Online Self-Help Intervention for Insomnia: With or Without Feedback
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Utrecht University
- Enrollment
- 262
- Locations
- 2
- Primary Endpoint
- Sleep diary
Study Overview
Brief Summary
The object of this study is to determine whether feedback added to a self-help protocol for insomnia enhances the treatment effect. In this study all participants receive an online self-help cognitive behavioral therapy (CBT) intervention consisting of information (psycho-education) about sleep and cognitive-behavioural exercises. Adult persons with insomnia will be invited via a popular scientific website to fill out online questionnaires. Half of the participants will received by e-mail from a therapist, the other half of the participants will do the intervention without feedback. Participants will be measured 4, 16, and 40 weeks after intervention with the same questionnaires.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Access to internet
- •Dutch citizen
Exclusion Criteria
- •Alcohol or substance abuse
- •Being suicidal
- •Sleep apnea
- •Schizophrenic or having a psychosis disorder
Outcomes
Primary Outcomes
Sleep diary
Time Frame: baseline
Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Sleep Quality.
Diary
Time Frame: 6 month follow-up
Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Sleep Quality.
Secondary Outcomes
- Insomnia Severity(6 month follow-up)
- Insomnia severity(4-week follow-up)
- Anxiety(6-month follow-up)
- Depression(6-month follow-up)