Group Treatment for Insomnia in Primary Health Care (Sleep Prime)
Primary Purpose
Insomnia
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Group treatment for insomnia
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia focused on measuring Insomnia, Primary health care
Eligibility Criteria
Inclusion Criteria:
- Insomnia symptoms regarding DSM-V
- Motivated to group treatment.
Exclusion Criteria:
- Insomnia Severity Index less than 7 points
- Presence of acute life crises, acute psychiatric illness, bipolar disorder
- Shift work
- Linguistic or cognitive difficulties causing inability participate in group or fill in forms
- Insomnia directly caused by medical illness. Other sleep disorder.
Sites / Locations
- Centre for family medicine
- Centrum för allmanmedicin
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Group treatment for insomnia
No intervention
Arm Description
Group treatment for insomnia.
Treatment as usual
Outcomes
Primary Outcome Measures
Insomnia severity Index
Insomnia Severity Index (ISI)is a seven item self assessment scale measuring severity of insomnia symptoms during the last two weeks. The items asks about sleep disturbance, daytime functioning and worrying about sleep. The possibly response is 0 "None" 1 "Mild" 2 "Moderate" 3 "Severe" 4 "Very severe". The sum is added and 0-7 p grades the insomnia to "none clinically significant insomnia", 8-14 p "subtreshold insomnia", 15-21 p "moderate insomnia", 22-28 p "severe insomnia".
Secondary Outcome Measures
Fatigue severity scale
Measures fatigue symptoms in a seven item self assessment scale. Response from 1-7 points
Full Information
NCT ID
NCT01731223
First Posted
November 16, 2012
Last Updated
August 7, 2018
Sponsor
Jeanette Westman
Collaborators
Region Stockholm, Karolinska Institutet
1. Study Identification
Unique Protocol Identification Number
NCT01731223
Brief Title
Group Treatment for Insomnia in Primary Health Care
Acronym
Sleep Prime
Official Title
Group Treatment for Insomnia in Primary Health Care: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jeanette Westman
Collaborators
Region Stockholm, Karolinska Institutet
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to analyze if group treatment is effective to treat insomnia in primary healthcare.
Detailed Description
Insomnia is a common health problem. Untreated insomnia may lead to decreased physical and mental health. The patients turns to Primary Health Care when daytime symptoms decrease social and occupational function. Previous studies have shown that cognitive and behavioral therapy have effects on insomnia and recommends as first line treatment but is not widely available in primary health care.
The purpose is to test the effect of group intervention in Primary Health Care for patients with insomnia. The outcomes is insomnia severity, sleep habits, use of hypnotics, Fatigue, general health and health related quality of life. Characters with insomnia visiting in Primary Health Care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
Insomnia, Primary health care
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
165 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group treatment for insomnia
Arm Type
Experimental
Arm Description
Group treatment for insomnia.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
Treatment as usual
Intervention Type
Behavioral
Intervention Name(s)
Group treatment for insomnia
Intervention Description
Experimental: Group treatment of insomnia The intervention is a group treatment based on cognitive and behavioral changing methods. It is including seven sessions during 10 weeks. Each session last for 2 hours with a 20 minutes pause. The intervention includes psycho education about sleep. Methods as relaxation, coping with worry, sleep restriction, stimulus control, sleep hygiene, stress coping strategies, strategies for coping with daytime symptom, identify and reformulate negative and dysfunctional thoughts about sleep, daytime functioning and stress and strategies for reducing hypnotics.
Primary Outcome Measure Information:
Title
Insomnia severity Index
Description
Insomnia Severity Index (ISI)is a seven item self assessment scale measuring severity of insomnia symptoms during the last two weeks. The items asks about sleep disturbance, daytime functioning and worrying about sleep. The possibly response is 0 "None" 1 "Mild" 2 "Moderate" 3 "Severe" 4 "Very severe". The sum is added and 0-7 p grades the insomnia to "none clinically significant insomnia", 8-14 p "subtreshold insomnia", 15-21 p "moderate insomnia", 22-28 p "severe insomnia".
Time Frame
One year
Secondary Outcome Measure Information:
Title
Fatigue severity scale
Description
Measures fatigue symptoms in a seven item self assessment scale. Response from 1-7 points
Time Frame
one year
Other Pre-specified Outcome Measures:
Title
Sleep Logg
Description
Sleep log for every night during two weeks. The patient logs time going to bed, sleep latency, awakes during the night, time going up from bed in the morning, total sleep time, sleep quality graded from 1-5. ! is very bad and 5 is very good). Use of alcohol, hypnotics and herbs are noted
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Insomnia symptoms regarding DSM-V
Motivated to group treatment.
Exclusion Criteria:
Insomnia Severity Index less than 7 points
Presence of acute life crises, acute psychiatric illness, bipolar disorder
Shift work
Linguistic or cognitive difficulties causing inability participate in group or fill in forms
Insomnia directly caused by medical illness. Other sleep disorder.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeanette Westman, PhD
Organizational Affiliation
Karolinska Institutet, Stockholm, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for family medicine
City
Stockholm
State/Province
Huddinge
ZIP/Postal Code
14183
Country
Sweden
Facility Name
Centrum för allmanmedicin
City
Stockholm
State/Province
Huddinge
ZIP/Postal Code
14183
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
17662752
Citation
LeBlanc M, Beaulieu-Bonneau S, Merette C, Savard J, Ivers H, Morin CM. Psychological and health-related quality of life factors associated with insomnia in a population-based sample. J Psychosom Res. 2007 Aug;63(2):157-66. doi: 10.1016/j.jpsychores.2007.03.004.
Results Reference
background
PubMed Identifier
20813762
Citation
Wilson SJ, Nutt DJ, Alford C, Argyropoulos SV, Baldwin DS, Bateson AN, Britton TC, Crowe C, Dijk DJ, Espie CA, Gringras P, Hajak G, Idzikowski C, Krystal AD, Nash JR, Selsick H, Sharpley AL, Wade AG. British Association for Psychopharmacology consensus statement on evidence-based treatment of insomnia, parasomnias and circadian rhythm disorders. J Psychopharmacol. 2010 Nov;24(11):1577-601. doi: 10.1177/0269881110379307. Epub 2010 Sep 2.
Results Reference
background
Links:
URL
http://www.cefam.se
Description
Related Info
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Group Treatment for Insomnia in Primary Health Care
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