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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Insomnia, Major Depression, Minor Depression

Intervention / Treatment
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* Behavioral: Therapist guided Internet-CBT for insomnia w. extra support
* Behavioral: Therapist guided Internet-CBT for insomnia
* Behavioral: Therapist guided Internet-CBT for insomnia and depression
* Behavioral: Therapist Guided Internet-CBT for depression plus insomnia placebo


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: (Study 1) ICBT for insomnia and depression<br> | Behavioral: Therapist guided Internet-CBT for insomnia and depression<br>* (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.<br>|
| Active Comparator: (Study 1) ICBT for depr. plus placebo insomnia intervention<br> | Behavioral: Therapist Guided Internet-CBT for depression plus insomnia placebo<br>* (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.<br>|
| Experimental: (Study 2) ICBT for insomnia with added support<br> | Behavioral: Therapist guided Internet-CBT for insomnia w. extra support<br>* (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.<br>|
| Active Comparator: (Study 2) ICBT for insomnia with regular level of support<br> | Behavioral: Therapist guided Internet-CBT for insomnia<br>* (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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive behavior therapy, Internet treatment, Self-help treatment, Insomnia, Depression, ICBT, CBT-i, CBT-d