Trial Outcomes & Findings for Effect of Telehealth Mindfulness on Sleep and Anxiety in Acquired Brain Injury Population (NCT NCT06717399)

Last Updated: 2025-08-13

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

12 participants

Primary outcome timeframe

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

Results posted on

2025-08-13

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	12
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Death	1

Baseline Characteristics

Effect of Telehealth Mindfulness on Sleep and Anxiety in Acquired Brain Injury Population

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Eight- Session of Mindfulness Meditation n=11 Participants 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.
Age, Continuous	30.91 years STANDARD_DEVIATION 16.60 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
the Pittsburgh Sleep Quality Index (PSQI) and PROMIS Anxiety Short Form PSQI	7.73 units on a scale STANDARD_DEVIATION 3.17 • n=5 Participants
the Pittsburgh Sleep Quality Index (PSQI) and PROMIS Anxiety Short Form PROMIS Anxiety Short Form	58.18 units on a scale STANDARD_DEVIATION 4.30 • n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Eight- Session of Mindfulness Meditation n=11 Participants 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.
Pittsburgh Sleep Quality Index (PSQI) Pre- test	7.73 units on a scale Standard Deviation 3.17
Pittsburgh Sleep Quality Index (PSQI) Post -test	4.00 units on a scale Standard Deviation 2.66

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Eight- Session of Mindfulness Meditation n=11 Participants 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.
Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form Pre-test	58.18 units on a scale Standard Deviation 4.30
Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form Post-test	52.99 units on a scale Standard Deviation 3.82

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Eight- Session of Mindfulness Meditation n=11 Participants 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.
Patient Global Impression of Change (PGIC)	2.36 units on a scale Standard Deviation 0.50

Adverse Events

Eight- Session of Mindfulness Meditation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nabila Enam

Saint Joseph's University

Phone: 2155967348

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place