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Cognitive Behavior Therapy for Insomnia in Primary Care (TIRED)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01655797
First Posted: August 2, 2012
Last Update Posted: August 2, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Uppsala-Örebro Regional Research Council
Information provided by (Responsible Party):
Uppsala University
  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
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treating Insomnia in Primary Care: A Study of Effectiveness and Dissemination

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 ]
    A brief self-report screening form


Secondary Outcome Measures:
  • 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


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT01655797     History of Changes
Other Study ID Numbers: RFR-10276
First Submitted: July 4, 2012
First Posted: August 2, 2012
Last Update Posted: August 2, 2012
Last Verified: July 2012

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 Wake Disorders
Nervous System Diseases
Mental Disorders