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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Stockholm County Council, Sweden
Karolinska Institutet
Information provided by (Responsible Party):
Jeanette Westman, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01731223
First received: November 16, 2012
Last updated: June 16, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention
Insomnia
Behavioral: Group treatment for insomnia

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Group Treatment for Insomnia in Primary Health Care: a Randomized Controlled Trial

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Insomnia severity Index [ Time Frame: One year ] [ Designated as safety issue: No ]
    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 [ Time Frame: one year ] [ Designated as safety issue: No ]
    Measures fatigue symptoms in a seven item self assessment scale. Response from 1-7 points


Other Outcome Measures:
  • Sleep Logg [ Time Frame: one year ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 120
Study Start Date: August 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01731223

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

Additional Information:
No publications provided

Responsible Party: Jeanette Westman, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01731223     History of Changes
Other Study ID Numbers: CeFAM, Karolinska Institutet
Study First Received: November 16, 2012
Last Updated: June 16, 2014
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Karolinska Institutet:
Insomnia
Primary health care

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

ClinicalTrials.gov processed this record on July 20, 2014