Self-help Cognitive Behavioral Therapy (CBT) for Insomnia

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

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.

Study Overview

• Status: Completed
• Conditions: Insomnia
• Intervention / Treatment: Behavioral: Self-help CBT-I

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.

• Study Type: Interventional
• Enrollment (Actual): 133
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 171 77
    • Karolinska Institutet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Stiftelsen Professor Bror Gadelius Minnesfond
• Investigators: Study Chair: Mats Lekander, Ass prof, Karolinska Institutet

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: April 12, 2010
• First Submitted That Met QC Criteria: April 14, 2010
• First Posted (Estimate): April 16, 2010

Study Record Updates

• Last Update Posted (Estimate): April 16, 2010
• Last Update Submitted That Met QC Criteria: April 14, 2010
• Last Verified: April 1, 2010

More Information

Terms related to this study

• Keywords: Insomnia; CBT; Self-help; Bibliotherapy; Co-morbid
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 2008/23-31/4