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

Not Applicable

Not yet recruiting

• Conditions: Acquired Brain Injury

• Registration Number: NCT06717399
• Lead Sponsor: Saint Joseph's University, Philadelphia

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.

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-26
• Study First Submitted QC: 2024-12-03
• Study First Posted: 2024-12-05
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-16
• Study Start: 2025-01-13
• Primary Completion: 2025-05-02
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Pittsburgh Sleep Quality Index (PSQI)	Before the start of the intervention (baseline) and 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	Before the start of the intervention (baseline) and 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. 1 corresponds with "never," 2 with "rarely," 3 with "sometimes," 4 with "often," and 5 with "always." The lowest possible score is 8, and the highest possible score is 40. The higher score indicates a greater severity of anxiety.

Trial Locations

Locations (1)

Saint Jospeh's University; 🇺🇸 Philadelphia, Pennsylvania, United States