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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02619916
Enrollment
192
Registered
2015-12-02
Start date
2015-05-31
Completion date
2018-09-30
Last updated
2016-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Symptoms

Keywords

Cancer, Depression, MBCT, CBT

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.

Interventions

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.

Sponsors

University of Groningen
CollaboratorOTHER
Dutch Cancer Society
CollaboratorOTHER
University Medical Center Groningen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change in severity of depressive symptomspre-treatment (baseline) to post-treatment (approximately 3 months after baseline) and 3- and 9-month follow-upSeverity of depressive symptoms will be assessed with the Beck Depression Inventory-II (BDI-II)

Secondary

MeasureTime frameDescription
Change in generalized anxietypre-treatment (baseline) to post-treatment (approximately 3 months after baseline) and 3- and 9-month follow-upGeneralized anxiety is measured by the Generalised Anxiety Disorder Assessment (GAD 7)
Change in well-beingpre-treatment (baseline) to post-treatment (approximately 3 months after baseline) and 3- and 9-month follow-upWell-being is measured by the WHO Well-being Index (WHO-5)
Change in fear of recurrencepre-treatment (baseline) to post-treatment (approximately 3 months after baseline) and 3- and 9-month follow-upFear of recurrence will be measured by Concerns About Recurrence Scale (CARS)
Change in fatiguepre-treatment (baseline) to post-treatment (approximately 3 months after baseline) and 3- and 9-month follow-upFatigue is measured by the subsequent scale of the Multidimensional Fatigue Inventory (MFI-20)

Countries

Netherlands

Contacts

Primary ContactAnnika Tovote, Dr.
k.a.tovote@umcg.nl0031(0)503632955

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026