Self-help Cognitive Behavioral Therapy (CBT) for Insomnia

Not Applicable

Completed

• Conditions: Insomnia
• Interventions: Behavioral: Self-help CBT-I

• Registration Number: NCT01105052
• Lead Sponsor: Karolinska Institutet

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.

Study Timeline

• Study Start: 2008-02
• Primary Completion: 2009-01
• Study Completion: 2009-12
• Status Verified: 2010-04
• Study First Submitted: 2010-04-12
• Study First Submitted QC: 2010-04-14
• Last Update Submitted: 2010-04-14
• Study First Posted: 2010-04-16
• Last Update Posted: 2010-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bibliotherapy	Self-help CBT-I	A group receiving a self-help book to work on for six weeks with no therapist support.
Bibliotherapy with support	Self-help CBT-I	A group receiving a self-help book to work on for six weeks, together with brief weekly telephone calls (\<15 minutes) from a therapist.

Primary Outcome Measures

Name	Time	Method
Sleep diary	15 months after the end of treatment	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

Name	Time	Method
Insomnia Severity Index	15 months after the end of treatment	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).

Trial Locations

Locations (1)

Karolinska Institutet; 🇸🇪 Stockholm, Sweden