NCT01955928

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2013

Completed
10 days until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 8, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

October 15, 2018

Status Verified

October 1, 2018

Enrollment Period

7 months

First QC Date

September 21, 2013

Last Update Submit

October 10, 2018

Conditions

Insomnia

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (9)

  • Depression measured with the CES-D

    Change from baseline to post-test, 3-months, and 6-months follow-up

  • Anxiety measured with the HADS-A

    Change from baseline to post-test, 3-months, and 6-months follow-up

  • Sleep related safety behaviors measured with the SRBQ

    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

  • +4 more secondary outcomes

Study Arms (2)

Online Cognitive behavioral treatment for insomnia

EXPERIMENTAL

Online Cognitive behavioral treatment for insomnia

Behavioral: Online Cognitive behavioral treatment for insomnia

Waiting-list

NO INTERVENTION

Waiting-list

Interventions

Online Cognitive behavioral treatment for insomniaBEHAVIORAL
Online Cognitive behavioral treatment for insomnia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Psychology

Amsterdam, North Holland, 1018XA, Netherlands

Location

Related 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. Epub 2015 May 27.

    PMID: 26012890RESULT

Related Links

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

September 21, 2013

First Posted

October 8, 2013

Study Start

October 1, 2013

Primary Completion

May 1, 2014

Study Completion

December 1, 2014

Last Updated

October 15, 2018

Record last verified: 2018-10

Locations

NL(1)