Online Self-Help Intervention for Insomnia: With or Without Feedback

Phase 3

Completed

• Conditions: Insomnia
• Interventions: Behavioral: CBT for insomnia

• Registration Number: NCT01456637
• Lead Sponsor: Utrecht University

Brief Summary

The object of this study is to determine whether feedback added to a self-help protocol for insomnia enhances the treatment effect. In this study all participants receive an online self-help cognitive behavioral therapy (CBT) intervention 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. Half of the participants will received by e-mail from a therapist, the other half of the participants will do the intervention without feedback. Participants will be measured 4, 16, and 40 weeks after intervention with the same questionnaires.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-20
• Study First Submitted QC: 2011-10-20
• Study First Posted: 2011-10-21
• Primary Completion: 2012-05
• Study Completion: 2012-12
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-07
• Last Update Posted: 2013-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 262

Inclusion Criteria

• Insomnia
• Access to internet
• Dutch citizen

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBT for insomnia with feedback	CBT for insomnia	In this arm participants received internet based self-help CBT for insomnia with e-mail feedback form a therapist.
CBT for insomnia without feedback	CBT for insomnia	In this arm participants receive internet based self-help CBT for insomnia without feedback from a therapist.

Primary Outcome Measures

Name	Time	Method
Sleep diary	baseline	Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Sleep Quality.
Diary	6 month follow-up	Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Sleep Quality.

Secondary Outcome Measures

Name	Time	Method
Insomnia Severity	6 month follow-up	Insomnia Severity Index
Insomnia severity	4-week follow-up	Insomnia Severity Index
Anxiety	6-month follow-up	HADS
Depression	6-month follow-up	CES-D

Trial Locations

Locations (1)

Utrecht University; 🇳🇱 Utrecht, Netherlands