Internet-CBT for Insomnia

Study Overview
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Brief Summary
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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.

Official Title
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Guided Internet-treatment for Insomnia. Treatment Effects, Health Economics and Interaction With Depression

Conditions
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Insomnia, Depression

Intervention / Treatment
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* Behavioral: Therapist guided Internet-CBT for insomnia
* Behavioral: Brief Internet-CBT for insomnia, without support
* Behavioral: Therapist Guided Internet-CBT for depression


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 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

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Guided Internet-CBT for insomnia<br> | Behavioral: Therapist guided Internet-CBT for insomnia<br>* 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<br>|
| Placebo Comparator: Control treatment<br> | Behavioral: Brief Internet-CBT for insomnia, without support<br>* No support and less text, not including the CBT-methods that are presumed to be most effective to reduce Insomnia symptoms<br>|
| Experimental: Guided Internet-CBT for insomnia (9)<br>(9 weeks instead of 8) | Behavioral: Therapist guided Internet-CBT for insomnia<br>* 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<br>|
| Active Comparator: Guided Internet-CBT for depression<br> | Behavioral: Therapist Guided Internet-CBT for depression<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia Severity Index (ISI) | 7-item, self-rated questionnaire measuring 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. | Post-treatment (9 weeks) | 
| MADRS-S | The use of two primary outcomes are motivated since the purpose is to look at effects on both insomnia and depression. In trial 1 the former is used to predict the latter, and in Trial 2 the patientents suffer from both conditions. The MADRS-S is a 9-item self-rated measure of depression severity and 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. | Post-treatment (9 weeks) | 
| ISI |  | 6-month follow-up | 
| ISI |  | 1-year follow-up | 
| ISI |  | 3-years follow-up | 
| MADRS-S |  | 6-month follow-up | 
| MADRS-S |  | 1-year follow-up | 
| MADRS-S |  | 3-years follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Diary | One week of self-ratings on a number of sleep parameters, resluting in measures of sleep latency, total sleep time, sleep efficacy, number of nighttime awakenings, subjecitve sleep quality and daytime functioning | Same as primary outcomes | 
| Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P) | Health economic questionnaire evalutation cost for health care, abscence 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 | Same as Primary outcomes | 
| 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. | Same as primary outcomes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Self-help treatment, Internet treatment, CBT, Prevention, Comorbidity