Internet-based Treatment for Insomnia

Norwegian Institute of Public Health200 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

200

Conditions

Psychophysiologic Insomnia

Interventions

CBT for insomnia SHUTiBEHAVIORAL

SHUTi

passive patient education/sleep hygieneBEHAVIORAL

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Norwegian Institute of Public Health

Bergen, Norway

Outcomes

Primary Outcomes

Insomnia symptoms

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

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

Secondary Outcomes

Daytime functioning (mental health problems and fatigue)

Self-reported questionnaires

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

Sleep diary data

Sleep duration, sleep onset latency and nocturnal wake time: change from baseline to post-treatment and FU

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

Data from ClinicalTrials.gov

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