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Online Mindfulness for Women Treated for Breast Cancer and Men Treated for Prostate Cancer

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: NCT03100981
Recruitment Status : Completed
First Posted : April 4, 2017
Last Update Posted : January 8, 2019
Sponsor:
Collaborators:
Aarhus University Hospital
Karolinska Institutet
Stockholm County Council, Sweden
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

Other Names:
  • Mindfulness-Based Cognitive Therapy
  • I-MBCT
  • MBCT

Waitlist control
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




Primary Outcome Measures :
  1. 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)

  2. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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+)


Other Outcome Measures:
  1. 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)

  2. 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)

  3. 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)



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 and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT03100981


Locations
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Denmark
Department of Psychology, Aarhus University
Aarhus, Central Region Denmark, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Karolinska Institutet
Stockholm County Council, Sweden
Investigators
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Study Chair: Eva R Nissen, MSc University of Aarhus
Publications:
Baer, 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
Bartley, T. Mindfulness-Based Cognitive Therapy for Cancer. (Wiley-Blackwell, 2012)
Segal, Z. V., Williams, J. M. G. & Teasdale, J. D. Mindfulness-Based Cognitive Therapy for Depression. (The Guilford Press, 2013).
Beck, A. T., Steere, R. A. & Brown, G. . Manual for the revised Beck Depression Inventory. (The Psychological Corporation, 1996)
Gorsuch, R. L., Lushere, R. E. & Alto, P. State-Trait Anxiety Inventory. Prof. Psychol. 3, 389-390 (1971)
Neff, K. D. The Development and Validation of a Scale to Measure Self-Compassion. Self Identity 2, 223-250 (2003)
Horvath, A. O. & Greenberg, L. S. Development and validation of the Working Alliance Inventory. J. Couns. Psychol. 36, 223-233 (1989)

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03100981    
Other Study ID Numbers: Krop & Sind
R87-A5432 ( Other Grant/Funding Number: The Danish Cancer Society (preparation scholarship) )
7-12.0736 ( Other Grant/Funding Number: The Danish Foundation TrygFonden )
R113-A7015-14-S34 ( Other Grant/Funding Number: The Danish Cancer Society (Knæk Cancer) )
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Aarhus:
Mindfulness-Based Cognitive Therapy
Internet-delivered
Breast cancer
Prostate cancer
Survivors
Depression
Anxiety
Stress
Additional relevant MeSH terms:
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Breast Neoplasms
Prostatic Neoplasms
Depression
Depressive Disorder
Anxiety Disorders
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders