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Trial record 5 of 584 for:    insomnia
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Cognitive Behavior Therapy for Insomnia in Primary Care (TIRED)

This study has been completed.
Sponsor:
Collaborator:
Uppsala-Örebro Regional Research Council
Information provided by (Responsible Party):
Uppsala University
ClinicalTrials.gov Identifier:
NCT01655797
First received: July 4, 2012
Last updated: July 30, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention
Insomnia
 Behavioral: Cognitive behavior therapy for insomnia

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treating Insomnia in Primary Care: A Study of Effectiveness and Dissemination

Resource links provided by NLM:

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Further study details as provided by Uppsala University:

Primary Outcome Measures:
  • Change from baseline in the Insomnia severity index (ISI) [ Time Frame: After 9 weeks ] [ Designated as safety issue: No ]
    A brief self-report screening form


Secondary Outcome Measures:
  • Change from baseline in sleep-onset latency (SOL) [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    Time to fall asleep, measured with sleep diary

  • Change from baseline in wake time after sleep onset (WASO) [ Time Frame: After 9 weeks ] [ Designated as safety issue: No ]
    Time awake during the night, measured with sleep diary

  • Change from baseline in number of awakenings during the night (NWAK) [ Time Frame: After 9 weeks ] [ Designated as safety issue: No ]
    Measured with sleep diary

  • Change from baseline in Sleep efficiency (SE) [ Time Frame: After 9 weeks ] [ Designated as safety issue: No ]
    Time actually spent sleeping out of the total time in bed (%), measured with sleep diary

  • Change from baseline in time in bed (TIB) [ Time Frame: After 9 weeks ] [ Designated as safety issue: No ]
    Measured with sleep diary

  • Change from baseline in total sleep time (TST) [ Time Frame: After 9 weeks ] [ Designated as safety issue: No ]
    Measured with sleep diary

  • Change from baseline in sleep quality (SQ) [ Time Frame: After 9 weeks ] [ Designated as safety issue: No ]
    Subjective sleep quality (likert scale)

  • Change from baseline in the fatigue severity scale (FSS) [ Time Frame: After 9 weeks ] [ Designated as safety issue: No ]
    Self-report questionnaire

  • Change from baseline in the MOS 36-item short-form health survey, SF-36 [ Time Frame: After 9 weeks ] [ Designated as safety issue: No ]
    Questionnaire assessing physical and mental health

  • Change from baseline in the Hospital anxiety and depression scale, HADS [ Time Frame: After 9 weeks ] [ Designated as safety issue: No ]
    Self-report questionnaire measuring depression and anxiety

  • Change from baseline in the Epworth sleepiness scale, ESS [ Time Frame: After 9 weeks ] [ Designated as safety issue: No ]
    Self-report questionnaire assessing daytime sleepiness

  • Change form baseline in the Pittsburgh sleep quality index (PSQI) [ Time Frame: After 9 weeks ] [ Designated as safety issue: No ]
    Self-report form assessing sleep quality

  • Change from baseline in the Minimal insomnia severity scale, MISS [ Time Frame: After 9 weeks ] [ Designated as safety issue: No ]
    Ultra short screening questionnaire for insomnia

  • Change from baseline in the Insomnia acceptance questionnaire, IQA [ Time Frame: After 9 weeks ] [ Designated as safety issue: No ]
    A questionnaire intended to assess acceptance of insomnia

  • Change from baseline in Body mass index [ Time Frame: After 9 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in sagittal abdominal diameter [ Time Frame: After 9 weeks ] [ Designated as safety issue: No ]
    Abdominal height (cm)

  • Change from baseline in waist-hip ratio [ Time Frame: After 9 weeks ] [ Designated as safety issue: No ]
    A ratio of the circumference of the waist to the hips

  • Change from baseline in blood pressure [ Time Frame: After 9 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in heart rate [ Time Frame: After 9 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in ALAT [ Time Frame: After 9 weeks ] [ Designated as safety issue: No ]
    Liver function

  • Change from baseline in HbA 1c [ Time Frame: After 9 weeks ] [ Designated as safety issue: No ]
    Glycated hemoglobin

  • Change from baseline in blood glucose [ Time Frame: After 9 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in triglycerides [ Time Frame: After 9 weeks ] [ Designated as safety issue: No ]
    A type of fat found in the blood

  • Change from baseline in cholesterol (LDL/HDL) [ Time Frame: After 9 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in sleep-onset latency (SOL) [ Time Frame: After 18 months ] [ Designated as safety issue: No ]
    Time to fall asleep, measured with sleep diary

  • Change from baseline in wake time after sleep onset (WASO) [ Time Frame: After 18 months ] [ Designated as safety issue: No ]
    Time awake during the night, measured with sleep diary

  • Change from baseline in number of awakenings during the night (NWAK) [ Time Frame: After 18 months ] [ Designated as safety issue: No ]
    Measured with sleep diary

  • Change from baseline in Sleep efficiency (SE) [ Time Frame: After 18 months ] [ Designated as safety issue: No ]
    Time actually spent sleeping out of the total time in bed (%), measured with sleep diary

  • Change from baseline in time in bed (TIB) [ Time Frame: After 18 months ] [ Designated as safety issue: No ]
    Measured with sleep diary

  • Change from baseline in total sleep time (TST) [ Time Frame: After 18 months ] [ Designated as safety issue: No ]
    Measured with sleep diary

  • Change from baseline in sleep quality (SQ) [ Time Frame: After 18 months ] [ Designated as safety issue: No ]
    Subjective sleep quality (likert scale)

  • Change from baseline in the fatigue severity scale (FSS) [ Time Frame: After 18 months ] [ Designated as safety issue: No ]
    Self-report questionnaire

  • Change from baseline in the MOS 36-item short-form health survey, SF-36 [ Time Frame: After 18 months ] [ Designated as safety issue: No ]
    Questionnaire assessing physical and mental health

  • Change from baseline in the Hospital anxiety and depression scale, HADS [ Time Frame: After 18 months ] [ Designated as safety issue: No ]
    Self-report questionnaire measuring depression and anxiety

  • Change from baseline in the Epworth sleepiness scale, ESS [ Time Frame: After 18 moths ] [ Designated as safety issue: No ]
    Self-report questionnaire assessing daytime sleepiness

  • Change form baseline in the Pittsburgh sleep quality index (PSQI) [ Time Frame: After 18 months ] [ Designated as safety issue: No ]
    Self-report form assessing sleep quality

  • Change from baseline in the Minimal insomnia severity scale, MISS [ Time Frame: After 18 months ] [ Designated as safety issue: No ]
    Ultra short screening questionnaire for insomnia

  • Change from baseline in the Insomnia acceptance questionnaire, IQA [ Time Frame: After 18 months ] [ Designated as safety issue: No ]
    A questionnaire intended to assess acceptance of insomnia

  • Change from baseline in Body mass index [ Time Frame: After 18 months ] [ Designated as safety issue: No ]
  • Change from baseline in sagittal abdominal diameter [ Time Frame: After 18 months ] [ Designated as safety issue: No ]
    Abdominal height (cm)

  • Change from baseline in waist-hip ratio [ Time Frame: After 18 months ] [ Designated as safety issue: No ]
    A ratio of the circumference of the waist to the hips

  • Change from baseline in blood pressure [ Time Frame: After 18 months ] [ Designated as safety issue: No ]
  • Change from baseline in heart rate [ Time Frame: After 18 months ] [ Designated as safety issue: No ]
  • Change from baseline in ALAT [ Time Frame: After 18 months ] [ Designated as safety issue: No ]
    Liver function

  • Change from baseline in HbA 1c [ Time Frame: After 18 months ] [ Designated as safety issue: No ]
    Glycated hemoglobin

  • Change from baseline in blood glucose [ Time Frame: After 18 months ] [ Designated as safety issue: No ]
  • Change from baseline in triglycerides [ Time Frame: After 18 months ] [ Designated as safety issue: No ]
    A type of fat found in the blood

  • Change from baseline in cholesterol (LDL/HDL) [ Time Frame: After 18 months ] [ Designated as safety issue: No ]
  • Change from baseline in the Insomnia severity index (ISI) [ Time Frame: After 18 months ] [ Designated as safety issue: No ]
    A brief self-report screening form


Enrollment: 66
Study Start Date: May 2008
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
 Behavioral: 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.
No Intervention: Wait-list
A deferred treatment wait-list condition, with no restrictions placed on the usual care.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01655797

Locations
Sweden
Uppsala University
Uppsala, Sweden, 75105
Sponsors and Collaborators
Uppsala University
Uppsala-Örebro Regional Research Council
Investigators
Principal Investigator: Jan-Erik Broman, PhD Uppsala University
  More Information

Publications:

Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT01655797     History of Changes
Other Study ID Numbers: RFR-10276
Study First Received: July 4, 2012
Last Updated: July 30, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Uppsala University:
insomnia
cognitive behavior therapy
primary care

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
 Sleep Disorders
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013