InsomniaTIREDNCT01655797
Cognitive Behavior Therapy for Insomnia in Primary Care
A study testing Cognitive behavior therapy for insomnia in people with Insomnia, run by Uppsala University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia
- What is being tested?
- Cognitive behavior therapy for insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSweden
- Study dates
- May 2008to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fulfilled research criteria for chronic insomnia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Insomnia
- Being tested
- Cognitive behavior therapy for insomnia
- Keywords
- insomnia, cognitive behavior therapy, primary care
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavior therapy for insomniaBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CBT | Experimental | 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. Receives: Behavioral: Cognitive behavior therapy for insomnia |
| Wait-list | No intervention | A deferred treatment wait-list condition, with no restrictions placed on the usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the Insomnia severity index (ISI)
A brief self-report screening form
Measured: After 9 weeks
Secondary outcomes (49)
Change from baseline in sleep-onset latency (SOL)
Time to fall asleep, measured with sleep diary
Measured: 9 weeks
Change from baseline in wake time after sleep onset (WASO)
Time awake during the night, measured with sleep diary
Measured: After 9 weeks
Change from baseline in number of awakenings during the night (NWAK)
Measured with sleep diary
Measured: After 9 weeks
Change from baseline in Sleep efficiency (SE)
Time actually spent sleeping out of the total time in bed (%), measured with sleep diary
Measured: After 9 weeks
Change from baseline in time in bed (TIB)
Measured with sleep diary
Measured: After 9 weeks
Change from baseline in total sleep time (TST)
Measured with sleep diary
Measured: After 9 weeks
Change from baseline in sleep quality (SQ)
Subjective sleep quality (likert scale)
Measured: After 9 weeks
Change from baseline in the fatigue severity scale (FSS)
Self-report questionnaire
Measured: After 9 weeks
Change from baseline in the MOS 36-item short-form health survey, SF-36
Questionnaire assessing physical and mental health
Measured: After 9 weeks
Change from baseline in the Hospital anxiety and depression scale, HADS
Self-report questionnaire measuring depression and anxiety
Measured: After 9 weeks
Change from baseline in the Epworth sleepiness scale, ESS
Self-report questionnaire assessing daytime sleepiness
Measured: After 9 weeks
Change form baseline in the Pittsburgh sleep quality index (PSQI)
Self-report form assessing sleep quality
Measured: After 9 weeks
Change from baseline in the Minimal insomnia severity scale, MISS
Ultra short screening questionnaire for insomnia
Measured: After 9 weeks
Change from baseline in the Insomnia acceptance questionnaire, IQA
A questionnaire intended to assess acceptance of insomnia
Measured: After 9 weeks
Change from baseline in Body mass index
Measured: After 9 weeks
Change from baseline in sagittal abdominal diameter
Abdominal height (cm)
Measured: After 9 weeks
Change from baseline in waist-hip ratio
A ratio of the circumference of the waist to the hips
Measured: After 9 weeks
Change from baseline in blood pressure
Measured: After 9 weeks
Change from baseline in heart rate
Measured: After 9 weeks
Change from baseline in ALAT
Liver function
Measured: After 9 weeks
Change from baseline in HbA 1c
Glycated hemoglobin
Measured: After 9 weeks
Change from baseline in blood glucose
Measured: After 9 weeks
Change from baseline in triglycerides
A type of fat found in the blood
Measured: After 9 weeks
Change from baseline in cholesterol (LDL/HDL)
Measured: After 9 weeks
Change from baseline in sleep-onset latency (SOL)
Time to fall asleep, measured with sleep diary
Measured: After 18 months
Change from baseline in wake time after sleep onset (WASO)
Time awake during the night, measured with sleep diary
Measured: After 18 months
Change from baseline in number of awakenings during the night (NWAK)
Measured with sleep diary
Measured: After 18 months
Change from baseline in Sleep efficiency (SE)
Time actually spent sleeping out of the total time in bed (%), measured with sleep diary
Measured: After 18 months
Change from baseline in time in bed (TIB)
Measured with sleep diary
Measured: After 18 months
Change from baseline in total sleep time (TST)
Measured with sleep diary
Measured: After 18 months
Change from baseline in sleep quality (SQ)
Subjective sleep quality (likert scale)
Measured: After 18 months
Change from baseline in the fatigue severity scale (FSS)
Self-report questionnaire
Measured: After 18 months
Change from baseline in the MOS 36-item short-form health survey, SF-36
Questionnaire assessing physical and mental health
Measured: After 18 months
Change from baseline in the Hospital anxiety and depression scale, HADS
Self-report questionnaire measuring depression and anxiety
Measured: After 18 months
Change from baseline in the Epworth sleepiness scale, ESS
Self-report questionnaire assessing daytime sleepiness
Measured: After 18 moths
Change form baseline in the Pittsburgh sleep quality index (PSQI)
Self-report form assessing sleep quality
Measured: After 18 months
Change from baseline in the Minimal insomnia severity scale, MISS
Ultra short screening questionnaire for insomnia
Measured: After 18 months
Change from baseline in the Insomnia acceptance questionnaire, IQA
A questionnaire intended to assess acceptance of insomnia
Measured: After 18 months
Change from baseline in Body mass index
Measured: After 18 months
Change from baseline in sagittal abdominal diameter
Abdominal height (cm)
Measured: After 18 months
Change from baseline in waist-hip ratio
A ratio of the circumference of the waist to the hips
Measured: After 18 months
Change from baseline in blood pressure
Measured: After 18 months
Change from baseline in heart rate
Measured: After 18 months
Change from baseline in ALAT
Liver function
Measured: After 18 months
Change from baseline in HbA 1c
Glycated hemoglobin
Measured: After 18 months
Change from baseline in blood glucose
Measured: After 18 months
Change from baseline in triglycerides
A type of fat found in the blood
Measured: After 18 months
Change from baseline in cholesterol (LDL/HDL)
Measured: After 18 months
Change from baseline in the Insomnia severity index (ISI)
A brief self-report screening form
Measured: After 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2012 (estimated)
- Study startMay 2008
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala-Örebro Regional Research Council
- Responsible party
- Sponsor
- Investigators
- Jan-Erik Broman, PhD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01655797
- Sponsor's protocol ID
- RFR-10276
- Acronym
- TIRED
- Status last verified
- Jul 2012
- First submitted
- 4 Jul 2012
- Last updated
- 2 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17552372Bothelius 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.
PubMed 23859625
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Insomnia in Primary Care: A Study of Effectiveness and Dissemination
- ClinicalTrials.gov ID
- NCT01655797
- Acronym / sponsor ID
- TIRED / RFR-10276
- Conditions
- Insomnia
- Keywords
- insomnia, cognitive behavior therapy, primary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Uppsala-Örebro Regional Research Council
- Study start
- May 2008
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 2 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT | Experimental | Behavioral: Cognitive behavior therapy for insomniaThe 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. |
| Wait-list | No intervention | –A deferred treatment wait-list condition, with no restrictions placed on the usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Fulfilled research criteria for chronic insomnia
Key exclusion criteria (7 listed)
- other untreated sleep disturbance
- pregnancy
- shift work
- concurrent medical or psychiatric condition that could be negatively affected by the treatment
- drug abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behavior therapy for insomniaTreatment 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. | Behavioural | CBT |
Primary outcome
Change from baseline in the Insomnia severity index (ISI)
Time frame: After 9 weeks
A brief self-report screening form
49 secondary outcomes
Change from baseline in sleep-onset latency (SOL)
Time frame: 9 weeks
Change from baseline in wake time after sleep onset (WASO)
Time frame: After 9 weeks
Change from baseline in number of awakenings during the night (NWAK)
Time frame: After 9 weeks
Change from baseline in Sleep efficiency (SE)
Time frame: After 9 weeks
Change from baseline in time in bed (TIB)
Time frame: After 9 weeks
Change from baseline in total sleep time (TST)
Time frame: After 9 weeks
Change from baseline in sleep quality (SQ)
Time frame: After 9 weeks
Change from baseline in the fatigue severity scale (FSS)
Time frame: After 9 weeks
Change from baseline in the MOS 36-item short-form health survey, SF-36
Time frame: After 9 weeks
Change from baseline in the Hospital anxiety and depression scale, HADS
Time frame: After 9 weeks
Change from baseline in the Epworth sleepiness scale, ESS
Time frame: After 9 weeks
Change form baseline in the Pittsburgh sleep quality index (PSQI)
Time frame: After 9 weeks
Change from baseline in the Minimal insomnia severity scale, MISS
Time frame: After 9 weeks
Change from baseline in the Insomnia acceptance questionnaire, IQA
Time frame: After 9 weeks
Change from baseline in Body mass index
Time frame: After 9 weeks
Change from baseline in sagittal abdominal diameter
Time frame: After 9 weeks
Change from baseline in waist-hip ratio
Time frame: After 9 weeks
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
Change from baseline in HbA 1c
Time frame: After 9 weeks
Change from baseline in blood glucose
Time frame: After 9 weeks
Change from baseline in triglycerides
Time frame: After 9 weeks
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
Change from baseline in wake time after sleep onset (WASO)
Time frame: After 18 months
Change from baseline in number of awakenings during the night (NWAK)
Time frame: After 18 months
Change from baseline in Sleep efficiency (SE)
Time frame: After 18 months
Change from baseline in time in bed (TIB)
Time frame: After 18 months
Change from baseline in total sleep time (TST)
Time frame: After 18 months
Change from baseline in sleep quality (SQ)
Time frame: After 18 months
Change from baseline in the fatigue severity scale (FSS)
Time frame: After 18 months
Change from baseline in the MOS 36-item short-form health survey, SF-36
Time frame: After 18 months
Change from baseline in the Hospital anxiety and depression scale, HADS
Time frame: After 18 months
Change from baseline in the Epworth sleepiness scale, ESS
Time frame: After 18 moths
Change form baseline in the Pittsburgh sleep quality index (PSQI)
Time frame: After 18 months
Change from baseline in the Minimal insomnia severity scale, MISS
Time frame: After 18 months
Change from baseline in the Insomnia acceptance questionnaire, IQA
Time frame: After 18 months
Change from baseline in Body mass index
Time frame: After 18 months
Change from baseline in sagittal abdominal diameter
Time frame: After 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2012.
- Background: PubMed 17552372Espie 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.
- Derived from this study: PubMed 23859625Bothelius 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan-Erik Broman, PhD principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavior therapy for insomnia in people with Insomnia, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the Insomnia severity index (ISI) (time frame: After 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01655797, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2012; AzTrials last refreshed its copy on 30 Oct 2026.