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Completed

NCT Number: NCT01731223

Group Treatment for Insomnia in Primary Health Care

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

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for family medicine, Stockholm, Huddinge, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Group treatment for insomnia

Behavioral

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.

Primary outcomes

  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 outcomes

  1. Fatigue severity scale

    Time frame: one year

    Measures fatigue symptoms in a seven item self assessment scale. Response from 1-7 points

Other outcomes

  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

Sponsors and collaborators

Lead sponsor

Jeanette Westman

Other

Collaborators

  • Karolinska Institutet
  • Region Stockholm

Registry information

Official study title

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

Acronym: Sleep Prime

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Nov 21, 2012
Registry last updated
Aug 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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