Clinical trial NCT01663844: New Clinical Applications for Internet-based Cognitive Behavior Therapy for Insomnia and Depression
Official title: New Clinical Applications for Internet-based Cognitive Behavior Therapy: An Adaptive Treatment Strategy to Decrease the Number of Failed Treatments, and a Combination Treatment for Insomnia and Depression.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Major Depression
Minor Depression
Keywords: Cognitive behavior therapy
Internet treatment
Self-help treatment
Insomnia
Depression
ICBT
CBT-i
CBT-d
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2012-08-13
Enrollment: 440
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. Both are included in this singe registration since they have parallel inclusion of participants and have been approved by the Swedish ethics board together in one application.

Trial 1 includes patients with both insomnia and major or minor depression. Participants are randomized to either a combined therapist guided Internet-CBT for insomnia and depression, or to Internet-CBT for depression with an addition of a placebo intervention for insomnia. The primary purpose is to evaluate changes in insomnia and depression severity for the combination treatment compared to the depression treatment, after treatment and at 6 and 36 months follow up. A secondary purpose is to evaluate cognitive functioning before and after treatment, as well as cost effectiveness. Recruitment is done in the Stockholm County through mass media and the Internet psychiatry clinic's regular patient recruitment.

Trial 2 includes patients with insomnia who do not meet criteria for major or minor depression. All participants start therapist guided Internet-CBT for insomnia. After 4 weeks patients that are judged to be at risk of treatment failure are randomized to either continued treatment or treatment with added support intended to enhance outcome. The primary purpose is to evaluate change in insomnia severity for participants who get added support, compared to continued treatment with regular support level. A secondary purpose is to evaluate cognitive functioning before and after treatment, as well as cost effectiveness. Recruitment is done in the Stockholm County through mass media and the Internet psychiatry clinic's regular patient recruitment.

NOTE:

The first participants in trial 1 will be regarded as pilots, due to problems with the experimental treatment: technical issues as well as problems with the design of treatment modules. These problems were corrected when discovered. 12 participants in the experimental arm were affected by these errors. The pilot participants will not be included in the main analyses of data. This was decided upon on 31st of October 2014.


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 1: Meets criteria for Major or Minor Depressive Disorder according to DSM-IV-TR (for minor depression a MADRS-S-level of \>19 is required).

Exclusion Criteria:

* Sleep disorders requiring other treatment
* Alcohol/drugs abuse
* 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 2: Meets criteria for Major or Minor Depressive Disorder according to DSM-IV-TR (for minor depression a MADRS-S-level of \>19 is required for exclusion).

Primary outcomes:
measure: Change (from baseline) in Insomnia Severity Index (ISI)
timeFrame: 0, 6 and 36 months after treatment
measure: Change (from baseline) in Montgomery Asberg Depression Rating Scale, MADRS-S
timeFrame: 0, 6 and 36 months after treatment
Secondary outcomes:
measure: Change (from baseline) in Sleep Diary
timeFrame: Directly after treatment
measure: Changes (from baseline) in Actigraph data
timeFrame: Directly post treatment
measure: Change (from baseline) in Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)
timeFrame: 0, 6 and 36 months after treatment
measure: Change (from baseline) in Cognitive functioning
timeFrame: Directly at post-treatment
measure: Change (from baseline) in EuroQuol. EQ-5D
timeFrame: 0, 6 and 36 months after treatment
measure: Change (from baseline) in Sheehan Disability Scale
timeFrame: 0, 6 and 36 months after treatment
measure: Change (from baseline) in Clinical Outcome in Routine Evaluation - 10, CORE-OM
timeFrame: 0, 6 and 36 months after treatment
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Internetpsykiatrienheten (Internet Psychiatry Clinic) Psykiatri Sydväst, SLSO
Study officials:
affiliation: Karolinska Institutet
name: Viktor Kaldo, PhD
role: PRINCIPAL_INVESTIGATOR
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: Forsell E, Jernelov S, Blom K, Kraepelien M, Svanborg C, Andersson G, Lindefors N, Kaldo V. Proof of Concept for an Adaptive Treatment Strategy to Prevent Failures in Internet-Delivered CBT: A Single-Blind Randomized Clinical Trial With Insomnia Patients. Am J Psychiatry. 2019 Apr 1;176(4):315-323. doi: 10.1176/appi.ajp.2018.18060699. Epub 2019 Jan 30.