Overview

This trial is active, not recruiting.

Condition insomnia
Treatment group treatment for insomnia
Sponsor Jeanette Westman
Collaborator Stockholm County Council, Sweden
Start date August 2010
End date December 2015
Trial size 120 participants
Trial identifier NCT01731223, CeFAM, Karolinska Institutet

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Group treatment for insomnia.
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)
Treatment as usual

Primary Outcomes

Measure
Insomnia severity Index
time frame: One year

Secondary Outcomes

Measure
Fatigue severity scale
time frame: one year

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Group Treatment for Insomnia in Primary Health Care: a Randomized Controlled Trial
Principal investigator Jeanette Westman, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Karolinska Institutet.