Clinical trial NCT02261272: Internet-based Treatment for Insomnia
Official title: Internet-based Treatment for Insomnia in Norway.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychophysiologic Insomnia
Lead sponsor: Norwegian Institute of Public Health
Sponsor class: OTHER_GOV
First posted: 2014-10-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: This study will develop and evaluate the feasibility of a cost-effective, more accessible alternative treatment approach for insomnia. Traditional CBT, including the behavioral, cognitive, and educational aspects, will be operationalized and transformed for an Internet intervention system, so individuals can access a personalized treatment any time, at their own convenience. Phase 1 of this study will involve developing the web program. The investigators research team and collaborators has extensive experience developing such web interventions, as well as considerable experience with insomnia. Phase 2 will be a large randomized controlled trial testing the Internet intervention compared to passive patient education/sleep hygiene. Two hundred individuals with insomnia will be assessed pre and post the six week treatment program. It is hypothesized that the Internet intervention will promote improvements in sleep, mood, and cognitive functioning. If successful, the current project may result in improved implementation of a low-threshold treatment for a common disorder with devastating impact on both individual and socioeconomic outcomes

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Insomnia symptoms
timeFrame: Assessment points: pre- and post-treatment (6 weeks after baseline), and 6 and 18 month FU
Secondary outcomes:
measure: Daytime functioning (mental health problems and fatigue)
timeFrame: Assessment points: pre- and post-treatment (6 weeks after baseline), and 6 and 18 month FU
measure: Sleep diary data
timeFrame: Assessment points: pre- and post-treatment (6 weeks after baseline), and 6 and 18 month FU
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Norwegian Institute of Public Health
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.