Insomnia
Conditions
Brief summary
The object of this study is to compare internet-delivered treatment for insomnia to face-to-face treatment and a waiting-list. In this study participants are randomized to: 1) online cognitive-behavioral intervention; 2) face-to-face cognitive behavioral intervention; 3) waiting-list. Both the online and face-to-face 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 fill out questionnaires and a dairy at baseline post-test, 3-month follow-up, and 6-month follow-up. Participants on the waiting-list receive online treatment after the first post-test. The investigators expect that the online-delivered treatment and the face-to-face treatment are equally effective.
Interventions
Cognitive behavioral treatment for insomnia, consisting of: psycho-education, sleep hygiene, stimulus control, sleep restriction, cognitive therapy.
Sponsors
Slaapmakend
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 * Possibility to travel to one of the treatment sites
Exclusion criteria
* Earlier cognitive behavioral treatment for insomnia * Start other psychological treatment in the last 6 months * Doing shift work * Major depression disorder * Pregnancy or breast feeding * Schizophrenia or psychosis * Suicidal plans * Sleep apnea * drugs or alcohol abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | For sleep continuity a 7-day sleep diary is used based on the consensus sleep diary. |
| Insomnia Severity Index | Change from baseline to post-test, 3-months, and 6-months follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Sleep related arousal measured with the Pre-arousal 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 medication usage per day measured with the sleep diary | 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 |
| Anxiety (HADS-A) | Change from baseline to post-test, 3-months, and 6-months follow-up |
Countries
Netherlands
Outcome results
None listed