Self-help Cognitive Behavioral Therapy (CBT) for Insomnia

NCT ID: NCT01105052

Last Updated: 2010-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 133 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2009-12-31

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.

Conditions

Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bibliotherapy

A group receiving a self-help book to work on for six weeks with no therapist support.

Group Type: ACTIVE_COMPARATOR

Self-help CBT-I

Intervention Type: BEHAVIORAL

Comparison between Bibliotherapy with and without support to a wait-list control group

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.

Group Type: EXPERIMENTAL

Self-help CBT-I

Intervention Type: BEHAVIORAL

Comparison between Bibliotherapy with and without support to a wait-list control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Self-help CBT-I

Comparison between Bibliotherapy with and without support to a wait-list control group

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stiftelsen Professor Bror Gadelius Minnesfond

UNKNOWN

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Karolinska Instutitet

Principal Investigators

Mats Lekander, Ass prof

Role: STUDY_CHAIR

Karolinska Institutet

Locations

Karolinska Institutet

Stockholm, , Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 33813233 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22264332 (View on PubMed)

Other Identifiers

2008/23-31/4

Identifier Type: -

Identifier Source: org_study_id