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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:
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness meditation | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Patient Global Impression of Change (PGIC) | The Patient Global Impression of Change is one question in a Likert-scale form for the participants to provide feedback about how the program ran. The scale ranges from 0 to 6. 0 corresponds with "very much improved," 1 with "much improved," 2 with "minimally improved," 3 with "no change," 4 with "minimally worse," 5 with "much worse," and 6 with "very much worse." The minimum score possible on the measurement is 0, and the maximum score possible is 6. The lower score on the measurement indicates improvement. |
Inclusion Criteria:
Exclusion Criteria:
• Diagnosis of aphasia.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Associate Professor, OTD | Saint Joseph's University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Jospeh's University | Philadelphia | Pennsylvania | 19131 | United States |
De-identified data will be made available by the primary investigator upon request.
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Participants were only included in the study if they met the inclusion criteria. They were eligible for this study if they had a known diagnosis of acquired brain injury, scored 19 or below on the SOMCT, were 18 years or older, could speak and comprehend English, and had access to an internet connection and an electronic device. Participants were excluded from the study if they had a diagnosis of aphasia.
The recruitment was rolling, starting after IRB approval (January 6, 2025), and the last recruitment day was February 28, 2025. The study utilized convenience, non-probability sampling in which emails and flyers were sent and posted in the community through ABI support groups and associations such as the Pennsylvania Brain Injury Association, the Brain Injury Alliance of New Jersey, the Brain Injury Association of Delaware, SJU campuses, and word of mouth.
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| ID | Title | Description |
|---|---|---|
| FG000 | Eight- Session of Mindfulness Meditation | Each mindfulness meditation session was 30 minutes long, consisting of a 5-minute introduction, 15 minutes of guided mindfulness meditation, and 10 minutes of educational discussion. Participants were required to complete two mindfulness meditation sessions per week. Participants must complete a minimum of 8 sessions over 4 to 5 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Eight- Session of Mindfulness Meditation | 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. Mindfulness meditation: 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | 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 |
|
5 weeks
The subject's death was due to a medical condition and not related to the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Eight- Session of Mindfulness Meditation | Each mindfulness meditation session was 30 minutes long, consisting of a 5-minute introduction, 15 minutes of guided mindfulness meditation, and 10 minutes of educational discussion. Participants were required to complete two mindfulness meditation sessions per week. Participants must complete a minimum of 8 sessions over 4 to 5 weeks. |
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The study may have had attentional bias due to participants' heightened awareness of their sleep quality and anxiety when completing self-reported outcome measures. Additional limitations are non-probability convenience sampling as a recruitment method. This method of recruitment does not provide an accurate representation of the ABI population. The positive outcomes cannot be attributed to the mindfulness meditation sessions alone, due to the lack of a control group.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nabila Enam | Saint Joseph's University | 2155967348 | nenam@sju.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 11, 2024 | Aug 11, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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| ID | Term |
|---|---|
| D064866 | Mindfulness |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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Quasi-experimental, one-group pretest-posttest, quantitative design
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| Post- test After the completion of 8 sessions of mindfulness meditation, up to 5 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| the Pittsburgh Sleep Quality Index (PSQI) and PROMIS Anxiety Short Form | The Pittsburgh Sleep Quality Index (PSQI) is a 19-item self-report tool assessing sleep quality over the past month. It includes seven components scored from 0-3, with a global score ranging from 0-21. A score >5 indicates poor sleep quality. The The Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form is an 8-item measure assessing anxiety over the past 7 days using a 5-point Likert scale (1-5). Total scores range from 8-40, with higher scores indicating greater anxiety. | Mean | Standard Deviation | units on a scale |
|
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | 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 |
|
|
|
|
| Other Pre-specified | Patient Global Impression of Change (PGIC) | The Patient Global Impression of Change is one question in a Likert-scale form for the participants to provide feedback about how the program ran. The scale ranges from 0 to 6. 0 corresponds with "very much improved," 1 with "much improved," 2 with "minimally improved," 3 with "no change," 4 with "minimally worse," 5 with "much worse," and 6 with "very much worse." The minimum score possible on the measurement is 0, and the maximum score possible is 6. The lower score on the measurement indicates improvement. | Posted | Mean | Standard Deviation | units on a scale | Post- test After the completion of 8 sessions of mindfulness meditation, up to 5 weeks |
|
|
|
| 1 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
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| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D001523 | Mental Disorders |