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Completed

NCT Number: NCT06717399

Effect of Telehealth Mindfulness on Sleep 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?

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saint Jospeh's University

Philadelphia, Pennsylvania, 19131, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. Patient Global Impression of Change (PGIC)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Saint Joseph's University, Philadelphia

Other

Registry information

Official study title

Pilot Study: The Effects of Telehealth Mindfulness Meditation Program on Sleep Quality and Anxiety in Acquired Brain Injury Population

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 5, 2024
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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