Group Treatment for Insomnia in Primary Health Care (Sleep Prime)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01731223
Recruitment Status : Active, not recruiting
First Posted : November 21, 2012
Last Update Posted : March 8, 2017
Stockholm County Council, Sweden
Karolinska Institutet
Information provided by (Responsible Party):
Jeanette Westman, Karolinska Institutet

Brief Summary:
The aim of this study is to analyze if group treatment is effective to treat insomnia in primary healthcare.

Condition or disease Intervention/treatment Phase
Insomnia Behavioral: Group treatment for insomnia Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Group Treatment for Insomnia in Primary Health Care: a Randomized Controlled Trial
Study Start Date : August 2010
Actual Primary Completion Date : December 2014
Estimated Study Completion Date : December 2017

Arm Intervention/treatment
Experimental: Group treatment for insomnia
Group treatment for insomnia.
Behavioral: Group treatment for insomnia
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.

No Intervention: No intervention
Treatment as usual

Primary Outcome Measures :
  1. Insomnia severity Index [ Time Frame: One year ]
    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 :
  1. Fatigue severity scale [ Time Frame: one year ]
    Measures fatigue symptoms in a seven item self assessment scale. Response from 1-7 points

Other Outcome Measures:
  1. Sleep Logg [ Time Frame: one year ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01731223

Centre for family medicine
Stockholm, Huddinge, Sweden, 14183
Centrum för allmanmedicin
Stockholm, Huddinge, Sweden, 14183
Sponsors and Collaborators
Jeanette Westman
Stockholm County Council, Sweden
Karolinska Institutet
Principal Investigator: Jeanette Westman, PhD Karolinska Institutet, Stockholm, Sweden

Additional Information:
Responsible Party: Jeanette Westman, PhD, Karolinska Institutet Identifier: NCT01731223     History of Changes
Other Study ID Numbers: CeFAM, Karolinska Institutet
First Posted: November 21, 2012    Key Record Dates
Last Update Posted: March 8, 2017
Last Verified: March 2017

Keywords provided by Jeanette Westman, Karolinska Institutet:
Primary health care

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders