Online or Face-to-face Treatment for Insomnia?

Insomnia Clinical Trial

Official title:

Online or Face-to-face Treatment for Insomnia? A Wait-list Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01955850
• Other study ID #: UvA-2013-KP-3125
• Status: Completed
• Phase: Phase 3
• First received: September 20, 2013
• Last updated: December 29, 2014
• Start date: October 2013
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: VU University of Amsterdam
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• 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

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insomnia

Intervention

Behavioral:
• Cognitive behavioral treatment for insomnia
Cognitive behavioral treatment for insomnia, consisting of: psycho-education, sleep hygiene, stimulus control, sleep restriction, cognitive therapy.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
VU University of Amsterdam	Slaapmakend

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Insomnia Severity Index		Change from baseline to post-test, 3-months, and 6-months follow-up	No
Secondary	Anxiety (HADS-A)		Change from baseline to post-test, 3-months, and 6-months follow-up	No
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	No
Secondary	Sleep related arousal measured with the Pre-arousal sleep scale		Change from baseline to post-test, 3-months, and 6-months follow-up	No
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	No
Secondary	Sleep medication usage per day measured with the sleep diary		Change from baseline to post-test, 3-months, and 6-months follow-up	No
Secondary	Depression measured with the CES-D		Change from baseline to post-test, 3-months, and 6-months follow-up	No

External Links

•   General website for insomnia and used for the recruitment