Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
191 participants
INTERVENTIONAL
2010-01-31
2015-02-28
Brief Summary
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In trial 1 patients suffering from insomnia but not meeting the criteria for depression are randomised to either therapist guided Internet-based CBT for insomnia or to a control group with a non-guided, brief self-help program that acts as a placebo control. The primary purpose is to evaluate reduction in Insomnia severity (compared to placebo) after treatment and at follow-ups at 6-month, 1 year and 3 years. Secondary purpose is to evaluate the costeffectiveness of the treatment and to evaluate if the insomnia treatment has a preventive effect on future depressive episodes. Recruitment is done through mass media and includes all regions of Sweden. Initial assessment based on questionnaires and telephone interviews.
Trial 2 includes patients suffering from both Insomnia and depression. Randomization is done between either CBT for insomnia or CBT for depression (both Internet-based) to evaluate each respective treatment's effect on both insomnia and depression. The patients need for further treatment after the initial one will be measured and used as a secondary outcome. Recruitment is done through mass media but only citizens in the Stockholm area are included since the initial assessment are based on both questionnaires and telephone interviews as well as a visit at a psychiatrist located at the Internet psychiatry clinic in Stockholm.
Both trials will include health economic data and analysis. For the longer follow-up periods (1 and 3 years), registers will be used to analyse consumption of sleep medication and antidepressants as well as general health care utilization.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Guided Internet-CBT for insomnia
Therapist guided Internet-CBT for insomnia
An 8 week long, structured self-help program with weekly reports to, and feedback from, a CBT therapist over the Internet. Includes traditional CBT-methods for insomnia
Control treatment
Brief Internet-CBT for insomnia, without support
No support and less text, not including the CBT-methods that are presumed to be most effective to reduce Insomnia symptoms
Guided Internet-CBT for insomnia (9)
(9 weeks instead of 8)
Therapist guided Internet-CBT for insomnia
An 8 week long, structured self-help program with weekly reports to, and feedback from, a CBT therapist over the Internet. Includes traditional CBT-methods for insomnia
Guided Internet-CBT for depression
Therapist Guided Internet-CBT for depression
An 9 week long, structured self-help program with weekly reports to, and feedback from, a CBT therapist over the Internet. Includes traditional CBT-methods for depression. Information and methods regarding sleep difficulties removed
Interventions
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Therapist guided Internet-CBT for insomnia
An 8 week long, structured self-help program with weekly reports to, and feedback from, a CBT therapist over the Internet. Includes traditional CBT-methods for insomnia
Brief Internet-CBT for insomnia, without support
No support and less text, not including the CBT-methods that are presumed to be most effective to reduce Insomnia symptoms
Therapist Guided Internet-CBT for depression
An 9 week long, structured self-help program with weekly reports to, and feedback from, a CBT therapist over the Internet. Includes traditional CBT-methods for depression. Information and methods regarding sleep difficulties removed
Eligibility Criteria
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Inclusion Criteria
* Meets criteria for Insomnia according to DSM-IV-TR
* Enough language skills
* Only Trial 2: Meets criteria for Major Depressive Disorder according to DSM-IV-TR
Exclusion Criteria
* High consumption of alcohol/drugs that affect sleep
* Started to use or changed the dose of antidepressant drug during the last 2 months
* Somatic or psychiatric conditions requiring acute care
* Working night shifts
* Only Trial 1: Meets criteria for Major Depressive Disorder according to DSM-IV-TR
18 Years
ALL
No
Sponsors
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Region Stockholm
OTHER_GOV
Karolinska Institutet
OTHER
Responsible Party
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Viktor Kaldo
Principal Investigator
Locations
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Karolinska Institutet
Stockholm, , Sweden
Countries
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References
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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.
Blom K, Jernelov S, Ruck C, Lindefors N, Kaldo V. Three-Year Follow-Up Comparing Cognitive Behavioral Therapy for Depression to Cognitive Behavioral Therapy for Insomnia, for Patients With Both Diagnoses. Sleep. 2017 Aug 1;40(8). doi: 10.1093/sleep/zsx108.
Blom K, Jernelov S, Ruck C, Lindefors N, Kaldo V. Three-Year Follow-Up of Insomnia and Hypnotics after Controlled Internet Treatment for Insomnia. Sleep. 2016 Jun 1;39(6):1267-74. doi: 10.5665/sleep.5850.
Blom K, Jernelov S, Kraepelien M, Bergdahl MO, Jungmarker K, Ankartjarn L, Lindefors N, Kaldo V. Internet treatment addressing either insomnia or depression, for patients with both diagnoses: a randomized trial. Sleep. 2015 Feb 1;38(2):267-77. doi: 10.5665/sleep.4412.
Related Links
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The public page of the Internet-CBT treatment platform
Other Identifiers
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2009/1810-31/3
Identifier Type: -
Identifier Source: org_study_id
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