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Status unknownNCT02619916Updated May 18, 2016

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

An interventional study of Mindfulness-Based Cognitive Therapy (MBCT) and Cognitive Behavioral Therapy (CBT) in Depressive Symptoms, sponsored by University Medical Center Groningen. Status unknown at 1 site in Netherlands. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-05-18.

Sponsored by University Medical Center Groningen · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
192
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Depressive Symptoms

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Keywords

  • Cancer
  • Depression
  • MBCT
  • CBT
03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's planned enrollment of 192 is above the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

University Medical Center Groningen is the lead sponsor of 609 studies on the registry; 174 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
192 participants (estimated)

Study arms

  • Experimental
    MBCT

    Mindfulness-Based Cognitive Therapy

    Behavioral: Mindfulness-Based Cognitive Therapy (MBCT)

  • Experimental
    CBT

    Cognitive Behavioral Therapy

    Behavioral: Cognitive Behavioral Therapy (CBT)

  • No intervention
    TAU

    Treatment as usual

Interventions

  • BehavioralMindfulness-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

  • BehavioralCognitive Behavioral Therapy (CBT)

    The intervention consists of 8 weekly individual sessions of CBT. Each session will be administered individually and will last 60 minutes.

06

What researchers measure

Primary outcomes

  1. Change in severity of depressive symptoms

    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 outcomes

  1. Change in generalized anxiety

    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

  2. Change in well-being

    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

  3. Change in fear of recurrence

    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

  4. Change in fatigue

    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

07

Study locations

1 of 1 sites recruiting
  • UMCG
    Groningen, Netherlands
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02619916
Lead sponsor
University Medical Center Groningen
Collaborators
University of Groningen, Dutch Cancer Society
Responsible party
Maya Schroevers (Dr. M. Schroevers, University Medical Center Groningen) — Principal investigator
First posted
Dec 2, 2015
Start date
May 2015
Primary completion
Sep 2017 (estimated)
Completion
Sep 2018 (estimated)
Last update
May 18, 2016

Study contacts

Annika Tovote, Dr.
Contact
k.a.tovote@umcg.nl
0031(0)503632955
Maya Schroevers, Dr.
principal investigator · University Medical Center Groningen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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