Self-help Cognitive Behavioral Therapy (CBT) for Insomnia
Primary Purpose
Insomnia
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Self-help CBT-I
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia focused on measuring Insomnia, Co-morbid, CBT, Self-help, Bibliotherapy
Eligibility Criteria
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
Sites / Locations
- Karolinska Institutet
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
No Intervention
Arm Label
Bibliotherapy
Bibliotherapy with support
Wait-list control group
Arm Description
A group receiving a self-help book to work on for six weeks with no therapist 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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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).
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).
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).
Full Information
NCT ID
NCT01105052
First Posted
April 12, 2010
Last Updated
April 14, 2010
Sponsor
Karolinska Institutet
Collaborators
Stiftelsen Professor Bror Gadelius Minnesfond
1. Study Identification
Unique Protocol Identification Number
NCT01105052
Brief Title
Self-help Cognitive Behavioral Therapy (CBT) for Insomnia
Official Title
Cognitive Behavioral Therapy as Guided Self-help for Insomnia - a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Karolinska Institutet
Collaborators
Stiftelsen Professor Bror Gadelius Minnesfond
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
Insomnia, Co-morbid, CBT, Self-help, Bibliotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
133 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bibliotherapy
Arm Type
Active Comparator
Arm Description
A group receiving a self-help book to work on for six weeks with no therapist support.
Arm Title
Bibliotherapy with support
Arm Type
Experimental
Arm Description
A group receiving a self-help book to work on for six weeks, together with brief weekly telephone calls (<15 minutes) from a therapist.
Arm Title
Wait-list control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Self-help CBT-I
Intervention Description
Comparison between Bibliotherapy with and without support to a wait-list control group
Primary Outcome Measure Information:
Title
Sleep diary
Description
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.
Time Frame
Six weeks after beginning of treatment
Title
Sleep diary
Description
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.
Time Frame
5 months after beginning of treatment (i.e. about three months after the end of treatment)
Title
Sleep diary
Description
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.
Time Frame
15 months after the end of treatment
Secondary Outcome Measure Information:
Title
Insomnia Severity Index
Description
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).
Time Frame
Six weeks after beginning of treatment
Title
Insomnia Severity Index
Description
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).
Time Frame
5 months after beginning of treatment (i.e. about three months after the end of treatment)
Title
Insomnia Severity Index
Description
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).
Time Frame
15 months after the end of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mats Lekander, Ass prof
Organizational Affiliation
Karolinska Institutet
Official's Role
Study Chair
Facility Information:
Facility Name
Karolinska Institutet
City
Stockholm
ZIP/Postal Code
171 77
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
33813233
Citation
Kraepelien M, Blom K, Forsell E, Hentati Isacsson N, Bjurner P, Morin CM, Jernelov S, Kaldo V. A very brief self-report scale for measuring insomnia severity using two items from the Insomnia Severity Index - development and validation in a clinical population. Sleep Med. 2021 May;81:365-374. doi: 10.1016/j.sleep.2021.03.003. Epub 2021 Mar 16.
Results Reference
derived
PubMed Identifier
22264332
Citation
Jernelov S, Lekander M, Blom K, Rydh S, Ljotsson B, Axelsson J, Kaldo V. Efficacy of a behavioral self-help treatment with or without therapist guidance for co-morbid and primary insomnia--a randomized controlled trial. BMC Psychiatry. 2012 Jan 22;12:5. doi: 10.1186/1471-244X-12-5.
Results Reference
derived
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Self-help Cognitive Behavioral Therapy (CBT) for Insomnia
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