StrokeeWELLNCT06782321
Emotional Recovery Post-Stroke
A study testing modified Cognitive Behavioral Therapy (mCBT) and Occupational or Speech Therapy in people with Stroke and Mental Health Wellness 1, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The purpose of this study is to evaluate whether adding an emotional wellness component to occupational therapy (OT) and/or speech therapy (ST) telerehabilitation improves overall emotional well-being and activity participation for people with stroke. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Stroke, Mental Health Wellness 1
- What is being tested?
- modified Cognitive Behavioral Therapy (mCBT) and Occupational or Speech Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-reported stroke-related deficits in emotional wellness such as anxiety, sleep disturbance, dread, fear, loss of hope, sadness.
- Have experienced ischemic or hemorrhagic stroke at least 30 days prior
- Stroke-related aphasia and/or upper extremity hemiparesis
- Aged 21 years or older
- English as primary language
- Have corrected vision to be able to read text on a screen
- Able to participate fully in the study's tele-rehabilitation (Aim 1) and/or virtual group programing (Aim 2) with personally owned device (i.e., phone, tablet, or laptop) and personal Wi-Fi connection or cellular service
- Cognitive, language, and motor capacity to participate fully in the study's assessment session as per the judgment of the licensed, experienced stroke tele-rehabilitation occupational or speech therapist
Who cannot join
- Unable to follow 1-2 step instructions given by the study team member during the informed consent procedures.
- Pain that interferes with ability to participate in the study's upper extremity movement tasks.
- Have impaired decision making capacity as determined by the U-ARE protocol for assessing capacity to provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Kelly Rishe, MSOT, 843-985-1810, callahk@musc.edu
About this study
Official title: Centering Emotional Recovery Post-Stroke
The purpose of this study is to evaluate whether adding an emotional wellness component to occupational therapy (OT) and/or speech therapy (ST) telerehabilitation improves overall emotional well-being and activity participation for people with stroke.
Read the detailed description
The purpose of this study is to evaluate whether adding an emotional wellness component to occupational therapy (OT) and/or speech therapy (ST) telerehabilitation improves overall emotional well-being and activity participation for people with stroke. Participants will complete 9 telerehabilitation therapy sessions over 8 weeks. These sessions will take place over a video visit using a personal device (phone, tablet, or computer). Each session will last about 1 hour. Sessions will focus on occupational therapy and/or speech therapy depending on the participant's stroke-related movement and/or language deficits. Each study participant will be randomly assigned to one of two intervention groups. Both groups will include OT or ST; however, one group will include an emotional wellness component using a modified version of Cognitive Behavioral Therapy. Participants will also complete 2 assessment visits, one before the telerehabilitation begins and one after the telerehabilitation program ends. The assessment visits will also take place via a video visit using a personal device. Assessments include measures of emotional well-being, quality of life, activity engagement, arm/hand movement, communication/language skills, balance, and ability to perform daily activities.
- Conditions
- Stroke, Mental Health Wellness 1
- Being tested
- modified Cognitive Behavioral Therapy (mCBT), Occupational or Speech Therapy
- Keywords
- Rehabilitation Studies, Stroke, Stroke Recovery
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified Cognitive Behavioral Therapy (mCBT)Behavioural
The theoretical model underling Cognitive Behavioral Therapy (CBT) explains the interaction of thoughts, feelings, and behaviors during life situations. This model suggests that a person's thoughts/feeling/behaviors affect their functioning during life situations. This contrasts with a common belief that one's functioning during life situations is the only way to effect thoughts/feelings/behaviors. Applied to stroke, this model suggests that the stroke survivor can alter his/her functioning during life situations by altering his/her thoughts/feelings/behaviors. The purpose of CBT is to empower the person with the skills to alter his/her thoughts/feelings/behaviors in order to positively affect function in life situations.
The mCBT intervention includes 4 elements: psychoeducation, education about unhelpful thinking, behavioral activation therapy, education on sleep hygiene, and relaxation training.
Occupational or Speech TherapyBehavioural
If the participant demonstrates aphasia of any severity level on the Revised Western Aphasia Battery (WAB-R) assessment given at the PRE session, the subject will receive ST, provided by a Speech Language Pathologists (SLP), stroke telerehabilitation. If there is no aphasia, the subject will receive OT stroke telerehabilitation.
The OT and ST stroke telerehabilitation sessions will utilize a similar metacognitive strategy training approach which is focused on enabling the stroke survivor to re-engage with meaningful life activities. In the Occupational Therapy literature this approach is called Cognitive Orientation to Occupational Performance (CO-OP) and in the Speech Language Pathology Literature this approach is called the Life Participation Approach to Aphasia (LPAA).
Telerehabilitation CO-OP and LPAA within the OT or ST session include three common elements: Shared decision-making for goal setting, guidance/coaching from the therapist, and self-evaluation.
| Study group | Role | What they receive |
|---|---|---|
| modified Cognitive Behavioral Therapy + Telerehabilitation Occupational or Speech Therapy | Experimental | Not described Receives: Behavioral: modified Cognitive Behavioral Therapy (mCBT); Behavioral: Occupational or Speech Therapy |
| Telerehabilitation Occupational or Speech Therapy | Active comparator | Not described Receives: Behavioral: Occupational or Speech Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Warwick-Edinburgh Mental Wellbeing Scale (WEMWS)
14-item scale of mental well-being rated by participants on a 5-point scale (1=low, 5=high). Summed item ratings are reported out of 70 points so that higher scores indicate greater mental wellbeing.
Measured: Baseline, pre-intervention and immediately after the intervention, Week 8.
Patient Specific Functional Scale (PSFS)
A patient-reported measure of task-goal identification and difficulty performing the task on a 0-10-point ordinal scale with higher ratings indicating greater satisfaction with task performance.
Measured: Baseline, pre-intervention and immediately after the intervention, Week 8.
Stroke and Aphasia Quality of Life Scale (SAQoL)
39-item stroke-specific measure of health-related quality of life rated by participants on a 5-point scale (1 = couldn't do it at all, 5 = no trouble at all). An overall mean score is computed as well as three domain scores: physical, communication, and psychosocial. Higher scores indicate better quality of life.
Measured: Baseline, pre-intervention and immediately after the intervention, Week 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start1 May 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized rehabilitation clinical trial with adaptive design. At study midpoint, a preliminary analysis will identify the intervention showing the greatest effect on the majority of the primary outcome measures. Subsequently, the randomization ratio will be adapted to 2:1 in favor of that intervention
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- The Duke Endowment
- Responsible party
- Principal investigator, Michelle Woodbury, Medical University of South Carolina
- Investigators
- Michelle Woodbury, PhD, Principal investigator, Medical University of South CarolinaLisa McTeague, PhD, Principal investigator, Medical University of South CarolinaDeena Blackett, PhD, Principal investigator, University of Central Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06782321
- Sponsor's protocol ID
- Pro00138136
- Acronym
- eWELL
- Status last verified
- Jun 2026
- First submitted
- 13 Jan 2025
- Last updated
- 18 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ayerbe L, Ayis SA, Crichton S, Wolfe CD, Rudd AG. Natural history, predictors and associated outcomes of anxiety up to 10 years after stroke: the South London Stroke Register. Age Ageing. 2014 Jul;43(4):542-7. doi: 10.1093/ageing/aft208. Epub 2013 Dec 26.
PubMed 24375225Hackett ML, Pickles K. Part I: frequency of depression after stroke: an updated systematic review and meta-analysis of observational studies. Int J Stroke. 2014 Dec;9(8):1017-25. doi: 10.1111/ijs.12357. Epub 2014 Aug 12.
PubMed 25117911Bhattacharjee S, Axon DR, Goldstone L, Lee JK. Patterns and Predictors of Depression Treatment among Stroke Survivors with Depression in Ambulatory Settings in the United States. J Stroke Cerebrovasc Dis. 2018 Mar;27(3):563-567. doi: 10.1016/j.jstrokecerebrovasdis.2017.09.047. Epub 2017 Oct 31.
PubMed 29097059Paolucci S, Iosa M, Coiro P, Venturiero V, Savo A, De Angelis D, Morone G. Post-stroke Depression Increases Disability More Than 15% in Ischemic Stroke Survivors: A Case-Control Study. Front Neurol. 2019 Aug 27;10:926. doi: 10.3389/fneur.2019.00926. eCollection 2019.
PubMed 31507525Kowalska K, Krzywoszanski L, Dros J, Pasinska P, Wilk A, Klimkowicz-Mrowiec A. Early Depression Independently of Other Neuropsychiatric Conditions, Influences Disability and Mortality after Stroke (Research Study-Part of PROPOLIS Study). Biomedicines. 2020 Nov 17;8(11):509. doi: 10.3390/biomedicines8110509.
PubMed 33213019McKevitt C, Fudge N, Redfern J, Sheldenkar A, Crichton S, Rudd AR, Forster A, Young J, Nazareth I, Silver LE, Rothwell PM, Wolfe CD. Self-reported long-term needs after stroke. Stroke. 2011 May;42(5):1398-403. doi: 10.1161/STROKEAHA.110.598839. Epub 2011 Mar 24.
PubMed 21441153Skolarus LE, Lisabeth LD, Burke JF, Levine DA, Morgenstern LB, Williams LS, Pfeiffer PN, Brown DL. Racial and Ethnic Differences in Mental Distress among Stroke Survivors. Ethn Dis. 2015 Spring;25(2):138-44.
PubMed 26118139HRSA. Behavioral Health Workforce, 2023. In: HRSA, editor.: National Center for Health Workforce Analysis; 2023.
Services UDoHaH. South Carolina Mental Health Health Professional Shortage Areas (HPSA): GIS Office of Information Technology; 2023 [updated 03-07-2023]. Available from: https://scdhec.gov/sites/default/files/media/document/HPSA-Mental-Health-2023.pdf.
Hamilton RKB, Phelan CH, Chin NA, Wyman MF, Lambrou N, Cobb N, Kind AJH, Blazel H, Asthana S, Gleason CE. The U-ARE Protocol: A Pragmatic Approach to Decisional Capacity Assessment for Clinical Research. J Alzheimers Dis. 2020;73(2):431-442. doi: 10.3233/JAD-190457.
PubMed 31868663Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, Weich S, Parkinson J, Secker J, Stewart-Brown S. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation. Health Qual Life Outcomes. 2007 Nov 27;5:63. doi: 10.1186/1477-7525-5-63.
PubMed 18042300
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Centering Emotional Recovery Post-Stroke
- ClinicalTrials.gov ID
- NCT06782321
- Acronym / sponsor ID
- eWELL / Pro00138136
- Conditions
- Stroke, Mental Health Wellness 1
- Keywords
- Rehabilitation Studies, Stroke, Stroke Recovery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- The Duke Endowment
- Study start
- 1 May 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 17 Jan 2025 (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.
The purpose of this study is to evaluate whether adding an emotional wellness component to occupational therapy (OT) and/or speech therapy (ST) telerehabilitation improves overall emotional well-being and activity participation for people with stroke.
Detailed description
The purpose of this study is to evaluate whether adding an emotional wellness component to occupational therapy (OT) and/or speech therapy (ST) telerehabilitation improves overall emotional well-being and activity participation for people with stroke. Participants will complete 9 telerehabilitation therapy sessions over 8 weeks. These sessions will take place over a video visit using a personal device (phone, tablet, or computer). Each session will last about 1 hour. Sessions will focus on occupational therapy and/or speech therapy depending on the participant's stroke-related movement and/or language deficits. Each study participant will be randomly assigned to one of two intervention groups. Both groups will include OT or ST; however, one group will include an emotional wellness component using a modified version of Cognitive Behavioral Therapy. Participants will also complete 2 assessment visits, one before the telerehabilitation begins and one after the telerehabilitation program ends. The assessment visits will also take place via a video visit using a personal device. Assessments include measures of emotional well-being, quality of life, activity engagement, arm/hand movement, communication/language skills, balance, and ability to perform daily activities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized rehabilitation clinical trial with adaptive design. At study midpoint, a preliminary analysis will identify the intervention showing the greatest effect on the majority of the primary outcome measures. Subsequently, the randomization ratio will be adapted to 2:1 in favor of that intervention
| Arm | Type | Receives |
|---|---|---|
| modified Cognitive Behavioral Therapy + Telerehabilitation Occupational or Speech Therapy | Experimental | Behavioral: modified Cognitive Behavioral Therapy (mCBT), Behavioral: Occupational or Speech Therapy |
| Telerehabilitation Occupational or Speech Therapy | Active comparator | Behavioral: Occupational or Speech Therapy |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Self-reported stroke-related deficits in emotional wellness such as anxiety, sleep disturbance, dread, fear, loss of hope, sadness.
- Have experienced ischemic or hemorrhagic stroke at least 30 days prior
- Stroke-related aphasia and/or upper extremity hemiparesis
- Aged 21 years or older
- English as primary language
Key exclusion criteria (3 listed)
- Unable to follow 1-2 step instructions given by the study team member during the informed consent procedures.
- Pain that interferes with ability to participate in the study's upper extremity movement tasks.
- Have impaired decision making capacity as determined by the U-ARE protocol for assessing capacity to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| modified Cognitive Behavioral Therapy (mCBT)The theoretical model underling Cognitive Behavioral Therapy (CBT) explains the interaction of thoughts, feelings, and behaviors during life situations. This model suggests that a person's thoughts/feeling/behaviors affect their functioning during life situations. This contrasts with a common belief that one's functioning during life situations is the only way to effect thoughts/feelings/behaviors. Applied to stroke, this model suggests that the stroke survivor can alter his/her functioning during life situations by altering his/her thoughts/feelings/behaviors. The purpose of CBT is to empower the person with the skills to alter his/her thoughts/feelings/behaviors in order to positively affect function in life situations. The mCBT intervention includes 4 elements: psychoeducation, education about unhelpful thinking, behavioral activation therapy, education on sleep hygiene, and relaxation training. | Behavioural | modified Cognitive Behavioral Therapy + Telerehabilitation Occupational or Speech Therapy |
| Occupational or Speech TherapyIf the participant demonstrates aphasia of any severity level on the Revised Western Aphasia Battery (WAB-R) assessment given at the PRE session, the subject will receive ST, provided by a Speech Language Pathologists (SLP), stroke telerehabilitation. If there is no aphasia, the subject will receive OT stroke telerehabilitation. The OT and ST stroke telerehabilitation sessions will utilize a similar metacognitive strategy training approach which is focused on enabling the stroke survivor to re-engage with meaningful life activities. In the Occupational Therapy literature this approach is called Cognitive Orientation to Occupational Performance (CO-OP) and in the Speech Language Pathology Literature this approach is called the Life Participation Approach to Aphasia (LPAA). Telerehabilitation CO-OP and LPAA within the OT or ST session include three common elements: Shared decision-making for goal setting, guidance/coaching from the therapist, and self-evaluation. | Behavioural | Telerehabilitation Occupational or Speech Therapy, modified Cognitive Behavioral Therapy + Telerehabilitation Occupational or Speech Therapy |
Primary outcome
Warwick-Edinburgh Mental Wellbeing Scale (WEMWS)
Time frame: Baseline, pre-intervention and immediately after the intervention, Week 8.
14-item scale of mental well-being rated by participants on a 5-point scale (1=low, 5=high). Summed item ratings are reported out of 70 points so that higher scores indicate greater mental wellbeing.
Patient Specific Functional Scale (PSFS)
Time frame: Baseline, pre-intervention and immediately after the intervention, Week 8.
A patient-reported measure of task-goal identification and difficulty performing the task on a 0-10-point ordinal scale with higher ratings indicating greater satisfaction with task performance.
Stroke and Aphasia Quality of Life Scale (SAQoL)
Time frame: Baseline, pre-intervention and immediately after the intervention, Week 8.
39-item stroke-specific measure of health-related quality of life rated by participants on a 5-point scale (1 = couldn't do it at all, 5 = no trouble at all). An overall mean score is computed as well as three domain scores: physical, communication, and psychosocial. Higher scores indicate better quality of life.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Background: PubMed 24375225Ayerbe L, Ayis SA, Crichton S, Wolfe CD, Rudd AG. Natural history, predictors and associated outcomes of anxiety up to 10 years after stroke: the South London Stroke Register. Age Ageing. 2014 Jul;43(4):542-7. doi: 10.1093/ageing/aft208. Epub 2013 Dec 26.
- Background: PubMed 25117911Hackett ML, Pickles K. Part I: frequency of depression after stroke: an updated systematic review and meta-analysis of observational studies. Int J Stroke. 2014 Dec;9(8):1017-25. doi: 10.1111/ijs.12357. Epub 2014 Aug 12.
- Background: PubMed 29097059Bhattacharjee S, Axon DR, Goldstone L, Lee JK. Patterns and Predictors of Depression Treatment among Stroke Survivors with Depression in Ambulatory Settings in the United States. J Stroke Cerebrovasc Dis. 2018 Mar;27(3):563-567. doi: 10.1016/j.jstrokecerebrovasdis.2017.09.047. Epub 2017 Oct 31.
- Background: PubMed 31507525Paolucci S, Iosa M, Coiro P, Venturiero V, Savo A, De Angelis D, Morone G. Post-stroke Depression Increases Disability More Than 15% in Ischemic Stroke Survivors: A Case-Control Study. Front Neurol. 2019 Aug 27;10:926. doi: 10.3389/fneur.2019.00926. eCollection 2019.
- Background: PubMed 33213019Kowalska K, Krzywoszanski L, Dros J, Pasinska P, Wilk A, Klimkowicz-Mrowiec A. Early Depression Independently of Other Neuropsychiatric Conditions, Influences Disability and Mortality after Stroke (Research Study-Part of PROPOLIS Study). Biomedicines. 2020 Nov 17;8(11):509. doi: 10.3390/biomedicines8110509.
- Background: PubMed 21441153McKevitt C, Fudge N, Redfern J, Sheldenkar A, Crichton S, Rudd AR, Forster A, Young J, Nazareth I, Silver LE, Rothwell PM, Wolfe CD. Self-reported long-term needs after stroke. Stroke. 2011 May;42(5):1398-403. doi: 10.1161/STROKEAHA.110.598839. Epub 2011 Mar 24.
- Background: PubMed 26118139Skolarus LE, Lisabeth LD, Burke JF, Levine DA, Morgenstern LB, Williams LS, Pfeiffer PN, Brown DL. Racial and Ethnic Differences in Mental Distress among Stroke Survivors. Ethn Dis. 2015 Spring;25(2):138-44.
- BackgroundHRSA. Behavioral Health Workforce, 2023. In: HRSA, editor.: National Center for Health Workforce Analysis; 2023.
- BackgroundServices UDoHaH. South Carolina Mental Health Health Professional Shortage Areas (HPSA): GIS Office of Information Technology; 2023 [updated 03-07-2023]. Available from: https://scdhec.gov/sites/default/files/media/document/HPSA-Mental-Health-2023.pdf.
- Background: PubMed 31868663Hamilton RKB, Phelan CH, Chin NA, Wyman MF, Lambrou N, Cobb N, Kind AJH, Blazel H, Asthana S, Gleason CE. The U-ARE Protocol: A Pragmatic Approach to Decisional Capacity Assessment for Clinical Research. J Alzheimers Dis. 2020;73(2):431-442. doi: 10.3233/JAD-190457.
- Background: PubMed 18042300Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, Weich S, Parkinson J, Secker J, Stewart-Brown S. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation. Health Qual Life Outcomes. 2007 Nov 27;5:63. doi: 10.1186/1477-7525-5-63.
Related trials for Stroke
RecruitingPhase 1/2
Safety and Efficacy of CG-BM1 in Ischemic Stroke
Ischemic Stroke or High-risk TIA (ABCD² ≥ 4)
Not yet recruitingPhase 3
Recombinant Human Prourokinase for Acute Ischemic Stroke in the Extended Window Selected by CT-Based Artificial Intelligence
Acute Ischemic Stroke
Recruiting
Effects of Mirror Therapy and Motor Imagery on Upper Limb Motor Functions in Middle Cerebral Artery Stroke
Stroke
Recruiting
Rapid Local Ischemic Postconditioning on Stroke After Thrombectomy
Acute Ischemic Stroke
Not yet recruitingObservational study
The GEIR Registry: Rationale and Design of the First Nationwide Multicentre Retinal Stroke Registry in Spain
Retinal Artery Occlusion
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.
Michelle Woodbury, PhD principal investigator
Medical University of South Carolina
Lisa McTeague, PhD principal investigator
Medical University of South Carolina
Deena Blackett, PhD principal investigator
University of Central Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing modified Cognitive Behavioral Therapy (mCBT) and Occupational or Speech Therapy in people with Stroke and Mental Health Wellness 1, run by Medical University of South Carolina 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 8 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: looking for participants now, as of the sponsor's last update on 18 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patricia Finetto (843-792-8533, piersonp@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Warwick-Edinburgh Mental Wellbeing Scale (WEMWS) (time frame: Baseline, pre-intervention and immediately after the intervention, Week 8.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06782321, which also lists 11 linked publications.
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 18 Jun 2026.