Cognitive Behavior Therapy for Insomnia in Primary Care (TIRED)

July 30, 2012 updated by: Uppsala University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Uppsala, Sweden, 75105
        • Uppsala University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline in the Insomnia severity index (ISI)
Time Frame: After 9 weeks
A brief self-report screening form
After 9 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in sleep-onset latency (SOL)
Time Frame: 9 weeks
Time to fall asleep, measured with sleep diary
9 weeks
Change from baseline in wake time after sleep onset (WASO)
Time Frame: After 9 weeks
Time awake during the night, measured with sleep diary
After 9 weeks
Change from baseline in number of awakenings during the night (NWAK)
Time Frame: After 9 weeks
Measured with sleep diary
After 9 weeks
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
After 9 weeks
Change from baseline in time in bed (TIB)
Time Frame: After 9 weeks
Measured with sleep diary
After 9 weeks
Change from baseline in total sleep time (TST)
Time Frame: After 9 weeks
Measured with sleep diary
After 9 weeks
Change from baseline in sleep quality (SQ)
Time Frame: After 9 weeks
Subjective sleep quality (likert scale)
After 9 weeks
Change from baseline in the fatigue severity scale (FSS)
Time Frame: After 9 weeks
Self-report questionnaire
After 9 weeks
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
After 9 weeks
Change from baseline in the Hospital anxiety and depression scale, HADS
Time Frame: After 9 weeks
Self-report questionnaire measuring depression and anxiety
After 9 weeks
Change from baseline in the Epworth sleepiness scale, ESS
Time Frame: After 9 weeks
Self-report questionnaire assessing daytime sleepiness
After 9 weeks
Change form baseline in the Pittsburgh sleep quality index (PSQI)
Time Frame: After 9 weeks
Self-report form assessing sleep quality
After 9 weeks
Change from baseline in the Minimal insomnia severity scale, MISS
Time Frame: After 9 weeks
Ultra short screening questionnaire for insomnia
After 9 weeks
Change from baseline in the Insomnia acceptance questionnaire, IQA
Time Frame: After 9 weeks
A questionnaire intended to assess acceptance of insomnia
After 9 weeks
Change from baseline in Body mass index
Time Frame: After 9 weeks
After 9 weeks
Change from baseline in sagittal abdominal diameter
Time Frame: After 9 weeks
Abdominal height (cm)
After 9 weeks
Change from baseline in waist-hip ratio
Time Frame: After 9 weeks
A ratio of the circumference of the waist to the hips
After 9 weeks
Change from baseline in blood pressure
Time Frame: After 9 weeks
After 9 weeks
Change from baseline in heart rate
Time Frame: After 9 weeks
After 9 weeks
Change from baseline in ALAT
Time Frame: After 9 weeks
Liver function
After 9 weeks
Change from baseline in HbA 1c
Time Frame: After 9 weeks
Glycated hemoglobin
After 9 weeks
Change from baseline in blood glucose
Time Frame: After 9 weeks
After 9 weeks
Change from baseline in triglycerides
Time Frame: After 9 weeks
A type of fat found in the blood
After 9 weeks
Change from baseline in cholesterol (LDL/HDL)
Time Frame: After 9 weeks
After 9 weeks
Change from baseline in sleep-onset latency (SOL)
Time Frame: After 18 months
Time to fall asleep, measured with sleep diary
After 18 months
Change from baseline in wake time after sleep onset (WASO)
Time Frame: After 18 months
Time awake during the night, measured with sleep diary
After 18 months
Change from baseline in number of awakenings during the night (NWAK)
Time Frame: After 18 months
Measured with sleep diary
After 18 months
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
After 18 months
Change from baseline in time in bed (TIB)
Time Frame: After 18 months
Measured with sleep diary
After 18 months
Change from baseline in total sleep time (TST)
Time Frame: After 18 months
Measured with sleep diary
After 18 months
Change from baseline in sleep quality (SQ)
Time Frame: After 18 months
Subjective sleep quality (likert scale)
After 18 months
Change from baseline in the fatigue severity scale (FSS)
Time Frame: After 18 months
Self-report questionnaire
After 18 months
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
After 18 months
Change from baseline in the Hospital anxiety and depression scale, HADS
Time Frame: After 18 months
Self-report questionnaire measuring depression and anxiety
After 18 months
Change from baseline in the Epworth sleepiness scale, ESS
Time Frame: After 18 moths
Self-report questionnaire assessing daytime sleepiness
After 18 moths
Change form baseline in the Pittsburgh sleep quality index (PSQI)
Time Frame: After 18 months
Self-report form assessing sleep quality
After 18 months
Change from baseline in the Minimal insomnia severity scale, MISS
Time Frame: After 18 months
Ultra short screening questionnaire for insomnia
After 18 months
Change from baseline in the Insomnia acceptance questionnaire, IQA
Time Frame: After 18 months
A questionnaire intended to assess acceptance of insomnia
After 18 months
Change from baseline in Body mass index
Time Frame: After 18 months
After 18 months
Change from baseline in sagittal abdominal diameter
Time Frame: After 18 months
Abdominal height (cm)
After 18 months
Change from baseline in waist-hip ratio
Time Frame: After 18 months
A ratio of the circumference of the waist to the hips
After 18 months
Change from baseline in blood pressure
Time Frame: After 18 months
After 18 months
Change from baseline in heart rate
Time Frame: After 18 months
After 18 months
Change from baseline in ALAT
Time Frame: After 18 months
Liver function
After 18 months
Change from baseline in HbA 1c
Time Frame: After 18 months
Glycated hemoglobin
After 18 months
Change from baseline in blood glucose
Time Frame: After 18 months
After 18 months
Change from baseline in triglycerides
Time Frame: After 18 months
A type of fat found in the blood
After 18 months
Change from baseline in cholesterol (LDL/HDL)
Time Frame: After 18 months
After 18 months
Change from baseline in the Insomnia severity index (ISI)
Time Frame: After 18 months
A brief self-report screening form
After 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Uppsala University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Uppsala-Örebro Regional Research Council

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jan-Erik Broman, PhD, Uppsala University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 4, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 2, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 2, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RFR-10276

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings