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Online Self-Help Intervention for Insomnia: With or Without Feedback

Online Self-Help Intervention for Insomnia: With or Without Feedback

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01456637
Enrollment
262
Registered
2011-10-21
Start date
2011-10-31
Completion date
2012-12-31
Last updated
2013-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia

Keywords

Insomnia, Intervention, Self-help, Internet

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.

Interventions

BEHAVIORALCBT for insomnia

The techniques used throughout the self-help manual are all effective in reducing insomnia: 1) Stimulus control: patients should only go to bed when sleepy, use the bed and bedroom for sleep (and sex) only, maintain a regular rising time, avoid daytime naps and get out of bed and go into another room when unable to fall asleep within 15-20 minutes (return only when sleepy). 2) progressive muscle relaxation. 3) sleep hygiene education (improving health and environmental factors that affect sleep). 3). Sleep restriction, whereby participants will stay only the time in bed that they sleep. 4) cognitive therapy to challenge and dispute incorrect and unhelpful thoughts about sleep (e.g. I must sleep at least 8 hours, otherwise I'll be a wreck tomorrow).

Sponsors

Utrecht University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Insomnia * Access to internet * Dutch citizen

Exclusion criteria

* Alcohol or substance abuse * Being suicidal * Sleep apnea * Schizophrenic or having a psychosis disorder

Design outcomes

Primary

MeasureTime frameDescription
Sleep diarybaselineDaily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Sleep Quality.
Diary4-week follow-upDaily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Sleep Quality.

Secondary

MeasureTime frameDescription
Insomnia SeveritybaselineInsomnia Severity Index
Insomnia severity4-week follow-upInsomnia Severity Index
AnxietybaselineHADS
DepressionbaselineCES-D

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026