Online Mindfulness for Women Treated for Breast Cancer and Men Treated for Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT03100981|
Recruitment Status : Completed
First Posted : April 4, 2017
Last Update Posted : January 8, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Anxiety Depression Breast Cancer Female Prostate Cancer||Behavioral: Internet-delivered Mindfulness-Based Cognitive Therapy Behavioral: Waitlist control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
After baseline assessment, participants will be randomly assigned to either the intervention or the control group. Both groups will receive online questionnaires at 5 weeks (midway), 10 weeks (post treatment) and 36 weeks (6 months follow-up) after baseline assessment.
The intervention group receives a therapist phone call prior to enrollment in the internet-delivered treatment and then participates in 8 weeks of therapist-assisted internet-delivered Mindfulness-Based Cognitive Therapy. The internet-delivered treatment also comprises weekly distress measures, including suicide risk screening, and assessment of working alliance at week 2, 4, and 7 of the course.
|Masking:||Double (Investigator, Outcomes Assessor)|
|Masking Description:||Assessors performing introduction calls are masked in the sense that participants will not be randomized until after the introduction call. All questionnaires are completed as online surveys and are hence masked for group allocation.|
|Official Title:||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|
|Actual Study Start Date :||February 24, 2016|
|Actual Primary Completion Date :||November 27, 2017|
|Actual Study Completion Date :||June 27, 2018|
Experimental: Internet-delivered MBCT
The intervention group will immediately receive 8 weeks of therapist-assisted internet-delivered Mindfulness-Based Cognitive Therapy.
Behavioral: Internet-delivered Mindfulness-Based Cognitive Therapy
Internet-delivered Mindfulness-Based Cognitive Therapy is a trainer-assisted course based on the manual for Mindfulness-Based Cognitive Therapy for depression. The course consists of 8 modules, one per week, for 8 weeks and one additional week for flexibility for the participants. In total 9 weeks with weekly written contact to the personal instructor.
Each module has an overall theme with written theory, approximately 45 minutes of daily mindfulness practice and other daily assignments with the purpose of strengthening awareness in the everyday life.
The control group will be on a waiting list to participate in Internet-delivered MBCT after the 6-months follow-up time has passed.
Behavioral: Waitlist control
Participants in the control arm of the study will receive treatment as usual, which means that they are not offered interventions targeting psycho-social distress but also not prevented from participating in or seeking other psycho-social treatment during the course of the study.
After the 6-months follow-up time has passed participants will get the opportunity to participate in 8 weeks of therapist-assisted internet-delivered Mindfulness-Based Cognitive Therapy, if the intervention is found efficient.
Other Name: Treatment as usual
- Symptoms of Depression [ Time Frame: Change from baseline until post treatment (10 weeks after baseline) and 6 months post treatment ]Change in symptoms of depression assessed by Beck Depression Inventory II (BDI-II)
- Symptoms of Anxiety [ Time Frame: Change from baseline until post treatment (10 weeks after baseline) and 6 months post treatment ]Change in symptoms of anxiety assessed by State-Trait Anxiety Inventory Form Y (STAI-S)
- Symptoms of Stress [ Time Frame: Change from baseline until post treatment (10 weeks after baseline) and 6 months post treatment ]Change in symptoms of stress assessed by the Perceived Stress Scale (PSS)
- Cost-Effectiveness [ Time Frame: Change from baseline until post treatment (10 weeks after baseline) and 6 months post treatment ]Change in The Short Form Health Survey (SF-12+)
- Insomnia [ Time Frame: Change from baseline until post treatment (10 weeks after baseline) and 6 months post treatment ]Change in symptoms of insomnia assessed by Insomnia Severity Index (ISI)
- Self-compassion [ Time Frame: Change from baseline until post treatment (10 weeks after baseline) and 6 months post treatment ]Change in Self-compassion assessed by The Self-Compassion Scale (SCS)
- Quality of Life [ Time Frame: Change from baseline until post treatment (10 weeks after baseline) and 6 months post treatment ]Change in Quality of Life assessed by the World Health Organization Well-being index (WHO-5)
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): NCT03100981
|Department of Psychology, Aarhus University|
|Aarhus, Central Region Denmark, Denmark, 8000|
|Study Chair:||Eva R Nissen, MSc||University of Aarhus|