NCT03100981 — Online Mindfulness for Women Treated for Breast Cancer and Men Treated for Prostate Cancer · CancerIndex
Clinical trial · Interventional
Online Mindfulness for Women Treated for Breast Cancer and Men Treated for Prostate Cancer
Internet-delivered Mindfulness-Based Cognitive Therapy for Symptoms of Depression, Anxiety, and Stress Among Women Treated for Breast Cancer and Men Treated for Prostate Cancer - Effects and Mechanisms
AIM: The aim of the present study is to investigate if Internet-delivered Mindfulness-Based Cognitive Therapy (I-MBCT) can reduce symptoms of depression and anxiety among women treated for breast cancer and men treated for prostate cancer compared to a treatment as usual control group. Furthermore, the effect of I-MBCT on symptoms of stress, insomnia, quality of life, and self-compassion and the potential mediating effect of working alliance and mindfulness will be explored. Finally, the cost-effectiveness of the I-MBCT intervention will be explored.
BACKGROUND: Symptoms of depression, anxiety, and stress are prevalent late-effects among cancer patients and -survivors. Mindfulness-based interventions aim at improving affect tolerance and emotion regulation, which could be of particular relevance for cancer patients and survivors, and MBCT has been shown efficacious in treating symptoms of depression, anxiety, and stress among cancer patients and survivors. However, the availability of face-to-face delivered MBCT is limited and hence using the internet to deliver MBCT may be a cost-effective way of increasing the accessibility of the intervention to vulnerable patients with limited resources.
METHODS: A total of 155 participants will be recruited from Department of Oncology and Department of Urology at Aarhus University Hospital and randomized to two groups: I-MBCT and a treatment-as-usual wait-list control group. Assessments will be conducted at pre-, midway and post intervention and at a 6- months follow-up.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
The control group will be on a waiting list to participate in Internet-delivered MBCT after the 6-months follow-up time has passed.
interventionNames
Behavioral: Waitlist control
Primary outcomes (2)
measure
Symptoms of Depression
timeFrame
Eligibility
Eligibility (as posted)
Sex
All
Minimum age
18 Years
Show eligibility criteria text
Inclusion Criteria:
* Man treated for prostate cancer or woman treated for breast cancer
* Active cancer treatment must have been completed (radiation therapy, operation and chemotherapy) within the past 5 years. Ongoing endocrine therapy is all right.
* A minimum score of 3 on anxiety and/or depression items from Symptom Check-List-8, subscale in Common Mental Disorder Questionnaire (SCL-8, CMDQ).
* Internet access on a daily basis
* Must have a cell phone
Exclusion Criteria:
* Cancer recurrence or ongoing cancer treatment.
* Problems with reading and/or understanding Danish
* Insufficient IT skills
* Severe mental illness causing problems with following the internet-delivered treatment, e.g. dementia, known psychotic disorder or developmental disorder.
References
Publications (27)
BACKGROUNDAndersson G. Using the Internet to provide cognitive behaviour therapy. Behav Res Ther. 2009 Mar;47(3):175-80. doi: 10.1016/j.brat.2009.01.010. Epub 2009 Feb 20. PMID 19230862
BACKGROUNDCuijpers P, van Straten A, Andersson G. Internet-administered cognitive behavior therapy for health problems: a systematic review. J Behav Med. 2008 Apr;31(2):169-77. doi: 10.1007/s10865-007-9144-1. PMID 18165893
BACKGROUNDCook JE, Doyle C. Working alliance in online therapy as compared to face-to-face therapy: preliminary results. Cyberpsychol Behav. 2002 Apr;5(2):95-105. doi: 10.1089/109493102753770480. PMID 12025884
BACKGROUNDChristensen 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. PMID 18278553
BACKGROUNDO'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. PMID 21224851
BACKGROUNDStanton AL. Psychosocial concerns and interventions for cancer survivors. J Clin Oncol. 2006 Nov 10;24(32):5132-7. doi: 10.1200/JCO.2006.06.8775. PMID 17093275
BACKGROUNDDalton SO, Laursen TM, Ross L, Mortensen PB, Johansen C. Risk for hospitalization with depression after a cancer diagnosis: a nationwide, population-based study of cancer patients in Denmark from 1973 to 2003. J Clin Oncol. 2009 Mar 20;27(9):1440-5. doi: 10.1200/JCO.2008.20.5526. Epub 2009 Feb 17.
Change from baseline until post treatment (10 weeks after baseline) and 6 months post treatment
description
Change in symptoms of depression assessed by Beck Depression Inventory II (BDI-II)
measure
Symptoms of Anxiety
timeFrame
Change from baseline until post treatment (10 weeks after baseline) and 6 months post treatment
description
Change in symptoms of anxiety assessed by State-Trait Anxiety Inventory Form Y (STAI-S)
Secondary outcomes (2)
measure
Symptoms of Stress
timeFrame
Change from baseline until post treatment (10 weeks after baseline) and 6 months post treatment
description
Change in symptoms of stress assessed by the Perceived Stress Scale (PSS)
measure
Cost-Effectiveness
timeFrame
Change from baseline until post treatment (10 weeks after baseline) and 6 months post treatment
BACKGROUNDReich M, Lesur A, Perdrizet-Chevallier C. Depression, quality of life and breast cancer: a review of the literature. Breast Cancer Res Treat. 2008 Jul;110(1):9-17. doi: 10.1007/s10549-007-9706-5. Epub 2007 Aug 3. PMID 17674188
BACKGROUNDOsborn RL, Demoncada AC, Feuerstein M. Psychosocial interventions for depression, anxiety, and quality of life in cancer survivors: meta-analyses. Int J Psychiatry Med. 2006;36(1):13-34. doi: 10.2190/EUFN-RV1K-Y3TR-FK0L. PMID 16927576
BACKGROUNDHolm LV, Hansen DG, Johansen C, Vedsted P, Larsen PV, Kragstrup J, Sondergaard J. Participation in cancer rehabilitation and unmet needs: a population-based cohort study. Support Care Cancer. 2012 Nov;20(11):2913-24. doi: 10.1007/s00520-012-1420-0. Epub 2012 Mar 14. PMID 22415608
BACKGROUNDHofmann SG, Sawyer AT, Witt AA, Oh D. The effect of mindfulness-based therapy on anxiety and depression: A meta-analytic review. J Consult Clin Psychol. 2010 Apr;78(2):169-83. doi: 10.1037/a0018555. PMID 20350028
BACKGROUNDPiet J, Wurtzen H, Zachariae R. The effect of mindfulness-based therapy on symptoms of anxiety and depression in adult cancer patients and survivors: a systematic review and meta-analysis. J Consult Clin Psychol. 2012 Dec;80(6):1007-20. doi: 10.1037/a0028329. Epub 2012 May 7. PMID 22563637
BACKGROUNDWurtzen H, Dalton SO, Elsass P, Sumbundu AD, Steding-Jensen M, Karlsen RV, Andersen KK, Flyger HL, Pedersen AE, Johansen C. Mindfulness significantly reduces self-reported levels of anxiety and depression: results of a randomised controlled trial among 336 Danish women treated for stage I-III breast cancer. Eur J Cancer. 2013 Apr;49(6):1365-73. doi: 10.1016/j.ejca.2012.10.030. Epub 2012 Dec 19. PMID 23265707
BACKGROUNDLjotsson B, Falk L, Vesterlund AW, Hedman E, Lindfors P, Ruck C, Hursti T, Andreewitch S, Jansson L, Lindefors N, Andersson G. Internet-delivered exposure and mindfulness based therapy for irritable bowel syndrome--a randomized controlled trial. Behav Res Ther. 2010 Jun;48(6):531-9. doi: 10.1016/j.brat.2010.03.003. Epub 2010 Mar 16. PMID 20362976
BACKGROUNDAndersson G, Paxling B, Wiwe M, Vernmark K, Felix CB, Lundborg L, Furmark T, Cuijpers P, Carlbring P. Therapeutic alliance in guided internet-delivered cognitive behavioural treatment of depression, generalized anxiety disorder and social anxiety disorder. Behav Res Ther. 2012 Sep;50(9):544-50. doi: 10.1016/j.brat.2012.05.003. Epub 2012 May 18. PMID 22728647
BACKGROUNDSpek V, Cuijpers P, Nyklicek I, Riper H, Keyzer J, Pop V. Internet-based cognitive behaviour therapy for symptoms of depression and anxiety: a meta-analysis. Psychol Med. 2007 Mar;37(3):319-28. doi: 10.1017/S0033291706008944. Epub 2006 Nov 20. PMID 17112400
BACKGROUNDBaer, R. A. (2003), Mindfulness Training as a Clinical Intervention: A Conceptual and Empirical Review. Clinical Psychology: Science and Practice, 10: 125-143. doi:10.1093/clipsy.bpg015
BACKGROUNDBartley, T. Mindfulness-Based Cognitive Therapy for Cancer. (Wiley-Blackwell, 2012)
BACKGROUNDSegal, Z. V., Williams, J. M. G. & Teasdale, J. D. Mindfulness-Based Cognitive Therapy for Depression. (The Guilford Press, 2013).
BACKGROUNDBeck, A. T., Steere, R. A. & Brown, G. . Manual for the revised Beck Depression Inventory. (The Psychological Corporation, 1996)
BACKGROUNDGorsuch, R. L., Lushere, R. E. & Alto, P. State-Trait Anxiety Inventory. Prof. Psychol. 3, 389-390 (1971)
BACKGROUNDCohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available. PMID 6668417
BACKGROUNDBastien 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. PMID 11438246
BACKGROUNDNeff, K. D. The Development and Validation of a Scale to Measure Self-Compassion. Self Identity 2, 223-250 (2003)
BACKGROUNDHorvath, A. O. & Greenberg, L. S. Development and validation of the Working Alliance Inventory. J. Couns. Psychol. 36, 223-233 (1989)
BACKGROUNDBaer RA, Smith GT, Lykins E, Button D, Krietemeyer J, Sauer S, Walsh E, Duggan D, Williams JM. Construct validity of the five facet mindfulness questionnaire in meditating and nonmeditating samples. Assessment. 2008 Sep;15(3):329-42. doi: 10.1177/1073191107313003. Epub 2008 Feb 29. PMID 18310597