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MBCT and CBT for Depression in Patients After Cancer: a Randomized Controlled Trial

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ClinicalTrials.gov Identifier: NCT02619916
Recruitment Status : Unknown
Verified May 2016 by Maya Schroevers, University Medical Center Groningen.
Recruitment status was:  Recruiting
First Posted : December 2, 2015
Last Update Posted : May 18, 2016
Sponsor:
Collaborators:
University of Groningen
Dutch Cancer Society
Information provided by (Responsible Party):
Maya Schroevers, University Medical Center Groningen

Study Description
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Brief Summary:
The purpose of this study is to determine whether mindfulness-based cognitive therapy (MBCT) and cognitive behavioral therapy (CBT) are effective in reducing depressive symptoms in patients after cancer

Condition or disease Intervention/treatment Phase
Depressive Symptoms Behavioral: Mindfulness-Based Cognitive Therapy (MBCT) Behavioral: Cognitive Behavioral Therapy (CBT) Not Applicable

Detailed Description:
Cancer patients are prone to develop depressive symptoms, even after curative treatment. Conventional therapies such as cognitive behavioral therapy (CBT) and mindfulness-based cognitive therapy (MBCT) are frequently used for reducing these depressive symptoms in patients with medical conditions. However, until now evidence from proper designed randomized controlled trials regarding the effectiveness of both interventions in cancer survivors, is lacking. Therefore, our longitudinal study aims to investigate the effectiveness of CBT and MBCT in reducing depressive symptoms in cancer survivors. In addition, potential moderators and mediators of each intervention will be explored.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Individual Mindfulness-Based Cognitive Therapy (MBCT) and Individual Cognitive Behavioral Therapy (CBT) for Depression in Patients After Cancer: a Randomized Controlled Trial
Study Start Date : May 2015
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: MBCT
Mindfulness-Based Cognitive Therapy
 Behavioral: Mindfulness-Based Cognitive Therapy (MBCT)
The intervention consists of 8 weekly individual sessions of MBCT. Each session will be administered individually and will last 60 minutes
Experimental: CBT
Cognitive Behavioral Therapy
 Behavioral: Cognitive Behavioral Therapy (CBT)
The intervention consists of 8 weekly individual sessions of CBT. Each session will be administered individually and will last 60 minutes.
No Intervention: TAU
Treatment as usual


Outcome Measures
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Primary Outcome Measures :
  1. Change in severity of depressive symptoms [ Time Frame: pre-treatment (baseline) to post-treatment (approximately 3 months after baseline) and 3- and 9-month follow-up ]
    Severity of depressive symptoms will be assessed with the Beck Depression Inventory-II (BDI-II)


Secondary Outcome Measures :
  1. Change in generalized anxiety [ Time Frame: pre-treatment (baseline) to post-treatment (approximately 3 months after baseline) and 3- and 9-month follow-up ]
    Generalized anxiety is measured by the Generalised Anxiety Disorder Assessment (GAD 7)

  2. Change in well-being [ Time Frame: pre-treatment (baseline) to post-treatment (approximately 3 months after baseline) and 3- and 9-month follow-up ]
    Well-being is measured by the WHO Well-being Index (WHO-5)

  3. Change in fear of recurrence [ Time Frame: pre-treatment (baseline) to post-treatment (approximately 3 months after baseline) and 3- and 9-month follow-up ]
    Fear of recurrence will be measured by Concerns About Recurrence Scale (CARS)

  4. Change in fatigue [ Time Frame: pre-treatment (baseline) to post-treatment (approximately 3 months after baseline) and 3- and 9-month follow-up ]
    Fatigue is measured by the subsequent scale of the Multidimensional Fatigue Inventory (MFI-20)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent
  • Completion of curative cancer treatment (for primary diagnosis of cancer or possible recurrence of cancer) at least one year ago and no longer than five years ago.
  • Currently no active cancer.
  • ≥ 18 at the time of diagnosis of cancer and ≤ 75 at inclusion.
  • Depressive symptoms as assessed by a Patient Health Questionnaire (PHQ-9) score ≥ 10 (indicating presence of at least mild depressive symptoms).
  • Being able to read, write, and speak Dutch.

Exclusion Criteria:

  • Severe psychiatric co-morbidity (i.e. acute suicidal ideations or behavior, recently experienced psychosis, diagnosis of schizophrenia, bipolar disorder, drug abuse or substance dependence, serious cognitive or neurological problems).
  • Receiving psychological treatment for depressive symptoms, currently or less than two months prior to study participation.
  • Unstable antidepressant medication regimen two months prior to inclusion of the study
Contacts and Locations
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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): NCT02619916


Contacts
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Contact: Annika Tovote, Dr. 0031(0)503632955 k.a.tovote@umcg.nl

Locations
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Netherlands
UMCG Recruiting
Groningen, Netherlands
Contact: Annika Tovote, Dr.    0031(0)503632955    k.a.tovote@umcg.nl   
Sponsors and Collaborators
University Medical Center Groningen
University of Groningen
Dutch Cancer Society
Investigators
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Principal Investigator: Maya Schroevers, Dr. University Medical Center Groningen
More Information
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Responsible Party: Maya Schroevers, Dr. M. Schroevers, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT02619916    
Other Study ID Numbers: 2014-214
First Posted: December 2, 2015    Key Record Dates
Last Update Posted: May 18, 2016
Last Verified: May 2016
Keywords provided by Maya Schroevers, University Medical Center Groningen:
Cancer
Depression
MBCT
CBT
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms