"Get up" - The Sleep Study in Oppegard
- Conditions
- Sleep Initiation and Maintenance Disorders
- Registration Number
- NCT03177967
- Lead Sponsor
- Norwegian Institute of Public Health
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method 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). Reduction in score on the Insomnia Severity Index
- Secondary Outcome Measures
Name Time Method The Patient Health Questionnaire (PHQ-9) 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). Reduction in symptoms of depression by the end of the treatment period
Generalized Anxiety Disorder 7-item Scale (GAD-7) 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). Reduction in anxiety symptoms by the end of the treatment period
Trial Locations
- Locations (1)
Oppegård kommune
🇳🇴Kolbotn, Akershus, Norway
Oppegård kommune🇳🇴Kolbotn, Akershus, Norway