Sleep Initiation and Maintenance DisordersStå OppNCT03177967
"Get up" - The Sleep Study in Oppegard
A study testing Discussions about adverse cognitions about sleep and Psychoeducative advice about how to improve sleep in people with Sleep Initiation and Maintenance Disorders, run by Norwegian Institute of Public Health at 1 site in Norway.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Initiation and Maintenance Disorders
- What is being tested?
- Discussions about adverse cognitions about sleep and Psychoeducative advice about how to improve sleep
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteNorway
- Study dates
- 24 Apr 2017to 1 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: "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)
Read the 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.
- Being tested
- Sleep Restriction Therapy/Stimulus Control, Discussions about adverse cognitions about sleep, Psychoeducative advice about how to improve sleep
- Keywords
- Insomnia, Cognitive behavioral treatment for insomnia (CBT-I)
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Restriction Therapy/Stimulus ControlBehavioural
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 sleepOther
Group discussions about insomnia, CBT-i treatment and it's effects
Psychoeducative advice about how to improve sleepOther
Learning about sleep and sleep hygiene tips. It also includes learning about stimulus control and sleep restriction.
| Study group | Role | What they receive |
|---|---|---|
| Treatment groups spring (1,2) | Experimental | 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 Receives: Behavioral: Sleep Restriction Therapy/Stimulus Control; Other: Discussions about adverse cognitions about sleep |
| Waiting list - Treatment groups fall | Experimental | 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 Receives: Behavioral: Sleep Restriction Therapy/Stimulus Control; Other: Discussions about adverse cognitions about sleep |
| Psychoeducative course in Nesodden | Active comparator | 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 Receives: Other: Psychoeducative advice about how to improve sleep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index
Reduction in score on the Insomnia Severity Index
Measured: 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 outcomes (2)
Generalized Anxiety Disorder 7-item Scale (GAD-7)
Reduction in anxiety symptoms by the end of the treatment period
Measured: 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
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start24 Apr 2017
- Primary completion1 Dec 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Sleep Initiation and Maintenance DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian Institute of Public Health
- Sponsor type
- Other government
- Collaborators
- University of Oslo
- Responsible party
- Sponsor
- Investigators
- Knut Inge Klepp, PhD, Study chair, Executive director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03177967
- Sponsor's protocol ID
- 2017/462
- Acronym
- Stå Opp
- Status last verified
- Mar 2019
- First submitted
- 2 Jun 2017
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Okajima, I., Komada, Y. and Inoue, Y. (2011), A meta-analysis on the treatment effectiveness of cognitive behavioral therapy for primary insomnia. Sleep and Biological Rhythms, 9: 24-34. doi:10.1111/j.1479-8425.2010.00481.x
Pallesen S, Sivertsen B, Nordhus IH, Bjorvatn B. A 10-year trend of insomnia prevalence in the adult Norwegian population. Sleep Med. 2014 Feb;15(2):173-9. doi: 10.1016/j.sleep.2013.10.009. Epub 2013 Dec 1.
PubMed 24382513Kessler RC, Berglund PA, Coulouvrat C, Hajak G, Roth T, Shahly V, Shillington AC, Stephenson JJ, Walsh JK. Insomnia and the performance of US workers: results from the America insomnia survey. Sleep. 2011 Sep 1;34(9):1161-71. doi: 10.5665/SLEEP.1230.
PubMed 21886353Sivertsen B, Salo P, Mykletun A, Hysing M, Pallesen S, Krokstad S, Nordhus IH, Overland S. The bidirectional association between depression and insomnia: the HUNT study. Psychosom Med. 2012 Sep;74(7):758-65. doi: 10.1097/PSY.0b013e3182648619. Epub 2012 Aug 9.
PubMed 22879427Irwin MR, Cole JC, Nicassio PM. Comparative meta-analysis of behavioral interventions for insomnia and their efficacy in middle-aged adults and in older adults 55+ years of age. Health Psychol. 2006 Jan;25(1):3-14. doi: 10.1037/0278-6133.25.1.3.
PubMed 16448292Trauer JM, Qian MY, Doyle JS, Rajaratnam SM, Cunnington D. Cognitive Behavioral Therapy for Chronic Insomnia: A Systematic Review and Meta-analysis. Ann Intern Med. 2015 Aug 4;163(3):191-204. doi: 10.7326/M14-2841.
PubMed 26054060Falloon K, Elley CR, Fernando A 3rd, Lee AC, Arroll B. Simplified sleep restriction for insomnia in general practice: a randomised controlled trial. Br J Gen Pract. 2015 Aug;65(637):e508-15. doi: 10.3399/bjgp15X686137.
PubMed 26212846
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Get up" - The Sleep Study in Oppegard (Stå Opp - Søvnstudien i Oppegård)
- ClinicalTrials.gov ID
- NCT03177967
- Acronym / sponsor ID
- Stå Opp / 2017/462
- Keywords
- Insomnia, Cognitive behavioral treatment for insomnia (CBT-I)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Norwegian Institute of Public HealthOther government
- Collaborators
- University of Oslo
- Study start
- 24 Apr 2017 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 6 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment groups spring (1,2) | Experimental | Behavioral: Sleep Restriction Therapy/Stimulus Control, Other: Discussions about adverse cognitions about sleepSeven sessions CBT-I treatment for two different groups of eight participants (n=16) Interventions: Sleep restriction/Stimulus Control Discussion of adverse cognitions about sleep |
| Waiting list - Treatment groups fall | Experimental | Behavioral: Sleep Restriction Therapy/Stimulus Control, Other: Discussions about adverse cognitions about sleepThis 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 |
| Psychoeducative course in Nesodden | Active comparator | Other: Psychoeducative advice about how to improve sleepThis 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (8 listed)
- bipolar disorder
- epilepsy
- severe depressive episode
- psychosis disorders
- somatic sleep disorders (untreated sleep apnea, restless leg syndrome, narcolepsy, and sleepwalking)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep Restriction Therapy/Stimulus ControlSleep 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. | Behavioural | Treatment groups spring (1,2), Waiting list - Treatment groups fall |
| Discussions about adverse cognitions about sleepGroup discussions about insomnia, CBT-i treatment and it's effects | Other | Treatment groups spring (1,2), Waiting list - Treatment groups fall |
| Psychoeducative advice about how to improve sleepLearning about sleep and sleep hygiene tips. It also includes learning about stimulus control and sleep restriction. | Other | Psychoeducative course in Nesodden |
Primary outcome
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
2 secondary outcomes
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- BackgroundOkajima, I., Komada, Y. and Inoue, Y. (2011), A meta-analysis on the treatment effectiveness of cognitive behavioral therapy for primary insomnia. Sleep and Biological Rhythms, 9: 24-34. doi:10.1111/j.1479-8425.2010.00481.x
- Background: PubMed 24382513Pallesen S, Sivertsen B, Nordhus IH, Bjorvatn B. A 10-year trend of insomnia prevalence in the adult Norwegian population. Sleep Med. 2014 Feb;15(2):173-9. doi: 10.1016/j.sleep.2013.10.009. Epub 2013 Dec 1.
- Background: PubMed 21886353Kessler RC, Berglund PA, Coulouvrat C, Hajak G, Roth T, Shahly V, Shillington AC, Stephenson JJ, Walsh JK. Insomnia and the performance of US workers: results from the America insomnia survey. Sleep. 2011 Sep 1;34(9):1161-71. doi: 10.5665/SLEEP.1230.
- Background: PubMed 22879427Sivertsen B, Salo P, Mykletun A, Hysing M, Pallesen S, Krokstad S, Nordhus IH, Overland S. The bidirectional association between depression and insomnia: the HUNT study. Psychosom Med. 2012 Sep;74(7):758-65. doi: 10.1097/PSY.0b013e3182648619. Epub 2012 Aug 9.
- Background: PubMed 16448292Irwin MR, Cole JC, Nicassio PM. Comparative meta-analysis of behavioral interventions for insomnia and their efficacy in middle-aged adults and in older adults 55+ years of age. Health Psychol. 2006 Jan;25(1):3-14. doi: 10.1037/0278-6133.25.1.3.
- Background: PubMed 26054060Trauer JM, Qian MY, Doyle JS, Rajaratnam SM, Cunnington D. Cognitive Behavioral Therapy for Chronic Insomnia: A Systematic Review and Meta-analysis. Ann Intern Med. 2015 Aug 4;163(3):191-204. doi: 10.7326/M14-2841.
- Background: PubMed 26212846Falloon K, Elley CR, Fernando A 3rd, Lee AC, Arroll B. Simplified sleep restriction for insomnia in general practice: a randomised controlled trial. Br J Gen Pract. 2015 Aug;65(637):e508-15. doi: 10.3399/bjgp15X686137.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Knut Inge Klepp, PhD study chair
Executive director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Discussions about adverse cognitions about sleep and Psychoeducative advice about how to improve sleep in people with Sleep Initiation and Maintenance Disorders, run by Norwegian Institute of Public Health at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03177967, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2019.