Group Treatment for Insomnia in Primary Health Care

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

Detailed Description
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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.

Official Title
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Group Treatment for Insomnia in Primary Health Care: a Randomized Controlled Trial

Conditions
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Insomnia

Intervention / Treatment
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* Behavioral: Group treatment for insomnia


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group treatment for insomnia<br>Group treatment for insomnia. | Behavioral: Group treatment for insomnia<br>* 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.<br>|
| No Intervention: No intervention<br>Treatment as usual | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue severity scale | Measures fatigue symptoms in a seven item self assessment scale. Response from 1-7 points | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insomnia, Primary health care