StrokeMENDNCT03239132
MEditation for Post Stroke Depression
A study testing Breath-based meditation and Meditation educational materials in people with Stroke and Depression, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to establish the feasibility and acceptability of a breath-based meditation in stroke survivors with post-stroke depression (PSD) and their informal caregivers, as well as to examine the effects of the breath-based meditation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Depression
- What is being tested?
- Breath-based meditation and Meditation educational materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2017to 19 Feb 2019
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stroke survivors will be included if they speak English, can provide written informed consent, have a history of ischemic stroke, hemorrhagic, or transient ischemic attack within the past 8 weeks, have a Center for Epidemiologic Studies-Depression (CES-D) total score of 16 or greater suggestive of clinically significant depressive symptoms, and currently live at home.
- Informal caregivers will be included if they are speak English, can provide written informed consent, and self-identify as a first-time informal caregiver of a stroke survivor. -
- To reflect standard practice, stroke survivors and their informal caregivers will be eligible to participate in the study regardless of whether they are currently receiving anti-depressant medications; however, the dose must have been stable for at least one month prior to recruitment into the study.
Who cannot join
- Stroke survivors will be excluded if they currently reside outside of the home (e.g., rehabilitation center).
- Stroke survivors and their informal caregivers will be excluded if they have severe cognitive impairment (Montreal Cognitive Assessment (MoCA) cutoff score of 20), active psychosis, or bipolar disorder; if they currently abuse substances; or if they are acutely suicidal. Those currently receiving formal psychotherapy or currently engaging in self-identified meditation practices will also be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
The purpose of this study is to establish the feasibility and acceptability of a breath-based meditation in stroke survivors with post-stroke depression (PSD) and their informal caregivers, as well as to examine the effects of the breath-based meditation. The hypothesis is that the breath-based meditation will lead to decreases in the severity of symptoms of PSD, post-stroke anxiety (PSA), and post-traumatic stress disorder (PTSD), and decreases in plasma IL-1 pro-inflammatory cytokines post-intervention in stroke survivors with PSD and their informal caregivers.
- Conditions
- Stroke, Depression
- Being tested
- Breath-based meditation, Meditation educational materials
- Medical subject headings
- Stroke, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breath-based meditationBehavioural
The experimental group will receive 4 group sessions of breath-based meditation over 4 weeks.
Meditation educational materialsBehavioural
Meditation educational materials
| Study group | Role | What they receive |
|---|---|---|
| Breath-based meditation | Experimental | The experimental group will receive 4 group sessions of breath-based meditation over 4 weeks, as well as meditation educational materials. Receives: Behavioral: Breath-based meditation; Behavioral: Meditation educational materials |
| Control | Active comparator | The control will receive meditation educational materials. Receives: Behavioral: Meditation educational materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility as assessed by number screened per week
Measured: 2 years
Feasibility as assessed by proportion of those eligible who enroll to the study
Measured: 2 years
Feasibility as assessed by number of participants who completed the study
Measured: 2 years
Feasibility as assessed by number of participants who adhered to the protocol
Measured: 2 years
Feasibility as assessed by number of participants who completed all study assessments
Measured: 2 years
Secondary outcomes (3)
Post-Stroke Depression as assessed by the Center for Epidemiologic Studies Short Depression Scale (CES-D-R 10)
Measured: baseline, immediately after intervention ends, 4 weeks after intervention ends, 8 weeks after intervention ends
Post-Stroke Anxiety as assessed by the State-Trait Anxiety Inventory for Adults (STAI-AD)
Measured: baseline, immediately after intervention ends, 4 weeks after intervention ends, 8 weeks after intervention ends
Levels of plasma IL-1 family pro-inflammatory cytokines
Measured: baseline, immediately after intervention ends, 4 weeks after intervention ends, 8 weeks after intervention ends
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2017
- Study start15 Nov 2017
- Primary completion19 Feb 2019
- Study completion19 Feb 2019
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 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Beauchamp, The University of Texas Health Science Center, Houston
- Investigators
- Jennifer E Sanner, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03239132
- Sponsor's protocol ID
- HSC-SN-17-0583
- Acronym
- MEND
- Status last verified
- May 2023
- First submitted
- 1 Aug 2017
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Beauchamp JES, Sharrief A, Chaoul A, Casameni Montiel T, Love MF, Cron S, Prossin A, Selvaraj S, Dishman D, Savitz SI. Feasibility of a meditation intervention for stroke survivors and informal caregivers: a randomized controlled trial. BMC Psychol. 2023 Jan 12;11(1):9. doi: 10.1186/s40359-022-01031-z.
PubMed 36635775
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MEditation for Post Stroke Depression
- ClinicalTrials.gov ID
- NCT03239132
- Acronym / sponsor ID
- MEND / HSC-SN-17-0583
- Conditions
- Stroke, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 19 Feb 2019 (actual)
- Study completion
- 19 Feb 2019 (actual)
- First posted
- 3 Aug 2017 (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 establish the feasibility and acceptability of a breath-based meditation in stroke survivors with post-stroke depression (PSD) and their informal caregivers, as well as to examine the effects of the breath-based meditation. The hypothesis is that the breath-based meditation will lead to decreases in the severity of symptoms of PSD, post-stroke anxiety (PSA), and post-traumatic stress disorder (PTSD), and decreases in plasma IL-1 pro-inflammatory cytokines post-intervention in stroke survivors with PSD and their informal caregivers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breath-based meditation | Experimental | Behavioral: Breath-based meditation, Behavioral: Meditation educational materialsThe experimental group will receive 4 group sessions of breath-based meditation over 4 weeks, as well as meditation educational materials. |
| Control | Active comparator | Behavioral: Meditation educational materialsThe control will receive meditation educational materials. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stroke survivors will be included if they speak English, can provide written informed consent, have a history of ischemic stroke, hemorrhagic, or transient ischemic attack within the past 8 weeks, have a Center for Epidemiologic Studies-Depression (CES-D) total score of 16 or greater suggestive of clinically significant depressive symptoms, and currently live at home.
- Informal caregivers will be included if they are speak English, can provide written informed consent, and self-identify as a first-time informal caregiver of a stroke survivor. -
- To reflect standard practice, stroke survivors and their informal caregivers will be eligible to participate in the study regardless of whether they are currently receiving anti-depressant medications; however, the dose must have been stable for at least one month prior to recruitment into the study.
Key exclusion criteria (2 listed)
- Stroke survivors will be excluded if they currently reside outside of the home (e.g., rehabilitation center).
- Stroke survivors and their informal caregivers will be excluded if they have severe cognitive impairment (Montreal Cognitive Assessment (MoCA) cutoff score of 20), active psychosis, or bipolar disorder; if they currently abuse substances; or if they are acutely suicidal. Those currently receiving formal psychotherapy or currently engaging in self-identified meditation practices will also be excluded.
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 |
|---|---|---|
| Breath-based meditationThe experimental group will receive 4 group sessions of breath-based meditation over 4 weeks. | Behavioural | Breath-based meditation |
| Meditation educational materialsMeditation educational materials | Behavioural | Breath-based meditation, Control |
Primary outcome
Feasibility as assessed by number screened per week
Time frame: 2 years
Feasibility as assessed by proportion of those eligible who enroll to the study
Time frame: 2 years
Feasibility as assessed by number of participants who completed the study
Time frame: 2 years
Feasibility as assessed by number of participants who adhered to the protocol
Time frame: 2 years
Feasibility as assessed by number of participants who completed all study assessments
Time frame: 2 years
3 secondary outcomes
Post-Stroke Depression as assessed by the Center for Epidemiologic Studies Short Depression Scale (CES-D-R 10)
Time frame: baseline, immediately after intervention ends, 4 weeks after intervention ends, 8 weeks after intervention ends
Post-Stroke Anxiety as assessed by the State-Trait Anxiety Inventory for Adults (STAI-AD)
Time frame: baseline, immediately after intervention ends, 4 weeks after intervention ends, 8 weeks after intervention ends
Levels of plasma IL-1 family pro-inflammatory cytokines
Time frame: baseline, immediately after intervention ends, 4 weeks after intervention ends, 8 weeks after intervention ends
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
- Derived from this study: PubMed 36635775Beauchamp JES, Sharrief A, Chaoul A, Casameni Montiel T, Love MF, Cron S, Prossin A, Selvaraj S, Dishman D, Savitz SI. Feasibility of a meditation intervention for stroke survivors and informal caregivers: a randomized controlled trial. BMC Psychol. 2023 Jan 12;11(1):9. doi: 10.1186/s40359-022-01031-z.
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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.
Jennifer E Sanner, PhD 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 Breath-based meditation and Meditation educational materials in people with Stroke and 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 2 Jun 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility as assessed by number screened per week (time frame: 2 years). 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?
On the ClinicalTrials.gov record for NCT03239132, 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 2 Jun 2023.