"Get up" - The Sleep Study in Oppegard

NCT03177967 | Completed

• 1 other identifier: 2017/462
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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)

Conditions

Sleep Initiation and Maintenance Disorders

Keywords

Insomnia; Cognitive behavioral treatment for insomnia (CBT-I)

Outcome Measures

Primary Outcomes (1)

• Insomnia Severity Index

  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 Outcomes (2)

• 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).

• 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).

Study Arms (3)

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

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

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

Other: Psychoeducative advice about how to improve sleep

Interventions

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.

Treatment groups spring (1,2); Waiting list - Treatment groups fall

Discussions about adverse cognitions about sleep OTHER

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

Treatment groups spring (1,2); Waiting list - Treatment groups fall

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.

Psychoeducative course in Nesodden

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Norwegian Institute of Public Health: lead
• University of Oslo: collaborator

Study Sites (1)

Oppegård kommune

Kolbotn, Akershus, 1410, Norway

Location

Related Publications (7)

• 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

  BACKGROUND

• 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.

  PMID: 24382513 BACKGROUND

• Kessler 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.

  PMID: 21886353 BACKGROUND

• Sivertsen 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.

  PMID: 22879427 BACKGROUND

• Irwin 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.

  PMID: 16448292 BACKGROUND

• Trauer 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.

  PMID: 26054060 BACKGROUND

• Falloon 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.

  PMID: 26212846 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Knut Inge Klepp, PhD

  Executive director

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2017
• First Posted: June 6, 2017
• Study Start: April 24, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 13, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)