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

Study Overview
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Brief Summary
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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.

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

Conditions
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Insomnia

Intervention / Treatment
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* Behavioral: CBT for insomnia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Insomnia Access to internet Dutch citizen Exclusion Criteria: Alcohol or substance abuse Being suicidal Sleep apnea Schizophrenic or having a psychosis disorder

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT for insomnia with feedback<br>In this arm participants received internet based self-help CBT for insomnia with e-mail feedback form a therapist. | Behavioral: CBT for insomnia<br>* 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).<br>|
| Experimental: CBT for insomnia without feedback<br>In this arm participants receive internet based self-help CBT for insomnia without feedback from a therapist. | Behavioral: CBT for insomnia<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep diary | Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Sleep Quality. | baseline | 
| Diary | Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Sleep Quality. | 4-week follow-up | 
| Diary | Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Sleep Quality. | 6 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia Severity | Insomnia Severity Index | baseline | 
| Insomnia severity | Insomnia Severity Index | 4-week follow-up | 
| Insomnia Severity | Insomnia Severity Index | 6 month follow-up | 
| Anxiety | HADS | baseline | 
| Anxiety | HADS | 4-week follow-up | 
| Anxiety | HADS | 6-month follow-up | 
| Depression | CES-D | baseline | 
| Depression | CES-D | 4-week follow-up | 
| Depression | CES-D | 6-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insomnia, Intervention, Self-help, Internet