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Completed

NCT Number: NCT01655797

Cognitive Behavior Therapy for Insomnia in Primary Care

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.

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uppsala University

Uppsala, 75105, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Behavior Therapy for Insomnia

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.

Primary outcomes

  1. Change from baseline in the Insomnia severity index (ISI)

    Time frame: After 9 weeks

    A brief self-report screening form

Secondary outcomes

  1. Change from baseline in sleep-onset latency (SOL)

    Time frame: 9 weeks

    Time to fall asleep, measured with sleep diary

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

    Time frame: After 9 weeks

    Time awake during the night, measured with sleep diary

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

    Time frame: After 9 weeks

    Measured with sleep diary

  4. 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

  5. Change from baseline in time in bed (TIB)

    Time frame: After 9 weeks

    Measured with sleep diary

  6. Change from baseline in total sleep time (TST)

    Time frame: After 9 weeks

    Measured with sleep diary

  7. Change from baseline in sleep quality (SQ)

    Time frame: After 9 weeks

    Subjective sleep quality (likert scale)

  8. Change from baseline in the fatigue severity scale (FSS)

    Time frame: After 9 weeks

    Self-report questionnaire

  9. 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

  10. Change from baseline in the Hospital anxiety and depression scale, HADS

    Time frame: After 9 weeks

    Self-report questionnaire measuring depression and anxiety

  11. Change from baseline in the Epworth sleepiness scale, ESS

    Time frame: After 9 weeks

    Self-report questionnaire assessing daytime sleepiness

  12. Change form baseline in the Pittsburgh sleep quality index (PSQI)

    Time frame: After 9 weeks

    Self-report form assessing sleep quality

  13. Change from baseline in the Minimal insomnia severity scale, MISS

    Time frame: After 9 weeks

    Ultra short screening questionnaire for insomnia

  14. Change from baseline in the Insomnia acceptance questionnaire, IQA

    Time frame: After 9 weeks

    A questionnaire intended to assess acceptance of insomnia

  15. Change from baseline in Body mass index

    Time frame: After 9 weeks

  16. Change from baseline in sagittal abdominal diameter

    Time frame: After 9 weeks

    Abdominal height (cm)

  17. Change from baseline in waist-hip ratio

    Time frame: After 9 weeks

    A ratio of the circumference of the waist to the hips

  18. Change from baseline in blood pressure

    Time frame: After 9 weeks

  19. Change from baseline in heart rate

    Time frame: After 9 weeks

  20. Change from baseline in ALAT

    Time frame: After 9 weeks

    Liver function

  21. Change from baseline in HbA 1c

    Time frame: After 9 weeks

    Glycated hemoglobin

  22. Change from baseline in blood glucose

    Time frame: After 9 weeks

  23. Change from baseline in triglycerides

    Time frame: After 9 weeks

    A type of fat found in the blood

  24. Change from baseline in cholesterol (LDL/HDL)

    Time frame: After 9 weeks

  25. Change from baseline in sleep-onset latency (SOL)

    Time frame: After 18 months

    Time to fall asleep, measured with sleep diary

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

    Time frame: After 18 months

    Time awake during the night, measured with sleep diary

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

    Time frame: After 18 months

    Measured with sleep diary

  28. 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

  29. Change from baseline in time in bed (TIB)

    Time frame: After 18 months

    Measured with sleep diary

  30. Change from baseline in total sleep time (TST)

    Time frame: After 18 months

    Measured with sleep diary

  31. Change from baseline in sleep quality (SQ)

    Time frame: After 18 months

    Subjective sleep quality (likert scale)

  32. Change from baseline in the fatigue severity scale (FSS)

    Time frame: After 18 months

    Self-report questionnaire

  33. 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

  34. Change from baseline in the Hospital anxiety and depression scale, HADS

    Time frame: After 18 months

    Self-report questionnaire measuring depression and anxiety

  35. Change from baseline in the Epworth sleepiness scale, ESS

    Time frame: After 18 moths

    Self-report questionnaire assessing daytime sleepiness

  36. Change form baseline in the Pittsburgh sleep quality index (PSQI)

    Time frame: After 18 months

    Self-report form assessing sleep quality

  37. Change from baseline in the Minimal insomnia severity scale, MISS

    Time frame: After 18 months

    Ultra short screening questionnaire for insomnia

  38. Change from baseline in the Insomnia acceptance questionnaire, IQA

    Time frame: After 18 months

    A questionnaire intended to assess acceptance of insomnia

  39. Change from baseline in Body mass index

    Time frame: After 18 months

  40. Change from baseline in sagittal abdominal diameter

    Time frame: After 18 months

    Abdominal height (cm)

  41. Change from baseline in waist-hip ratio

    Time frame: After 18 months

    A ratio of the circumference of the waist to the hips

  42. Change from baseline in blood pressure

    Time frame: After 18 months

  43. Change from baseline in heart rate

    Time frame: After 18 months

  44. Change from baseline in ALAT

    Time frame: After 18 months

    Liver function

  45. Change from baseline in HbA 1c

    Time frame: After 18 months

    Glycated hemoglobin

  46. Change from baseline in blood glucose

    Time frame: After 18 months

  47. Change from baseline in triglycerides

    Time frame: After 18 months

    A type of fat found in the blood

  48. Change from baseline in cholesterol (LDL/HDL)

    Time frame: After 18 months

  49. Change from baseline in the Insomnia severity index (ISI)

    Time frame: After 18 months

    A brief self-report screening form

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

  • Uppsala-Örebro Regional Research Council

Registry information

Official study title

Treating Insomnia in Primary Care: A Study of Effectiveness and Dissemination

Acronym: TIRED

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Aug 2, 2012
Registry last updated
Aug 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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