Internet Delivered Self-Help CBT for Insomnia

Phase 3

Completed

• Conditions: Insomnia
• Interventions: Behavioral: Cognitive Behavioral Treatment

• Registration Number: NCT01224912
• Lead Sponsor: Utrecht University

Brief Summary

The object of this study is to determine variables associated with therapy-success of a cognitive behavioral self help intervention for insomnia. In this study all participants receive an online self-help CBT manual consisting of information (psycho-education) about sleep and cognitive-behavioural exercises. Adult persons with insomnia will be invited via a popular scientific website to fill out online questionnaires. Participants will be measured 4, 16, and 40 weeks after intervention with the same questionnaires.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-18
• Study First Submitted QC: 2010-10-19
• Study First Posted: 2010-10-20
• Primary Completion: 2011-12
• Study Completion: 2012-10
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-07
• Last Update Posted: 2013-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 479

Inclusion Criteria

• Insomnia
• Access to the internet

Exclusion Criteria

• Alcohol or substance abuse
• Being suicidal
• Sleep apnea
• Schizophrenic or having a psychosis disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Internet Deliviered CBT for Insomnia	Cognitive Behavioral Treatment	Cognitive behavioral self-help method for insomnia via the Internet

Primary Outcome Measures

Name	Time	Method
Sleep diary	48-week follow-up	Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Day ratings.

Secondary Outcome Measures

Name	Time	Method
Anxiety	48-week follow-up	HADS
Depression	48-week follow-up	CES-D
Sleep medication	48-week follow-up	Sleep medication as measured by the sleep diary
Insomnia Severity	Baseline	Insomnia Severity Index
Insomnia severity	48-week follow-up	Insomnia Severity Index

Trial Locations

Locations (1)

Utrecht University; 🇳🇱 Utrecht, Netherlands