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

NCT ID: NCT06717399

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-13
• Study Completion Date: 2025-05-07

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.

Conditions

Acquired Brain Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Mindfulness meditation

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Saint Joseph's University, Philadelphia

OTHER

Sponsor Role: lead

Responsible Party

Nabila Enam

Clinical Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Clinical Associate Professor, OTD

Role: PRINCIPAL_INVESTIGATOR

Saint Joseph's University

Locations

Saint Jospeh's University

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

StJosephU

Identifier Type: -

Identifier Source: org_study_id