"Get up" - The Sleep Study in Oppegard (Stå Opp)

Norwegian Institute of Public Health

Status: Completed

Conditions: Sleep Initiation and Maintenance Disorders

Treatments: Behavioral: Sleep Restriction Therapy/Stimulus Control; Other: Psychoeducative advice about how to improve sleep; Other: Discussions about adverse cognitions about sleep

Study type: Interventional

Funder types: Other

Identifiers

NCT03177967

2017/462

Details and patient eligibility

About

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)

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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38 participants in 3 patient groups

Treatment groups spring (1,2)

Experimental group

Description:

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

Treatment:

Behavioral: Sleep Restriction Therapy/Stimulus Control

Other: Discussions about adverse cognitions about sleep

Waiting list - Treatment groups fall

Experimental group

Description:

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

Treatment:

Behavioral: Sleep Restriction Therapy/Stimulus Control

Other: Discussions about adverse cognitions about sleep

Psychoeducative course in Nesodden

Active Comparator group

Description:

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

Treatment:

Other: Psychoeducative advice about how to improve sleep