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

Pilot Study: The Effects of Telehealth Mindfulness Meditation Program on Sleep Quality 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.

Study Overview

• Status: Completed
• Conditions: Acquired Brain Injury
• Intervention / Treatment: Other: Mindfulness meditation

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19131
      • Saint Jospeh's University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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.	Post- test After the completion of 8 sessions of mindfulness meditation, up to 5 weeks

Collaborators and Investigators

• Sponsor: Saint Joseph's University, Philadelphia
• Investigators: Principal Investigator: Clinical Associate Professor, OTD, Saint Joseph's University

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2025
• Primary Completion (Actual): May 2, 2025
• Study Completion (Actual): May 7, 2025

Study Registration Dates

• First Submitted: November 26, 2024
• First Submitted That Met QC Criteria: December 3, 2024
• First Posted (Actual): December 5, 2024

Study Record Updates

• Last Update Posted (Actual): August 13, 2025
• Last Update Submitted That Met QC Criteria: August 11, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Anxiety; Sleep; mindfulness meditation; Acquired brain injury
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Brain Injuries
• Other Study ID Numbers: StJosephU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data will be made available by the primary investigator upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No