Group Treatment for Insomnia in Primary Health Care

Not Applicable

Completed

• Conditions: Insomnia
• Interventions: Behavioral: Group treatment for insomnia

• Registration Number: NCT01731223
• Lead Sponsor: Jeanette Westman

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.

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2012-11-16
• Study First Submitted QC: 2012-11-20
• Study First Posted: 2012-11-21
• Primary Completion: 2015-06
• Study Completion: 2015-08
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-07
• Last Update Posted: 2018-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group treatment for insomnia	Group treatment for insomnia	Group treatment for insomnia.

Primary Outcome Measures

Name	Time	Method
Insomnia severity Index	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

Name	Time	Method
Fatigue severity scale	one year	Measures fatigue symptoms in a seven item self assessment scale. Response from 1-7 points

Trial Locations

Locations (2)

Centre for family medicine; 🇸🇪 Stockholm, Huddinge, Sweden

Centrum för allmanmedicin; 🇸🇪 Stockholm, Huddinge, Sweden