NCT03110263

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 10, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 12, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2018

Completed
Last Updated

January 14, 2019

Status Verified

January 1, 2019

Enrollment Period

1.2 years

First QC Date

March 28, 2017

Last Update Submit

January 10, 2019

Conditions

Insomnia

Outcome Measures

Primary Outcomes (3)

  • Insomnia Severity Index (ISI)

    Baseline

  • Insomnia Severity Index (ISI)

    8-weeks

  • Insomnia Severity Index (ISI)

    6-months

Secondary Outcomes (9)

  • Diagnosis of Insomnia

    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

  • +4 more secondary outcomes

Study Arms (3)

Multicomponent internet-based self-help

EXPERIMENTAL

Multicomponent internet-based self-help

Other: Multicomponent internet-based self-help

Internet-based sleep restriction

EXPERIMENTAL

Internet-based sleep restriction

Other: Internet-based sleep restriction

Waiting control group

NO INTERVENTION

Access to internet-based intervention after 8-weeks

Interventions

Multicomponent internet-based self-helpOTHER

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.

Multicomponent internet-based self-help
Internet-based sleep restrictionOTHER

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.

Internet-based sleep restriction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bern

Bern, 3012, Switzerland

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Thomas Berger, PhD

    University of Bern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2017

First Posted

April 12, 2017

Study Start

June 10, 2016

Primary Completion

August 16, 2017

Study Completion

January 7, 2018

Last Updated

January 14, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)