Phase 2
Completed N=118
Internet-based Treatment for Chronic Insomnia
Source: ClinicalTrials.gov NCT00821041 ↗Enrolled (actual)
118
Serious AEs
0.0%
Results posted
Sep 2011
Primary outcomePrimary: Sleep Quality — 1.77; 2.18 0-4 scale of sleep quality
Summary
Study Objectives. Despite effective cognitive behavioral treatments for chronic insomnia, such treatments are underutilized. This study evaluates the impact of a 6-week, online treatment for insomnia.
Design This is a randomized controlled trial with online treatment and waiting list control conditions.
Participants
Participants are adults in Manitoba Canada with chronic insomnia.
Setting
Participants receive online treatment from their homes. Intervention. Online treatment consists of psychoeducation, sleep hygiene and stimulus control instruction, sleep restriction treatment, mindfulness training, relaxation training, cognitive therapy, and help with medication tapering. Measurement and Results. The impact of online treatment on primary end points of sleep quality, insomnia severity, and daytime fatigue will be assessed.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sleep Quality |
1.77; 2.18 | — |
| SECONDARY Pre-Sleep Arousal |
25.46; 22.42 | — |
| SECONDARY Beliefs and Attitudes About Sleep |
— | — |
Eligibility Criteria
Inclusion Criteria
- Access to high speed internet, insomnia duration > 6 months and occurring at least 4 nights per week, sleep-onset latency > 30 minutes and/or time awake at night > 30 minutes, and/or early morning awakening > 30 minutes before desired time, at least one type of daytime impairment.
Exclusion Criteria
- Shift work, acute suicidality, mania, schizophrenia, head injury, alcohol intake > 14 drinks/week for males, > 12 drinks per week for females, current or past behavioral treatment for insomnia
Data sourced from ClinicalTrials.gov (NCT00821041). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.