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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03110263
Other study ID # 2016-00295
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


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
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