Get up - The Sleep Study in Oppegard

Study Overview
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Brief Summary
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A randomized, controlled study to examine the effect of group treatment for insomnia (CBT-I) in an outpatient clinic compared with waiting list and treatment-as-usual (sleep-hygiene based educational course)

Detailed Description
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Insomnia is a large public health concern with latest reports pointing to almost 15 % of the population in Norway having insomnia (Pallesen, Sivertsen, Nordhus, & Bjorvatn, 2014). At the same time there is a scientific consensus about how to best treat insomnia (CBT-I), and it is empirically proven that this is quite effective treatment (Okajima, Komada & Inoue, 2011). We therefore want to conduct a study to examine if CBT-I treatment in an public outpatient clinic is effective compared with waiting list and a psychoeducational course. The design is a randomized controlled study with three different conditions (CBT-I versus waiting list versus TAU) that will be compared over time. We will use an A-B-design which can effectively compare the different conditions in the study. We have recruited a total of 62 patients, and completed a individual session with each of these individuals resulting in a total admission of 38 participants in the study. The remaining 24 patients either didn't fit the selection criteria, or we were unable to get in touch with them to agree on an appointment. Of the 38 participants enrolled in the study, 16 will get CBT-I, Group based treatment during May and June of 2017 (a total of seven sessions over nine weeks), and the remaining 22 will get the same treatment in September and October 2017. The maximum number of patients per group is eight (8) and we randomized whether participants got assigned to treatment in May/June or September/October. We measure all participants at the individual pre-screening (T1), Treatment Group 1 and 2 gets treatment in May and June and will be measured in every other treatment session (2,4,6 and 7) From now on called (T2, T3, T4, T5). Treatment Group 3,4 and 5 (all getting treatment i September/October) is measured at T2 and T5. T1 was conducted during the last week of April and T5 is towards the end of June 2017. Treatment Group 3, 4 and 5 will start their treatment and be measured at session 2 (T6) in mid-September, and Treatment Group 1 and 2 will also be measured at this point. Treatment Group 3, 4 and 5 will then be measured at treatment session 4,6 and 7, just like treatment Group 1 and 2 was during their treatment. (From now on T7, T8, T9). Treatment Groups 1 and 2 will also be measured at T9. The treatment-as-usual condition is conducted in Nesodden kommune, and it is a psychoeducative, learning based course. This course consists of 4 sessions, and the participants is measured at session 1,3 and 4 in addition to a 6 months follow-up measure. They also get measured at pre-screening. We expect about 16 participants to complete this course.

Official Title
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Get up - The Sleep Study in Oppegard (Stå Opp - Søvnstudien i Oppegård)

Conditions
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Sleep Initiation and Maintenance Disorders

Intervention / Treatment
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* Behavioral: Sleep Restriction Therapy/Stimulus Control
* Other: Discussions about adverse cognitions about sleep
* Other: Psychoeducative advice about how to improve sleep


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: persons above the age of 18 living in the municipalities of Oppegård and Ski fits the criteria for moderate or severe clinical insomnia, as measured by Insomnia Severity Index (Bastien C. H., Valliéres A., Morin C. M., 2001) Exclusion Criteria: bipolar disorder epilepsy severe depressive episode psychosis disorders somatic sleep disorders (untreated sleep apnea, restless leg syndrome, narcolepsy, and sleepwalking) persons with a high risk of falling at home persons handling heavy machinery severe personality disorders

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment groups spring (1,2)<br>Seven sessions CBT-I treatment for two different groups of eight participants (n=16) Interventions: Sleep restriction/Stimulus Control Discussion of adverse cognitions about sleep | Behavioral: Sleep Restriction Therapy/Stimulus Control<br>* Sleep Restriction Therapy focuses on forcing your available sleep time into a fixed window. The sleeper sets a bedtime and wake-up time and sticks to those times closely. The time allocated for being allowed in bed is determined from an estimate of how long the patient in average has been sleeping during the night, in the week before treatment. The goal is to have the patient sleeping the entire time he or she is in bed by making this period so restricted that the patient has no chance of sleeping enough. Once this goal is achieved, the time allocated for bed can be slowly increased, for example by 15 minutes at a time. After enough iterations, an equilibrium is achieved that the patient can keep maintaining after treatment has completed.<br>Other: Discussions about adverse cognitions about sleep<br>* Group discussions about insomnia, CBT-i treatment and it's effects<br>|
| Experimental: Waiting list - Treatment groups fall<br>This group (n=22) receives no treatment during the spring and summer, and is measured three times as a waiting list control in this period of time. The same group will receive treatment i three different groups during sept/oct. Interventions: Sleep restriction/Stimulus Control Discussion of adverse cognitions about sleep | Behavioral: Sleep Restriction Therapy/Stimulus Control<br>* Sleep Restriction Therapy focuses on forcing your available sleep time into a fixed window. The sleeper sets a bedtime and wake-up time and sticks to those times closely. The time allocated for being allowed in bed is determined from an estimate of how long the patient in average has been sleeping during the night, in the week before treatment. The goal is to have the patient sleeping the entire time he or she is in bed by making this period so restricted that the patient has no chance of sleeping enough. Once this goal is achieved, the time allocated for bed can be slowly increased, for example by 15 minutes at a time. After enough iterations, an equilibrium is achieved that the patient can keep maintaining after treatment has completed.<br>Other: Discussions about adverse cognitions about sleep<br>* Group discussions about insomnia, CBT-i treatment and it's effects<br>|
| Active Comparator: Psychoeducative course in Nesodden<br>This group (expected to be n=16) will receive a four session psychoeducative learning based course on how to manage insomnia Interventions: Psychoeducative advice to improve sleep | Other: Psychoeducative advice about how to improve sleep<br>* Learning about sleep and sleep hygiene tips. It also includes learning about stimulus control and sleep restriction.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia Severity Index | Reduction in score on the Insomnia Severity Index | We expect the decline in insomnia symptoms to start by session four (late may, 2017), and continue through session six (medio june, 2017) and seven (late june, 2017), and to be maintained at six-months follow up (november, 2017). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Generalized Anxiety Disorder 7-item Scale (GAD-7) | Reduction in anxiety symptoms by the end of the treatment period | We expect the decline in anxiety symptoms to start declining by session four (late may, 2017), and to be maintained at six-months follow up (november, 2017). | 
| The Patient Health Questionnaire (PHQ-9) | Reduction in symptoms of depression by the end of the treatment period | We expect the decline in symptoms of depression to start declining by session four (late may, 2017), and to be maintained at six-months follow up (november, 2017). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insomnia, Cognitive behavioral treatment for insomnia (CBT-I)