NCT02261272

Brief Summary

The study will test an internet-based treatment for insomnia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
11 months until next milestone

First Posted

Study publicly available on registry

October 10, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

September 21, 2016

Status Verified

September 1, 2016

Enrollment Period

2.2 years

First QC Date

November 1, 2013

Last Update Submit

September 20, 2016

Conditions

Psychophysiologic Insomnia

Outcome Measures

Primary Outcomes (1)

  • Insomnia symptoms

    Self-reported questionnaires (Berge Insomnia Scale and Insomnia Severity Index)): change from baseline to post-treatment and FU

    Assessment points: pre- and post-treatment (6 weeks after baseline), and 6 and 18 month FU

Secondary Outcomes (2)

  • Daytime functioning (mental health problems and fatigue)

    Assessment points: pre- and post-treatment (6 weeks after baseline), and 6 and 18 month FU

  • Sleep diary data

    Assessment points: pre- and post-treatment (6 weeks after baseline), and 6 and 18 month FU

Study Arms (2)

CBT for insomnia

EXPERIMENTAL

Cognitive-behavioral therapy for insomnia

Behavioral: CBT for insomnia SHUTi

Sleep Hygiene

ACTIVE COMPARATOR

Psychoeducational intervention based on standard sleep hygiene advices

Behavioral: passive patient education/sleep hygiene

Interventions

CBT for insomnia SHUTiBEHAVIORAL

SHUTi

CBT for insomnia
passive patient education/sleep hygieneBEHAVIORAL
Sleep Hygiene

Eligibility Criteria

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

You may qualify if:

  • age 18 years or older
  • fulfillment of the DMS-IV criteria for insomnia
  • duration of at least 3 months
  • complaints of impaired daytime functioning

You may not qualify if:

  • presence of a major depressive disorder or other severe mental disorder as identified by in the telephone interview
  • working night shifts and unable to discontinue this work pattern
  • having a serious somatic condition preventing further participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian Institute of Public Health

Bergen, 5000, Norway

Location

Related Publications (3)

  • Lien M, Bredeli E, Sivertsen B, Kallestad H, Pallesen S, Smith ORF, Faaland P, Ritterband LM, Thorndike FP, Vedaa O. Short and long-term effects of unguided internet-based cognitive behavioral therapy for chronic insomnia in morning and evening persons: a post-hoc analysis. Chronobiol Int. 2019 Oct;36(10):1384-1398. doi: 10.1080/07420528.2019.1647435. Epub 2019 Aug 1.

    PMID: 31368382DERIVED

  • Vedaa O, Hagatun S, Kallestad H, Pallesen S, Smith ORF, Thorndike FP, Ritterband LM, Sivertsen B. Long-Term Effects of an Unguided Online Cognitive Behavioral Therapy for Chronic Insomnia. J Clin Sleep Med. 2019 Jan 15;15(1):101-110. doi: 10.5664/jcsm.7580.

    PMID: 30621837DERIVED

  • Hagatun S, Vedaa O, Harvey AG, Nordgreen T, Smith ORF, Pallesen S, Havik OE, Thorndike FP, Ritterband LM, Sivertsen B. Internet-delivered cognitive-behavioral therapy for insomnia and comorbid symptoms. Internet Interv. 2018 Feb 21;12:11-15. doi: 10.1016/j.invent.2018.02.003. eCollection 2018 Jun.

    PMID: 30135764DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 1, 2013

First Posted

October 10, 2014

Study Start

November 1, 2013

Primary Completion

January 1, 2016

Study Completion

August 1, 2016

Last Updated

September 21, 2016

Record last verified: 2016-09

Locations

NO(1)