Clinical trial NCT01955928: Internet-delivered CBT for Insomnia: Role of Sleep-related Cognitions
Official title: Internet-delivered CBT for Insomnia: Role of Sleep-related Cognitions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Lead sponsor: VU University of Amsterdam
Sponsor class: OTHER
First posted: 2013-10-08
Enrollment: 63
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 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.


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

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

Primary outcomes:
measure: Daytime symptoms of sleep related worry measured with the APSQ
timeFrame: Change from baseline to post-test, 3-months, and 6-months follow-up
measure: Daytime symptoms measured with diary consisting of the DASS-21
timeFrame: Change from baseline to post-test, 3-months, and 6-months follow-up
Secondary outcomes:
measure: Depression measured with the CES-D
timeFrame: Change from baseline to post-test, 3-months, and 6-months follow-up
measure: Anxiety measured with the HADS-A
timeFrame: Change from baseline to post-test, 3-months, and 6-months follow-up
measure: Sleep related safety behaviors measured with the SRBQ
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 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: Repetitive thinking measured with the Dutch Perseverative Thinking Questionnaire
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: 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
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Department of Clinical Psychology
state: Noord Holland
Study officials:
References:
citation: Lancee J, Eisma MC, van Straten A, Kamphuis JH. Sleep-Related Safety Behaviors and Dysfunctional Beliefs Mediate the Efficacy of Online CBT for Insomnia: A Randomized Controlled Trial. Cogn Behav Ther. 2015;44(5):406-22. doi: 10.1080/16506073.2015.1026386. Epub 2015 May 27.