Pilot Study: The Effects of Telehealth Mindfulness Meditation Program on Sleep Quality and Anxiety in Acquired Brain Injury Population
Phase: NA
Conditions: Acquired Brain Injury
Sponsor: Saint Joseph's University, Philadelphia

Title: Pilot Study: The effects of Telehealth Mindfulness Meditation Program on Sleep Quality 
and Anxiety in Acquired Brain Injury Population 
PI: Nabila Enam  
Date: 11/11/24 
Cover Page 
 
Identifiers: NCT06717399 
Title: Pilot Study: The Effects of Telehealth Mindfulness Meditation Program on Sleep 
Quality and Anxiety in Acquired Brain Injury Population 
Study status: Completed 
Study start: January 1, 2025 
Primary completion: May 2, 2025 
Study completion: May 7, 2025 
Sponsor/Collaborators: Saint Joseph’s University 
Principle Investigator: Nabila Enam, Clinical Associate Professor  
Affiliation: Saint Joseph’s University 
Human subject review: Board status: Approved 
Approved number: 2233742-1 
Board Name: Saint Joseph’s University 
Board Affiliation: Saint Joseph’s University 
Phone: 610-660-1206, email: ors@sju.edu 
Address: 5600 City Ave, Philadelphia, PA 19131 
  
 
 
 
 
 
 
 
 
 
 
 
 

Title: Pilot Study: The effects of Telehealth Mindfulness Meditation Program on Sleep Quality 
and Anxiety in Acquired Brain Injury Population 
PI: Nabila Enam  
Date: 11/11/24 
 
Study Protocol 
Study Description 
Brief Summary: Individuals with acquired brain injury (ABI), 18 years or older with minimum 
to moderate cognitive deficits, participated in 8 virtual mindfulness meditation sessions over 4 to 
5 weeks (minimum 2 sessions per week). Each session was 30 minutes long, consisting of 15 
minutes for guided mindfulness meditation led by researchers, followed by a brief period of 
educational discussion. Before starting the mindfulness meditation session, baseline data were 
collected. 
Detail Description: Sleep is regarded as the fifth pillar of health, essential for overall well-
being. Individuals with acquired brain injuries (ABI) are more susceptible to poor sleep quality 
and high anxiety due to neurological impairment. Mindfulness meditation may improve sleep 
quality and decrease anxiety in the ABI population. Limited research exists on virtual 
mindfulness meditation involving sleep quality and anxiety in the ABI population. The 
researchers measured changes in sleep quality and anxiety after participants completed eight 
virtual mindfulness meditation sessions, using the Pittsburgh Sleep Quality Index (PSQI) and the 
PROMIS anxiety short form. 
 
Conditions: Sleep 
Keywords: Sleep, anxiety, Acquired brain injury, mindfulness meditation 
 
Study design 
Study type: Interventional 
Primary purpose: Treatment 
Interventional study model: Single Group Assignment 
Number of arms: 1 
Masking: None 
Enrollment: 12 
 
Arms 
Assigned Interventions 
Virtual mindfulness meditation 
Virtual mindfulness meditation, subjects 
participated in 30 minutes of a virtual 
mindfulness meditation session, totaling eight 
sessions.  
 
Eligibility 
Minimum age: 18 years 
Sex: All 
Inclusion Criteria: 
• Known diagnosis of acquired brain injury 

Title: Pilot Study: The effects of Telehealth Mindfulness Meditation Program on Sleep Quality 
and Anxiety in Acquired Brain Injury Population 
PI: Nabila Enam  
Date: 11/11/24 
• 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 
 
Participant Flow: 
• 12 participants enrolled in the study. 11 participants completed the intervention sessions 
and outcome measures.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Title: Pilot Study: The effects of Telehealth Mindfulness Meditation Program on Sleep Quality 
and Anxiety in Acquired Brain Injury Population 
PI: Nabila Enam  
Date: 11/11/24 
Statistical Analysis Plan 
 
1. Primary Outcome 
Title: Pittsburg Sleep Quality Index (PSQI) 
Description: The PSQI is 19-question self-reported assessment is made up of seven 
subcategories, 1) subjective sleep quality, 2) sleep latency, 3) sleep duration, 4) habitual sleep 
efficiency, 5) sleep disturbances, 6) use of sleeping medication, and 7) daytime dysfunction. 
Each component is scored from “0” is no difficulty and “3” is severe difficulty during the past 
month. The component scores are summed to produce a global PSQI score, which ranges from 0 
(good sleep quality) to 21 (poor sleep quality). If individual scores higher than a 5 overall, it is an 
indication of poor sleep quality.  
Outcome measure time frame: 10 minutes 
2. Secondary outcome measure 
Title: PROMIS Anxiety Short Form 
Description: The PROMIS Anxiety Short Form is an eight-question self-report measure to assess 
anxiety. Participants were asked to rate their responses to questions relating to feelings of anxiety 
in the past seven days. Participants rated their feelings using a 5-point Likert scale, with 
responses ranging from 1 to 5. Responses were scored as follows: 1 corresponds with “never”, 2 
with “rarely”, 3 with “sometimes”, 4 with “often”, and 5 with “always. A higher score on the 
PROMIS Anxiety Short Form is an indication a greater severity of anxiety. 
Outcome measure time frame: 10 minutes 
3. Other Pre-specified Outcome 
Title: Patient Global Impression of Change (PGIC) 
Description: The PGIC is one question in a likert-scale format for the participants to 
provide feedback about how their overall status has changed from the beginning of the study to 
the completion of the program. The seven possible responses range from (1) very much 
improved to (7) very much worse. The lower the number, the greater the participant’s 
satisfaction with their overall status. 
Outcome measure timeframe: Less than 1 minute 
 
Microsoft Excel© statistical software package will be used to analyze data for the study. 
Descriptive and inferential statistics will be used to evaluate the quantitative data in the study. 
Pre-test and post-tests are provided in order to assess changes in anxiety and sleep quality since 
the implementation of mindfulness meditation sessions. In order to determine a statistical 
significance, a paired two-tailed t-test with an alpha level set at .05 will be used.