i-Sleep: Internet-based Treatment for Insomnia (i-Sleep)

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

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.

Study Overview

• Status: Terminated
• Conditions: Insomnia
• Intervention / Treatment: Other: Multicomponent internet-based self-help; Other: Internet-based sleep restriction

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3012
    • University of Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multicomponent internet-based self-help	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.
Experimental: Internet-based sleep restriction	Other: 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.
No Intervention: Waiting control group; Access to internet-based intervention after 8-weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Insomnia Severity Index (ISI)	Baseline
Insomnia Severity Index (ISI)	8-weeks
Insomnia Severity Index (ISI)	6-months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Bern
• Collaborators: University Hospital Inselspital, Berne
• Investigators: Principal Investigator: Thomas Berger, PhD, University of Bern

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2016
• Primary Completion (Actual): August 16, 2017
• Study Completion (Actual): January 7, 2018

Study Registration Dates

• First Submitted: March 28, 2017
• First Submitted That Met QC Criteria: April 5, 2017
• First Posted (Actual): April 12, 2017

Study Record Updates

• Last Update Posted (Actual): January 14, 2019
• Last Update Submitted That Met QC Criteria: January 10, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 2016-00295

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No