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| Name | Class |
|---|---|
| Slaapmakend | UNKNOWN |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Internet-delivered CBT for insomnia | Experimental | Online Cognitive behavioral treatment for insomnia |
|
| Face-to-face CBT for insomnia | Experimental | Face-to-face Cognitive behavioral treatment for insomnia |
|
| Waiting-list | No Intervention | Waiting-list |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive behavioral treatment for insomnia | Behavioral | Cognitive behavioral treatment for insomnia, consisting of: psycho-education, sleep hygiene, stimulus control, sleep restriction, cognitive therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep continuity (consisting of sleep latency, time awake after sleep onset, total sleep time) | For sleep continuity a 7-day sleep diary is used based on the consensus sleep diary. | Change from baseline to post-test, 3-months, and 6-months follow-up |
| Insomnia Severity Index | Change from baseline to post-test, 3-months, and 6-months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety (HADS-A) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaap Lancee, PhD | University of Amsterdam | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Clinical Psychology | Amsterdam | North Holland | 1018XA | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22055281 | Background | Lancee J, van den Bout J, van Straten A, Spoormaker VI. Internet-delivered or mailed self-help treatment for insomnia?: a randomized waiting-list controlled trial. Behav Res Ther. 2012 Jan;50(1):22-9. doi: 10.1016/j.brat.2011.09.012. Epub 2011 Oct 24. | |
| 26414893 | Derived | Lancee J, van Straten A, Morina N, Kaldo V, Kamphuis JH. Guided Online or Face-to-Face Cognitive Behavioral Treatment for Insomnia: A Randomized Wait-List Controlled Trial. Sleep. 2016 Jan 1;39(1):183-91. doi: 10.5665/sleep.5344. |
| Label | URL |
|---|---|
| General website for insomnia and used for the recruitment | View source |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| 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 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 |
| Depression measured with the CES-D | Change from baseline to post-test, 3-months, and 6-months follow-up |
| D001523 |
| Mental Disorders |