Post-stroke DepressionLIVE-WELNCT06864715
Behavioral Activation for the PreVention of Post-strokE Depression in LoW-incomE Older Stroke Survivors
A study testing Tele-delivered Behavioral Activation by lay counselors after Stroke (Tele-BA-S) and Treatment as Usual in people with Post-stroke Depression and Subthreshold Depression, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The overall objective of the project is to determine the effectiveness of tele-delivered behavioral activation (BA) by trained lay counselors (Tele-BA-S) to prevent Post-stroke depression (PSD) in low-income, older stroke survivors with subthreshold depression (SD). Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Post-stroke Depression, Subthreshold Depression
- What is being tested?
- Tele-delivered Behavioral Activation by lay counselors after Stroke (Tele-BA-S) and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2026to 1 Nov 2029
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Enrollment within 3-months +2 weeks of a first-time ischemic or hemorrhagic stroke
- 24-item HDRS score < 15 indicating subthreshold depression defined as the absence of depressive symptoms or presence of mild symptoms of depression
- Single person income less than or equal to $45,000
- Residing in a community residence
- Ability to speak and read in English or Spanish
- Mini-MoCA score > or equal to 11
Who cannot join
- Stroke event unrelated to vascular risk factors (e.g., drug use) or transient ischemic attack
- 24-item HDRS score > or equal to 15 indicating moderate to severe depression
- Actively participating in psychotherapy
- high suicide risk or severe psychiatric illness (e.g., bipolar disorder and active psychosis) and/or actively taking antipsychotics
- Diagnosed dementia and/or currently taking cognitive enhancers, amyloid-targeting medications, or orexin receptor antagonists
- Patient Health Questionnaire 9 score > or equal to 10 and/or answers positive to Q9
Show all 9Show fewer
- Diagnosed aphasia and/or severe cognitive impairments
- high-risk alcohol or drug misuse
- receiving medications for mood disorders and a change in dose or type within the last 4 weeks
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
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Jennifer Beauchamp, PhD, RN, 713-500-2114, Jennifer.e.Beauchamp@uth.tmc.edu
About this study
Official title: Behavioral Activation for the PreVention of Post-strokE Depression in LoW-incomE Older Stroke Survivors (LIVE-WEL)
The overall objective of the project is to determine the effectiveness of tele-delivered behavioral activation (BA) by trained lay counselors (Tele-BA-S) to prevent Post-stroke depression (PSD) in low-income, older stroke survivors with subthreshold depression (SD).
- Conditions
- Post-stroke Depression, Subthreshold Depression
- Being tested
- Tele-delivered Behavioral Activation by lay counselors after Stroke (Tele-BA-S), Treatment as Usual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-delivered Behavioral Activation by lay counselors after Stroke (Tele-BA-S)Behavioural
The Tele-BA-S intervention will comprise 5 weekly video-conferenced BA sessions delivered by trained lay counselors, homework, and 2 monthly follow-up booster calls. Participants will receive the standard hospital discharge post-stroke educational packet and a scheduled follow-up appointment with a stroke practitioner to evaluate patients at 7-14 days and 3 months ±14 days, according to current standard of care. They will be seen over video or in-person, according to their preference and capabilities.
Treatment as UsualBehavioural
Participants will receive the standard hospital discharge post-stroke educational packet and a scheduled follow-up appointment with a stroke practitioner to evaluate patients at 7-14 days and 3 months ±14 days, according to current standard of care. They will be seen over video or in-person, according to their preference and capabilities.
| Study group | Role | What they receive |
|---|---|---|
| Tele-delivered Behavioral Activation by lay counselors after Stroke (Tele-BA-S) | Experimental | Not described Receives: Behavioral: Tele-delivered Behavioral Activation by lay counselors after Stroke (Tele-BA-S) |
| Treatment as Usual | Active comparator | Not described Receives: Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Stroke Depression as Assessed by Score on the Hamilton Depression Rating Scale (HDRS) 24-item
Total score on the 24-item HDRS ranges from 0 to 52, with a higher score indicating greater depression.
Measured: baseline, 2 months, 4 months, 6 months, 9 months
Subthreshold Depression (Depressive Symptoms) as Assessed by the Patient Health Questionnaire (PHQ-9)
Total score on the PHQ-9 ranges from 0 to 27, with a higher score indicating greater depression.
Measured: baseline, 1 month, 2 months, 4 months, 6 months, 9 months
Secondary outcomes (9)
Anxiety as Assessed by the Generalized Anxiety Disorder- 7 Item (GAD-7)
Total score on the GAD-7 ranges from 0 to 15, with a higher score indicating greater anxiety.
Measured: baseline, 2 months, 4 months, 6 months, 9 months
Change in Emotional Distress as Assessed by the Ryff Psychological Well-being Scale (PWB)
Emotional distress will be evaluated using the Ryff Psychological Well-Being Scale (PWB), a validated self-report instrument measuring psychological well-being across six domains: autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, and self-acceptance. Participants rate agreement with statements on a 6-point Likert scale ranging from strongly disagree to strongly agree. Scores are calculated for each domain and/or as a total composite score, with higher scores indicating greater psychological well-being (lower emotional distress).
Measured: baseline, 2 months, 4 months, 6 months, 9 months
Quality of Life (QOL) as Assessed by the Short Form Stroke Specific Quality of Life Scale (SS-QOL)
Total score on the SS-QOL ranges from 12-60, with a higher score indicating better functioning.
Measured: baseline, 2 months, 4 months, 6 months, 9 months
Number of Self-Reported Emergency Room Visits Over the Course of the Study
calculated number of emergency room visits over course of study
Measured: From baseline to 9 months
Number of Hospitalizations Over the Course of the Study
calculated number of hospitalizations over course of study
Measured: From baseline to 9 months
Disability as Assessed by the Modified Rankin Scale (mRS)
Total score on the mRS ranges from 0-6, with a higher score indicating greater disability.
Measured: baseline, 2 months, 4 months, 6 months, 9 months
Medication Adherence Report Scale-5
Total score ranges from 5 to 25, with higher scores indicating higher self-reported adherence.
Measured: baseline, 2 months, 4 months, 6 months, 9 months
Rehabilitation Adherence Inventory
Greater total scores indicate greater adherence.
Measured: baseline, 2 months, 4 months, 6 months, 9 months
Barthel Index
Total scores range from 0 to 100, with lower scores indicating higher dependency.
Measured: baseline, 2 months, 4 months, 6 months, 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start10 Apr 2026
- Primary completion1 Nov 2029 (estimated)
- Study completion1 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-stroke DepressionStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Jennifer Beauchamp, The University of Texas Health Science Center, Houston
- Investigators
- Jennifer Beauchamp, PhD, RN, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06864715
- Sponsor's protocol ID
- HSC-SN-25-0265
- Acronym
- LIVE-WEL
- Status last verified
- Apr 2026
- First submitted
- 3 Mar 2025
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Beauchamp JES, Savitz SI, Sharrief A, Reininger BM, Acierno R, Suchting R, Burnett J, Rosales L, Albaqali JA, Rajan R, Choi NG. Behavioural activation for the prevention of poststroke depression in low-income older stroke survivors (LIVE WEL): protocol for a randomised controlled trial. BMJ Open. 2026 Jun 7;16(6):e120452. doi: 10.1136/bmjopen-2026-120452.
PubMed 42252135
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Activation for the PreVention of Post-strokE Depression in LoW-incomE Older Stroke Survivors (LIVE-WEL)
- ClinicalTrials.gov ID
- NCT06864715
- Acronym / sponsor ID
- LIVE-WEL / HSC-SN-25-0265
- Conditions
- Post-stroke Depression, Subthreshold Depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 10 Apr 2026 (actual)
- Primary completion
- 1 Nov 2029 (estimated)
- Study completion
- 1 Nov 2029 (estimated)
- First posted
- 7 Mar 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 overall objective of the project is to determine the effectiveness of tele-delivered behavioral activation (BA) by trained lay counselors (Tele-BA-S) to prevent Post-stroke depression (PSD) in low-income, older stroke survivors with subthreshold depression (SD).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tele-delivered Behavioral Activation by lay counselors after Stroke (Tele-BA-S) | Experimental | Behavioral: Tele-delivered Behavioral Activation by lay counselors after Stroke (Tele-BA-S) |
| Treatment as Usual | Active comparator | Behavioral: Treatment as Usual |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Enrollment within 3-months +2 weeks of a first-time ischemic or hemorrhagic stroke
- 24-item HDRS score < 15 indicating subthreshold depression defined as the absence of depressive symptoms or presence of mild symptoms of depression
- Single person income less than or equal to $45,000
- Residing in a community residence
- Ability to speak and read in English or Spanish
Key exclusion criteria (9 listed)
- Stroke event unrelated to vascular risk factors (e.g., drug use) or transient ischemic attack
- 24-item HDRS score > or equal to 15 indicating moderate to severe depression
- Actively participating in psychotherapy
- high suicide risk or severe psychiatric illness (e.g., bipolar disorder and active psychosis) and/or actively taking antipsychotics
- Diagnosed dementia and/or currently taking cognitive enhancers, amyloid-targeting medications, or orexin receptor antagonists
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 |
|---|---|---|
| Tele-delivered Behavioral Activation by lay counselors after Stroke (Tele-BA-S)The Tele-BA-S intervention will comprise 5 weekly video-conferenced BA sessions delivered by trained lay counselors, homework, and 2 monthly follow-up booster calls. Participants will receive the standard hospital discharge post-stroke educational packet and a scheduled follow-up appointment with a stroke practitioner to evaluate patients at 7-14 days and 3 months ±14 days, according to current standard of care. They will be seen over video or in-person, according to their preference and capabilities. | Behavioural | Tele-delivered Behavioral Activation by lay counselors after Stroke (Tele-BA-S) |
| Treatment as UsualParticipants will receive the standard hospital discharge post-stroke educational packet and a scheduled follow-up appointment with a stroke practitioner to evaluate patients at 7-14 days and 3 months ±14 days, according to current standard of care. They will be seen over video or in-person, according to their preference and capabilities. | Behavioural | Treatment as Usual |
Primary outcome
Post-Stroke Depression as Assessed by Score on the Hamilton Depression Rating Scale (HDRS) 24-item
Time frame: baseline, 2 months, 4 months, 6 months, 9 months
Total score on the 24-item HDRS ranges from 0 to 52, with a higher score indicating greater depression.
Subthreshold Depression (Depressive Symptoms) as Assessed by the Patient Health Questionnaire (PHQ-9)
Time frame: baseline, 1 month, 2 months, 4 months, 6 months, 9 months
Total score on the PHQ-9 ranges from 0 to 27, with a higher score indicating greater depression.
9 secondary outcomes
Anxiety as Assessed by the Generalized Anxiety Disorder- 7 Item (GAD-7)
Time frame: baseline, 2 months, 4 months, 6 months, 9 months
Change in Emotional Distress as Assessed by the Ryff Psychological Well-being Scale (PWB)
Time frame: baseline, 2 months, 4 months, 6 months, 9 months
Quality of Life (QOL) as Assessed by the Short Form Stroke Specific Quality of Life Scale (SS-QOL)
Time frame: baseline, 2 months, 4 months, 6 months, 9 months
Number of Self-Reported Emergency Room Visits Over the Course of the Study
Time frame: From baseline to 9 months
Number of Hospitalizations Over the Course of the Study
Time frame: From baseline to 9 months
Disability as Assessed by the Modified Rankin Scale (mRS)
Time frame: baseline, 2 months, 4 months, 6 months, 9 months
Medication Adherence Report Scale-5
Time frame: baseline, 2 months, 4 months, 6 months, 9 months
Rehabilitation Adherence Inventory
Time frame: baseline, 2 months, 4 months, 6 months, 9 months
Barthel Index
Time frame: baseline, 2 months, 4 months, 6 months, 9 months
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 28 Apr 2026.
- Derived from this study: PubMed 42252135Beauchamp JES, Savitz SI, Sharrief A, Reininger BM, Acierno R, Suchting R, Burnett J, Rosales L, Albaqali JA, Rajan R, Choi NG. Behavioural activation for the prevention of poststroke depression in low-income older stroke survivors (LIVE WEL): protocol for a randomised controlled trial. BMJ Open. 2026 Jun 7;16(6):e120452. doi: 10.1136/bmjopen-2026-120452.
- 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.
Jennifer Beauchamp, PhD, RN principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-delivered Behavioral Activation by lay counselors after Stroke (Tele-BA-S) and Treatment as Usual in people with Post-stroke Depression and Subthreshold Depression, run by The University of Texas Health Science Center, Houston 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 6 inclusion and 9 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 28 Apr 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 Jennifer Beauchamp, PhD, RN (713-500-2114, Jennifer.e.Beauchamp@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-Stroke Depression as Assessed by Score on the Hamilton Depression Rating Scale (HDRS) 24-item (time frame: baseline, 2 months, 4 months, 6 months, 9 months). The study lists 2 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 NCT06864715, which also lists 1 linked publication.
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 28 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.