MedPath

Online or Face-to-face Treatment for Insomnia?

Phase 3
Completed
Conditions
Insomnia
Registration Number
NCT01955850
Lead Sponsor
VU University of Amsterdam
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
90
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
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

For sleep continuity a 7-day sleep diary is used based on the consensus sleep diary.

Insomnia Severity IndexChange from baseline to post-test, 3-months, and 6-months follow-up
Secondary Outcome Measures
NameTimeMethod
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
Anxiety (HADS-A)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 diaryChange from baseline to post-test, 3-months, and 6-months follow-up
Depression measured with the CES-DChange 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

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.