A blended eHealth intervention for sleep-disorders after acquired brain injury

Phase 3

Completed

• Conditions: sleepdisorders; sleeping problems; 10040991

• Registration Number: NL-OMON46579
• Lead Sponsor: Heliomare Revalidatie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 76

Inclusion Criteria

-Acquired Brain Injury diagnosis (Traumatic Brain Injury, Stroke, Brain Tumor)
- Insomnia according to DSM-5 criteria
- Insomnia Severity Index > 10
- 18 years or older

Exclusion Criteria

- Untreated sleep-apnea
- Current treatment or expected treatment during the study with main focus on fatigue or sleep (such as the CBT group therapy: *omgaan met beperkte belastbaarheid*).
- Major untreated or unstable medical or psychiatric comorbid condition (eg, epilepsy, psychosis)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure is the change in insomnia severity.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome measures are the change in fatigue, emotional well-being,<br /><br>subjective cognitive functioning and participation.</p><br>