Group Treatment for Insomnia in Primary Health Care

Insomnia Clinical Trial

— Sleep Prime  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01731223
• Other study ID #: CeFAM, Karolinska Institutet
• Status: Completed
• Phase: N/A
• Start date: August 2010
• Est. completion date: August 2015

Study information

• Verified date: August 2018
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: August 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

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.

Locations

Country	Name	City	State
Sweden	Centre for family medicine	Stockholm	Huddinge
Sweden	Centrum för allmanmedicin	Stockholm	Huddinge

Sponsors (3)

Lead Sponsor	Collaborator
Jeanette Westman	Karolinska Institutet, Stockholm County Council, Sweden

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

LeBlanc M, Beaulieu-Bonneau S, Mérette C, Savard J, Ivers H, Morin CM. Psychological and health-related quality of life factors associated with insomnia in a population-based sample. J Psychosom Res. 2007 Aug;63(2):157-66. — View Citation

Wilson SJ, Nutt DJ, Alford C, Argyropoulos SV, Baldwin DS, Bateson AN, Britton TC, Crowe C, Dijk DJ, Espie CA, Gringras P, Hajak G, Idzikowski C, Krystal AD, Nash JR, Selsick H, Sharpley AL, Wade AG. British Association for Psychopharmacology consensus statement on evidence-based treatment of insomnia, parasomnias and circadian rhythm disorders. J Psychopharmacol. 2010 Nov;24(11):1577-601. doi: 10.1177/0269881110379307. Epub 2010 Sep 2. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sleep Logg	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	one year
Primary	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	Fatigue severity scale	Measures fatigue symptoms in a seven item self assessment scale. Response from 1-7 points	one year

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