No registrations found.
ID
Source
Health condition
insomnia, sleep disorder, acquired brain injury, TBI, stroke, CBT-I, eHealth
Sponsors and support
VU University Amsterdam
Intervention
Outcome measures
Primary outcome
1. Insomnia Severity (ISI and sleep diary)
Secondary outcome
1. Sleep quality (Pittsburgh Sleep Quality Index)
2. Sleep related behaviors (SRBQ)
3. Dysfunctional belief and attitudes about sleep (DBAS)
4. Fatigue (Dutch Multifactor Fatigue Scale)
5. Emotional well-being (HADS)
6. Subjective cognitive functioning(CFQ)
7. Participation (USER-Participation)
Background summary
Online versions of cognitive behavioural therapy for insomnia in the general population have been developed to reach a larger group of patients with insomnia and to create easier access to treatment. Recent reviews show that internet delivered CBT is effective in improving sleep in adults with insomnia in the general population (Seyffert et al., 2016; Zachariae, Lyby, Ritterband & O'Toole, 2016). Since cognitive behavioural therapy is also effective for sleep disorders after acquired brain injury, eHealth seems to be a suitable intervention for this group as well (Nguyen et al., 2017; Theadom et al, 2017). The main objective of this study is to evaluate the efficacy of an eHealth cognitive behavioural intervention to treat insomnia in people with acquired brain injury.
Study objective
The main objective of this study is to evaluate the efficacy of the blended eHealth cognitive behavioural intervention as an additional treatment to treat insomnia (e-CBT-I) in people with acquired brain injury.
The main research questions are:
1. Will the e-CBT-I result in a significant reduction of insomnia in people with acquired brain injury compared to a control group with treatment as usual, not specifically aimed at insomnia?
2. Does the treatment group improve more on subjective cognitive functioning, emotional well-being and participation than the control group?
Firstly, we expect to confirm that e-CBT-I is effective in the treatment of insomnia after brain injury. Secondly, we expect that treatment will improve subjective cognitive functioning, emotional well-being and (social) participation.
Study design
pre-measure (week 0), post-measures (week 7), 6-week follow-up (week 13)
Intervention
The eHealth CBT treatment for insomnia after acquired brain injury is based on well-established CBT for insomnia in the general population and includes educational, behavioural and cognitive techniques. These techniques include sleep hygiene education, stimulus control, sleep restriction, cognitive restructuring, activation, relaxation, fatigue- and stress management. The eHealth CBT treatment for insomnia has been adjusted to ABI in content and way of displaying information.
Inclusion criteria
1. Acquired Brain Injury diagnosis (Traumatic Brain Injury, Stroke)
2. Insomnia according to DSM-5 criteria
3. Insomnia Severity Index > 10
4. 18 years or older
5. Comprehension of Dutch language
6. Cognitive capable of using the internet
7. Regular internet access
8. Referred to an outpatient centre
Exclusion criteria
1. Untreated sleep-apnea
2. Current treatment or expected treatment during the study with main focus on fatigue or sleep
3. Alcohol abuse or drugs abuse
4. Major untreated or unstable medical or psychiatric comorbid condition (eg, epilepsy, psychosis)
5. Unstable medication regiments or medication known to produce insomnia.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6895 |
| NTR-old | NTR7082 |
| CCMO | NL63014.018.17 |
| OMON | NL-OMON46579 |