MBCT and CBT for Depression in Patients After Cancer: a Randomized Controlled Trial
- Conditions
- Depressive Symptoms
- Interventions
- Behavioral: Mindfulness-Based Cognitive Therapy (MBCT)Behavioral: Cognitive Behavioral Therapy (CBT)
- Registration Number
- NCT02619916
- Lead Sponsor
- University Medical Center Groningen
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 192
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MBCT Mindfulness-Based Cognitive Therapy (MBCT) Mindfulness-Based Cognitive Therapy CBT Cognitive Behavioral Therapy (CBT) Cognitive Behavioral Therapy
- Primary Outcome Measures
Name Time Method Change in severity of depressive symptoms pre-treatment (baseline) to post-treatment (approximately 3 months after baseline) and 3- and 9-month follow-up Severity of depressive symptoms will be assessed with the Beck Depression Inventory-II (BDI-II)
- Secondary Outcome Measures
Name Time Method Change in generalized anxiety pre-treatment (baseline) to post-treatment (approximately 3 months after baseline) and 3- and 9-month follow-up Generalized anxiety is measured by the Generalised Anxiety Disorder Assessment (GAD 7)
Change in well-being pre-treatment (baseline) to post-treatment (approximately 3 months after baseline) and 3- and 9-month follow-up Well-being is measured by the WHO Well-being Index (WHO-5)
Change in fatigue pre-treatment (baseline) to post-treatment (approximately 3 months after baseline) and 3- and 9-month follow-up Fatigue is measured by the subsequent scale of the Multidimensional Fatigue Inventory (MFI-20)
Change in fear of recurrence pre-treatment (baseline) to post-treatment (approximately 3 months after baseline) and 3- and 9-month follow-up Fear of recurrence will be measured by Concerns About Recurrence Scale (CARS)
Trial Locations
- Locations (1)
UMCG
🇳🇱Groningen, Netherlands