i-Sleep: Internet-based Treatment for Insomnia

Not Applicable

Terminated

• Conditions: Insomnia

• Registration Number: NCT03110263
• Lead Sponsor: University of Bern

Brief Summary

In this study, people who suffer from insomnia will be randomized to one of three study conditions. The first group receives a multicomponent internet-based cognitive behavioral self-help intervention. The second group has access to an internet-based self-help sleep restriction intervention. The third group is a waiting control group. In both active conditions additional care or treatment is allowed. The aim of the study is to investigate the effectiveness of a multicomponent internet-based cognitive behavioral self-help intervention as well as a stand-alone internet-based self-help sleep restriction intervention for insomnia symptoms compared to a waiting list. Assessments take place at baseline, and 8-weeks and 6-months post-randomization. After 8 weeks, participants in the waiting control group get access to the internet-based cognitive behavioural self-help intervention and also fill out questionnaires at 6-months post-randomization.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-10
• Study First Submitted: 2017-03-28
• Study First Submitted QC: 2017-04-05
• Study First Posted: 2017-04-12
• Primary Completion: 2017-08-16
• Study Completion: 2018-01-07
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-10
• Last Update Posted: 2019-01-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

• Being 18 years of age or older
• Meet ICSD-3 diagnostic criteria for Insomnia as confirmed by the telephone administered Interview
• Acess to the Internet
• Written informed consent

Exclusion Criteria

• Physiological Insomnia
• Serious psychiatric co-morbidity that requires alternative treatment including major depression disorder, anxiety disorder, substance dependence, bipolar affective disorder, psychotic illness
• Epilepsy (seizure disorder)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Insomnia Severity Index (ISI)	6-months

Secondary Outcome Measures

Name	Time	Method
Dysfunctional Beliefs and Attitudes about Sleep 16 (DBAS-16)	Baseline, 8-weeks, 6-months
Diagnosis of Insomnia	Baseline, 8-weeks, 6-months	International Classification of Insomnia Disorders (ICSD-3)
Sleep-diary: Sleep efficiency (SE)	8-weeks
EuroQol	Baseline, 8-weeks, 6-months
Sleep-Diary-data	8-weeks
Empowerment Scale (ES)	Baseline, 8-weeks, 6-months
Usability: Satisfaction with the online program (SUS)	8-weeks
Pittsburgh Sleep Quality Index (PSQI)	Baseline, 8-weeks, 6-months
Patient satisfaction (ZUF-8)	8-weeks

Trial Locations

Locations (1)

University of Bern; 🇨🇭 Bern, Switzerland