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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Depressive Symptoms

Intervention / Treatment
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* Behavioral: Mindfulness-Based Cognitive Therapy (MBCT)
* Behavioral: Cognitive Behavioral Therapy (CBT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MBCT<br>Mindfulness-Based Cognitive Therapy | Behavioral: Mindfulness-Based Cognitive Therapy (MBCT)<br>* The intervention consists of 8 weekly individual sessions of MBCT. Each session will be administered individually and will last 60 minutes<br>|
| Experimental: CBT<br>Cognitive Behavioral Therapy | Behavioral: Cognitive Behavioral Therapy (CBT)<br>* The intervention consists of 8 weekly individual sessions of CBT. Each session will be administered individually and will last 60 minutes.<br>|
| No Intervention: TAU<br>Treatment as usual | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in severity of depressive symptoms | Severity of depressive symptoms will be assessed with the Beck Depression Inventory-II (BDI-II) | pre-treatment (baseline) to post-treatment (approximately 3 months after baseline) and 3- and 9-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in generalized anxiety | Generalized anxiety is measured by the Generalised Anxiety Disorder Assessment (GAD 7) | pre-treatment (baseline) to post-treatment (approximately 3 months after baseline) and 3- and 9-month follow-up | 
| Change in well-being | Well-being is measured by the WHO Well-being Index (WHO-5) | pre-treatment (baseline) to post-treatment (approximately 3 months after baseline) and 3- and 9-month follow-up | 
| Change in fear of recurrence | Fear of recurrence will be measured by Concerns About Recurrence Scale (CARS) | pre-treatment (baseline) to post-treatment (approximately 3 months after baseline) and 3- and 9-month follow-up | 
| Change in fatigue | Fatigue is measured by the subsequent scale of the Multidimensional Fatigue Inventory (MFI-20) | pre-treatment (baseline) to post-treatment (approximately 3 months after baseline) and 3- and 9-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Depression, MBCT, CBT