i-Sleep: Internet-based Treatment for Insomnia

Insomnia Clinical Trial

— i-Sleep  

Official title:

i-Sleep: Internet-based Treatment for Insomnia. A Randomized Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03110263
• Other study ID #: 2016-00295
• Status: Terminated
• Phase: N/A
• Start date: June 10, 2016
• Est. completion date: January 7, 2018

Study information

• Verified date: January 2019
• Source: University of Bern
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 104
• Est. completion date: January 7, 2018
• Est. primary completion date: August 16, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Other:
• Multicomponent internet-based self-help
Internet-based self-help on the basis of (Perlis, M. L., Jungquist, C., Smith, M. T., & Posner, D., 2006). The self-help program consists of eight text-based sessions and tasks. All participants in the active conditions receive guidance during 8-weeks treatment.
• Internet-based sleep restriction
Internet-based self-help on the basis of (Perlis, M. L., Jungquist, C., Smith, M. T., & Posner, D., 2006). The self-help program consists of five text-based sessions and tasks. All participants in the active conditions receive guidance during 8-weeks treatment.

Locations

Country	Name	City	State
Switzerland	University of Bern	Bern

Sponsors (2)

Lead Sponsor	Collaborator
University of Bern	University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

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