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Cognitive Behavior Therapy for Insomnia in Primary Care (TIRED)

Primary Purpose

Insomnia

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Cognitive behavior therapy for insomnia
Sponsored by
Uppsala University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring insomnia, cognitive behavior therapy, primary care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Uppsala University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CBT

Wait-list

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Change from baseline in the Insomnia severity index (ISI)
A brief self-report screening form

Secondary Outcome Measures

Change from baseline in sleep-onset latency (SOL)
Time to fall asleep, measured with sleep diary
Change from baseline in wake time after sleep onset (WASO)
Time awake during the night, measured with sleep diary
Change from baseline in number of awakenings during the night (NWAK)
Measured with sleep diary
Change from baseline in Sleep efficiency (SE)
Time actually spent sleeping out of the total time in bed (%), measured with sleep diary
Change from baseline in time in bed (TIB)
Measured with sleep diary
Change from baseline in total sleep time (TST)
Measured with sleep diary
Change from baseline in sleep quality (SQ)
Subjective sleep quality (likert scale)
Change from baseline in the fatigue severity scale (FSS)
Self-report questionnaire
Change from baseline in the MOS 36-item short-form health survey, SF-36
Questionnaire assessing physical and mental health
Change from baseline in the Hospital anxiety and depression scale, HADS
Self-report questionnaire measuring depression and anxiety
Change from baseline in the Epworth sleepiness scale, ESS
Self-report questionnaire assessing daytime sleepiness
Change form baseline in the Pittsburgh sleep quality index (PSQI)
Self-report form assessing sleep quality
Change from baseline in the Minimal insomnia severity scale, MISS
Ultra short screening questionnaire for insomnia
Change from baseline in the Insomnia acceptance questionnaire, IQA
A questionnaire intended to assess acceptance of insomnia
Change from baseline in Body mass index
Change from baseline in sagittal abdominal diameter
Abdominal height (cm)
Change from baseline in waist-hip ratio
A ratio of the circumference of the waist to the hips
Change from baseline in blood pressure
Change from baseline in heart rate
Change from baseline in ALAT
Liver function
Change from baseline in HbA 1c
Glycated hemoglobin
Change from baseline in blood glucose
Change from baseline in triglycerides
A type of fat found in the blood
Change from baseline in cholesterol (LDL/HDL)
Change from baseline in sleep-onset latency (SOL)
Time to fall asleep, measured with sleep diary
Change from baseline in wake time after sleep onset (WASO)
Time awake during the night, measured with sleep diary
Change from baseline in number of awakenings during the night (NWAK)
Measured with sleep diary
Change from baseline in Sleep efficiency (SE)
Time actually spent sleeping out of the total time in bed (%), measured with sleep diary
Change from baseline in time in bed (TIB)
Measured with sleep diary
Change from baseline in total sleep time (TST)
Measured with sleep diary
Change from baseline in sleep quality (SQ)
Subjective sleep quality (likert scale)
Change from baseline in the fatigue severity scale (FSS)
Self-report questionnaire
Change from baseline in the MOS 36-item short-form health survey, SF-36
Questionnaire assessing physical and mental health
Change from baseline in the Hospital anxiety and depression scale, HADS
Self-report questionnaire measuring depression and anxiety
Change from baseline in the Epworth sleepiness scale, ESS
Self-report questionnaire assessing daytime sleepiness
Change form baseline in the Pittsburgh sleep quality index (PSQI)
Self-report form assessing sleep quality
Change from baseline in the Minimal insomnia severity scale, MISS
Ultra short screening questionnaire for insomnia
Change from baseline in the Insomnia acceptance questionnaire, IQA
A questionnaire intended to assess acceptance of insomnia
Change from baseline in Body mass index
Change from baseline in sagittal abdominal diameter
Abdominal height (cm)
Change from baseline in waist-hip ratio
A ratio of the circumference of the waist to the hips
Change from baseline in blood pressure
Change from baseline in heart rate
Change from baseline in ALAT
Liver function
Change from baseline in HbA 1c
Glycated hemoglobin
Change from baseline in blood glucose
Change from baseline in triglycerides
A type of fat found in the blood
Change from baseline in cholesterol (LDL/HDL)
Change from baseline in the Insomnia severity index (ISI)
A brief self-report screening form

Full Information

First Posted
July 4, 2012
Last Updated
July 30, 2012
Sponsor
Uppsala University
Collaborators
Uppsala-Örebro Regional Research Council
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1. Study Identification

Unique Protocol Identification Number
NCT01655797
Brief Title
Cognitive Behavior Therapy for Insomnia in Primary Care
Acronym
TIRED
Official Title
Treating Insomnia in Primary Care: A Study of Effectiveness and Dissemination
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uppsala University
Collaborators
Uppsala-Örebro Regional Research Council

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
insomnia, cognitive behavior therapy, primary care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBT
Arm Type
Experimental
Arm Description
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.
Arm Title
Wait-list
Arm Type
No Intervention
Arm Description
A deferred treatment wait-list condition, with no restrictions placed on the usual care.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavior therapy for insomnia
Intervention Description
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 Outcome Measure Information:
Title
Change from baseline in the Insomnia severity index (ISI)
Description
A brief self-report screening form
Time Frame
After 9 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in sleep-onset latency (SOL)
Description
Time to fall asleep, measured with sleep diary
Time Frame
9 weeks
Title
Change from baseline in wake time after sleep onset (WASO)
Description
Time awake during the night, measured with sleep diary
Time Frame
After 9 weeks
Title
Change from baseline in number of awakenings during the night (NWAK)
Description
Measured with sleep diary
Time Frame
After 9 weeks
Title
Change from baseline in Sleep efficiency (SE)
Description
Time actually spent sleeping out of the total time in bed (%), measured with sleep diary
Time Frame
After 9 weeks
Title
Change from baseline in time in bed (TIB)
Description
Measured with sleep diary
Time Frame
After 9 weeks
Title
Change from baseline in total sleep time (TST)
Description
Measured with sleep diary
Time Frame
After 9 weeks
Title
Change from baseline in sleep quality (SQ)
Description
Subjective sleep quality (likert scale)
Time Frame
After 9 weeks
Title
Change from baseline in the fatigue severity scale (FSS)
Description
Self-report questionnaire
Time Frame
After 9 weeks
Title
Change from baseline in the MOS 36-item short-form health survey, SF-36
Description
Questionnaire assessing physical and mental health
Time Frame
After 9 weeks
Title
Change from baseline in the Hospital anxiety and depression scale, HADS
Description
Self-report questionnaire measuring depression and anxiety
Time Frame
After 9 weeks
Title
Change from baseline in the Epworth sleepiness scale, ESS
Description
Self-report questionnaire assessing daytime sleepiness
Time Frame
After 9 weeks
Title
Change form baseline in the Pittsburgh sleep quality index (PSQI)
Description
Self-report form assessing sleep quality
Time Frame
After 9 weeks
Title
Change from baseline in the Minimal insomnia severity scale, MISS
Description
Ultra short screening questionnaire for insomnia
Time Frame
After 9 weeks
Title
Change from baseline in the Insomnia acceptance questionnaire, IQA
Description
A questionnaire intended to assess acceptance of insomnia
Time Frame
After 9 weeks
Title
Change from baseline in Body mass index
Time Frame
After 9 weeks
Title
Change from baseline in sagittal abdominal diameter
Description
Abdominal height (cm)
Time Frame
After 9 weeks
Title
Change from baseline in waist-hip ratio
Description
A ratio of the circumference of the waist to the hips
Time Frame
After 9 weeks
Title
Change from baseline in blood pressure
Time Frame
After 9 weeks
Title
Change from baseline in heart rate
Time Frame
After 9 weeks
Title
Change from baseline in ALAT
Description
Liver function
Time Frame
After 9 weeks
Title
Change from baseline in HbA 1c
Description
Glycated hemoglobin
Time Frame
After 9 weeks
Title
Change from baseline in blood glucose
Time Frame
After 9 weeks
Title
Change from baseline in triglycerides
Description
A type of fat found in the blood
Time Frame
After 9 weeks
Title
Change from baseline in cholesterol (LDL/HDL)
Time Frame
After 9 weeks
Title
Change from baseline in sleep-onset latency (SOL)
Description
Time to fall asleep, measured with sleep diary
Time Frame
After 18 months
Title
Change from baseline in wake time after sleep onset (WASO)
Description
Time awake during the night, measured with sleep diary
Time Frame
After 18 months
Title
Change from baseline in number of awakenings during the night (NWAK)
Description
Measured with sleep diary
Time Frame
After 18 months
Title
Change from baseline in Sleep efficiency (SE)
Description
Time actually spent sleeping out of the total time in bed (%), measured with sleep diary
Time Frame
After 18 months
Title
Change from baseline in time in bed (TIB)
Description
Measured with sleep diary
Time Frame
After 18 months
Title
Change from baseline in total sleep time (TST)
Description
Measured with sleep diary
Time Frame
After 18 months
Title
Change from baseline in sleep quality (SQ)
Description
Subjective sleep quality (likert scale)
Time Frame
After 18 months
Title
Change from baseline in the fatigue severity scale (FSS)
Description
Self-report questionnaire
Time Frame
After 18 months
Title
Change from baseline in the MOS 36-item short-form health survey, SF-36
Description
Questionnaire assessing physical and mental health
Time Frame
After 18 months
Title
Change from baseline in the Hospital anxiety and depression scale, HADS
Description
Self-report questionnaire measuring depression and anxiety
Time Frame
After 18 months
Title
Change from baseline in the Epworth sleepiness scale, ESS
Description
Self-report questionnaire assessing daytime sleepiness
Time Frame
After 18 moths
Title
Change form baseline in the Pittsburgh sleep quality index (PSQI)
Description
Self-report form assessing sleep quality
Time Frame
After 18 months
Title
Change from baseline in the Minimal insomnia severity scale, MISS
Description
Ultra short screening questionnaire for insomnia
Time Frame
After 18 months
Title
Change from baseline in the Insomnia acceptance questionnaire, IQA
Description
A questionnaire intended to assess acceptance of insomnia
Time Frame
After 18 months
Title
Change from baseline in Body mass index
Time Frame
After 18 months
Title
Change from baseline in sagittal abdominal diameter
Description
Abdominal height (cm)
Time Frame
After 18 months
Title
Change from baseline in waist-hip ratio
Description
A ratio of the circumference of the waist to the hips
Time Frame
After 18 months
Title
Change from baseline in blood pressure
Time Frame
After 18 months
Title
Change from baseline in heart rate
Time Frame
After 18 months
Title
Change from baseline in ALAT
Description
Liver function
Time Frame
After 18 months
Title
Change from baseline in HbA 1c
Description
Glycated hemoglobin
Time Frame
After 18 months
Title
Change from baseline in blood glucose
Time Frame
After 18 months
Title
Change from baseline in triglycerides
Description
A type of fat found in the blood
Time Frame
After 18 months
Title
Change from baseline in cholesterol (LDL/HDL)
Time Frame
After 18 months
Title
Change from baseline in the Insomnia severity index (ISI)
Description
A brief self-report screening form
Time Frame
After 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan-Erik Broman, PhD
Organizational Affiliation
Uppsala University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uppsala University
City
Uppsala
ZIP/Postal Code
75105
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
17552372
Citation
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.
Results Reference
background
PubMed Identifier
23859625
Citation
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.
Results Reference
derived

Learn more about this trial

Cognitive Behavior Therapy for Insomnia in Primary Care

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