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

U

University Medical Center Groningen (UMCG)

Status

Unknown

Conditions

Depressive Symptoms

Treatments

Behavioral: Cognitive Behavioral Therapy (CBT)
Behavioral: Mindfulness-Based Cognitive Therapy (MBCT)

Study type

Interventional

Funder types

Other

Identifiers

NCT02619916
2014-214

Details and patient eligibility

About

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

Full 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.

Enrollment

192 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

192 participants in 3 patient groups

MBCT
Experimental group
Description:
Mindfulness-Based Cognitive Therapy
Treatment:
Behavioral: Mindfulness-Based Cognitive Therapy (MBCT)
CBT
Experimental group
Description:
Cognitive Behavioral Therapy
Treatment:
Behavioral: Cognitive Behavioral Therapy (CBT)
TAU
No Intervention group
Description:
Treatment as usual

Trial contacts and locations

1

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Central trial contact

Annika Tovote, Dr.

Data sourced from clinicaltrials.gov

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