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

May 17, 2016 updated by: Maya Schroevers, University Medical Center Groningen

Individual Mindfulness-Based Cognitive Therapy (MBCT) and Individual Cognitive Behavioral Therapy (CBT) for Depression in Patients After Cancer: a Randomized Controlled Trial

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

192

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
pre-treatment (baseline) to post-treatment (approximately 3 months after baseline) and 3- and 9-month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
pre-treatment (baseline) to post-treatment (approximately 3 months after baseline) and 3- and 9-month follow-up
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)
pre-treatment (baseline) to post-treatment (approximately 3 months after baseline) and 3- and 9-month follow-up
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)
pre-treatment (baseline) to post-treatment (approximately 3 months after baseline) and 3- and 9-month follow-up
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)
pre-treatment (baseline) to post-treatment (approximately 3 months after baseline) and 3- and 9-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Collaborators

University of Groningen
Dutch Cancer Society

Investigators

  • Principal Investigator: Maya Schroevers, Dr., University Medical Center Groningen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

November 30, 2015

First Submitted That Met QC Criteria

November 30, 2015

First Posted (Estimate)

December 2, 2015

Study Record Updates

Last Update Posted (Estimate)

May 18, 2016

Last Update Submitted That Met QC Criteria

May 17, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-214

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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