Depressive SymptomsNCT02619916
MBCT and CBT for Depression in Patients After Cancer: a Randomized Controlled Trial
A study testing Mindfulness-Based Cognitive Therapy (MBCT) and Cognitive Behavioral Therapy (CBT) in people with Depressive Symptoms, run by University Medical Center Groningen at 1 site in Netherlands.
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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Depressive Symptoms
- What is being tested?
- Mindfulness-Based Cognitive Therapy (MBCT) and Cognitive Behavioral Therapy (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2015to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
UMCG
Groningen, Provincie Groningen
Annika Tovote, Dr., 0031(0)503632955, k.a.tovote@umcg.nl
About this study
Official title: Individual Mindfulness-Based Cognitive Therapy (MBCT) and Individual Cognitive Behavioral Therapy (CBT) for Depression in Patients After Cancer: a Randomized Controlled Trial
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
Read the 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.
- Conditions
- Depressive Symptoms
- Being tested
- Mindfulness-Based Cognitive Therapy (MBCT), Cognitive Behavioral Therapy (CBT)
- Keywords
- Cancer, Depression, MBCT, CBT
- Medical subject headings
- Depression, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Cognitive Therapy (MBCT)Behavioural
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)Behavioural
The intervention consists of 8 weekly individual sessions of CBT. Each session will be administered individually and will last 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| MBCT | Experimental | Mindfulness-Based Cognitive Therapy Receives: Behavioral: Mindfulness-Based Cognitive Therapy (MBCT) |
| CBT | Experimental | Cognitive Behavioral Therapy Receives: Behavioral: Cognitive Behavioral Therapy (CBT) |
| TAU | No intervention | Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in severity of depressive symptoms
Severity of depressive symptoms will be assessed with the Beck Depression Inventory-II (BDI-II)
Measured: pre-treatment (baseline) to post-treatment (approximately 3 months after baseline) and 3- and 9-month follow-up
Secondary outcomes (4)
Change in generalized anxiety
Generalized anxiety is measured by the Generalised Anxiety Disorder Assessment (GAD 7)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: pre-treatment (baseline) to post-treatment (approximately 3 months after baseline) and 3- and 9-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study startMay 2015
- Primary completionSep 2017 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Groningen, Dutch Cancer Society
- Responsible party
- Principal investigator, Maya Schroevers, University Medical Center Groningen
- Investigators
- Maya Schroevers, Dr., Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02619916
- Sponsor's protocol ID
- 2014-214
- Status last verified
- May 2016
- First submitted
- 30 Nov 2015
- Last updated
- 18 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual Mindfulness-Based Cognitive Therapy (MBCT) and Individual Cognitive Behavioral Therapy (CBT) for Depression in Patients After Cancer: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02619916
- Acronym / sponsor ID
- 2014-214
- Conditions
- Depressive Symptoms
- Keywords
- Cancer, Depression, MBCT, CBT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- University of Groningen, Dutch Cancer Society
- Study start
- May 2015
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 2 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MBCT | Experimental | Behavioral: Mindfulness-Based Cognitive Therapy (MBCT)Mindfulness-Based Cognitive Therapy |
| CBT | Experimental | Behavioral: Cognitive Behavioral Therapy (CBT)Cognitive Behavioral Therapy |
| TAU | No intervention | –Treatment as usual |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | MBCT |
| 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. | Behavioural | CBT |
Primary outcome
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)
4 secondary outcomes
Change in generalized anxiety
Time frame: pre-treatment (baseline) to post-treatment (approximately 3 months after baseline) and 3- and 9-month follow-up
Change in well-being
Time frame: pre-treatment (baseline) to post-treatment (approximately 3 months after baseline) and 3- and 9-month follow-up
Change in fear of recurrence
Time frame: pre-treatment (baseline) to post-treatment (approximately 3 months after baseline) and 3- and 9-month follow-up
Change in fatigue
Time frame: pre-treatment (baseline) to post-treatment (approximately 3 months after baseline) and 3- and 9-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2016.
Related trials for Depressive Symptoms
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Active, not recruiting
NYUCI-ES: Psychosocial Intervention to Improve Health Outcomes for Chinese and Korean ADRD Caregivers
Dementia Caregivers, Diabetes
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maya Schroevers, Dr. principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Cognitive Therapy (MBCT) and Cognitive Behavioral Therapy (CBT) in people with Depressive Symptoms, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Annika Tovote, Dr. (0031(0)503632955, k.a.tovote@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2016.