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Completed

NCT Number: NCT01105052

Self-help Cognitive Behavioral Therapy (CBT) for Insomnia

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.

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institutet

Stockholm, 171 77, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-help CBT-I

Behavioral

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

Primary outcomes

  1. Sleep diary

    Time frame: Six weeks after beginning 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.

  2. Sleep diary

    Time frame: 5 months after beginning of treatment (i.e. about three 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.

  3. Sleep diary

    Time frame: 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 outcomes

  1. Insomnia Severity Index

    Time frame: Six weeks after beginning 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).

  2. Insomnia Severity Index

    Time frame: 5 months after beginning of treatment (i.e. about three 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).

  3. Insomnia Severity Index

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Stiftelsen Professor Bror Gadelius Minnesfond

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Apr 16, 2010
Registry last updated
Apr 16, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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