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

NCT06717399 | Completed Results

• 1 other identifier: StJosephU
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Acquired Brain Injury

Keywords

Sleep; Anxiety; mindfulness meditation; Acquired brain injury

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Patient Global Impression of Change (PGIC)

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

Study Arms (1)

Eight- session of mindfulness meditation

EXPERIMENTAL

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

Interventions

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.

Eight- session of mindfulness meditation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Known diagnosis of acquired brain injury
• Score 19 or below on the Short Orientation-Memory-Concentration Test of Cognitive Impairment (SOMC)
• years or older
• Can speak and comprehend English
• Have access to an internet connection and an electronic device

You may not qualify if:

• Diagnosis of aphasia.

Sponsors & Collaborators

• Saint Joseph's University, Philadelphia: lead

Study Sites (1)

Saint Jospeh's University

Philadelphia, Pennsylvania, 19131, United States

Location

MeSH Terms

Conditions

Brain Injuries; Anxiety Disorders

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

The study may have had attentional bias due to participants' heightened awareness of their sleep quality and anxiety when completing self-reported outcome measures. Additional limitations are non-probability convenience sampling as a recruitment method. This method of recruitment does not provide an accurate representation of the ABI population. The positive outcomes cannot be attributed to the mindfulness meditation sessions alone, due to the lack of a control group.

Results Point of Contact

• Title: Nabila Enam
• Organization: Saint Joseph's University

nenam@sju.edu

2155967348

Study Officials

• Clinical Associate Professor, OTD

  Saint Joseph's University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: Quasi-experimental, one-group pretest-posttest, quantitative design

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 5, 2024
• Study Start: January 13, 2025
• Primary Completion: May 2, 2025
• Study Completion: May 7, 2025
• Last Updated: August 13, 2025
• Results First Posted: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)