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

March 12, 2019 updated by: Norwegian Institute of Public Health

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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Akershus
      • Kolbotn, Akershus, Norway, 1410
        • Oppegård kommune

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment groups spring (1,2)

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
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.
Other: Discussions about adverse cognitions about sleep
Group discussions about insomnia, CBT-i treatment and it's effects
Experimental: Waiting list - Treatment groups fall

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
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.
Other: Discussions about adverse cognitions about sleep
Group discussions about insomnia, CBT-i treatment and it's effects
Active Comparator: Psychoeducative course in Nesodden

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
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
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)
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
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian Institute of Public Health

Collaborators

University of Oslo

Investigators

  • Study Chair: Knut Inge Klepp, PhD, Executive Director

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2017

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

June 2, 2017

First Submitted That Met QC Criteria

June 5, 2017

First Posted (Actual)

June 6, 2017

Study Record Updates

Last Update Posted (Actual)

March 13, 2019

Last Update Submitted That Met QC Criteria

March 12, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017/462

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

  1. Study Protocol
    Information comments: The study protocol is unfortunately only available in Norwegian at the time being.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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