StrokeNCT05380037
Post-stroke Psychosocial Recovery
An observational study of Stroke, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Stroke is a neurological injury that adversely impacts psychosocial functioning and quality of life. This may occur due to direct insult to the brain circuits integral to adaptive psychosocial functioning, and/or indirectly via significant disruption to routine motor, sensory and cognitive performance. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2023to 1 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A single, cross-sectional qualitative assessment of 1) Veteran chronic stroke survivors (n=50), 2) their loved ones/caregivers (n=25), and 3) VA stroke rehabilitation providers (e.g., physical, speech, and occupational therapists, neurologists, neuropsychologists; n=25).
Who may be able to join
- Participants must be 18 years or greater and will be recruited from all racial, ethnic and gender categories.
- Veterans with chronic stroke (n=50) must:
- 1) have ischemic or hemorrhagic stroke, primary intracerebral hematoma, or subarachnoid hemorrhage with at least 6 month chronicity
- 2) demonstrate ability to perform the interview and complete questionnaires
- 3) endorse mild to severe psychosocial impairment on the Brief Inventory of Psychosocial Functioning (B-IPF; Rodriguez et al., 2018), a 7-item measure developed specifically on Veterans with impairment in important domains of daily psychosocial function
- Caregiver/Loved ones (n=25) must be familiar with the trajectory of function and recovery of the identified Veteran with chronic stroke.
- Rehabilitation providers (n=25) of Veterans with chronic stroke must provide stroke-related care in the VA Healthcare system including (but not limited to) physical, speech, and occupational therapists, neurologists, and neuropsychologists.
Who cannot join
- Veterans with chronic stroke will be excluded for moderate to severe global aphasia that precludes qualitative interview completion, if those individuals cannot or do not wish to complete study procedures via written responses. (Note that to avoid limiting generalizability, these individuals will be invited to complete the questionnaire-based assessments in Aim 2).
- Participants will also be excluded for comorbid conditions that impact recall of stroke recovery history (e.g., dementia or psychosis).
- Caregiver/Loved ones will be excluded if the veteran stroke survivor has not provided consent for caregiver/loved one participation.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, 29401-5703
Lisa M McTeague, PhD, 843-577-5011, Lisa.Mcteague@va.gov
Lisa M. McTeague, PhD
About this study
Official title: Developing a Novel Cognitive-Behavioral Intervention for Psychosocial Rehabilitation in Chronic Stroke
Stroke is a neurological injury that adversely impacts psychosocial functioning and quality of life. This may occur due to direct insult to the brain circuits integral to adaptive psychosocial functioning, and/or indirectly via significant disruption to routine motor, sensory and cognitive performance. Yet, few evidence-based interventions exist for addressing the broad disruption to emotional and interpersonal functioning specific to stroke, highlighting a clear unmet need. The investigators propose that 1) identifying the most significant disruptions and 2) developing a cognitive-behavioral intervention to promote psychosocial functioning post-stroke is particularly important for overall quality of life, but additionally for adherence to physical rehabilitation and related interventions intended to promote holistic recovery.
Read the detailed description
Stroke is a neurological injury that adversely impacts psychosocial functioning and quality of life. This may occur due to direct insult to the neurocircuit substrates of adaptive psychosocial functioning, and/or indirectly via significant disruption to routine motor, sensory and cognitive performance. For example, the sequelae of stroke often prompt role changes, and associated occupational and financial strain that could have profound impact on the daily functioning of stroke survivors and their loved ones. This is likely not only in the acute aftermath of stroke, but also in the chronic stage when the potential durability of impairments becomes clear. While rehabilitation interventions for post-stroke motor and sensory impairments are well established, relatively few options exist for cognitive impairment. With the exception of post-stroke depression, few evidence-based interventions exist for addressing the broad disruption to emotional and interpersonal functioning specific to stroke, highlighting a clear unmet need. The investigators propose that adaptive psychosocial functioning post-stroke is likely particularly important for overall quality of life, but additionally for adherence to physical rehabilitation and related interventions intended to promote holistic recovery.
The long-term purpose of this line of research is to establish an efficacious, evidence-based, cognitive-behavioral intervention for psychosocial rehabilitation in chronic stroke toward optimally enhancing Veteran quality of life and functional independence. The short-term purpose of this line of research is to rigorously establish the domains of psychosocial functioning most adversely impacted by chronic stroke and to develop a cognitive-behavioral intervention (CBT) tailored to addressing corresponding psychosocial impairments, which could ultimately be delivered alone or adjunctively to physical rehabilitation. Importantly, the investigators additionally propose that such an intervention would be most broadly applicable and effective for Veterans with chronic stroke if CBT modules did not focus on comorbid diagnoses of mental illness, but rather focused on domains of post-stroke psychosocial impairment. The VA Healthcare System is a world leader in the dissemination of evidence-based CBT and is already staffed with mental healthcare providers who are experts, particularly in psychosocial adjustment to stressors and trauma. Thus, a scalable, remote, post-stroke tailored CBT intervention could be readily implemented within the VA Healthcare System.
To forward this novel line of work, the investigators propose as Aim 1, to complete via VA Video Connect (VVC) a single, cross-sectional qualitative assessment of 1) Veteran chronic stroke survivors (n=50), 2) their loved ones/caregivers (n=25), and 3) VA stroke rehabilitation providers (e.g., physical, speech, and occupational therapists, neurologists, neuropsychologists; n=25). For characterization relative to normed quantitative measures, Veterans (n=50) and loved ones n=25) who complete qualitative interviews from Aim1 will also complete quantitative measures of psychosocial functioning (Aim 2).
The investigators hypothesize that identified domains will include a range of psychosocial domains typically not addressed in stroke physical rehabilitation and related to post-stroke adjustment including: emotional functioning (stress, anxiety about observable impairments, coping), sleep, behavioral activation, parenting, intimate relationships, substance use. The investigators also expect concordance across informants regarding domains of greatest impairment, thus facilitating identification of productive candidates for intervention. The investigators further hypothesize that brief CBT modules that attend to the intersection of stroke recovery and psychosocial functioning will be deemed important and rated as acceptable and credible. Taken together, these findings will foundationally inform on psychosocial functioning in chronic stroke and point to a means of intervening with evidence-based cognitive-behavioral techniques, tailored to chronic stroke and readily scalable in the VA Healthcare System.
- Conditions
- Stroke
- Keywords
- quality of life, rehabilitation, depression, anxiety
- Medical subject headings
- Stroke, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Veterans with chronic stroke | Veterans with chronic stroke (n=50) must 1) have ischemic or hemorrhagic stroke, primary intracerebral hematoma, or subarachnoid hemorrhage with at least 6 month chronicity; 2) demonstrate ability to perform the interview and complete questionnaires and 3) endorse mild to severe psychosocial impairment | |
| Caregiver/Loved ones | Caregiver/Loved ones (n=25) must be familiar with the trajectory of function and recovery of the identified Veteran with chronic stroke | |
| Rehabilitation providers | Rehabilitation providers (n=25) of Veterans with chronic stroke must provide stroke-related care in the VA Healthcare system including (but not limited to) physical, speech, and occupational therapists, neurologists, and neuropsychologists |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative report of psychosocial function
Qualitative responses to an interview on the impact of stroke on psychosocial function in multiple domains and unmet needs for rehabilitation
Measured: Once at cross-sectional assessment on one day for approximately 2-3 hours
Inventory of Psychosocial Functioning
All Veteran chronic stroke survivors will complete the self-report Inventory of Psychosocial Functioning (IPF; Rodriguez et al., 2018). The Inventory of Psychosocial Functioning is an 80-item self-report measure used to assess functional impairment across multiple psychosocial domains within the last 30 days. Items are rated in regards to frequency (never to always). Total score range=0-480, with higher scores indicating greater impairment.
Measured: Once at cross-sectional assessment on one day for approximately 2-3 hours
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form is a self-reported questionnaire, with 16 items, designed to assess overall enjoyment and satisfaction with physical health, mood, work, household and leisure activities, social and family relationships, daily functioning, sexual life, economic status, overall well-being and medications. Responses are scored on a 5-point scale ('not at all or never' to 'frequently or all the time'), where higher scores indicate better enjoyment and satisfaction with life (possible range 14-70). Fourteen summated items create the total Q-LES-Q - SF score. Two last items on medications and overall life satisfaction, are independent scores. Total score range=16-80, with higher scores indicating greater satisfaction.
Measured: Once at cross-sectional assessment on one day for approximately 2-3 hours
Brief-COPE
The Brief COPE is a 28-item self-report measure of coping strategies used for responding to stressors. Items are rated on a scale from 1, I haven't been doing this at all, to 4, I've been doing this a lot. There are 14 two-item subscales within the Brief COPE, and each is analyzed separately with a score from 2 to 8 for each subscale: (1) self-distraction, (2) active coping, (3) denial, (4) substance use, (5) use of emotional support, (6) use of instrumental support, (7) behavioral disengagement, (8) venting, (9) positive reframing, (10) planning, (11) humor, (12) acceptance, (13) religion, and (14) self-blame. Higher scores indicate higher usage of that coping strategy.
Measured: Once at cross-sectional assessment on one day for approximately 2-3 hours
Stroke Impact Scale
The stroke impact scale is a self-report measure of a quality of life across multiple domains of functioning since stroke.
Measured: Once at cross-sectional assessment on one day for approximately 2-3 hours
Secondary outcomes (5)
Montreal Cognitive Assessment
The Montreal Cognitive Assessment is a rapid neuropsychological screening instrument for cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Total score ranges from 0-30 with a higher score reflecting better performance.
Measured: Once at cross-sectional assessment on one day for approximately 2-3 hours
Mini-International Neuropsychiatric Interview
The Mini-International Neuropsychiatric Interview is a short structured diagnostic interview for DSM-IV and ICD-10 psychiatric disorders. Diagnostic threshold is indicated by presence (0) or absence (1). In addition to characterizing the diagnostic profile, the number of disorders can be summed for a total score of psychiatric morbidity. Total score range 0-17 with a higher count reflecting more diagnoses.
Measured: Once at cross-sectional assessment on one day for approximately 2-3 hours
PTSD Checklist-5
PTSD Checklist-5 is a self-report measure of symptoms of posttraumatic stress. Total score range is 0-18 with a higher score reflecting more posttraumatic stress.
Measured: Once at cross-sectional assessment on one day for approximately 2-3 hours
Life Events Checklist
The Life Events Checklist is a self-report checklist of lifetime exposure to potentially traumatic events and stressors. Total score range is 0-16 with a higher score reflecting more potentially traumatic events and stressors.
Measured: Once at cross-sectional assessment on one day for approximately 2-3 hours
Patient Health Questionnaire-9
The Patient Health Questionnaire-9 is a self-report measure of symptoms of depression. Total score range is 0-27 with a higher score reflecting more depression.
Measured: Once at cross-sectional assessment on one day for approximately 2-3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start9 Jan 2023
- Primary completion13 Jan 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Lisa M. McTeague, PhD, Principal investigator, Ralph H. Johnson VA Medical Center, Charleston, SC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05380037
- Sponsor's protocol ID
- D3881-P
- Other IDs
- I21RX003881-01A1
- Status last verified
- Feb 2024
- First submitted
- 12 May 2022
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Novel Cognitive-Behavioral Intervention for Psychosocial Rehabilitation in Chronic Stroke
- ClinicalTrials.gov ID
- NCT05380037
- Acronym / sponsor ID
- D3881-P
- Conditions
- Stroke
- Keywords
- quality of life, rehabilitation, depression, anxiety
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 13 Jan 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 18 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stroke is a neurological injury that adversely impacts psychosocial functioning and quality of life. This may occur due to direct insult to the brain circuits integral to adaptive psychosocial functioning, and/or indirectly via significant disruption to routine motor, sensory and cognitive performance. Yet, few evidence-based interventions exist for addressing the broad disruption to emotional and interpersonal functioning specific to stroke, highlighting a clear unmet need. The investigators propose that 1) identifying the most significant disruptions and 2) developing a cognitive-behavioral intervention to promote psychosocial functioning post-stroke is particularly important for overall quality of life, but additionally for adherence to physical rehabilitation and related interventions intended to promote holistic recovery.
Detailed description
Stroke is a neurological injury that adversely impacts psychosocial functioning and quality of life. This may occur due to direct insult to the neurocircuit substrates of adaptive psychosocial functioning, and/or indirectly via significant disruption to routine motor, sensory and cognitive performance. For example, the sequelae of stroke often prompt role changes, and associated occupational and financial strain that could have profound impact on the daily functioning of stroke survivors and their loved ones. This is likely not only in the acute aftermath of stroke, but also in the chronic stage when the potential durability of impairments becomes clear. While rehabilitation interventions for post-stroke motor and sensory impairments are well established, relatively few options exist for cognitive impairment. With the exception of post-stroke depression, few evidence-based interventions exist for addressing the broad disruption to emotional and interpersonal functioning specific to stroke, highlighting a clear unmet need. The investigators propose that adaptive psychosocial functioning post-stroke is likely particularly important for overall quality of life, but additionally for adherence to physical rehabilitation and related interventions intended to promote holistic recovery.
The long-term purpose of this line of research is to establish an efficacious, evidence-based, cognitive-behavioral intervention for psychosocial rehabilitation in chronic stroke toward optimally enhancing Veteran quality of life and functional independence. The short-term purpose of this line of research is to rigorously establish the domains of psychosocial functioning most adversely impacted by chronic stroke and to develop a cognitive-behavioral intervention (CBT) tailored to addressing corresponding psychosocial impairments, which could ultimately be delivered alone or adjunctively to physical rehabilitation. Importantly, the investigators additionally propose that such an intervention would be most broadly applicable and effective for Veterans with chronic stroke if CBT modules did not focus on comorbid diagnoses of mental illness, but rather focused on domains of post-stroke psychosocial impairment. The VA Healthcare System is a world leader in the dissemination of evidence-based CBT and is already staffed with mental healthcare providers who are experts, particularly in psychosocial adjustment to stressors and trauma. Thus, a scalable, remote, post-stroke tailored CBT intervention could be readily implemented within the VA Healthcare System.
To forward this novel line of work, the investigators propose as Aim 1, to complete via VA Video Connect (VVC) a single, cross-sectional qualitative assessment of 1) Veteran chronic stroke survivors (n=50), 2) their loved ones/caregivers (n=25), and 3) VA stroke rehabilitation providers (e.g., physical, speech, and occupational therapists, neurologists, neuropsychologists; n=25). For characterization relative to normed quantitative measures, Veterans (n=50) and loved ones n=25) who complete qualitative interviews from Aim1 will also complete quantitative measures of psychosocial functioning (Aim 2).
The investigators hypothesize that identified domains will include a range of psychosocial domains typically not addressed in stroke physical rehabilitation and related to post-stroke adjustment including: emotional functioning (stress, anxiety about observable impairments, coping), sleep, behavioral activation, parenting, intimate relationships, substance use. The investigators also expect concordance across informants regarding domains of greatest impairment, thus facilitating identification of productive candidates for intervention. The investigators further hypothesize that brief CBT modules that attend to the intersection of stroke recovery and psychosocial functioning will be deemed important and rated as acceptable and credible. Taken together, these findings will foundationally inform on psychosocial functioning in chronic stroke and point to a means of intervening with evidence-based cognitive-behavioral techniques, tailored to chronic stroke and readily scalable in the VA Healthcare System.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Veterans with chronic stroke | – | –Veterans with chronic stroke (n=50) must 1) have ischemic or hemorrhagic stroke, primary intracerebral hematoma, or subarachnoid hemorrhage with at least 6 month chronicity; 2) demonstrate ability to perform the interview and complete questionnaires and 3) endorse mild to severe psychosocial impairment |
| Caregiver/Loved ones | – | –Caregiver/Loved ones (n=25) must be familiar with the trajectory of function and recovery of the identified Veteran with chronic stroke |
| Rehabilitation providers | – | –Rehabilitation providers (n=25) of Veterans with chronic stroke must provide stroke-related care in the VA Healthcare system including (but not limited to) physical, speech, and occupational therapists, neurologists, and neuropsychologists |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A single, cross-sectional qualitative assessment of 1) Veteran chronic stroke survivors (n=50), 2) their loved ones/caregivers (n=25), and 3) VA stroke rehabilitation providers (e.g., physical, speech, and occupational therapists, neurologists, neuropsychologists; n=25).
Key inclusion criteria (7 listed)
- Participants must be 18 years or greater and will be recruited from all racial, ethnic and gender categories.
- Veterans with chronic stroke (n=50) must:
- Caregiver/Loved ones (n=25) must be familiar with the trajectory of function and recovery of the identified Veteran with chronic stroke.
- Rehabilitation providers (n=25) of Veterans with chronic stroke must provide stroke-related care in the VA Healthcare system including (but not limited to) physical, speech, and occupational therapists, neurologists, and neuropsychologists.
Key exclusion criteria (3 listed)
- Veterans with chronic stroke will be excluded for moderate to severe global aphasia that precludes qualitative interview completion, if those individuals cannot or do not wish to complete study procedures via written responses. (Note that to avoid limiting generalizability, these individuals will be invited to complete the questionnaire-based assessments in Aim 2).
- Participants will also be excluded for comorbid conditions that impact recall of stroke recovery history (e.g., dementia or psychosis).
- Caregiver/Loved ones will be excluded if the veteran stroke survivor has not provided consent for caregiver/loved one participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Qualitative report of psychosocial function
Time frame: Once at cross-sectional assessment on one day for approximately 2-3 hours
Qualitative responses to an interview on the impact of stroke on psychosocial function in multiple domains and unmet needs for rehabilitation
Inventory of Psychosocial Functioning
Time frame: Once at cross-sectional assessment on one day for approximately 2-3 hours
All Veteran chronic stroke survivors will complete the self-report Inventory of Psychosocial Functioning (IPF; Rodriguez et al., 2018). The Inventory of Psychosocial Functioning is an 80-item self-report measure used to assess functional impairment across multiple psychosocial domains within the last 30 days. Items are rated in regards to frequency (never to always). Total score range=0-480, with higher scores indicating greater impairment.
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form
Time frame: Once at cross-sectional assessment on one day for approximately 2-3 hours
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form is a self-reported questionnaire, with 16 items, designed to assess overall enjoyment and satisfaction with physical health, mood, work, household and leisure activities, social and family relationships, daily functioning, sexual life, economic status, overall well-being and medications. Responses are scored on a 5-point scale ('not at all or never' to 'frequently or all the time'), where higher scores indicate better enjoyment and satisfaction with life (possible range 14-70). Fourteen summated items create the total Q-LES-Q - SF score. Two last items on medications and overall life satisfaction, are independent scores. Total score range=16-80, with higher scores indicating greater satisfaction.
Brief-COPE
Time frame: Once at cross-sectional assessment on one day for approximately 2-3 hours
The Brief COPE is a 28-item self-report measure of coping strategies used for responding to stressors. Items are rated on a scale from 1, I haven't been doing this at all, to 4, I've been doing this a lot. There are 14 two-item subscales within the Brief COPE, and each is analyzed separately with a score from 2 to 8 for each subscale: (1) self-distraction, (2) active coping, (3) denial, (4) substance use, (5) use of emotional support, (6) use of instrumental support, (7) behavioral disengagement, (8) venting, (9) positive reframing, (10) planning, (11) humor, (12) acceptance, (13) religion, and (14) self-blame. Higher scores indicate higher usage of that coping strategy.
Stroke Impact Scale
Time frame: Once at cross-sectional assessment on one day for approximately 2-3 hours
The stroke impact scale is a self-report measure of a quality of life across multiple domains of functioning since stroke.
5 secondary outcomes
Montreal Cognitive Assessment
Time frame: Once at cross-sectional assessment on one day for approximately 2-3 hours
Mini-International Neuropsychiatric Interview
Time frame: Once at cross-sectional assessment on one day for approximately 2-3 hours
PTSD Checklist-5
Time frame: Once at cross-sectional assessment on one day for approximately 2-3 hours
Life Events Checklist
Time frame: Once at cross-sectional assessment on one day for approximately 2-3 hours
Patient Health Questionnaire-9
Time frame: Once at cross-sectional assessment on one day for approximately 2-3 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa M. McTeague, PhD principal investigator
Ralph H. Johnson VA Medical Center, Charleston, SC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lisa M McTeague, PhD ((843) 577-5011, Lisa.Mcteague@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative report of psychosocial function (time frame: Once at cross-sectional assessment on one day for approximately 2-3 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024; AzTrials last refreshed its copy on 30 Oct 2026.