Self-help Cognitive Behavioral Therapy (CBT) for Insomnia

This study has been completed.
Sponsor:
Collaborator:
Stiftelsen Professor Bror Gadelius Minnesfond
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01105052
First received: April 12, 2010
Last updated: April 14, 2010
Last verified: April 2010
  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

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01105052

Locations
Sweden
Karolinska Institutet
Stockholm, Sweden, 171 77
Sponsors and Collaborators
Karolinska Institutet
Stiftelsen Professor Bror Gadelius Minnesfond
Investigators
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 April 15, 2014