Clinical trial NCT02619916: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Depressive Symptoms
Keywords: Cancer
Depression
MBCT
CBT
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: University of Groningen
name: Dutch Cancer Society
First posted: 2015-12-02
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in severity of depressive symptoms
timeFrame: pre-treatment (baseline) to post-treatment (approximately 3 months after baseline) and 3- and 9-month follow-up
Secondary outcomes:
measure: Change in generalized anxiety
timeFrame: pre-treatment (baseline) to post-treatment (approximately 3 months after baseline) and 3- and 9-month follow-up
measure: Change in well-being
timeFrame: pre-treatment (baseline) to post-treatment (approximately 3 months after baseline) and 3- and 9-month follow-up
measure: Change in fear of recurrence
timeFrame: pre-treatment (baseline) to post-treatment (approximately 3 months after baseline) and 3- and 9-month follow-up
measure: Change in fatigue
timeFrame: pre-treatment (baseline) to post-treatment (approximately 3 months after baseline) and 3- and 9-month follow-up
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: UMCG
Study officials:
affiliation: University Medical Center Groningen
name: Maya Schroevers, Dr.
role: PRINCIPAL_INVESTIGATOR
References: