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Cognitive Behavior Therapy for Insomnia in Primary Care

NCT ID: NCT01655797

Last Updated: 2012-08-02

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

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2011-09-30

Brief Summary

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The aim of this study was to investigate the clinical effectiveness of protocol-driven cognitive behavioral therapy (CBT) for insomnia delivered by ordinary primary care personnel (primary care nurses and social workers) in general medical practice with unselected patients, in line with a stepped care approach. The study design was a randomised controlled parallel group design, with allocation to CBT and waiting list control group (WL). Following an active treatment-control period, the control group were re-assigned to CBT. The study hypothesis was that the CBT group would experience less symptoms of insomnia after treatment compared with the WL group. Primary outcome measure was a brief self-report screening form, Insomnia severity index.

Detailed Description

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Conditions

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Insomnia

Keywords

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insomnia cognitive behavior therapy primary care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CBT

The treatment group received manualized CBT-I using a adapted version of a manual designed for use by primary care personnel. Treatment comprised information about sleep and insomnia, methods for medication tapering, sleep hygiene, stimulus control, sleep restriction, progressive muscle relaxation, and dealing with sleep interfering thoughts.

Group Type EXPERIMENTAL

Cognitive behavior therapy for insomnia

Intervention Type BEHAVIORAL

Treatment comprised information about sleep and insomnia, methods for medication tapering, sleep hygiene, stimulus control, sleep restriction, progressive muscle relaxation, and dealing with sleep interfering thoughts.

Wait-list

A deferred treatment wait-list condition, with no restrictions placed on the usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cognitive behavior therapy for insomnia

Treatment comprised information about sleep and insomnia, methods for medication tapering, sleep hygiene, stimulus control, sleep restriction, progressive muscle relaxation, and dealing with sleep interfering thoughts.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Fulfilled research criteria for chronic insomnia

Exclusion Criteria

* other untreated sleep disturbance
* pregnancy
* shift work
* concurrent medical or psychiatric condition that could be negatively affected by the treatment
* drug abuse
* severe depression
* dementia
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uppsala-Örebro Regional Research Council

OTHER

Sponsor Role collaborator

Uppsala University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jan-Erik Broman, PhD

Role: PRINCIPAL_INVESTIGATOR

Uppsala University

Locations

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Uppsala University

Uppsala, , Sweden

Site Status

Countries

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Sweden

References

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Espie CA, MacMahon KM, Kelly HL, Broomfield NM, Douglas NJ, Engleman HM, McKinstry B, Morin CM, Walker A, Wilson P. Randomized clinical effectiveness trial of nurse-administered small-group cognitive behavior therapy for persistent insomnia in general practice. Sleep. 2007 May;30(5):574-84. doi: 10.1093/sleep/30.5.574.

Reference Type BACKGROUND
PMID: 17552372 (View on PubMed)

Bothelius K, Kyhle K, Espie CA, Broman JE. Manual-guided cognitive-behavioural therapy for insomnia delivered by ordinary primary care personnel in general medical practice: a randomized controlled effectiveness trial. J Sleep Res. 2013 Dec;22(6):688-96. doi: 10.1111/jsr.12067. Epub 2013 Jul 16.

Reference Type DERIVED
PMID: 23859625 (View on PubMed)

Other Identifiers

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RFR-10276

Identifier Type: -

Identifier Source: org_study_id