Clinical trial NCT01256099: Internet-CBT for Insomnia
Official title: Guided Internet-treatment for Insomnia. Treatment Effects, Health Economics and Interaction With Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Depression
Keywords: Self-help treatment
Internet treatment
CBT
Prevention
Comorbidity
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2010-12-08
Enrollment: 191
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: This study includes two sub-trials.

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.


Eligibility criteria: Inclusion Criteria:

* Clinical level of Insomnia (more than 10 on ISI)
* 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:

* Sleep disorders requiring other treatment
* 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

Primary outcomes:
measure: Insomnia Severity Index (ISI)
timeFrame: Post-treatment (9 weeks)
measure: MADRS-S
timeFrame: Post-treatment (9 weeks)
measure: ISI
timeFrame: 6-month follow-up
measure: ISI
timeFrame: 1-year follow-up
measure: ISI
timeFrame: 3-years follow-up
measure: MADRS-S
timeFrame: 6-month follow-up
measure: MADRS-S
timeFrame: 1-year follow-up
measure: MADRS-S
timeFrame: 3-years follow-up
Secondary outcomes:
measure: Sleep Diary
timeFrame: Same as primary outcomes
measure: Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)
timeFrame: Same as Primary outcomes
measure: EQ-5D
timeFrame: Same as primary outcomes
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
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: 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.
citation: 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.
citation: 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.