Internet-delivered CBT for Insomnia: Role of Sleep-related Cognitions

Insomnia Clinical Trial

Official title:

Internet-delivered CBT for Insomnia: Role of Sleep-related Cognitions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01955928
• Other study ID #: UvA-2013-KP-3152
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Est. completion date: December 2014

Study information

• Verified date: October 2018
• Source: VU University of Amsterdam
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: December 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Online Cognitive behavioral treatment for insomnia

Locations

Country	Name	City	State
Netherlands	Department of Clinical Psychology	Amsterdam	Noord Holland

Sponsors (1)

Lead Sponsor	Collaborator
VU University of Amsterdam

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daytime symptoms of sleep related worry measured with the APSQ	Daytime symptoms of sleep related worry will be measured with a daily Anxiety and Pre-occupation about sleep questionnaire.	Change from baseline to post-test, 3-months, and 6-months follow-up
Primary	Daytime symptoms measured with diary consisting of the DASS-21	The daytime symptoms will be measured with the 7 items of the stress scale of the DASS-21	Change from baseline to post-test, 3-months, and 6-months follow-up
Secondary	Depression measured with the CES-D		Change from baseline to post-test, 3-months, and 6-months follow-up
Secondary	Anxiety measured with the HADS-A		Change from baseline to post-test, 3-months, and 6-months follow-up
Secondary	Sleep related safety behaviors measured with the SRBQ		Change from baseline to post-test, 3-months, and 6-months follow-up
Secondary	Sleep related arousal measured with the Pre-arousal sleep scale		Change from baseline to post-test, 3-months, and 6-months follow-up
Secondary	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
Secondary	Repetitive thinking measured with the Dutch Perseverative Thinking Questionnaire		Change from baseline to post-test, 3-months, and 6-months follow-up
Secondary	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
Secondary	Sleep medication usage per day measured with the sleep diary		Change from baseline to post-test, 3-months, and 6-months follow-up
Secondary	sleep continuity (consisting of sleep latency, time awake after sleep onset, total sleep time)	Sleep continuity is measured with a 7-day sleep diary based on the consensus sleep diary.	Change from baseline to post-test, 3-months, and 6-months follow-up

External Links

•   General website about insomnia