Clinical trial NCT06717399: Effect of Telehealth Mindfulness on Sleep and Anxiety in Acquired Brain Injury Population
Official title: Pilot Study: the Effects of Telehealth Mindfulness Meditation Program on Sleep Quality and Anxiety in Acquired Brain Injury Population
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acquired Brain Injury
Keywords: Sleep
Anxiety
mindfulness meditation
Acquired brain injury
Lead sponsor: Saint Joseph's University, Philadelphia
Sponsor class: OTHER
First posted: 2024-12-05
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Quasi-experimental, one-group pretest-posttest, quantitative design
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Before the start of the intervention (baseline) and after the completion of 8 sessions of mindfulness meditation, up to 5 weeks
measure: Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form
timeFrame: Before the start of the intervention (baseline) and after the completion of 8 sessions of mindfulness meditation, up to 5 weeks
Secondary outcomes:
Other outcomes:
measure: Patient Global Impression of Change (PGIC)
timeFrame: After the completion of 8 sessions of mindfulness meditation, up to 5 weeks
Locations:
city: Philadelphia
country: United States
facility: Saint Jospeh's University
state: Pennsylvania
Study officials:
affiliation: Saint Joseph's University
name: Clinical Associate Professor, OTD
role: PRINCIPAL_INVESTIGATOR
References: