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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46579

Enrollment

Registered

2017-10-12

Start date

2018-03-19

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

sleepdisorders sleeping problems

Interventions

The eHealth intervention (CBT) for sleep complaints after acquired brain injury consists of 6 eHealth sessions combined with 2 face-to-face sessions given on a weekly basis to the treatment group. T

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
The primary outcome measure is the change in insomnia severity.	—

Secondary

Measure	Time frame
Secondary outcome measures are the change in fatigue, emotional well-being, subjective cognitive functioning and participation.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)