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

Saint Joseph's University, Philadelphia

Status: Not yet enrolling

Conditions: Acquired Brain Injury

Treatments: Other: Mindfulness meditation

Study type: Interventional

Funder types: Other

Identifiers

NCT06717399

StJosephU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Eight- session of mindfulness meditation

Experimental group

Description:

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.

Treatment:

Other: Mindfulness meditation