Individual Mindfulness-Based Cognitive Therapy (MBCT) and Individual Cognitive Behavioral Therapy (CBT) for Depression in Patients After Cancer: a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Depressive Symptoms
- Sponsor
- University Medical Center Groningen
- Enrollment
- 192
- Locations
- 1
- Primary Endpoint
- Change in severity of depressive symptoms
- Last Updated
- 9 years ago
Overview
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.
Investigators
Maya Schroevers
Dr. M. Schroevers
University Medical Center Groningen
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
Outcomes
Primary Outcomes
Change in severity of depressive symptoms
Time Frame: 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 Outcomes
- Change in generalized anxiety(pre-treatment (baseline) to post-treatment (approximately 3 months after baseline) and 3- and 9-month follow-up)
- Change in well-being(pre-treatment (baseline) to post-treatment (approximately 3 months after baseline) and 3- and 9-month follow-up)
- Change in fatigue(pre-treatment (baseline) to post-treatment (approximately 3 months after baseline) and 3- and 9-month follow-up)
- Change in fear of recurrence(pre-treatment (baseline) to post-treatment (approximately 3 months after baseline) and 3- and 9-month follow-up)