Online or Face-to-face Treatment for Insomnia?
- 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
- 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
- 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
Name Time Method 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 Index Change from baseline to post-test, 3-months, and 6-months follow-up
- Secondary Outcome Measures
Name Time Method 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 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 diary Change from baseline to post-test, 3-months, and 6-months follow-up Depression measured with the CES-D 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
Trial Locations
- Locations (1)
Department of Clinical Psychology
🇳🇱Amsterdam, Noord Holland, Netherlands
Department of Clinical Psychology🇳🇱Amsterdam, Noord Holland, Netherlands