Self-help Cognitive Behavioral Therapy (CBT) for Insomnia

Study Overview
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Brief Summary
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The purpose of this study is to investigate whether a self-help book for insomnia, with or without therapist support, can improve sleep and alleviate insomnia symptoms in individuals suffering from insomnia, also for persons presenting with different kinds of co-morbid problems.

Detailed Description
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CBT has previously been identified as an effective treatment for insomnia. However, there is a lack of trained CBT-therapists, and self-help is beginning to prove useful for many areas of psychological distress. Earlier studies of different kinds of self-help (e.g. computer based and bibliotherapeutic) suggest that many patients do indeed benefit from self-help treatments for insomnia, but there is a need for independent replications. Also, most previous studies have had very strict inclusion criteria, such that for instance only individuals with primary insomnia and no co-morbid problems have been included. A general question in self-help is whether patients need therapist support to benefit from treatment, or if a book is enough to alleviate symptoms.

Official Title
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Cognitive Behavioral Therapy as Guided Self-help for Insomnia - a Randomized Controlled Trial

Conditions
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Insomnia

Intervention / Treatment
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* Behavioral: Self-help CBT-I


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 and above Diagnosis of Insomnia (Research Diagnostic Criteria) Access to computer Ability to read and write Swedish Exclusion Criteria: Severe psychopathology (e.g. bipolar disorder, suicidality) Shift work

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 |
| --- | --- |
| Active Comparator: Bibliotherapy<br>A group receiving a self-help book to work on for six weeks with no therapist support. | Behavioral: Self-help CBT-I<br>* Comparison between Bibliotherapy with and without support to a wait-list control group<br>|
| Experimental: Bibliotherapy with support<br>A group receiving a self-help book to work on for six weeks, together with brief weekly telephone calls (<15 minutes) from a therapist. | Behavioral: Self-help CBT-I<br>* Comparison between Bibliotherapy with and without support to a wait-list control group<br>|
| No Intervention: Wait-list control group<br>This group receives no intervention until about five months after the two treatment groups, when participants in this group receive the self-help book without therapist support. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep diary | Daily self-observation of sleeping behaviours used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and gagues Sleep Quality, Daytime Ratings, Daytime Fatique and Bedtime Stress. | Six weeks after beginning of treatment | 
| Sleep diary | Daily self-observation of sleeping behaviours used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and gagues Sleep Quality, Daytime Ratings, Daytime Fatique and Bedtime Stress. | 5 months after beginning of treatment (i.e. about three months after the end of treatment) | 
| Sleep diary | Daily self-observation of sleeping behaviours used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and gagues Sleep Quality, Daytime Ratings, Daytime Fatique and Bedtime Stress. | 15 months after the end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia Severity Index | 7-item patient-reported outcome assessing the severity of initial, middle and late insomnia; sleep satisfaction; interference of insomnia with daytime functioning; noticeability of sleep problems by others; and distress about sleep difficulties. A 5-point scale is used to rate each item, yielding a total score of 0 to 28. Higher score indicates more severe insomnia within 4 severity categories: absence of insomnia (score of 0-7); subthreshold insomnia (8-14); moderate insomnia (15-21) and severe insomnia (22-28). | Six weeks after beginning of treatment | 
| Insomnia Severity Index | 7-item patient-reported outcome assessing the severity of initial, middle and late insomnia; sleep satisfaction; interference of insomnia with daytime functioning; noticeability of sleep problems by others; and distress about sleep difficulties. A 5-point scale is used to rate each item, yielding a total score of 0 to 28. Higher score indicates more severe insomnia within 4 severity categories: absence of insomnia (score of 0-7); subthreshold insomnia (8-14); moderate insomnia (15-21) and severe insomnia (22-28). | 5 months after beginning of treatment (i.e. about three months after the end of treatment) | 
| Insomnia Severity Index | 7-item patient-reported outcome assessing the severity of initial, middle and late insomnia; sleep satisfaction; interference of insomnia with daytime functioning; noticeability of sleep problems by others; and distress about sleep difficulties. A 5-point scale is used to rate each item, yielding a total score of 0 to 28. Higher score indicates more severe insomnia within 4 severity categories: absence of insomnia (score of 0-7); subthreshold insomnia (8-14); moderate insomnia (15-21) and severe insomnia (22-28). | 15 months after the end of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insomnia, Co-morbid, CBT, Self-help, Bibliotherapy