.
Time frame: Absolute values at 12 weeks post-treatment are being reported
Population: Estimates of changes in patient-reported outcomes were calculated using intent to-treat approach. The paired change in outcome scores from baseline to the end of the study and differences in paired change in scores in treatment and EUC arms were compared with zero using Wilcoxon's signed-rank test.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| I'm Whole | Stroke Specific Quality of Life Scale Change | 41.24 units on a scale | Standard Deviation 6.3 |
| Education + Usual Care | Stroke Specific Quality of Life Scale Change | 41.67 units on a scale | Standard Deviation 5.8 |
Secondary
Community Integration Questionnaire Change
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.
Time frame: The absolute values at 12 weeks post-treatment are being reported
Population: Estimates of changes in patient-reported outcomes were calculated using intent to-treat approach. The paired change in outcome scores from baseline to the end of the study and differences in paired change in scores in treatment and EUC arms were compared with zero using Wilcoxon's signed-rank test.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| I'm Whole | Community Integration Questionnaire Change | 16.8 units on a scale | Standard Deviation 4.21 |
| Education + Usual Care | Community Integration Questionnaire Change | 13.8 units on a scale | Standard Deviation 4.23 |
Secondary
General Anxiety Disorder-7 Change
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.
Time frame: The absolute values at 12 weeks post-treatment are being reported
Population: Estimates of changes in patient-reported outcomes were calculated using intent to-treat approach. The paired change in outcome scores from baseline to the end of the study and differences in paired change in scores in treatment and EUC arms were compared with zero using Wilcoxon's signed-rank test.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| I'm Whole | General Anxiety Disorder-7 Change | 2.80 units on a scale | Standard Deviation 0.82 |
| Education + Usual Care | General Anxiety Disorder-7 Change | 3.91 units on a scale | Standard Deviation 1.03 |
Secondary
Patient Health Questionnaire-8 Item Change
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.
Time frame: The absolute values at 12 weeks post-treatment are being reported
Population: Estimates of changes in patient-reported outcomes were calculated using intent to-treat approach. The paired change in outcome scores from baseline to the end of the study and differences in paired change in scores in treatment and EUC arms were compared with zero using Wilcoxon's signed-rank test.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| I'm Whole | Patient Health Questionnaire-8 Item Change | 4.00 units on a scale | Standard Deviation 1.1 |
| Education + Usual Care | Patient Health Questionnaire-8 Item Change | 8.21 units on a scale | Standard Deviation 0.8 |
Secondary
Physical Activity and Disability Survey Change
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.
Time frame: The absolute values at 12 weeks post-treatment are being reported
Population: Estimates of changes in patient-reported outcomes were calculated using intent to-treat approach. The paired change in outcome scores from baseline to the end of the study and differences in paired change in scores in treatment and EUC arms were compared with zero using Wilcoxon's signed-rank test.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| I'm Whole | Physical Activity and Disability Survey Change | 602 units on a scale | Standard Deviation 48 |
| Education + Usual Care | Physical Activity and Disability Survey Change | 60 units on a scale | Standard Deviation 22 |