Self-help Cognitive Behavioral Therapy (CBT) for Insomnia
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Insomnia |
Behavioral: Self-help CBT-I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Cognitive Behavioral Therapy as Guided Self-help for Insomnia - a Randomized Controlled Trial |
- Sleep diary [ Time Frame: Six weeks after beginning of treatment ] [ Designated as safety issue: No ]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.
- Sleep diary [ Time Frame: 5 months after beginning of treatment (i.e. about three months after the end of treatment) ] [ Designated as safety issue: No ]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.
- Sleep diary [ Time Frame: 15 months after the end of treatment ] [ Designated as safety issue: No ]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.
- Insomnia Severity Index [ Time Frame: Six weeks after beginning of treatment ] [ Designated as safety issue: No ]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).
- Insomnia Severity Index [ Time Frame: 5 months after beginning of treatment (i.e. about three months after the end of treatment) ] [ Designated as safety issue: No ]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).
- Insomnia Severity Index [ Time Frame: 15 months after the end of treatment ] [ Designated as safety issue: No ]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).
| Enrollment: | 133 |
| Study Start Date: | February 2008 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Bibliotherapy
A group receiving a self-help book to work on for six weeks with no therapist support.
|
Behavioral: Self-help CBT-I
Comparison between Bibliotherapy with and without support to a wait-list control group
|
|
Experimental: Bibliotherapy with support
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
Comparison between Bibliotherapy with and without support to a wait-list control group
|
|
No Intervention: Wait-list control group
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.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Sweden | |
| Karolinska Institutet | |
| Stockholm, Sweden, 171 77 | |
| Study Chair: | Mats Lekander, Ass prof | Karolinska Institutet |
More Information
No publications provided by Karolinska Institutet
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Mats Lekander, Karolinska Instutitet |
| ClinicalTrials.gov Identifier: | NCT01105052 History of Changes |
| Other Study ID Numbers: | 2008/23-31/4 |
| Study First Received: | April 12, 2010 |
| Last Updated: | April 14, 2010 |
| Health Authority: | Sweden: Regional Ethical Review Board |
Keywords provided by Karolinska Institutet:
|
Insomnia Co-morbid CBT Self-help Bibliotherapy |
Additional relevant MeSH terms:
|
Sleep Initiation and Maintenance Disorders Sleep Disorders, Intrinsic Dyssomnias |
Sleep Disorders Nervous System Diseases Mental Disorders |
ClinicalTrials.gov processed this record on May 19, 2013