Acquired Brain Injury
Conditions
Keywords
Sleep, Anxiety, mindfulness meditation, Acquired brain injury
Brief 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. 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.
Interventions
OTHERMindfulness 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.
Sponsors
Saint Joseph's University, Philadelphia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Quasi-experimental, one-group pretest-posttest, quantitative design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
• Diagnosis of aphasia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pittsburgh Sleep Quality Index (PSQI) | 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 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient Global Impression of Change (PGIC) | Post- test After the completion of 8 sessions of mindfulness meditation, up to 5 weeks | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 11 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
Baseline characteristics
| Characteristic | Eight- Session of Mindfulness Meditation |
|---|---|
| Age, Continuous | 30.91 years STANDARD_DEVIATION 16.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 2 Participants |
| the Pittsburgh Sleep Quality Index (PSQI) and PROMIS Anxiety Short Form PROMIS Anxiety Short Form | 58.18 units on a scale STANDARD_DEVIATION 4.3 |
| the Pittsburgh Sleep Quality Index (PSQI) and PROMIS Anxiety Short Form PSQI | 7.73 units on a scale STANDARD_DEVIATION 3.17 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 12 |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
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.
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eight- Session of Mindfulness Meditation | Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form | Pre-test | 58.18 units on a scale | Standard Deviation 4.3 |
| Eight- Session of Mindfulness Meditation | Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form | Post-test | 52.99 units on a scale | Standard Deviation 3.82 |
p-value: 0.004t-test, 2 sided
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.
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eight- Session of Mindfulness Meditation | Pittsburgh Sleep Quality Index (PSQI) | Post -test | 4.00 units on a scale | Standard Deviation 2.66 |
| Eight- Session of Mindfulness Meditation | Pittsburgh Sleep Quality Index (PSQI) | Pre- test | 7.73 units on a scale | Standard Deviation 3.17 |
Comparison: Null Hypothesis:~● There will not be a change in sleep quality after participation in eight mindfulness meditation sessions as measured by the Pittsburgh Sleep Quality Index.p-value: 0.00058t-test, 2 sided
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.
Time frame: Post- test After the completion of 8 sessions of mindfulness meditation, up to 5 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Eight- Session of Mindfulness Meditation | Patient Global Impression of Change (PGIC) | 2.36 units on a scale | Standard Deviation 0.5 |