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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

July 4, 2012
July 30, 2012
May 2008
September 2011   (Final data collection date for primary outcome measure)
Change from baseline in the Insomnia severity index (ISI) [ Time Frame: After 9 weeks ]
A brief self-report screening form
Same as current
No Changes Posted
  • Change from baseline in sleep-onset latency (SOL) [ Time Frame: 9 weeks ]
    Time to fall asleep, measured with sleep diary
  • Change from baseline in wake time after sleep onset (WASO) [ Time Frame: After 9 weeks ]
    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 ]
    Measured with sleep diary
  • Change from baseline in Sleep efficiency (SE) [ Time Frame: After 9 weeks ]
    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 ]
    Measured with sleep diary
  • Change from baseline in total sleep time (TST) [ Time Frame: After 9 weeks ]
    Measured with sleep diary
  • Change from baseline in sleep quality (SQ) [ Time Frame: After 9 weeks ]
    Subjective sleep quality (likert scale)
  • Change from baseline in the fatigue severity scale (FSS) [ Time Frame: After 9 weeks ]
    Self-report questionnaire
  • Change from baseline in the MOS 36-item short-form health survey, SF-36 [ Time Frame: After 9 weeks ]
    Questionnaire assessing physical and mental health
  • Change from baseline in the Hospital anxiety and depression scale, HADS [ Time Frame: After 9 weeks ]
    Self-report questionnaire measuring depression and anxiety
  • Change from baseline in the Epworth sleepiness scale, ESS [ Time Frame: After 9 weeks ]
    Self-report questionnaire assessing daytime sleepiness
  • Change form baseline in the Pittsburgh sleep quality index (PSQI) [ Time Frame: After 9 weeks ]
    Self-report form assessing sleep quality
  • Change from baseline in the Minimal insomnia severity scale, MISS [ Time Frame: After 9 weeks ]
    Ultra short screening questionnaire for insomnia
  • Change from baseline in the Insomnia acceptance questionnaire, IQA [ Time Frame: After 9 weeks ]
    A questionnaire intended to assess acceptance of insomnia
  • Change from baseline in Body mass index [ Time Frame: After 9 weeks ]
  • Change from baseline in sagittal abdominal diameter [ Time Frame: After 9 weeks ]
    Abdominal height (cm)
  • Change from baseline in waist-hip ratio [ Time Frame: After 9 weeks ]
    A ratio of the circumference of the waist to the hips
  • Change from baseline in blood pressure [ Time Frame: After 9 weeks ]
  • Change from baseline in heart rate [ Time Frame: After 9 weeks ]
  • Change from baseline in ALAT [ Time Frame: After 9 weeks ]
    Liver function
  • Change from baseline in HbA 1c [ Time Frame: After 9 weeks ]
    Glycated hemoglobin
  • Change from baseline in blood glucose [ Time Frame: After 9 weeks ]
  • Change from baseline in triglycerides [ Time Frame: After 9 weeks ]
    A type of fat found in the blood
  • Change from baseline in cholesterol (LDL/HDL) [ Time Frame: After 9 weeks ]
  • Change from baseline in sleep-onset latency (SOL) [ Time Frame: After 18 months ]
    Time to fall asleep, measured with sleep diary
  • Change from baseline in wake time after sleep onset (WASO) [ Time Frame: After 18 months ]
    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 ]
    Measured with sleep diary
  • Change from baseline in Sleep efficiency (SE) [ Time Frame: After 18 months ]
    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 ]
    Measured with sleep diary
  • Change from baseline in total sleep time (TST) [ Time Frame: After 18 months ]
    Measured with sleep diary
  • Change from baseline in sleep quality (SQ) [ Time Frame: After 18 months ]
    Subjective sleep quality (likert scale)
  • Change from baseline in the fatigue severity scale (FSS) [ Time Frame: After 18 months ]
    Self-report questionnaire
  • Change from baseline in the MOS 36-item short-form health survey, SF-36 [ Time Frame: After 18 months ]
    Questionnaire assessing physical and mental health
  • Change from baseline in the Hospital anxiety and depression scale, HADS [ Time Frame: After 18 months ]
    Self-report questionnaire measuring depression and anxiety
  • Change from baseline in the Epworth sleepiness scale, ESS [ Time Frame: After 18 moths ]
    Self-report questionnaire assessing daytime sleepiness
  • Change form baseline in the Pittsburgh sleep quality index (PSQI) [ Time Frame: After 18 months ]
    Self-report form assessing sleep quality
  • Change from baseline in the Minimal insomnia severity scale, MISS [ Time Frame: After 18 months ]
    Ultra short screening questionnaire for insomnia
  • Change from baseline in the Insomnia acceptance questionnaire, IQA [ Time Frame: After 18 months ]
    A questionnaire intended to assess acceptance of insomnia
  • Change from baseline in Body mass index [ Time Frame: After 18 months ]
  • Change from baseline in sagittal abdominal diameter [ Time Frame: After 18 months ]
    Abdominal height (cm)
  • Change from baseline in waist-hip ratio [ Time Frame: After 18 months ]
    A ratio of the circumference of the waist to the hips
  • Change from baseline in blood pressure [ Time Frame: After 18 months ]
  • Change from baseline in heart rate [ Time Frame: After 18 months ]
  • Change from baseline in ALAT [ Time Frame: After 18 months ]
    Liver function
  • Change from baseline in HbA 1c [ Time Frame: After 18 months ]
    Glycated hemoglobin
  • Change from baseline in blood glucose [ Time Frame: After 18 months ]
  • Change from baseline in triglycerides [ Time Frame: After 18 months ]
    A type of fat found in the blood
  • Change from baseline in cholesterol (LDL/HDL) [ Time Frame: After 18 months ]
  • Change from baseline in the Insomnia severity index (ISI) [ Time Frame: After 18 months ]
    A brief self-report screening form
Same as current
Not Provided
Not Provided
 
Cognitive Behavior Therapy for Insomnia in Primary Care
Treating Insomnia in Primary Care: A Study of Effectiveness and Dissemination
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Insomnia
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.
  • 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.
    Intervention: Behavioral: Cognitive behavior therapy for insomnia
  • No Intervention: Wait-list
    A deferred treatment wait-list condition, with no restrictions placed on the usual care.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
September 2011
September 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
 
NCT01655797
RFR-10276
No
Not Provided
Not Provided
Not Provided
Uppsala University
Uppsala University
Uppsala-Örebro Regional Research Council
Principal Investigator: Jan-Erik Broman, PhD Uppsala University
Uppsala University
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP