Online or Face-to-face Treatment for Insomnia?

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

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.

Study Overview

• Status: Completed
• Conditions: Insomnia
• Intervention / Treatment: Behavioral: Cognitive behavioral treatment for insomnia

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 3

Contacts and Locations

Study Locations

• Netherlands
  • Noord Holland
    • Amsterdam, Noord Holland, Netherlands, 1018XA
      • Department of Clinical Psychology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Waiting-list
Experimental: Internet-delivered CBT for insomnia; Online Cognitive behavioral treatment for insomnia	Behavioral: Cognitive behavioral treatment for insomnia; Cognitive behavioral treatment for insomnia, consisting of: psycho-education, sleep hygiene, stimulus control, sleep restriction, cognitive therapy.
Experimental: Face-to-face CBT for insomnia; Face-to-face Cognitive behavioral treatment for insomnia	Behavioral: Cognitive behavioral treatment for insomnia; Cognitive behavioral treatment for insomnia, consisting of: psycho-education, sleep hygiene, stimulus control, sleep restriction, cognitive therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Time Frame
Depression measured with the CES-D	Change from baseline to post-test, 3-months, and 6-months follow-up
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 worry measured with the Anxiety and Pre-occupation about 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
Anxiety (HADS-A)	Change from baseline to post-test, 3-months, and 6-months follow-up

Collaborators and Investigators

• Sponsor: VU University of Amsterdam
• Collaborators: Slaapmakend

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• General website for insomnia and used for the recruitment

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: September 20, 2013
• First Submitted That Met QC Criteria: October 7, 2013
• First Posted (Estimate): October 8, 2013

Study Record Updates

• Last Update Posted (Estimate): December 30, 2014
• Last Update Submitted That Met QC Criteria: December 29, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: UvA-2013-KP-3125