Clinical trial NCT01105052: Self-help Cognitive Behavioral Therapy (CBT) for Insomnia
Official title: Cognitive Behavioral Therapy as Guided Self-help for Insomnia - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Keywords: Insomnia
Co-morbid
CBT
Self-help
Bibliotherapy
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Stiftelsen Professor Bror Gadelius Minnesfond
First posted: 2010-04-16
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Sleep diary
timeFrame: Six weeks after beginning of treatment
measure: Sleep diary
timeFrame: 5 months after beginning of treatment (i.e. about three months after the end of treatment)
measure: Sleep diary
timeFrame: 15 months after the end of treatment
Secondary outcomes:
measure: Insomnia Severity Index
timeFrame: Six weeks after beginning of treatment
measure: Insomnia Severity Index
timeFrame: 5 months after beginning of treatment (i.e. about three months after the end of treatment)
measure: Insomnia Severity Index
timeFrame: 15 months after the end of treatment
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Mats Lekander, Ass prof
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.