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

Primary Purpose

Depressive Symptoms

Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Mindfulness-Based Cognitive Therapy (MBCT)
Cognitive Behavioral Therapy (CBT)
Sponsored by
University Medical Center Groningen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Symptoms focused on measuring Cancer, Depression, MBCT, CBT

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UMCGRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

MBCT

CBT

TAU

Arm Description

Mindfulness-Based Cognitive Therapy

Cognitive Behavioral Therapy

Treatment as usual

Outcomes

Primary Outcome Measures

Change in severity of depressive symptoms
Severity of depressive symptoms will be assessed with the Beck Depression Inventory-II (BDI-II)

Secondary Outcome Measures

Change in generalized anxiety
Generalized anxiety is measured by the Generalised Anxiety Disorder Assessment (GAD 7)
Change in well-being
Well-being is measured by the WHO Well-being Index (WHO-5)
Change in fear of recurrence
Fear of recurrence will be measured by Concerns About Recurrence Scale (CARS)
Change in fatigue
Fatigue is measured by the subsequent scale of the Multidimensional Fatigue Inventory (MFI-20)

Full Information

First Posted
November 30, 2015
Last Updated
May 17, 2016
Sponsor
University Medical Center Groningen
Collaborators
University of Groningen, Dutch Cancer Society
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1. Study Identification

Unique Protocol Identification Number
NCT02619916
Brief Title
MBCT and CBT for Depression in Patients After Cancer: a Randomized Controlled Trial
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 Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Groningen
Collaborators
University of Groningen, Dutch Cancer Society

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms
Keywords
Cancer, Depression, MBCT, CBT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
192 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MBCT
Arm Type
Experimental
Arm Description
Mindfulness-Based Cognitive Therapy
Arm Title
CBT
Arm Type
Experimental
Arm Description
Cognitive Behavioral Therapy
Arm Title
TAU
Arm Type
No Intervention
Arm Description
Treatment as usual
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Cognitive Therapy (MBCT)
Intervention Description
The intervention consists of 8 weekly individual sessions of MBCT. Each session will be administered individually and will last 60 minutes
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy (CBT)
Intervention Description
The intervention consists of 8 weekly individual sessions of CBT. Each session will be administered individually and will last 60 minutes.
Primary Outcome Measure Information:
Title
Change in severity of depressive symptoms
Description
Severity of depressive symptoms will be assessed with the Beck Depression Inventory-II (BDI-II)
Time Frame
pre-treatment (baseline) to post-treatment (approximately 3 months after baseline) and 3- and 9-month follow-up
Secondary Outcome Measure Information:
Title
Change in generalized anxiety
Description
Generalized anxiety is measured by the Generalised Anxiety Disorder Assessment (GAD 7)
Time Frame
pre-treatment (baseline) to post-treatment (approximately 3 months after baseline) and 3- and 9-month follow-up
Title
Change in well-being
Description
Well-being is measured by the WHO Well-being Index (WHO-5)
Time Frame
pre-treatment (baseline) to post-treatment (approximately 3 months after baseline) and 3- and 9-month follow-up
Title
Change in fear of recurrence
Description
Fear of recurrence will be measured by Concerns About Recurrence Scale (CARS)
Time Frame
pre-treatment (baseline) to post-treatment (approximately 3 months after baseline) and 3- and 9-month follow-up
Title
Change in fatigue
Description
Fatigue is measured by the subsequent scale of the Multidimensional Fatigue Inventory (MFI-20)
Time Frame
pre-treatment (baseline) to post-treatment (approximately 3 months after baseline) and 3- and 9-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Annika Tovote, Dr.
Phone
0031(0)503632955
Email
k.a.tovote@umcg.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maya Schroevers, Dr.
Organizational Affiliation
University Medical Center Groningen
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMCG
City
Groningen
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annika Tovote, Dr.
Phone
0031(0)503632955
Email
k.a.tovote@umcg.nl

12. IPD Sharing Statement

Learn more about this trial

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

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