N/A
Completed N=12
Effect of Telehealth Mindfulness on Sleep and Anxiety in Acquired Brain Injury Population
Source: ClinicalTrials.gov NCT06717399 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcomePrimary: Pittsburgh Sleep Quality Index (PSQI) — 7.73; 4.00 units on a scale — p=0.00058
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pittsburgh Sleep Quality Index (PSQI) |
7.73; 4.00 | 0.00058 sig |
| PRIMARY Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form |
58.18; 52.99 | 0.004 sig |
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.
Data sourced from ClinicalTrials.gov (NCT06717399). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.