Acquired Brain InjuryNCT06717399
Effect of Telehealth Mindfulness on Sleep and Anxiety in Acquired Brain Injury Population
A study testing Mindfulness meditation in people with Acquired Brain Injury, run by Saint Joseph's University, Philadelphia at 1 site in United States.
Trial summary
The goal of this study is to learn the effect of a telehealth mindfulness meditation program on sleep quality and anxiety in individuals with brain injury living in the community. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acquired Brain Injury
- What is being tested?
- Mindfulness meditation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2025to 7 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Known diagnosis of acquired brain injury
- Score 19 or below on the Short Orientation-Memory-Concentration Test of Cognitive Impairment (SOMC)
- 18 years or older
- Can speak and comprehend English
- Have access to an internet connection and an electronic device
Who cannot join
- Diagnosis of aphasia.
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Jospeh's University
Philadelphia, Pennsylvania, 19131
About this study
Official title: Pilot Study: The Effects of Telehealth Mindfulness Meditation Program on Sleep Quality and Anxiety in Acquired Brain Injury Population
The goal of this study is to learn the effect of a telehealth mindfulness meditation program on sleep quality and anxiety in individuals with brain injury living in the community. The main questions it aims to answer are:
- Does an eight-session mindfulness meditation program change sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI) in individuals with acquired brain injury?
- Does an eight-session mindfulness meditation program change anxiety levels as assessed by the Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form in individuals with acquired brain injury?
Read more
Participants will:
- Complete eight sessions of mindfulness meditation over 4 to 5 weeks
- Complete two mindfulness meditation sessions per week.
- Complete two additional sessions for pre- and post-test measurements.
Read the detailed description
This is a pilot study examining the effects of a mindfulness meditation program on sleep quality and anxiety levels in individuals with acquired brain injury living in the community. Participants will receive a thirty-minute mindfulness meditation session. Each thirty-minute session will consist of five minutes of introduction, 15 minutes of guided mindfulness meditation, and 10 minutes of education and discussion. Participants will need to complete eight sessions of mindfulness meditation and pre-and post-tests to be included in the data analysis.
- Conditions
- Acquired Brain Injury
- Being tested
- Mindfulness meditation
- Keywords
- Sleep, Anxiety, mindfulness meditation, Acquired brain injury
- Medical subject headings
- Brain Injuries, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness meditationOther
Each mindfulness meditation session will be 30 minutes long, consisting of a 5-minute introduction, 15 minutes of guided mindfulness meditation, and 10 minutes of educational discussion.
| Study group | Role | What they receive |
|---|---|---|
| Eight- session of mindfulness meditation | Experimental | Each mindfulness meditation session will be 30 minutes long, consisting of a 5-minute introduction, 15 minutes of guided mindfulness meditation, and 10 minutes of educational discussion. Participants are required to complete two mindfulness meditation sessions per week. Participants must complete a minimum of 8 sessions over 4 to 5 weeks. Receives: Other: Mindfulness meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality Index (PSQI)
The Pittsburg Sleep Quality Index assesses sleep disturbances and quality through a self-rated questionnaire. The 19-question self-reported assessment has seven subcategories. The questionnaire is made up of scaled responses from 0-3; 0 is not during the past month, 1 is less than once a week, 2 is once or twice a week, and 3 is three or more times a week. The minimum total score is 0, maximum score is 21.If the individual scores higher than a 5 overall, it is an indication of poor sleep quality.
Measured: Pre-test Before the start of the intervention (baseline) and Post test after the completion of 8 sessions of mindfulness meditation, up to 5 weeks
Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form
The Patient Reported Outcomes Measurement Information System Anxiety Short Form is an eight-question self-report measure to assess anxiety. Participants will be asked to rate their responses to questions relating to feelings of anxiety in the past seven days. Participants will rate their feelings using a 5-point Likert scale, where answers can range from 1-5. One corresponds with "never," 2 with "rarely," 3 with "sometimes," 4 with "often," and 5 with "always." Lowest possible raw score is 8, and the highest possible raw score is 40. Raw scores are converted into T-scores. T-scores conversion ranges from 30 to 80. The higher score indicates a greater severity of anxiety. The general population mean for T-score is 50, and the Standard deviation is 10. A T-score of less than or equal to 55 is indicative of within normal limits, T-scores between 55- 60 mild, a score between 60-70 moderate, and a score > 70 severe anxiety.
Measured: Pre-test Before the start of the intervention (baseline) and Post-test after the completion of 8 sessions of mindfulness meditation, up to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start13 Jan 2025
- Primary completion2 May 2025
- Study completion7 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acquired Brain InjuryStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Quasi-experimental, one-group pretest-posttest, quantitative design
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Joseph's University, Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nabila Enam, Saint Joseph's University, Philadelphia
- Investigators
- Clinical Associate Professor, OTD, Principal investigator, Saint Joseph's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06717399
- Sponsor's protocol ID
- StJosephU
- Status last verified
- Aug 2025
- First submitted
- 26 Nov 2024
- Last updated
- 13 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be made available by the primary investigator upon request.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: The Effects of Telehealth Mindfulness Meditation Program on Sleep Quality and Anxiety in Acquired Brain Injury Population
- ClinicalTrials.gov ID
- NCT06717399
- Acronym / sponsor ID
- StJosephU
- Conditions
- Acquired Brain Injury
- Keywords
- Sleep, Anxiety, mindfulness meditation, Acquired brain injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Saint Joseph's University, PhiladelphiaUniversity, hospital or other
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- 2 May 2025 (actual)
- Study completion
- 7 May 2025 (actual)
- First posted
- 5 Dec 2024 (actual)
- Results
- Posted 13 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to learn the effect of a telehealth mindfulness meditation program on sleep quality and anxiety in individuals with brain injury living in the community. The main questions it aims to answer are:
- Does an eight-session mindfulness meditation program change sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI) in individuals with acquired brain injury?
- Does an eight-session mindfulness meditation program change anxiety levels as assessed by the Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form in individuals with acquired brain injury?
Participants will:
- Complete eight sessions of mindfulness meditation over 4 to 5 weeks
- Complete two mindfulness meditation sessions per week.
- Complete two additional sessions for pre- and post-test measurements.
Detailed description
This is a pilot study examining the effects of a mindfulness meditation program on sleep quality and anxiety levels in individuals with acquired brain injury living in the community. Participants will receive a thirty-minute mindfulness meditation session. Each thirty-minute session will consist of five minutes of introduction, 15 minutes of guided mindfulness meditation, and 10 minutes of education and discussion. Participants will need to complete eight sessions of mindfulness meditation and pre-and post-tests to be included in the data analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Quasi-experimental, one-group pretest-posttest, quantitative design
| Arm | Type | Receives |
|---|---|---|
| Eight- session of mindfulness meditation | Experimental | Other: Mindfulness meditationEach mindfulness meditation session will be 30 minutes long, consisting of a 5-minute introduction, 15 minutes of guided mindfulness meditation, and 10 minutes of educational discussion. Participants are required to complete two mindfulness meditation sessions per week. Participants must complete a minimum of 8 sessions over 4 to 5 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Known diagnosis of acquired brain injury
- Score 19 or below on the Short Orientation-Memory-Concentration Test of Cognitive Impairment (SOMC)
- 18 years or older
- Can speak and comprehend English
- Have access to an internet connection and an electronic device
Key exclusion criteria (1 listed)
- Diagnosis of aphasia.
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 |
|---|---|---|
| Mindfulness meditationEach mindfulness meditation session will be 30 minutes long, consisting of a 5-minute introduction, 15 minutes of guided mindfulness meditation, and 10 minutes of educational discussion. | Other | Eight- session of mindfulness meditation |
Primary outcome
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Pre-test Before the start of the intervention (baseline) and Post test after the completion of 8 sessions of mindfulness meditation, up to 5 weeks
The Pittsburg Sleep Quality Index assesses sleep disturbances and quality through a self-rated questionnaire. The 19-question self-reported assessment has seven subcategories. The questionnaire is made up of scaled responses from 0-3; 0 is not during the past month, 1 is less than once a week, 2 is once or twice a week, and 3 is three or more times a week. The minimum total score is 0, maximum score is 21.If the individual scores higher than a 5 overall, it is an indication of poor sleep quality.
Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form
Time frame: Pre-test Before the start of the intervention (baseline) and Post-test after the completion of 8 sessions of mindfulness meditation, up to 5 weeks
The Patient Reported Outcomes Measurement Information System Anxiety Short Form is an eight-question self-report measure to assess anxiety. Participants will be asked to rate their responses to questions relating to feelings of anxiety in the past seven days. Participants will rate their feelings using a 5-point Likert scale, where answers can range from 1-5. One corresponds with "never," 2 with "rarely," 3 with "sometimes," 4 with "often," and 5 with "always." Lowest possible raw score is 8, and the highest possible raw score is 40. Raw scores are converted into T-scores. T-scores conversion ranges from 30 to 80. The higher score indicates a greater severity of anxiety. The general population mean for T-score is 50, and the Standard deviation is 10. A T-score of less than or equal to 55 is indicative of within normal limits, T-scores between 55- 60 mild, a score between 60-70 moderate, and a score > 70 severe anxiety.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. De-identified data will be made available by the primary investigator upon request.
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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.
Clinical Associate Professor, OTD principal investigator
Saint Joseph's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness meditation in people with Acquired Brain Injury, run by Saint Joseph's University, Philadelphia 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 5 inclusion and 1 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 13 Aug 2025. 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?
Yes. Results are posted in the registry (first posted 13 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pittsburgh Sleep Quality Index (PSQI) (time frame: Pre-test Before the start of the intervention (baseline) and Post test after the completion of 8 sessions of mindfulness meditation, up to 5 weeks). 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?
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 13 Aug 2025.