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Feasibility and Efficacy of Internet-delivered CBT for Insomnia in a National Cohort of Danish Breast Cancer Survivors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02444026
Recruitment Status : Unknown
Verified December 2014 by University of Aarhus.
Recruitment status was:  Recruiting
First Posted : May 14, 2015
Last Update Posted : May 14, 2015
Sponsor:
Collaborator:
Danish Breast Cancer Cooperative Group
Information provided by (Responsible Party):
University of Aarhus

Brief 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 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).

Condition or disease Intervention/treatment Phase
Insomnia Behavioral: iCBT for Insomnia Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility and Efficacy of an Internet-delivered Cognitive-behavioral Intervention for Insomnia in a National Cohort of Danish Breast Cancer Survivors
Study Start Date : December 2014
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


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)
Behavioral: iCBT for Insomnia
Internet-delivered Cognitive Behavioural Therapy for Insomnia

No Intervention: Control
The control group will be offered the intervention AFTER the study



Primary Outcome Measures :
  1. 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).

  2. The Pittsburgh Sleep Quality Index [ Time Frame: Up to 7 month ]
  3. The Insomnia Severity Index [ Time Frame: Up to 7 month ]

Secondary Outcome Measures :
  1. Functional Assessment of Chronic Illness Therapy (FACIT) [ Time Frame: Up to 7 month ]
  2. Beck's Depression Inventory (BDI-II) [ Time Frame: Up to 7 month ]
  3. State-Trait Anxiety Inventory (STAI) [ Time Frame: Up to 7 month ]
  4. EQ-5D [ Time Frame: Up to 7 month ]
  5. SF-12 [ Time Frame: Up to 7 month ]
    Quality of life (QoL) is measured with the SF-12

  6. Cognitive Failures Questionnaire (CFQ) [ Time Frame: Up to 7 month ]
  7. 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.

  8. 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 ]
  9. Pain (questionnaire) [ Time Frame: Up to 7 month ]
    A short questionnaire assessing pain is included


Other Outcome Measures:
  1. Moderator - Fear of Cancer Recurrence (FCR) [ Time Frame: Up to 7 month ]
  2. Moderator - Depressive symptoms (BDI-II) [ Time Frame: Up to 7 month ]
  3. Moderator - Charlson comorbidity index [ Time Frame: Up to 7 month ]
  4. Moderator -Emotional Control Scale (ECQ-R) [ Time Frame: Up to 7 month ]
  5. 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

  6. Moderator - Use of health services, self-help methods, sleep medication, and complementary and alternative medicine/treatment [ Time Frame: Up to 7 month ]
  7. Moderator - Pain [ Time Frame: Up to 7 month ]
    A short questionnaire assessing pain has been developed

  8. 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)


  9. Moderator - Traumatic Life Events Questionnaire (TLEQ) [ Time Frame: Up to 7 month ]
  10. Mediator - Changes in sleep habits and sleep-related lifestyle from baseline to post-intervention [ Time Frame: Up to 7 month ]
  11. 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.

    )




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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) .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02444026


Contacts
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Contact: Robert Zachariae, MDSci +45 871 65878 bzach@aarhus.rm.dk
Contact: Jesper Dahlgaard, PhD +45 8716 5494 / +45 23254157 jesper@psy.au.dk

Locations
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Denmark
Unit for Psychooncology and Health Psychology, Dept. of Oncology, Aarhus University Hospital and Dept of Psychology and Behavioural Science, Aarhus University Recruiting
Aarhus, Denmark, 8000
Contact: Robert Zachariae, DMSci    +45 871 65878    bzach@aarhus.rm.dk   
Contact: Jesper Dahlgaard, PhD    +45 8716 5494 / +45 23254157    jesper@psy.au.dk   
Sponsors and Collaborators
University of Aarhus
Danish Breast Cancer Cooperative Group
Investigators
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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:
American Psychiatric Asssociation. Diagnostic and Statistical Manual of Mental Disor ders. Washington, DC: American Psychiatric Association; 2000.
Ritterband LM, Bailey ET, Thorndike FP, Lord HR, Farrell-Carnahan L, Baum LD. Psychooncology 2011 Apr 29.
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.
Beck AT, Steer RA, Brown GK. Manual: Beck Depression Inventory. 2 ed. San Antonio, TX: The Psychological Corporation. Hartcourt & Brace.; 1996.
Spielberger CD. Psychological Assessment Resources Odessa FA 1988 1988.
Bjørner JB, Damsgaard MT, Watt T, Bech P, Rasmussen NK, Kristensen TS, et al. Copenhagen: Lif; 1997.
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.
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.
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.

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02444026    
Other Study ID Numbers: M-2012-553-12
First Posted: May 14, 2015    Key Record Dates
Last Update Posted: May 14, 2015
Last Verified: December 2014
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders