Depressive SymptomsG/I-MBCTNCT02314390
Group- Versus Individual-Mindfulness-Based Cognitive Therapy: a Randomized Trial
A study testing Group-Mindfulness-Based Cognitive Therapy and Individual-Mindfulness-Based Cognitive Therapy in people with Depressive Symptoms, run by University Medical Center Groningen.
Trial summary
The purpose of this study is to determine whether both group and individual mindfulness-based cognitive therapy (MBCT) are effective in reducing depressive symptoms in patients with a chronic somatic disease. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Depressive Symptoms
- What is being tested?
- Group-Mindfulness-Based Cognitive Therapy and Individual-Mindfulness-Based Cognitive Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Aug 2014
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic somatic disease
- Age ≥ 18 and ≤ 70
- Depressive symptoms as assessed by BDI-II score ≥ 14 (cut-off score indicating the presence of at least mild symptoms of depression)
Who cannot join
- Not being able to read and write Dutch
- Severe (psychiatric) co-morbidity
- Acute suicidal ideations or behavior
- Receiving an alternative psychological treatment during or less than two months prior to starting the participation in the study
- Using an antidepressant drug during participation in the present study is allowed, on condition that a patient has been on stable medication regimen for at least two months prior to inclusion in the study, and that no new treatment with an antidepressant is initiated during the course of the study
About this study
Official title: Group- Versus Individual-Mindfulness-Based Cognitive Therapy for Patients With a Chronic Somatic Disease and Comorbid Depressive Symptoms: a Randomized Trial
The purpose of this study is to determine whether both group and individual mindfulness-based cognitive therapy (MBCT) are effective in reducing depressive symptoms in patients with a chronic somatic disease.
Read the detailed description
Depression is a common co-morbidity in patients with a chronic somatic disease which has a negative impact on patients' physical and mental health. In recent years, Mindfulness-Based Cognitive Therapy (MBCT) has gained interest and popularity as a treatment not only for preventing recurrence of depression, but also to treat current symptoms. Usually, the training is delivered in group format, thus little is known about the feasibility and effectiveness of MBCT as an individual training.
This pilot study aims to compare the effectiveness and feasibility of group and individual MBCT in reducing depressive symptoms in patients with a chronic somatic disease.
- Conditions
- Depressive Symptoms
- Being tested
- Group-Mindfulness-Based Cognitive Therapy, Individual-Mindfulness-Based Cognitive Therapy
- Keywords
- Depression, Mindfulness, MBCT
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group-Mindfulness-Based Cognitive TherapyBehavioural
Also called G-MBCT
The intervention consists of 8 weekly sessions of MBCT. Each session will be administered in a group and will last 2 1/2 hours.
Individual-Mindfulness-Based Cognitive TherapyBehavioural
Also called I-MBCT
The intervention consists of 8 weekly sessions of MBCT. Each session will be administered individually and will last 45 to 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| G-MBCT | Experimental | Group-Mindfulness-Based Cognitive Therapy Receives: Behavioral: Group-Mindfulness-Based Cognitive Therapy |
| I-MBCT | Experimental | Individual-Mindfulness-Based Cognitive Therapy Receives: Behavioral: Individual-Mindfulness-Based Cognitive Therapy |
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 are assessed with the Beck Depression Inventory-II
Measured: Pre-treatment to post-treatment (primary measurement point; approximately 3 months after pre-treatment) and 3-months follow-up
Secondary outcomes (2)
Change in well-being
Well-being is measured by the Well-being Index (WHO-5)
Measured: Pre-treatment to post-treatment (primary measurement point; approximately 3 months after pre-treatment) and 3-months follow-up
Change in generalized anxiety
Generalized anxiety is measured by the Generalised Anxiety Disorder Assessment (GAD 7)
Measured: Pre-treatment to post-treatment (primary measurement point; approximately 3 months after pre-treatment) and 3-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2014 (estimated)
- Study startSep 2013
- Primary completionMar 2014
- Study completionAug 2014
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.
- 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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Groningen
- Responsible party
- Principal investigator, Maya Schroevers, University Medical Center Groningen
- Investigators
- Robbert Sanderman, Prof., Study chair, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02314390
- Sponsor's protocol ID
- FVHH
- Acronym
- G/I-MBCT
- Status last verified
- Dec 2014
- First submitted
- 1 Dec 2014
- Last updated
- 11 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group- Versus Individual-Mindfulness-Based Cognitive Therapy for Patients With a Chronic Somatic Disease and Comorbid Depressive Symptoms: a Randomized Trial
- ClinicalTrials.gov ID
- NCT02314390
- Acronym / sponsor ID
- G/I-MBCT / FVHH
- Conditions
- Depressive Symptoms
- Keywords
- Depression, Mindfulness, MBCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- University of Groningen
- Study start
- Sep 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 11 Dec 2014 (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 both group and individual mindfulness-based cognitive therapy (MBCT) are effective in reducing depressive symptoms in patients with a chronic somatic disease.
Detailed description
Depression is a common co-morbidity in patients with a chronic somatic disease which has a negative impact on patients' physical and mental health. In recent years, Mindfulness-Based Cognitive Therapy (MBCT) has gained interest and popularity as a treatment not only for preventing recurrence of depression, but also to treat current symptoms. Usually, the training is delivered in group format, thus little is known about the feasibility and effectiveness of MBCT as an individual training.
This pilot study aims to compare the effectiveness and feasibility of group and individual MBCT in reducing depressive symptoms in patients with a chronic somatic disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G-MBCT | Experimental | Behavioral: Group-Mindfulness-Based Cognitive TherapyGroup-Mindfulness-Based Cognitive Therapy |
| I-MBCT | Experimental | Behavioral: Individual-Mindfulness-Based Cognitive TherapyIndividual-Mindfulness-Based Cognitive Therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic somatic disease
- Age ≥ 18 and ≤ 70
- Depressive symptoms as assessed by BDI-II score ≥ 14 (cut-off score indicating the presence of at least mild symptoms of depression)
Key exclusion criteria (5 listed)
- Not being able to read and write Dutch
- Severe (psychiatric) co-morbidity
- Acute suicidal ideations or behavior
- Receiving an alternative psychological treatment during or less than two months prior to starting the participation in the study
- Using an antidepressant drug during participation in the present study is allowed, on condition that a patient has been on stable medication regimen for at least two months prior to inclusion in the study, and that no new treatment with an antidepressant is initiated during the course 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 |
|---|---|---|
| Group-Mindfulness-Based Cognitive TherapyAlso: G-MBCTThe intervention consists of 8 weekly sessions of MBCT. Each session will be administered in a group and will last 2 1/2 hours. | Behavioural | G-MBCT |
| Individual-Mindfulness-Based Cognitive TherapyAlso: I-MBCTThe intervention consists of 8 weekly sessions of MBCT. Each session will be administered individually and will last 45 to 60 minutes. | Behavioural | I-MBCT |
Primary outcome
Change in severity of depressive symptoms
Time frame: Pre-treatment to post-treatment (primary measurement point; approximately 3 months after pre-treatment) and 3-months follow-up
Severity of depressive symptoms are assessed with the Beck Depression Inventory-II
2 secondary outcomes
Change in well-being
Time frame: Pre-treatment to post-treatment (primary measurement point; approximately 3 months after pre-treatment) and 3-months follow-up
Change in generalized anxiety
Time frame: Pre-treatment to post-treatment (primary measurement point; approximately 3 months after pre-treatment) and 3-months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2014.
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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.
Robbert Sanderman, Prof. study chair
University Medical Center Groningen
Questions about this trial
What is this clinical trial studying?
A study testing Group-Mindfulness-Based Cognitive Therapy and Individual-Mindfulness-Based Cognitive Therapy in people with Depressive Symptoms, run by University Medical Center Groningen.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 11 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in severity of depressive symptoms (time frame: Pre-treatment to post-treatment (primary measurement point; approximately 3 months after pre-treatment) and 3-months 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 11 Dec 2014.