Clinical trial NCT01955850: Online or Face-to-face Treatment for Insomnia?
Official title: Online or Face-to-face Treatment for Insomnia? A Wait-list Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Insomnia
Lead sponsor: VU University of Amsterdam
Sponsor class: OTHER
Collaborators: name: Slaapmakend
First posted: 2013-10-08
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Sleep continuity (consisting of sleep latency, time awake after sleep onset, total sleep time)
timeFrame: Change from baseline to post-test, 3-months, and 6-months follow-up
measure: Insomnia Severity Index
timeFrame: Change from baseline to post-test, 3-months, and 6-months follow-up
Secondary outcomes:
measure: Anxiety (HADS-A)
timeFrame: Change from baseline to post-test, 3-months, and 6-months follow-up
measure: Sleep related worry measured with the Anxiety and Pre-occupation about Sleep Scale
timeFrame: Change from baseline to post-test, 3-months, and 6-months follow-up
measure: Sleep related arousal measured with the Pre-arousal sleep scale
timeFrame: Change from baseline to post-test, 3-months, and 6-months follow-up
measure: Sleep related cognitions measured with the Dysfunctional Beliefs and Attitudes about sleep scale (DBAS)
timeFrame: Change from baseline to post-test, 3-months, and 6-months follow-up
measure: Sleep medication usage per day measured with the sleep diary
timeFrame: Change from baseline to post-test, 3-months, and 6-months follow-up
measure: Depression measured with the CES-D
timeFrame: Change from baseline to post-test, 3-months, and 6-months follow-up
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Department of Clinical Psychology
state: Noord Holland
Study officials:
affiliation: University of Amsterdam
name: Jaap Lancee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.