Major Depressive Disorder, RecurrentNCT03353493
Mechanisms of Mindfulness-Based Cognitive Therapy in the Treatment of Recurrent Major Depressive Disorder
A study testing MBCT and TAU in people with Major Depressive Disorder, Recurrent, run by University of Aarhus at 1 site in Denmark.
Trial summary
The primary purpose of this study is to investigate neural mechanisms and predictors of treatment outcome in Mindfulness-Based Cognitive Therapy (MBCT) for recurrent Major Depressive Disorder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder, Recurrent
- What is being tested?
- MBCT and TAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Feb 2017to 1 Jun 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age above 18 years
- Meeting DSM-IV criteria for a history of recurrent Major Depressive Disorder (MDD) with or without a current episode of depression
- Recurrent MDD evaluated a being the primary disorder.
- Danish literacy
Who cannot join
- A history of schizophrenia, schizoaffective disorder, bipolar disorder, current severe substance abuse, organic mental disorder, current/past psychosis, pervasive developmental delay, persistent antisocial behaviour, persistent self-injury requiring clinical management/therapy
- Formal concurrent psychotherapy
- Previous Mindfulness-Based Cognitive Therapy/Mindfulness-Based Stress Reduction
- Anti-psychotic medication and benzodiazepines
- Standard exclusion criteria for undergoing magnetic resonance imaging (MRI) procedures for research purposes, i.e., claustrophobia, pregnancy, cardiac pacemaker, prosthetic heart valve, neurostimulator, implanted pumps, cochlear implants, non-MR-compatible implants or devices.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neural, Molecular and Psychological Mechanisms and Predictors of Treatment Response to Mindfulness-based Cognitive Therapy in the Treatment of Recurrent Major Depressive Disorder
The primary purpose of this study is to investigate neural mechanisms and predictors of treatment outcome in Mindfulness-Based Cognitive Therapy (MBCT) for recurrent Major Depressive Disorder.
Read the detailed description
AIM AND HYPOTHESES
The primary aim is to investigate treatment mechanisms of MBCT and markers of relapse risk.
Controlled design:
First, we aim to first investigate the effect of treatment on clinical outcomes in the controlled design post treatment and at 3 months follow up. Second, we will run mediation analyses of hypothesized mechanisms (increased mindfulness skills, decentering, interoceptive and decreased rumination, and change in neural connectivity in a priori networks), and finally check for moderating influences of vulnerability markers (childhood trauma, no. episodes of depression and residual symptoms).
Prospective design:
We aim to investigate predictors of relapse risk at 12 month follow treatment using i) baseline markers and ii) mechanism outcomes that change significantly due to treatment, and iii) check for moderating influences of vulnerability markers
- Conditions
- Major Depressive Disorder, Recurrent
- Being tested
- MBCT, TAU
- Keywords
- Mindfulness-Based Cognitive Therapy, Neural, psychological and molecular mechanisms
- Medical subject headings
- Depressive Disorder, Major, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBCTBehavioural
Mindfulness-Based Cognitive Therapy (MBCT) is an 8 week manualised group intervention. MBCT will be delivered according to the manual by Segal, Williams \& Teasdale (2013).
TAUOther
Treatment as usual (TAU)
| Study group | Role | What they receive |
|---|---|---|
| MBCT + TAU | Experimental | Mindfulness-based Cognitive Therapy (MBCT) a 8 week group based intervention delivered according to the protocol by Segal, Williams and Teasdale (2013) plus treatment as usual (TAU) . TAU is restricted to antidepressant medication and no psychological therapy. Receives: Behavioral: MBCT; Other: TAU |
| TAU | Other | Treatment as Usual (TAU). TAU is restricted to antidepressant medication and no psychological therapy. Receives: Other: TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in neural connectivity
Neural connectivity will be measured with functional magnetic resonance (fMRI). Selected a priory networks for seed-based analyses: Default mode Network and Salience Network
Measured: Baseline and 8 weeks
Secondary outcomes (20)
Change in mindfulness skills
Five Factor Mindfulness Questionnaire (FFMQ)
Measured: Baseline and 8 weeks
Change in decentering
Experiences Questionaire (EQ)
Measured: Baseline and 8 weeks
Change in rumination
Rumination Response Scale (RRS)
Measured: Baseline and 8 weeks
Change in emotional processing bias
Facial Expression Recognition task (FERT)
Measured: Baseline and 8 weeks
Change in interoceptive awareness
Multidimensional Assessment of Interoceptive Awareness (MAIA)
Measured: Baseline and 8 weeks
Change in perceived stress
Perceived Stress Scale (PSS)
Measured: Baseline and 8 weeks
Time to relapse or recurrence of depression
Structured clinical interview for DSM-IV
Measured: 12 months follow up
Change in depressive symptoms
Quick Inventory for Depressive Symptomology (QIDS-SR)
Measured: Baseline and 8 weeks
Change in interleukin gene expression
IL-1, IL-2, IL-4,IL-6, IL-8, IL-10, IL-12p70, IL-13,
Measured: Baseline and 8 weeks
Change in interleukin protein expression
IL-1, IL-2, IL-4,IL-6, IL-8, IL-10, IL-12p70, IL-13,
Measured: Baseline and 8 weeks
Change in gene expression of norepinephrine transporter
Norepinephrine transporter (NET)
Measured: Baseline and 8 weeks
Change in gene expression of glutamate receptor
Glutamate receptor (GRM7)
Measured: Baseline and 8 weeks
Change in gene expression of TNF
Change in gene expression of tumor necrosis factor (previous nomenclature TNF-alfa)
Measured: Baseline and 8 weeks
Change in protein expression of tumor necrosis factor
Tumor necrosis factor
Measured: Baseline and 8 weeks
cRP expression
c reactive protein expression
Measured: Baseline and 8 weeks
Change in NF-kB gene expression
Nuclear factor kappa-light-chain-enhancer of activated B cells gene expression
Measured: Baseline and 8 weeks
Change in NF-kB protein expression
Nuclear factor kappa-light-chain-enhancer of activated B cells protein expression
Measured: Baseline and 8 weeks
Change in INFG gene expression
Interferon gamma gene expresison
Measured: Baseline and 8 weeks
Change in Interferon gamma protein expression
Interferon gamma protein expresison
Measured: Baseline and 8 weeks
Mitochondrial DNA Copy Number
Copy number is assessed using quantitative real-time-PCR
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2017
- Study start15 Feb 2017
- Primary completion1 Jun 2018
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive Disorder, RecurrentStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised to Mindfulness-based cognitive therapy plus treatment as usual, or treatment as usual.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford, VIA University College, University of York, Harvard Medical School (HMS and HSDM)
- Responsible party
- Principal investigator, Anne Maj van der Velden, University of Aarhus
- Investigators
- Anne Maj van der Velden, Msc, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03353493
- Sponsor's protocol ID
- 314 #2016-051-000001
- Status last verified
- Jun 2019
- First submitted
- 8 Sep 2017
- Last updated
- 5 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van der Velden AM, Scholl J, Elmholdt EM, Fjorback LO, Harmer CJ, Lazar SW, O'Toole MS, Smallwood J, Roepstorff A, Kuyken W. Mindfulness Training Changes Brain Dynamics During Depressive Rumination: A Randomized Controlled Trial. Biol Psychiatry. 2023 Feb 1;93(3):233-242. doi: 10.1016/j.biopsych.2022.06.038. Epub 2022 Jul 22.
PubMed 36328822
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural, Molecular and Psychological Mechanisms and Predictors of Treatment Response to Mindfulness-based Cognitive Therapy in the Treatment of Recurrent Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT03353493
- Acronym / sponsor ID
- 314 #2016-051-000001
- Conditions
- Major Depressive Disorder, Recurrent
- Keywords
- Mindfulness-Based Cognitive Therapy, Neural, psychological and molecular mechanisms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- University of Oxford, VIA University College, University of York, Harvard Medical School (HMS and HSDM)
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 27 Nov 2017 (actual)
- 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 primary purpose of this study is to investigate neural mechanisms and predictors of treatment outcome in Mindfulness-Based Cognitive Therapy (MBCT) for recurrent Major Depressive Disorder.
Detailed description
AIM AND HYPOTHESES
The primary aim is to investigate treatment mechanisms of MBCT and markers of relapse risk.
Controlled design:
First, we aim to first investigate the effect of treatment on clinical outcomes in the controlled design post treatment and at 3 months follow up. Second, we will run mediation analyses of hypothesized mechanisms (increased mindfulness skills, decentering, interoceptive and decreased rumination, and change in neural connectivity in a priori networks), and finally check for moderating influences of vulnerability markers (childhood trauma, no. episodes of depression and residual symptoms).
Prospective design:
We aim to investigate predictors of relapse risk at 12 month follow treatment using i) baseline markers and ii) mechanism outcomes that change significantly due to treatment, and iii) check for moderating influences of vulnerability markers
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised to Mindfulness-based cognitive therapy plus treatment as usual, or treatment as usual.
| Arm | Type | Receives |
|---|---|---|
| MBCT + TAU | Experimental | Behavioral: MBCT, Other: TAUMindfulness-based Cognitive Therapy (MBCT) a 8 week group based intervention delivered according to the protocol by Segal, Williams and Teasdale (2013) plus treatment as usual (TAU) . TAU is restricted to antidepressant medication and no psychological therapy. |
| TAU | Other | Other: TAUTreatment as Usual (TAU). TAU is restricted to antidepressant medication and no psychological therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age above 18 years
- Meeting DSM-IV criteria for a history of recurrent Major Depressive Disorder (MDD) with or without a current episode of depression
- Recurrent MDD evaluated a being the primary disorder.
- Danish literacy
Key exclusion criteria (5 listed)
- A history of schizophrenia, schizoaffective disorder, bipolar disorder, current severe substance abuse, organic mental disorder, current/past psychosis, pervasive developmental delay, persistent antisocial behaviour, persistent self-injury requiring clinical management/therapy
- Formal concurrent psychotherapy
- Previous Mindfulness-Based Cognitive Therapy/Mindfulness-Based Stress Reduction
- Anti-psychotic medication and benzodiazepines
- Standard exclusion criteria for undergoing magnetic resonance imaging (MRI) procedures for research purposes, i.e., claustrophobia, pregnancy, cardiac pacemaker, prosthetic heart valve, neurostimulator, implanted pumps, cochlear implants, non-MR-compatible implants or devices.
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 |
|---|---|---|
| MBCTMindfulness-Based Cognitive Therapy (MBCT) is an 8 week manualised group intervention. MBCT will be delivered according to the manual by Segal, Williams \& Teasdale (2013). | Behavioural | MBCT + TAU |
| TAUTreatment as usual (TAU) | Other | MBCT + TAU, TAU |
Primary outcome
Change in neural connectivity
Time frame: Baseline and 8 weeks
Neural connectivity will be measured with functional magnetic resonance (fMRI). Selected a priory networks for seed-based analyses: Default mode Network and Salience Network
20 secondary outcomes
Change in mindfulness skills
Time frame: Baseline and 8 weeks
Change in decentering
Time frame: Baseline and 8 weeks
Change in rumination
Time frame: Baseline and 8 weeks
Change in emotional processing bias
Time frame: Baseline and 8 weeks
Change in interoceptive awareness
Time frame: Baseline and 8 weeks
Change in perceived stress
Time frame: Baseline and 8 weeks
Time to relapse or recurrence of depression
Time frame: 12 months follow up
Change in depressive symptoms
Time frame: Baseline and 8 weeks
Change in interleukin gene expression
Time frame: Baseline and 8 weeks
Change in interleukin protein expression
Time frame: Baseline and 8 weeks
Change in gene expression of norepinephrine transporter
Time frame: Baseline and 8 weeks
Change in gene expression of glutamate receptor
Time frame: Baseline and 8 weeks
Change in gene expression of TNF
Time frame: Baseline and 8 weeks
Change in protein expression of tumor necrosis factor
Time frame: Baseline and 8 weeks
cRP expression
Time frame: Baseline and 8 weeks
Change in NF-kB gene expression
Time frame: Baseline and 8 weeks
Change in NF-kB protein expression
Time frame: Baseline and 8 weeks
Change in INFG gene expression
Time frame: Baseline and 8 weeks
Change in Interferon gamma protein expression
Time frame: Baseline and 8 weeks
Mitochondrial DNA Copy Number
Time frame: Baseline and 8 weeks
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 5 Jun 2019.
- Derived from this study: PubMed 36328822van der Velden AM, Scholl J, Elmholdt EM, Fjorback LO, Harmer CJ, Lazar SW, O'Toole MS, Smallwood J, Roepstorff A, Kuyken W. Mindfulness Training Changes Brain Dynamics During Depressive Rumination: A Randomized Controlled Trial. Biol Psychiatry. 2023 Feb 1;93(3):233-242. doi: 10.1016/j.biopsych.2022.06.038. Epub 2022 Jul 22.
- Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Anne Maj van der Velden, Msc principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MBCT and TAU in people with Major Depressive Disorder, Recurrent, run by University of Aarhus at 1 site in Denmark.
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 4 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 5 Jun 2019. 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 Denmark. 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?
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 neural connectivity (time frame: Baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03353493, which also lists 1 linked publication.
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 5 Jun 2019.