search
Back to results

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

Primary Purpose

Insomnia

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Online 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

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

Sites / Locations

  • Department of Clinical Psychology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Online Cognitive behavioral treatment for insomnia

Waiting-list

Arm Description

Online Cognitive behavioral treatment for insomnia

Waiting-list

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

Depression measured with the CES-D
Anxiety measured with the HADS-A
Sleep related safety behaviors measured with the SRBQ
Sleep related arousal measured with the Pre-arousal sleep scale
Sleep related worry measured with the Anxiety and Pre-occupation about Sleep Scale
Repetitive thinking measured with the Dutch Perseverative Thinking Questionnaire
Sleep related cognitions measured with the Dysfunctional Beliefs and Attitudes about sleep scale (DBAS)
Sleep medication usage per day measured with the sleep diary
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.

Full Information

First Posted
September 21, 2013
Last Updated
October 10, 2018
Sponsor
VU University of Amsterdam
search

1. Study Identification

Unique Protocol Identification Number
NCT01955928
Brief Title
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

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
May 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

4. Oversight

5. Study Description

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.

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
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Online Cognitive behavioral treatment for insomnia
Arm Type
Experimental
Arm Description
Online Cognitive behavioral treatment for insomnia
Arm Title
Waiting-list
Arm Type
No Intervention
Arm Description
Waiting-list
Intervention Type
Behavioral
Intervention Name(s)
Online Cognitive behavioral treatment for insomnia
Primary Outcome Measure Information:
Title
Daytime symptoms of sleep related worry measured with the APSQ
Description
Daytime symptoms of sleep related worry will be measured with a daily Anxiety and Pre-occupation about sleep questionnaire.
Time Frame
Change from baseline to post-test, 3-months, and 6-months follow-up
Title
Daytime symptoms measured with diary consisting of the DASS-21
Description
The daytime symptoms will be measured with the 7 items of the stress scale of the DASS-21
Time Frame
Change from baseline to post-test, 3-months, and 6-months follow-up
Secondary Outcome Measure Information:
Title
Depression measured with the CES-D
Time Frame
Change from baseline to post-test, 3-months, and 6-months follow-up
Title
Anxiety measured with the HADS-A
Time Frame
Change from baseline to post-test, 3-months, and 6-months follow-up
Title
Sleep related safety behaviors measured with the SRBQ
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 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
Repetitive thinking measured with the Dutch Perseverative Thinking Questionnaire
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
sleep continuity (consisting of sleep latency, time awake after sleep onset, total sleep time)
Description
Sleep continuity is measured with a 7-day sleep diary based on the consensus sleep diary.
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 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
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
26012890
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.
Results Reference
result
Links:
URL
http://www.insomnie.nl
Description
General website about insomnia

Learn more about this trial

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

We'll reach out to this number within 24 hrs