Insomnia
Conditions
Brief summary
The object of this study is to compare internet-delivered treatment for insomnia to a waiting-list. In this study participants are randomized to: 1) online cognitive-behavioral 2) waiting-list. Participants in the waiting-list condition receive treatment after the post-test. The interventions consist of: diary; psycho-education; relaxation exercises; stimulus control/sleep hygiene; sleep restriction; challenging the misconceptions about sleep; and paradoxical exercise. Adult persons with insomnia will be invited via a popular scientific website to fill out online questionnaires. Participants will fill out questionnaires and a dairy at baseline post-test, 3-month follow-up, and 6-month follow-up. In this study we are interested in sleep-related worry and daily complaints measured with a diary. We expect that the online intervention ameliorates both the sleep-related worry and the daily complaints. Furthermore, we expect that the sleep related worry mediates the effect of the intervention on sleep- and daily complaints.
Interventions
BEHAVIORALOnline Cognitive behavioral treatment for insomnia
Sponsors
VU University of Amsterdam
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Insomnia disorder according to DSM-5 * Sleep onset latency/wake after sleep onset \> 30 minutes , three times or more a week * Insomnia three months or longer * Access to internet
Exclusion criteria
* Earlier cognitive behavioral treatment for insomnia * Start other psychological treatment in the last 6 months * Doing shift work * Pregnancy or breast feeding * Schizophrenia or psychosis * Suicidal plans * Sleep apnea * drugs or alcohol abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daytime symptoms of sleep related worry measured with the APSQ | Change from baseline to post-test, 3-months, and 6-months follow-up | Daytime symptoms of sleep related worry will be measured with a daily Anxiety and Pre-occupation about sleep questionnaire. |
| Daytime symptoms measured with diary consisting of the DASS-21 | Change from baseline to post-test, 3-months, and 6-months follow-up | The daytime symptoms will be measured with the 7 items of the stress scale of the DASS-21 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep related safety behaviors measured with the SRBQ | Change from baseline to post-test, 3-months, and 6-months follow-up | — |
| Sleep related arousal measured with the Pre-arousal sleep scale | Change from baseline to post-test, 3-months, and 6-months follow-up | — |
| Sleep related worry measured with the Anxiety and Pre-occupation about Sleep Scale | Change from baseline to post-test, 3-months, and 6-months follow-up | — |
| Depression measured with the CES-D | Change from baseline to post-test, 3-months, and 6-months follow-up | — |
| Sleep related cognitions measured with the Dysfunctional Beliefs and Attitudes about sleep scale (DBAS) | Change from baseline to post-test, 3-months, and 6-months follow-up | — |
| Sleep medication usage per day measured with the sleep diary | Change from baseline to post-test, 3-months, and 6-months follow-up | — |
| sleep continuity (consisting of sleep latency, time awake after sleep onset, total sleep time) | Change from baseline to post-test, 3-months, and 6-months follow-up | Sleep continuity is measured with a 7-day sleep diary based on the consensus sleep diary. |
| Repetitive thinking measured with the Dutch Perseverative Thinking Questionnaire | Change from baseline to post-test, 3-months, and 6-months follow-up | — |
| Anxiety measured with the HADS-A | Change from baseline to post-test, 3-months, and 6-months follow-up | — |
Countries
Netherlands
Outcome results
None listed