MedPath

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

Not Applicable
Completed
Conditions
Insomnia
Registration Number
NCT01955928
Lead Sponsor
VU University of Amsterdam
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
63
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Daytime symptoms of sleep related worry measured with the APSQChange from baseline to post-test, 3-months, and 6-months follow-up

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-21Change from baseline to post-test, 3-months, and 6-months follow-up

The daytime symptoms will be measured with the 7 items of the stress scale of the DASS-21

Secondary Outcome Measures
NameTimeMethod
Depression measured with the CES-DChange from baseline to post-test, 3-months, and 6-months follow-up
Anxiety measured with the HADS-AChange from baseline to post-test, 3-months, and 6-months follow-up
Sleep related safety behaviors measured with the SRBQChange from baseline to post-test, 3-months, and 6-months follow-up
Sleep related arousal measured with the Pre-arousal sleep scaleChange from baseline to post-test, 3-months, and 6-months follow-up
Sleep related worry measured with the Anxiety and Pre-occupation about Sleep ScaleChange from baseline to post-test, 3-months, and 6-months follow-up
Repetitive thinking measured with the Dutch Perseverative Thinking QuestionnaireChange 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 diaryChange from baseline to post-test, 3-months, and 6-months follow-up
sleep continuity (consisting of sleep latency, time awake after sleep onset, total sleep time)Change from baseline to post-test, 3-months, and 6-months follow-up

Sleep continuity is measured with a 7-day sleep diary based on the consensus sleep diary.

Trial Locations

Locations (1)

Department of Clinical Psychology

🇳🇱

Amsterdam, Noord Holland, Netherlands

Department of Clinical Psychology
🇳🇱Amsterdam, Noord Holland, Netherlands

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.