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Online or Face-to-face Treatment for Insomnia?

Primary Purpose

Insomnia

Status
Completed
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
Cognitive behavioral treatment for insomnia
Sponsored by
VU University of Amsterdam
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Clinical Psychology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Internet-delivered CBT for insomnia

Face-to-face CBT for insomnia

Waiting-list

Arm Description

Online Cognitive behavioral treatment for insomnia

Face-to-face Cognitive behavioral treatment for insomnia

Waiting-list

Outcomes

Primary Outcome Measures

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.
Insomnia Severity Index

Secondary Outcome Measures

Anxiety (HADS-A)
Sleep related worry measured with the Anxiety and Pre-occupation about Sleep Scale
Sleep related arousal measured with the Pre-arousal sleep scale
Sleep related cognitions measured with the Dysfunctional Beliefs and Attitudes about sleep scale (DBAS)
Sleep medication usage per day measured with the sleep diary
Depression measured with the CES-D

Full Information

First Posted
September 20, 2013
Last Updated
December 29, 2014
Sponsor
VU University of Amsterdam
Collaborators
Slaapmakend
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1. Study Identification

Unique Protocol Identification Number
NCT01955850
Brief Title
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

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VU University of Amsterdam
Collaborators
Slaapmakend

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Internet-delivered CBT for insomnia
Arm Type
Experimental
Arm Description
Online Cognitive behavioral treatment for insomnia
Arm Title
Face-to-face CBT for insomnia
Arm Type
Experimental
Arm Description
Face-to-face Cognitive behavioral treatment for insomnia
Arm Title
Waiting-list
Arm Type
No Intervention
Arm Description
Waiting-list
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral treatment for insomnia
Intervention Description
Cognitive behavioral treatment for insomnia, consisting of: psycho-education, sleep hygiene, stimulus control, sleep restriction, cognitive therapy.
Primary Outcome Measure Information:
Title
Sleep continuity (consisting of sleep latency, time awake after sleep onset, total sleep time)
Description
For sleep continuity a 7-day sleep diary is used based on the consensus sleep diary.
Time Frame
Change from baseline to post-test, 3-months, and 6-months follow-up
Title
Insomnia Severity Index
Time Frame
Change from baseline to post-test, 3-months, and 6-months follow-up
Secondary Outcome Measure Information:
Title
Anxiety (HADS-A)
Time Frame
Change from baseline to post-test, 3-months, and 6-months follow-up
Title
Sleep related worry measured with the Anxiety and Pre-occupation about Sleep Scale
Time Frame
Change from baseline to post-test, 3-months, and 6-months follow-up
Title
Sleep related arousal measured with the Pre-arousal sleep scale
Time Frame
Change from baseline to post-test, 3-months, and 6-months follow-up
Title
Sleep related cognitions measured with the Dysfunctional Beliefs and Attitudes about sleep scale (DBAS)
Time Frame
Change from baseline to post-test, 3-months, and 6-months follow-up
Title
Sleep medication usage per day measured with the sleep diary
Time Frame
Change from baseline to post-test, 3-months, and 6-months follow-up
Title
Depression measured with the CES-D
Time Frame
Change from baseline to post-test, 3-months, and 6-months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaap Lancee, PhD
Organizational Affiliation
University of Amsterdam
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinical Psychology
City
Amsterdam
State/Province
Noord Holland
ZIP/Postal Code
1018XA
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
22055281
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.
Results Reference
background
PubMed Identifier
26414893
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.
Results Reference
derived
Links:
URL
http://www.insomnie.nl
Description
General website for insomnia and used for the recruitment

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