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Clinical Trials/NCT06717399
NCT06717399
Completed
Not Applicable

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

Saint Joseph's University, Philadelphia1 site in 1 country12 target enrollmentJanuary 13, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acquired Brain Injury
Sponsor
Saint Joseph's University, Philadelphia
Enrollment
12
Locations
1
Primary Endpoint
Pittsburgh Sleep Quality Index (PSQI)
Status
Completed
Last Updated
8 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 13, 2025
End Date
May 7, 2025
Last Updated
8 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Saint Joseph's University, Philadelphia
Responsible Party
Principal Investigator
Principal Investigator

Nabila Enam

Clinical Associate Professor

Saint Joseph's University, Philadelphia

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

Study Sites (1)

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