Group Treatment for Insomnia in Primary Health Care

NCT ID: NCT01731223

Last Updated: 2018-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2015-08-31

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.

Conditions

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Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group treatment for insomnia

Group treatment for insomnia.

Group Type EXPERIMENTAL

Group treatment for insomnia

Intervention Type 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.

No intervention

Treatment as usual

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Stockholm

OTHER_GOV

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role collaborator

Jeanette Westman

OTHER

Sponsor Role lead

Responsible Party

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Jeanette Westman

PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jeanette Westman, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Centre for family medicine

Stockholm, Huddinge, Sweden

Site Status

Centrum för allmanmedicin

Stockholm, Huddinge, Sweden

Site Status

Countries

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Sweden

References

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LeBlanc M, Beaulieu-Bonneau S, Merette 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. doi: 10.1016/j.jpsychores.2007.03.004.

Reference Type BACKGROUND
PMID: 17662752 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20813762 (View on PubMed)

Related Links

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Other Identifiers

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CeFAM, Karolinska Institutet

Identifier Type: -

Identifier Source: org_study_id

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