New Clinical Applications for Internet-based Cognitive Behavior Therapy for Insomnia and Depression

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.

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.

Study Overview

• Status: Completed
• Conditions: Insomnia; Major Depression; Minor Depression
• Intervention / Treatment: Behavioral: Therapist guided Internet-CBT for insomnia and depression; Behavioral: Therapist Guided Internet-CBT for depression plus insomnia placebo; Behavioral: Therapist guided Internet-CBT for insomnia w. extra support; Behavioral: Therapist guided Internet-CBT for insomnia

• Study Type: Interventional
• Enrollment (Anticipated): 440
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, S-14186
    • Internetpsykiatrienheten (Internet Psychiatry Clinic) Psykiatri Sydväst, SLSO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: (Study 1) ICBT for insomnia and depression	Behavioral: Therapist guided Internet-CBT for insomnia and depression; (Study 1) A 12 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 and depression.
Active Comparator: (Study 1) ICBT for depr. plus placebo insomnia intervention	Behavioral: Therapist Guided Internet-CBT for depression plus insomnia placebo; (Study 1) A 12 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. A placebo intervention for insomnia is added.
Experimental: (Study 2) ICBT for insomnia with added support	Behavioral: Therapist guided Internet-CBT for insomnia w. extra support; (Study 2) A 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 insomnia plus extra therapist support.
Active Comparator: (Study 2) ICBT for insomnia with regular level of support	Behavioral: Therapist guided Internet-CBT for insomnia; (Study 2) A 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 insomnia. Regular therapist support.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change (from baseline) in Insomnia Severity Index (ISI)	7-item, self-rated questionnaire measuring change in insomnia severity. Bastien, C. H., Vallières, A., & Morin, C. M. (2001). Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Medicine, 2, 297-307.	0, 6 and 36 months after treatment
Change (from baseline) in Montgomery Asberg Depression Rating Scale, MADRS-S	Defined as secondary outcome measure in Trial 2. The use of two primary outcomes in trial 1 is motivated since participants have both diagnoses and the purpose is to look at effects on both insomnia and depression. The MADRS-S is a 9-item self-rated measure of change in depression severity. It also screens for suicidality. Mattila-Evenden, M., Svanborg, P., Gustavsson, P., & Åsberg, M. (1996). Determinants of self-rating and expert rating concordance in psychiatric out-patients, using the affective subscales of CPRS. Acta Psychiatr Scand, 94, 386-396.	0, 6 and 36 months after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change (from baseline) in Sleep Diary	One week of self-ratings on a number of sleep parameters, resulting in measures of sleep latency, total sleep time, sleep efficacy, number of nighttime awakenings, subjective sleep quality and daytime functioning.	Directly after treatment
Changes (from baseline) in Actigraph data	An actigraph is placed on the participant's arm for one week. They measure participants' activity in the form of movements. It will be used for acquiring sleep data and calculate sleep latency, total sleep time, sleep efficacy, number of nighttime awakenings and daytime activity.	Directly post treatment
Change (from baseline) in Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)	Health economic questionnaire evaluation cost for health care, absence of work capacity and related costs. Hakkaart-Van Roijen, L.,Van Straten, A., & Donker, M. (2002). Manual: Trimbos/iMTA Questionnaire for Costs Associated with Psychiatric Illness. Rotterdam: Erasmus University	0, 6 and 36 months after treatment
Change (from baseline) in Cognitive functioning	Computer based testing of executive functions, concentration, speed and memory.	Directly at post-treatment
Change (from baseline) in EuroQuol. EQ-5D	General quality of life measure to complement the TIC-P in health economic analysis. Hinz, A., Klaiberg, A., Brahler, E., & Konig, H.H. (2006). The Quality of Life Questionnaire EQ-5D: modelling and norm values for the general population. Psychother.Psychosom.Med.Psychol., 56, 42-48.	0, 6 and 36 months after treatment
Change (from baseline) in Sheehan Disability Scale	Measures daily life functioning. Sheehan, D. V. (1983). The Anxiety disease. Scribner: New York	0, 6 and 36 months after treatment
Change (from baseline) in Clinical Outcome in Routine Evaluation - 10, CORE-OM	Measures psychological health in general. Evans, C., Connell, J., Barkham, M., Margison, F., McGrath, G., Mellor-Clark, J. & Audin, K. (2002). Towards a standardised brief outcome measure: psychometric properties and utility of the CORE-OM. The British journal of psychiatry : the journal of mental science 180, 51-60.	0, 6 and 36 months after treatment

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Region Stockholm
• Investigators: Principal Investigator: Viktor Kaldo, PhD, Karolinska Institutet

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• The public page of the Internet Psychiatry Clinic

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): May 1, 2022

Study Registration Dates

• First Submitted: August 3, 2012
• First Submitted That Met QC Criteria: August 9, 2012
• First Posted (Estimate): August 13, 2012

Study Record Updates

• Last Update Posted (Actual): July 18, 2022
• Last Update Submitted That Met QC Criteria: July 15, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Depression; Insomnia; Cognitive behavior therapy; Internet treatment; Self-help treatment; ICBT; CBT-i; CBT-d
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Nervous System Diseases; Mood Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Depression; Depressive Disorder; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 2012/934-31/4