NCT01655797

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2012

Completed
29 days until next milestone

First Posted

Study publicly available on registry

August 2, 2012

Completed
Last Updated

August 2, 2012

Status Verified

July 1, 2012

Enrollment Period

3.3 years

First QC Date

July 4, 2012

Last Update Submit

July 30, 2012

Conditions

Insomnia

Keywords

insomniacognitive behavior therapyprimary care

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in the Insomnia severity index (ISI)

    A brief self-report screening form

    After 9 weeks

Secondary Outcomes (49)

  • Change from baseline in sleep-onset latency (SOL)

    9 weeks

  • Change from baseline in wake time after sleep onset (WASO)

    After 9 weeks

  • Change from baseline in number of awakenings during the night (NWAK)

    After 9 weeks

  • Change from baseline in Sleep efficiency (SE)

    After 9 weeks

  • Change from baseline in time in bed (TIB)

    After 9 weeks

  • +44 more secondary outcomes

Study Arms (2)

CBT

EXPERIMENTAL

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.

Behavioral: Cognitive behavior therapy for insomnia

Wait-list

NO INTERVENTION

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

Interventions

Cognitive behavior therapy for insomniaBEHAVIORAL

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.

CBT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fulfilled research criteria for chronic insomnia

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uppsala University

Uppsala, 75105, Sweden

Location

Related Publications (2)

  • 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.

    PMID: 17552372BACKGROUND

  • 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.

    PMID: 23859625DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Jan-Erik Broman, PhD

    Uppsala University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2012

First Posted

August 2, 2012

Study Start

May 1, 2008

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

August 2, 2012

Record last verified: 2012-07

Locations

SE(1)