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Completed

NCT Number: NCT03177967

"Get up" - The Sleep Study in Oppegard

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)

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Key information

Conditions

Sleep Initiation and Maintenance Disorders Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oppegård kommune

Kolbotn, Akershus, 1410, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sleep Restriction Therapy/Stimulus Control

Behavioral

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.

Discussions about adverse cognitions about sleep

Other

Group discussions about insomnia, CBT-i treatment and it's effects

Psychoeducative advice about how to improve sleep

Other

Learning about sleep and sleep hygiene tips. It also includes learning about stimulus control and sleep restriction.

Primary outcomes

  1. Insomnia Severity Index

    Time frame: 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 outcomes

  1. Generalized Anxiety Disorder 7-item Scale (GAD-7)

    Time frame: 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

  2. The Patient Health Questionnaire (PHQ-9)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Norwegian Institute of Public Health

Other Gov

Collaborators

  • University of Oslo

Registry information

Official study title

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

Acronym: Stå Opp

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 6, 2017
Registry last updated
Mar 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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