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NCT00851188 Clinical Trial

Internet Delivered Self-help for Insomnia

Insomnia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00851188
Other study ID # UU-vandenBout
Secondary ID
Status Completed
Phase N/A
First received February 24, 2009
Last updated June 12, 2012
Start date January 2009
Est. completion date April 2010

Study information
Verified date June 2012
Source Utrecht University
Contact n/a
Is FDA regulated No
Health authority Netherlands: Medical Ethics Review Committee (METC)
Study type Interventional

Clinical Trial Summary

The current study aims to evaluate the effects of internet-delivered self-help CBT for insomnia through a randomised controlled trial. Adult persons with insomnia will be invited via a popular scientific website to fill out online questionnaires. Participants will be randomised into treatment groups or the waiting list. Participants will be measured 4, 16, and 40 weeks after intervention with the same questionnaires.

Recruitment information / eligibility
Status Completed
Enrollment 626
Est. completion date April 2010
Est. primary completion date April 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Insomnia

- Access to the internet

Exclusion Criteria:

- Alcohol or substance abuse

- Severe depression

- Being suicidal

- Sleep apnea

- Schizophrenic or having a psychosis disorder

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Behavioral:
• Internet CBT self-help
Internet based Cognitive behavioral self-help method for insomnia
• CBT self-help booklet
Cognitive behavioral self-help method for insomnia via booklet
Other:
• Waiting list
Waiting list

Locations
Country Name City State
Netherlands Utrecht University Utrecht

Sponsors (1)
Lead Sponsor Collaborator
Jaap Lancee

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sleep Diary Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Day ratings. 1 year No
Secondary Anxiety rating Measured with the HADS 1 year No
Secondary Depression ratings Measured with the CES-D 1 year No
Secondary Sleep medication Measured in the daily diary log 1 year No
See also
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Not yet recruiting NCT06348082 - Project Women's Insomnia Sleep Health Equity Study (WISHES) N/A
Not yet recruiting NCT06363799 - Osteopathic Protocol for Insomnia in College Students N/A
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