- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02444026
Feasibility and Efficacy of Internet-delivered CBT for Insomnia in a National Cohort of Danish Breast Cancer Survivors
Feasibility and Efficacy of an Internet-delivered Cognitive-behavioral Intervention for Insomnia in a National Cohort of Danish Breast Cancer Survivors
Study Overview
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).
B) 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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Robert Zachariae, MDSci
- Phone Number: +45 871 65878
- Email: bzach@aarhus.rm.dk
Study Contact Backup
- Name: Jesper Dahlgaard, PhD
- Phone Number: +45 8716 5494 / +45 23254157
- Email: jesper@psy.au.dk
Study Locations
-
-
-
Aarhus, Denmark, 8000
- Recruiting
- Unit for Psychooncology and Health Psychology, Dept. of Oncology, Aarhus University Hospital and Dept of Psychology and Behavioural Science, Aarhus University
-
Contact:
- Jesper Dahlgaard, PhD
- Phone Number: +45 8716 5494 / +45 23254157
- Email: jesper@psy.au.dk
-
Contact:
- Robert Zachariae, DMSci
- Phone Number: +45 871 65878
- Email: bzach@aarhus.rm.dk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Reported moderate-to-severe sleep disturbances, defined as a score> 5 on the Pittsburgh Sleep Quality Index (PSQI).
- Disease free.
- Access to the Internet.
Exclusion Criteria:
- 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) .
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: iCBT for Insomnia
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)
|
Internet-delivered Cognitive Behavioural Therapy for Insomnia
|
No Intervention: Control
The control group will be offered the intervention AFTER the study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Up to 7 month
|
The Pittsburgh Sleep Quality Index
Time Frame: Up to 7 month
|
Up to 7 month
|
|
The Insomnia Severity Index
Time Frame: Up to 7 month
|
Up to 7 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional Assessment of Chronic Illness Therapy (FACIT)
Time Frame: Up to 7 month
|
Up to 7 month
|
|
Beck's Depression Inventory (BDI-II)
Time Frame: Up to 7 month
|
Up to 7 month
|
|
State-Trait Anxiety Inventory (STAI)
Time Frame: Up to 7 month
|
Up to 7 month
|
|
EQ-5D
Time Frame: Up to 7 month
|
Up to 7 month
|
|
SF-12
Time Frame: Up to 7 month
|
Quality of life (QoL) is measured with the SF-12
|
Up to 7 month
|
Cognitive Failures Questionnaire (CFQ)
Time Frame: Up to 7 month
|
Up to 7 month
|
|
Sleep habits and sleep-relevant lifestyle
Time Frame: Up to 7 month
|
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.
|
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
|
Up to 7 month
|
|
Pain (questionnaire)
Time Frame: Up to 7 month
|
A short questionnaire assessing pain is included
|
Up to 7 month
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Moderator - Fear of Cancer Recurrence (FCR)
Time Frame: Up to 7 month
|
Up to 7 month
|
|
Moderator - Depressive symptoms (BDI-II)
Time Frame: Up to 7 month
|
Up to 7 month
|
|
Moderator - Charlson comorbidity index
Time Frame: Up to 7 month
|
Up to 7 month
|
|
Moderator -Emotional Control Scale (ECQ-R)
Time Frame: Up to 7 month
|
Up to 7 month
|
|
Moderator - The expected effects of and motivation to complete the intervention
Time Frame: Up to 7 month
|
A short questionnaire has been developed to assess the expected effects of and motivation to complete the intervention
|
Up to 7 month
|
Moderator - Use of health services, self-help methods, sleep medication, and complementary and alternative medicine/treatment
Time Frame: Up to 7 month
|
Up to 7 month
|
|
Moderator - Pain
Time Frame: Up to 7 month
|
A short questionnaire assessing pain has been developed
|
Up to 7 month
|
Moderator - Subjective response to a specific traumatic event
Time Frame: Up to 7 month
|
The impact of event scale-revised (Weiss, D.S. The Impact of Event Scale-Revised. In J.P. Wilson, & T.M. Keane (Eds.), Assessing psychological trauma and PTSD: A practitioner'shandbook (2nd ed., pp. 168-189).2004. New York: Guilford Press ) is included as a measure of subjective response to a specific traumatic event. This scale approximates the DSM-IV criteria for posttraumatic stress disorder. Subjective response to both breast cancer and one other self-chosen traumatic event is assessed. The delineation of the self-chosen traumatic event is based on the traumatic life event questionnaire (TLEQ) |
Up to 7 month
|
Moderator - Traumatic Life Events Questionnaire (TLEQ)
Time Frame: Up to 7 month
|
Up to 7 month
|
|
Mediator - Changes in sleep habits and sleep-related lifestyle from baseline to post-intervention
Time Frame: Up to 7 month
|
Up to 7 month
|
|
Mediator - The experience of and satisfaction with the intervention
Time Frame: Up to 7 month
|
Weiss, D.S. The Impact of Event Scale-Revised. In J.P. Wilson, & T.M. Keane (Eds.), Assessing psychological trauma and PTSD: A practitioner'shandbook (2nd ed., pp. 168-189).2004. New York: Guilford Press Weiss, D.S. The Impact of Event Scale-Revised. In J.P. Wilson, & T.M. Keane (Eds.), Assessing psychological trauma and PTSD: A practitioner'shandbook (2nd ed., pp. 168-189).2004. New York: Guilford Press Measured by the instrument developed in the first trials of the SHUTi intervention (Thorndike FP, Saylor DK, Bailey ET, Gonder-Frederick L, Morin CM, Ritterband LM. Develop- ment and Perceived Utility and Impact of an Internet Intervention for Insomnia. E J Appl Psychol 2008;4(2):32-42. ) |
Up to 7 month
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Robert Zachariae, MDSci, Unit for Psychooncology and Health Psychology Dept. of Oncology, Aarhus University Hospital and Dept of Psychology and Behavioural Science, Aarhus University
Publications and helpful links
General Publications
- Gandek B, Ware JE, Aaronson NK, Apolone G, Bjorner JB, Brazier JE, Bullinger M, Kaasa S, Leplege A, Prieto L, Sullivan M. Cross-validation of item selection and scoring for the SF-12 Health Survey in nine countries: results from the IQOLA Project. International Quality of Life Assessment. J Clin Epidemiol. 1998 Nov;51(11):1171-8. doi: 10.1016/s0895-4356(98)00109-7.
- Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
- Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.
- Yellen SB, Cella DF, Webster K, Blendowski C, Kaplan E. Measuring fatigue and other anemia-related symptoms with the Functional Assessment of Cancer Therapy (FACT) measurement system. J Pain Symptom Manage. 1997 Feb;13(2):63-74. doi: 10.1016/s0885-3924(96)00274-6.
- Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c869. doi: 10.1136/bmj.c869. No abstract available.
- MacKinnon DP, Lockwood CM, Hoffman JM, West SG, Sheets V. A comparison of methods to test mediation and other intervening variable effects. Psychol Methods. 2002 Mar;7(1):83-104. doi: 10.1037/1082-989x.7.1.83.
- Espie CA, Kyle SD, Williams C, Ong JC, Douglas NJ, Hames P, Brown JS. A randomized, placebo-controlled trial of online cognitive behavioral therapy for chronic insomnia disorder delivered via an automated media-rich web application. Sleep. 2012 Jun 1;35(6):769-81. doi: 10.5665/sleep.1872.
- Baron RM, Kenny DA. The moderator-mediator variable distinction in social psychological research: conceptual, strategic, and statistical considerations. J Pers Soc Psychol. 1986 Dec;51(6):1173-82. doi: 10.1037//0022-3514.51.6.1173.
- Savard 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.
- Savard MH, Savard J, Simard S, Ivers H. Empirical validation of the Insomnia Severity Index in cancer patients. Psychooncology. 2005 Jun;14(6):429-41. doi: 10.1002/pon.860.
- 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.
- American Psychiatric Asssociation. Diagnostic and Statistical Manual of Mental Disor ders. Washington, DC: American Psychiatric Association; 2000.
- Buysse DJ. Insomnia state of the science: an evolutionary, evidence-based assessment. Sleep. 2005 Sep;28(9):1045-6. No abstract available.
- Roth T. Insomnia: definition, prevalence, etiology, and consequences. J Clin Sleep Med. 2007 Aug 15;3(5 Suppl):S7-10. No abstract available.
- Fiorentino L, Ancoli-Israel S. Sleep dysfunction in patients with cancer. Curr Treat Options Neurol. 2007 Sep;9(5):337-46.
- Price 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.
- Colagiuri 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.
- Hall 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.
- Irwin 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.
- Baron 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.
- Hairston 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.
- Vgontzas 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.
- Cappuccio 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.
- Dew 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. Erratum In: Psychosom Med. 2003 Mar-Apr;65(2):210.
- Sleep complaints: Whenever possible, avoid the use of sleeping pills. Prescrire Int. 2008 Oct;17(97):206-12.
- Belleville G. Mortality hazard associated with anxiolytic and hypnotic drug use in the National Population Health Survey. Can J Psychiatry. 2010 Sep;55(9):558-67. doi: 10.1177/070674371005500904.
- Moore TA, Berger AM, Dizona P. Sleep aid use during and following breast cancer adjuvant chemotherapy. Psychooncology. 2011 Mar;20(3):321-5. doi: 10.1002/pon.1756.
- van Straten A, Cuijpers P. Self-help therapy for insomnia: a meta-analysis. Sleep Med Rev. 2009 Feb;13(1):61-71. doi: 10.1016/j.smrv.2008.04.006. Epub 2008 Oct 26.
- de Niet G, Tiemens B, Lendemeijer B, Hutschemaekers G. Music-assisted relaxation to improve sleep quality: meta-analysis. J Adv Nurs. 2009 Jul;65(7):1356-64. doi: 10.1111/j.1365-2648.2009.04982.x. Epub 2009 Apr 28.
- Irwin MR, Cole JC, Nicassio PM. Comparative meta-analysis of behavioral interventions for insomnia and their efficacy in middle-aged adults and in older adults 55+ years of age. Health Psychol. 2006 Jan;25(1):3-14. doi: 10.1037/0278-6133.25.1.3.
- Smith MT, Perlis ML, Park A, Smith MS, Pennington J, Giles DE, Buysse DJ. Comparative meta-analysis of pharmacotherapy and behavior therapy for persistent insomnia. Am J Psychiatry. 2002 Jan;159(1):5-11. doi: 10.1176/appi.ajp.159.1.5.
- Morin CM, Culbert JP, Schwartz SM. Nonpharmacological interventions for insomnia: a meta-analysis of treatment efficacy. Am J Psychiatry. 1994 Aug;151(8):1172-80. doi: 10.1176/ajp.151.8.1172.
- Ritterband LM, Bailey ET, Thorndike FP, Lord HR, Farrell-Carnahan L, Baum LD. Initial evaluation of an Internet intervention to improve the sleep of cancer survivors with insomnia. Psychooncology. 2012 Jul;21(7):695-705. doi: 10.1002/pon.1969. Epub 2011 Apr 29.
- Ritterband LM, Thorndike FP, Gonder-Frederick LA, Magee JC, Bailey ET, Saylor DK, Morin CM. Efficacy of an Internet-based behavioral intervention for adults with insomnia. Arch Gen Psychiatry. 2009 Jul;66(7):692-8. doi: 10.1001/archgenpsychiatry.2009.66. Erratum In: Arch Gen Psychiatry. 2010 Mar;67(3):311.
- Vincent N, Lewycky S. Logging on for better sleep: RCT of the effectiveness of online treatment for insomnia. Sleep. 2009 Jun;32(6):807-15. doi: 10.1093/sleep/32.6.807.
- 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. doi: 10.1539/joh.l7154. Epub 2008 Aug 19.
- Strom L, Pettersson R, Andersson G. Internet-based treatment for insomnia: a controlled evaluation. J Consult Clin Psychol. 2004 Feb;72(1):113-20. doi: 10.1037/0022-006X.72.1.113.
- Riley WT, Mihm P, Behar A, Morin CM. A computer device to deliver behavioral interventions for insomnia. Behav Sleep Med. 2010;8(1):2-15. doi: 10.1080/15402000903425314.
- Cheng SK, Dizon J. Computerised cognitive behavioural therapy for insomnia: a systematic review and meta-analysis. Psychother Psychosom. 2012;81(4):206-16. doi: 10.1159/000335379. Epub 2012 May 11.
- Beck SL, Schwartz AL, Towsley G, Dudley W, Barsevick A. Psychometric evaluation of the Pittsburgh Sleep Quality Index in cancer patients. J Pain Symptom Manage. 2004 Feb;27(2):140-8. doi: 10.1016/j.jpainsymman.2003.12.002.
- NIH State-of-the-Science Conference Statement on manifestations and management of chronic insomnia in adults. NIH Consens State Sci Statements. 2005 Jun 13-15;22(2):1-30.
- Thorndike FP, Saylor DK, Bailey ET, Gonder-Frederick L, Morin CM, Ritterband LM. Development and Perceived Utility and Impact of an Internet Intervention for Insomnia. E J Appl Psychol. 2008;4(2):32-42. doi: 10.7790/ejap.v4i2.133.
- Buysse DJ, Ancoli-Israel S, Edinger JD, Lichstein KL, Morin CM. Recommendations for a standard research assessment of insomnia. Sleep. 2006 Sep;29(9):1155-73. doi: 10.1093/sleep/29.9.1155. Erratum In: Sleep. 2006 Nov 1;29(11):1380.
- Backhaus J, Junghanns K, Broocks A, Riemann D, Hohagen F. Test-retest reliability and validity of the Pittsburgh Sleep Quality Index in primary insomnia. J Psychosom Res. 2002 Sep;53(3):737-40. doi: 10.1016/s0022-3999(02)00330-6.
- Thomsen DK, Mehlsen MY, Christensen S, Zachariae Rt. Pers Individ Diff 2003;34:1293-301.
- Morin CM. Insomnia: psychological assessment and management. New York: Guilford Press; 1993.
- Thorndike FP, Ritterband LM, Saylor DK, Magee JC, Gonder-Frederick LA, Morin CM. Validation of the insomnia severity index as a web-based measure. Behav Sleep Med. 2011;9(4):216-23. doi: 10.1080/15402002.2011.606766.
- Beck AT, Steer RA, Brown GK. Manual: Beck Depression Inventory. 2 ed. San Antonio, TX: The Psychological Corporation. Hartcourt & Brace.; 1996.
- Christensen S, Zachariae R, Jensen AB, Vaeth M, Moller S, Ravnsbaek J, von der Maase H. Prevalence and risk of depressive symptoms 3-4 months post-surgery in a nationwide cohort study of Danish women treated for early stage breast-cancer. Breast Cancer Res Treat. 2009 Jan;113(2):339-55. doi: 10.1007/s10549-008-9920-9. Epub 2008 Feb 16.
- Spielberger CD. Psychological Assessment Resources Odessa FA 1988 1988.
- Zachariae R, Melchiorsen H, Frobert O, Bjerring P, Bagger JP. Experimental pain and psychologic status of patients with chest pain with normal coronary arteries or ischemic heart disease. Am Heart J. 2001 Jul;142(1):63-71. doi: 10.1067/mhj.2001.115794.
- Bjørner JB, Damsgaard MT, Watt T, Bech P, Rasmussen NK, Kristensen TS, et al. Copenhagen: Lif; 1997.
- Broadbent DE, Cooper PF, FitzGerald P, Parkes KR. The Cognitive Failures Questionnaire (CFQ) and its correlates. Br J Clin Psychol. 1982 Feb;21(1):1-16. doi: 10.1111/j.2044-8260.1982.tb01421.x.
- Katz JN, Chang LC, Sangha O, Fossel AH, Bates DW. Can comorbidity be measured by questionnaire rather than medical record review? Med Care. 1996 Jan;34(1):73-84. doi: 10.1097/00005650-199601000-00006.
- Charlson M, Szatrowski TP, Peterson J, Gold J. Validation of a combined comorbidity index. J Clin Epidemiol. 1994 Nov;47(11):1245-51. doi: 10.1016/0895-4356(94)90129-5.
- Roger D, Najarian B. Pers Indiv Diff 1989;10(8):845-53.
- Weiss, D.S. The Impact of Event Scale-Revised. In J.P. Wilson, & T.M. Keane (Eds.), Assessing psychological trauma and PTSD: A practitioner'shandbook (2nd ed., pp. 168-189).2004. New York: Guilford Press.
- Kubany ES, Haynes SN, Leisen MB, Owens JA, Kaplan AS, Watson SB, Burns K. Development and preliminary validation of a brief broad-spectrum measure of trauma exposure: the Traumatic Life Events Questionnaire. Psychol Assess. 2000 Jun;12(2):210-24. doi: 10.1037//1040-3590.12.2.210.
- O'Connor M, Christensen S, Jensen AB, Moller S, Zachariae R. How traumatic is breast cancer? Post-traumatic stress symptoms (PTSS) and risk factors for severe PTSS at 3 and 15 months after surgery in a nationwide cohort of Danish women treated for primary breast cancer. Br J Cancer. 2011 Feb 1;104(3):419-26. doi: 10.1038/sj.bjc.6606073. Epub 2011 Jan 11.
- Pedersen CG, Christensen S, Jensen AB, Zachariae R. Prevalence, socio-demographic and clinical predictors of post-diagnostic utilisation of different types of complementary and alternative medicine (CAM) in a nationwide cohort of Danish women treated for primary breast cancer. Eur J Cancer. 2009 Dec;45(18):3172-81. doi: 10.1016/j.ejca.2009.09.005. Epub 2009 Oct 5.
- Kenny DA, Kashy DA, Bolger N. Data analysis in social psychology. In: Gilbert D, Fiske S,Lindzey G, editors. The handbook of social psychology. 4 ed. Boston,MA: McGraw-Hill; 1998. p. 233-65.
- Sobel ME. Asymptotic intervals for indirect effects in structural equation models. In: Leinhart S, editor. Sociological methodology.San Francisco: Jossey-Bass; 1982. p. 290-312.
- Muller D, Judd CM, Yzerbyt VY. When moderation is mediated and mediation is moderated. J Pers Soc Psychol. 2005 Dec;89(6):852-63. doi: 10.1037/0022-3514.89.6.852.
- Danmarks Statistik (Statistics Denmark). Befolkningens brug af internet (Internet use in the Danish population). Copenhagen: Danmarks Statistik (Statistics Denmark); 2011.
- Jensen-Johansen M, Christensen S, Valdimarsdottir H, Zakowski S, Bovbjerg DH, Jensen AB, et al. Unpublished manuscript 2010.
- Uniform requirements for manuscripts submitted to biomedical journals. International Committee of Medical Journal Editors. Ann Intern Med. 1997 Jan 1;126(1):36-47. doi: 10.7326/0003-4819-126-1-199701010-00006. No abstract available.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M-2012-553-12
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.
Clinical Trials on Insomnia
-
Leiden UniversityBioClock Consortium; Caring UniveristiesCompleted
-
National Science Council, TaiwanCompleted
-
Sunshine Lake Pharma Co., Ltd.Unknown
-
Pfizer's Upjohn has merged with Mylan to form Viatris...Completed
-
Massachusetts General HospitalNational Institutes of Health (NIH)Completed
-
IpsenCompletedThe Effectiveness of Circadin in Improving Quality of Sleep in Patients Aged 55 or Over (QUALISLEEP)InsomniaRussian Federation
-
Charite University, Berlin, GermanyCompleted
-
Roxane LaboratoriesCompleted
-
Butler HospitalSunovionCompleted
Clinical Trials on iCBT for Insomnia
-
I.M. Sechenov First Moscow State Medical UniversityUniversity of BernRecruitingChronic InsomniaRussian Federation
-
Linkoeping UniversityCompletedChronic Pain | Insomnia Due to Medical ConditionSweden
-
Chinese University of Hong KongNot yet recruitingSocial Anxiety Disorder
-
Northwestern UniversityCompletedDepressionUnited States
-
Stanford UniversityNational Institute of Nursing Research (NINR)Completed
-
US Department of Veterans AffairsTerminated
-
Linkoeping UniversityCompleted
-
Oregon State UniversityMonash University; Stanford University; American Academy of Sleep MedicineRecruitingSleep Initiation and Maintenance Disorders | Circadian Rhythm Sleep-Wake Disorders, Shift Work TypeUnited States
-
University of Kansas Medical CenterCompletedMultiple SclerosisUnited States