InsomniaNCT02444026
Feasibility and Efficacy of Internet-delivered CBT for Insomnia in a National Cohort of Danish Breast Cancer Survivors
A study testing iCBT for Insomnia in people with Insomnia, run by University of Aarhus at 1 site in Denmark.
Trial summary
The aim is, in a randomized controlled trial, to test the feasibility and evaluate the efficacy of an internet-based treatment for insomnia, previously tested in a group of 28 US cancer patients, in a large sample of Danish breast cancer survivors who are experiencing significant sleep problems 0-3 years after… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Insomnia
- What is being tested?
- iCBT for Insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2014to Dec 2015
- 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 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Reported moderate-to-severe sleep disturbances, defined as a score> 5 on the Pittsburgh Sleep Quality Index (PSQI).
- Disease free.
- Access to the Internet.
Who cannot join
- Recurrence of breast cancer
- A second cancer
- Other serious physical or psychological comorbidity (e.g. depression, cardiovascular disease, and COPD)
- Night work schedule
- Other sleep disorders (sleep apnea, narcolepsy) .
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Unit for Psychooncology and Health Psychology, Dept. of Oncology, Aarhus University Hospital and Dept of Psychology and Behavioural Science, Aarhus University
Aarhus, Denmark, 8000
Robert Zachariae, DMSci, +45 871 65878, bzach@aarhus.rm.dk
Jesper Dahlgaard, PhD, +45 8716 5494 / +45 23254157, jesper@psy.au.dk
About this study
Official title: Feasibility and Efficacy of an Internet-delivered Cognitive-behavioral Intervention for Insomnia in a National Cohort of Danish Breast Cancer Survivors
The aim is, in a randomized controlled trial, to test the feasibility and evaluate the efficacy of an internet-based treatment for insomnia, previously tested in a group of 28 US cancer patients, in a large sample of Danish breast cancer survivors who are experiencing significant sleep problems 0-3 years after treatment. The investigators aim to test the following hypotheses: That a group receiving Internet-delivered cognitive-behavioral therapy (CCBT) for insomnia (CCBT-I) will experience reduced sleep latency, more hours of sleep, fewer awakenings during the night, improved sleep efficiency, increased subjective sleep quality, and improved quality of life after the intervention, when compared to a waiting list control group. The investigators also aim to explore a number of possible moderators of the effect (comorbidity, depression, fear of cancer recurrence tendency to ruminate) and mediating mechanisms (changes in sleep habits and sleep-related lifestyle factors).
Read the detailed description
METHODS PARTICIPANTS
The participants are able, legally competent women, 18 years or older, from a national cohort of Danish women treated for primary breast cancer between 1st of June 2011 and 1st of Juli 2014:
Inclusion criteria: 1) Reported moderate-to-severe sleep disturbances, defined as a score> 5 on the Pittsburgh Sleep Quality Index (PSQI) (32;33) (see below), and 2) are found to be disease free. Furthermore, participants 3) are required to have access to the Internet.
Exclusion criteria: 1) Recurrence of breast cancer, 2) a second cancer, 3) and other serious physical or psychological comorbidity (e.g. depression, cardiovascular disease, and COPD), 4) shift work schedule, 5) other sleep disorders (sleep apnea, narcolepsy).
PROCEDURE INFORMATION AND REQUEST TO PARTICIPATE Women who fulfill the inclusion criteria and indicate an interest in receiving further information receive an information folder by post informing.
BASELINE MEASURES:
The baseline questionnaires contains questions about sleep quality, fatigue, depression, anxiety, quality of life, sleep habits and sleep-relevant lifestyles, together with use of health care services, sleep medication, and use of alternative medicine with the aim of treating sleep problems.
INTERVENTION:
The intervention program is designed to be completed in 6 weeks. To ensure that all participants have opportunity to complete the program they are granted access to the program for nine weeks .
POST-INTERVENTION:
After the intervention, participants in both groups are asked to complete a post-intervention questionnaire package and then to fill in the sleep diary for a 2-week period.
FOLLOW-UP:
After an additional 4 weeks both groups complete two sleep questionnaires (PSQI and the insomnia severity index) after which the waiting list group is offered the intervention.
INTERVENTION The Internet intervention offered is the SHUT-i program (Sleep Healthy Using The Internet), which is based on the existing consensus concerning non-pharmacological treatment of insomnia and builds on previous validated CBT's for insomnia (CBT -I) (34).
CONTROL GROUP Participants randomly assigned to the control condition are told that for practical reasons, they have to wait 15 weeks before partaking in the intervention.
PRIMARY ENDPOINTS A) Sleep diary (bedtime, sleep onset latency (SOL), number of awakenings, total length of awakenings, wake time, arising time, daytime naps, rating of soundness of previous night's sleep, rating of refreshed feeling upon morning awakening, and information about sleep aids : medication and/or alcohol use).
- The Pittsburgh Sleep Quality Index (PSQI) (33). C) The Insomnia Severity Index (ISI) (39).
NUMBER OF PARTICIPANTS The combined effects found in the meta-analysis of published randomized trials of Internet-based treatment for insomnia (30) are: sleep quality (d=0.41), sleep efficiency (d=0.40), number of awakenings (d=-0.45), sleep onset latency (d=-0.55), total minutes slept (d=.22), time spent in bed (d=.25). If the investigators aim to detect an effect corresponding to an average of the effects above (d = 0.38) with 80% statistical power, at least 2 x 109 participants are required.
ETHICAL CONSIDERATIONS The investigators will adhere to the general ethical guidelines for human trials. All participants receive oral and written information about the project. They are informed that they can withdraw at any time from the study with no consequence for their current or future treatment. Participants are advised to continue any medical treatment for insomnia, and to consult a doctor before changing medical regimen.
PRIVACY AND DATA SECURITY The SHUT-I program stores any personal information in a separate one-way system that cannot be accessed from the Internet but only locally by the SHUT-i administrators. Connections between personal information and other data are encrypted. Data is stored physically on servers in locked facilities, in the United States.
ADVERSE EFFECTS, INCONVENIENCES, BENEFITS, AND RISKS The investigators do not expect Internet-based cognitive behavioral therapy to be associated with any adverse health effects or risks as no adverse effects has been reported for conventional CBT for insomnia.
- Conditions
- Insomnia
- Being tested
- iCBT for Insomnia
- 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.
iCBT for InsomniaBehavioural
Internet-delivered Cognitive Behavioural Therapy for Insomnia
| Study group | Role | What they receive |
|---|---|---|
| iCBT for Insomnia | Experimental | The Internet intervention offered is the SHUT-i program (Sleep Healthy Using The Internet), which is based on the existing consensus concerning non-pharmacological treatment of insomnia and builds on previous validated CBT's for insomnia (CBT -I) Receives: Behavioral: iCBT for Insomnia |
| Control | No intervention | The control group will be offered the intervention AFTER the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep diary
The online sleep diaries contains 10 standard questions including information about bedtime, sleep onset latency (SOL), number of awakenings, total length of awakenings, wake time, arising time, daytime naps, rating of soundness of previous night's sleep, rating of refreshed feeling upon morning awakening, and information about sleep aids (medication and/or alcohol use).
Measured: Up to 7 month
The Pittsburgh Sleep Quality Index
Measured: Up to 7 month
The Insomnia Severity Index
Measured: Up to 7 month
Secondary outcomes (9)
Functional Assessment of Chronic Illness Therapy (FACIT)
Measured: Up to 7 month
Beck's Depression Inventory (BDI-II)
Measured: Up to 7 month
State-Trait Anxiety Inventory (STAI)
Measured: Up to 7 month
EQ-5D
Measured: Up to 7 month
SF-12
Quality of life (QoL) is measured with the SF-12
Measured: Up to 7 month
Cognitive Failures Questionnaire (CFQ)
Measured: Up to 7 month
Sleep habits and sleep-relevant lifestyle
Is assessed by adapting, further developing, and testing in the first phase of the study an existing instrument (Suzuki E, Tsuchiya M, Hirokawa K, Taniguchi T, Mitsuhashi T, Kawakami N. Evaluation of an internet-based self-help program for better quality of sleep among Japanese workers: a randomized controlled trial. J Occup Health 2008;50(5):387-99.), that measures: activities before bedtime, eating habits before bedtime, use of stimulants (coffee, tea, cola), alcohol, activities in the bedroom, exercise, thought patterns concerning sleep, etc.
Measured: Up to 7 month
Use of health services, self-help methods, sleep medication,fatigue, morningness-eveningness type, and complementary and alternative medicine/treatment
Measured: Up to 7 month
Pain (questionnaire)
A short questionnaire assessing pain is included
Measured: Up to 7 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2015 (estimated)
- Study startDec 2014
- Primary completionJul 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (67)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Breast Cancer Cooperative Group
- Responsible party
- Sponsor
- Investigators
- Robert Zachariae, MDSci, Study director, Unit for Psychooncology and Health Psychology Dept. of Oncology, Aarhus University Hospital and Dept of Psychology and Behavioural Science, Aarhus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02444026
- Sponsor's protocol ID
- M-2012-553-12
- Status last verified
- Dec 2014
- First submitted
- 10 Dec 2014
- Last updated
- 14 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
American Psychiatric Asssociation. Diagnostic and Statistical Manual of Mental Disor ders. Washington, DC: American Psychiatric Association; 2000.
Ohayon MM. Epidemiology of insomnia: what we know and what we still need to learn. Sleep Med Rev. 2002 Apr;6(2):97-111. doi: 10.1053/smrv.2002.0186.
PubMed 12531146Buysse DJ. Insomnia state of the science: an evolutionary, evidence-based assessment. Sleep. 2005 Sep;28(9):1045-6. No abstract available.
PubMed 16268371Roth T. Insomnia: definition, prevalence, etiology, and consequences. J Clin Sleep Med. 2007 Aug 15;3(5 Suppl):S7-10. No abstract available.
PubMed 17824495Fiorentino L, Ancoli-Israel S. Sleep dysfunction in patients with cancer. Curr Treat Options Neurol. 2007 Sep;9(5):337-46.
PubMed 17716597Savard J, Ivers H, Villa J, Caplette-Gingras A, Morin CM. Natural course of insomnia comorbid with cancer: an 18-month longitudinal study. J Clin Oncol. 2011 Sep 10;29(26):3580-6. doi: 10.1200/JCO.2010.33.2247. Epub 2011 Aug 8.
PubMed 21825267Price MA, Zachariae R, Butow PN, deFazio A, Chauhan D, Espie CA, Friedlander M, Webb PM; Australian Ovarian Cancer Study Group; Australian Ovarian Cancer Study - Quality of Life Study Investigators. Prevalence and predictors of insomnia in women with invasive ovarian cancer: anxiety a major factor. Eur J Cancer. 2009 Dec;45(18):3262-70. doi: 10.1016/j.ejca.2009.05.030. Epub 2009 Jun 18.
PubMed 19540748Colagiuri B, Christensen S, Jensen AB, Price MA, Butow PN, Zachariae R. Prevalence and predictors of sleep difficulty in a national cohort of women with primary breast cancer three to four months postsurgery. J Pain Symptom Manage. 2011 Nov;42(5):710-20. doi: 10.1016/j.jpainsymman.2011.02.012. Epub 2011 May 26.
PubMed 21620648Hall M, Baum A, Buysse DJ, Prigerson HG, Kupfer DJ, Reynolds CF 3rd. Sleep as a mediator of the stress-immune relationship. Psychosom Med. 1998 Jan-Feb;60(1):48-51. doi: 10.1097/00006842-199801000-00011.
PubMed 9492239Irwin M. Effects of sleep and sleep loss on immunity and cytokines. Brain Behav Immun. 2002 Oct;16(5):503-12. doi: 10.1016/s0889-1591(02)00003-x.
PubMed 12401464Baron KG, Reid KJ, Kern AS, Zee PC. Role of sleep timing in caloric intake and BMI. Obesity (Silver Spring). 2011 Jul;19(7):1374-81. doi: 10.1038/oby.2011.100. Epub 2011 Apr 28.
PubMed 21527892Hairston KG, Bryer-Ash M, Norris JM, Haffner S, Bowden DW, Wagenknecht LE. Sleep duration and five-year abdominal fat accumulation in a minority cohort: the IRAS family study. Sleep. 2010 Mar;33(3):289-95. doi: 10.1093/sleep/33.3.289.
PubMed 20337186Vgontzas AN, Bixler EO. Short sleep and obesity: are poor sleep, chronic stress, and unhealthy behaviors the link? Sleep. 2008 Sep;31(9):1203. No abstract available.
PubMed 18788643Cappuccio FP, D'Elia L, Strazzullo P, Miller MA. Sleep duration and all-cause mortality: a systematic review and meta-analysis of prospective studies. Sleep. 2010 May;33(5):585-92. doi: 10.1093/sleep/33.5.585.
PubMed 20469800Dew MA, Hoch CC, Buysse DJ, Monk TH, Begley AE, Houck PR, Hall M, Kupfer DJ, Reynolds CF 3rd. Healthy older adults' sleep predicts all-cause mortality at 4 to 19 years of follow-up. Psychosom Med. 2003 Jan-Feb;65(1):63-73. doi: 10.1097/01.psy.0000039756.23250.7c.
PubMed 12554816
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Efficacy of an Internet-delivered Cognitive-behavioral Intervention for Insomnia in a National Cohort of Danish Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT02444026
- Acronym / sponsor ID
- M-2012-553-12
- Conditions
- Insomnia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Danish Breast Cancer Cooperative Group
- Study start
- Dec 2014
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 14 May 2015 (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 is, in a randomized controlled trial, to test the feasibility and evaluate the efficacy of an internet-based treatment for insomnia, previously tested in a group of 28 US cancer patients, in a large sample of Danish breast cancer survivors who are experiencing significant sleep problems 0-3 years after treatment. The investigators aim to test the following hypotheses: That a group receiving Internet-delivered cognitive-behavioral therapy (CCBT) for insomnia (CCBT-I) will experience reduced sleep latency, more hours of sleep, fewer awakenings during the night, improved sleep efficiency, increased subjective sleep quality, and improved quality of life after the intervention, when compared to a waiting list control group. The investigators also aim to explore a number of possible moderators of the effect (comorbidity, depression, fear of cancer recurrence tendency to ruminate) and mediating mechanisms (changes in sleep habits and sleep-related lifestyle factors).
Detailed description
METHODS PARTICIPANTS
The participants are able, legally competent women, 18 years or older, from a national cohort of Danish women treated for primary breast cancer between 1st of June 2011 and 1st of Juli 2014:
Inclusion criteria: 1) Reported moderate-to-severe sleep disturbances, defined as a score> 5 on the Pittsburgh Sleep Quality Index (PSQI) (32;33) (see below), and 2) are found to be disease free. Furthermore, participants 3) are required to have access to the Internet.
Exclusion criteria: 1) Recurrence of breast cancer, 2) a second cancer, 3) and other serious physical or psychological comorbidity (e.g. depression, cardiovascular disease, and COPD), 4) shift work schedule, 5) other sleep disorders (sleep apnea, narcolepsy).
PROCEDURE INFORMATION AND REQUEST TO PARTICIPATE Women who fulfill the inclusion criteria and indicate an interest in receiving further information receive an information folder by post informing.
BASELINE MEASURES:
The baseline questionnaires contains questions about sleep quality, fatigue, depression, anxiety, quality of life, sleep habits and sleep-relevant lifestyles, together with use of health care services, sleep medication, and use of alternative medicine with the aim of treating sleep problems.
INTERVENTION:
The intervention program is designed to be completed in 6 weeks. To ensure that all participants have opportunity to complete the program they are granted access to the program for nine weeks .
POST-INTERVENTION:
After the intervention, participants in both groups are asked to complete a post-intervention questionnaire package and then to fill in the sleep diary for a 2-week period.
FOLLOW-UP:
After an additional 4 weeks both groups complete two sleep questionnaires (PSQI and the insomnia severity index) after which the waiting list group is offered the intervention.
INTERVENTION The Internet intervention offered is the SHUT-i program (Sleep Healthy Using The Internet), which is based on the existing consensus concerning non-pharmacological treatment of insomnia and builds on previous validated CBT's for insomnia (CBT -I) (34).
CONTROL GROUP Participants randomly assigned to the control condition are told that for practical reasons, they have to wait 15 weeks before partaking in the intervention.
PRIMARY ENDPOINTS A) Sleep diary (bedtime, sleep onset latency (SOL), number of awakenings, total length of awakenings, wake time, arising time, daytime naps, rating of soundness of previous night's sleep, rating of refreshed feeling upon morning awakening, and information about sleep aids : medication and/or alcohol use).
- The Pittsburgh Sleep Quality Index (PSQI) (33). C) The Insomnia Severity Index (ISI) (39).
NUMBER OF PARTICIPANTS The combined effects found in the meta-analysis of published randomized trials of Internet-based treatment for insomnia (30) are: sleep quality (d=0.41), sleep efficiency (d=0.40), number of awakenings (d=-0.45), sleep onset latency (d=-0.55), total minutes slept (d=.22), time spent in bed (d=.25). If the investigators aim to detect an effect corresponding to an average of the effects above (d = 0.38) with 80% statistical power, at least 2 x 109 participants are required.
ETHICAL CONSIDERATIONS The investigators will adhere to the general ethical guidelines for human trials. All participants receive oral and written information about the project. They are informed that they can withdraw at any time from the study with no consequence for their current or future treatment. Participants are advised to continue any medical treatment for insomnia, and to consult a doctor before changing medical regimen.
PRIVACY AND DATA SECURITY The SHUT-I program stores any personal information in a separate one-way system that cannot be accessed from the Internet but only locally by the SHUT-i administrators. Connections between personal information and other data are encrypted. Data is stored physically on servers in locked facilities, in the United States.
ADVERSE EFFECTS, INCONVENIENCES, BENEFITS, AND RISKS The investigators do not expect Internet-based cognitive behavioral therapy to be associated with any adverse health effects or risks as no adverse effects has been reported for conventional CBT for insomnia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iCBT for Insomnia | Experimental | Behavioral: iCBT for InsomniaThe Internet intervention offered is the SHUT-i program (Sleep Healthy Using The Internet), which is based on the existing consensus concerning non-pharmacological treatment of insomnia and builds on previous validated CBT's for insomnia (CBT -I) |
| Control | No intervention | –The control group will be offered the intervention AFTER the study |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Reported moderate-to-severe sleep disturbances, defined as a score> 5 on the Pittsburgh Sleep Quality Index (PSQI).
- Disease free.
- Access to the Internet.
Key exclusion criteria (5 listed)
- Recurrence of breast cancer
- A second cancer
- Other serious physical or psychological comorbidity (e.g. depression, cardiovascular disease, and COPD)
- Night work schedule
- Other sleep disorders (sleep apnea, narcolepsy) .
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 |
|---|---|---|
| iCBT for InsomniaInternet-delivered Cognitive Behavioural Therapy for Insomnia | Behavioural | iCBT for Insomnia |
Primary outcome
Sleep diary
Time frame: Up to 7 month
The online sleep diaries contains 10 standard questions including information about bedtime, sleep onset latency (SOL), number of awakenings, total length of awakenings, wake time, arising time, daytime naps, rating of soundness of previous night's sleep, rating of refreshed feeling upon morning awakening, and information about sleep aids (medication and/or alcohol use).
The Pittsburgh Sleep Quality Index
Time frame: Up to 7 month
The Insomnia Severity Index
Time frame: Up to 7 month
9 secondary outcomes
Functional Assessment of Chronic Illness Therapy (FACIT)
Time frame: Up to 7 month
Beck's Depression Inventory (BDI-II)
Time frame: Up to 7 month
State-Trait Anxiety Inventory (STAI)
Time frame: Up to 7 month
EQ-5D
Time frame: Up to 7 month
SF-12
Time frame: Up to 7 month
Cognitive Failures Questionnaire (CFQ)
Time frame: Up to 7 month
Sleep habits and sleep-relevant lifestyle
Time frame: Up to 7 month
Use of health services, self-help methods, sleep medication,fatigue, morningness-eveningness type, and complementary and alternative medicine/treatment
Time frame: Up to 7 month
Pain (questionnaire)
Time frame: Up to 7 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2015.
- BackgroundAmerican Psychiatric Asssociation. Diagnostic and Statistical Manual of Mental Disor ders. Washington, DC: American Psychiatric Association; 2000.
- Background: PubMed 12531146Ohayon MM. Epidemiology of insomnia: what we know and what we still need to learn. Sleep Med Rev. 2002 Apr;6(2):97-111. doi: 10.1053/smrv.2002.0186.
- Background: PubMed 16268371Buysse DJ. Insomnia state of the science: an evolutionary, evidence-based assessment. Sleep. 2005 Sep;28(9):1045-6. No abstract available.
- Background: PubMed 17824495Roth T. Insomnia: definition, prevalence, etiology, and consequences. J Clin Sleep Med. 2007 Aug 15;3(5 Suppl):S7-10. No abstract available.
- Background: PubMed 17716597Fiorentino L, Ancoli-Israel S. Sleep dysfunction in patients with cancer. Curr Treat Options Neurol. 2007 Sep;9(5):337-46.
- Background: PubMed 21825267Savard J, Ivers H, Villa J, Caplette-Gingras A, Morin CM. Natural course of insomnia comorbid with cancer: an 18-month longitudinal study. J Clin Oncol. 2011 Sep 10;29(26):3580-6. doi: 10.1200/JCO.2010.33.2247. Epub 2011 Aug 8.
- Background: PubMed 19540748Price MA, Zachariae R, Butow PN, deFazio A, Chauhan D, Espie CA, Friedlander M, Webb PM; Australian Ovarian Cancer Study Group; Australian Ovarian Cancer Study - Quality of Life Study Investigators. Prevalence and predictors of insomnia in women with invasive ovarian cancer: anxiety a major factor. Eur J Cancer. 2009 Dec;45(18):3262-70. doi: 10.1016/j.ejca.2009.05.030. Epub 2009 Jun 18.
- Background: PubMed 21620648Colagiuri B, Christensen S, Jensen AB, Price MA, Butow PN, Zachariae R. Prevalence and predictors of sleep difficulty in a national cohort of women with primary breast cancer three to four months postsurgery. J Pain Symptom Manage. 2011 Nov;42(5):710-20. doi: 10.1016/j.jpainsymman.2011.02.012. Epub 2011 May 26.
- Background: PubMed 9492239Hall M, Baum A, Buysse DJ, Prigerson HG, Kupfer DJ, Reynolds CF 3rd. Sleep as a mediator of the stress-immune relationship. Psychosom Med. 1998 Jan-Feb;60(1):48-51. doi: 10.1097/00006842-199801000-00011.
- Background: PubMed 12401464Irwin M. Effects of sleep and sleep loss on immunity and cytokines. Brain Behav Immun. 2002 Oct;16(5):503-12. doi: 10.1016/s0889-1591(02)00003-x.
- Background: PubMed 21527892Baron KG, Reid KJ, Kern AS, Zee PC. Role of sleep timing in caloric intake and BMI. Obesity (Silver Spring). 2011 Jul;19(7):1374-81. doi: 10.1038/oby.2011.100. Epub 2011 Apr 28.
- Background: PubMed 20337186Hairston KG, Bryer-Ash M, Norris JM, Haffner S, Bowden DW, Wagenknecht LE. Sleep duration and five-year abdominal fat accumulation in a minority cohort: the IRAS family study. Sleep. 2010 Mar;33(3):289-95. doi: 10.1093/sleep/33.3.289.
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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.
Robert Zachariae, MDSci study director
Unit for Psychooncology and Health Psychology Dept. of Oncology, Aarhus University Hospital and Dept of Psychology and Behavioural Science, Aarhus 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 iCBT for Insomnia in people with Insomnia, run by University of Aarhus at 1 site in Denmark.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 14 May 2015. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert Zachariae, MDSci (+45 871 65878, bzach@aarhus.rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep diary (time frame: Up to 7 month). The study lists 3 primary outcomes in all. 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 NCT02444026, which also lists 67 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 14 May 2015.