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

Depressive Symptoms Clinical 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02619916
• Other study ID #: 2014-214
• Status: Recruiting
• Phase: N/A
• First received: November 30, 2015
• Last updated: May 17, 2016
• Start date: May 2015
• Est. completion date: September 2018

Study information

• Verified date: May 2016
• Source: University Medical Center Groningen
• Contact: Annika Tovote, Dr.
• Phone: 0031(0)503632955
• Email: k.a.tovote[@]umcg.nl
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 192
• Est. completion date: September 2018
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depressive Symptoms

Intervention

Behavioral:
• Mindfulness-Based Cognitive Therapy (MBCT)
The intervention consists of 8 weekly individual sessions of MBCT. Each session will be administered individually and will last 60 minutes
• Cognitive Behavioral Therapy (CBT)
The intervention consists of 8 weekly individual sessions of CBT. Each session will be administered individually and will last 60 minutes.

Locations

Country	Name	City	State
Netherlands	UMCG	Groningen

Sponsors (3)

Lead Sponsor	Collaborator
University Medical Center Groningen	Dutch Cancer Society, University of Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No