Major Depression (in Remission)NCT02226042
Investigating the Mechanisms of Mindfulness-based Cognitive Therapy (MBCT)
A study testing Mindfulness-based Cognitive Therapy in people with Major Depression (in Remission), run by University of Manchester at 1 site in United Kingdom.
Trial summary
This research will investigate the neuropsychological mechanisms underlying the eight-week Mindfulness-based Cognitive Therapy (MBCT) programme. Participants in remission from depression will be seen pre- and post-MBCT to assess the underlying neuropsychological mechanisms. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depression (in Remission)
- What is being tested?
- 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
- 112 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2014to Oct 2017
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants with remitted depression (rMDD):
- At least two previous episodes of DSM-IV major depression in adulthood, diagnosed using the Mini International Neuropsychiatric Interview (M.I.N.I).
- Full or partial remission for at least three months with two depressive episodes within the last five years.
- A score of less than or equal to 12 on the Montgomery Asberg Depression Rating Scale (MADRS) mood assessment.
- If on medication, no recent or planned major changes
- Healthy volunteers:
Show all 12Show fewer
- In good psychological health screened with the M.I.N.I
- All participants:
- in good physical health (to reduce risk of confounding physical health problems).
- sufficiently fluent in English to ensure valid understanding and completion of the tasks.
- minimum I.Q level of 80 to ensure sufficient understanding of the neurocognitive tasks administered.
- colour vision and acuity within normal/corrected to normal limits.
Who cannot join
- Any current mental health diagnosis (DSM-IV diagnosis including current major depression, bipolar disorder, psychosis, Obsessive Compulsive Disorder (OCD), substance abuse or dependence, eating disorders)
- Physical health or neurological disorders that might interfere with the interpretation of the tasks, including a history of significant head injury.
- In addition healthy volunteers will be without a history mental health disorders (DSM-IV)
- Current or previous experience of mindfulness-based treatments or extensive cognitive behavioural treatment, or planned participation in psychological treatments during the key time for the study (between pre and post visits).
- Planned major alteration in drug treatment for depression between pre and post visits.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Manchester
Manchester, Greater Manchester, M13 9PT
About this study
Official title: Investigating the Neuropsychological Mechanisms Underlying Mindfulness-based Cognitive Therapy
This research will investigate the neuropsychological mechanisms underlying the eight-week Mindfulness-based Cognitive Therapy (MBCT) programme.
Participants in remission from depression will be seen pre- and post-MBCT to assess the underlying neuropsychological mechanisms. All will be followed-up over 12 months to assess the relationship of these neuropsychological changes with relapse risk.
The research will focus primarily on changes in self-compassion, rumination, attention and structural brain changes, with secondary focus on other mechanisms of emotional processing and memory.
Read the detailed description
There will be three groups in total.
- The first group will take 36 participants in remission from major depression (rMDD) through the 8 week MBCT program.
- A control group of 36 rMDD participants will not receive the intervention.
- A group of never depressed healthy control participants will also be recruited.
Research visits for participants not undergoing MBCT will be separated by an 8 week gap.
All participants will be seen before and after the 8 weeks for completion of neuropsychological assessments and questionnaires.
rMDD participants will be followed up over the following 12 months to identify any predictors of relapse.
- Conditions
- Major Depression (in Remission)
- Being tested
- Mindfulness-based Cognitive Therapy
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based Cognitive TherapyBehavioural
Also called MBCT
MBCT: Mindfulness-based Cognitive Therapy is an 8 week group-based programme consisting of approximately 12 participants per group. There is also a full one day of practice around week 6. MBCT was initially designed for individuals in remission from depression and at risk of relapsing. The intervention is a mix of mindfulness meditation, cognitive behavioural therapy exercises and psychoeducation. MBCT has been shown to be effective in reducing relapse risk over 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-based Cognitive Therapy | Experimental | Individuals currently in remission from depression will choose to enter the Mindfulness-based Cognitive Therapy (MBCT) arm and undergo the 8 week MBCT group programme Receives: Behavioral: Mindfulness-based Cognitive Therapy |
| Non-MBCT arm | No intervention | Individuals currently in remission from depression will choose not to undergo the 8 week MBCT group programme |
| Healthy volunteers | No intervention | Individuals who have never experienced major depression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in self-compassion following MBCT measured by both neuropsychological and self-report measures
Two neuropsychological measures of self-compassion have been developed and will be administerat baseline and after MBCT/8 week gap (8 weeks post baseline). Self-report questionnaires will be administered before and after MBCT/8 week gap and at subsequent follow-up visits (3, 6, 12 months).
Measured: measured at baseline and post intervention (8 weeks post baseline) and at each follow-up visit (3 in total)
Secondary outcomes (3)
Changes in levels of rumination following MBCT measured through both neuropsychological and self-report measures
One neuropsychological measure of rumination has been developed and will be administered at baseline and immediately after MBCT/8 week gap (8 weeks post baseline).
Self-report questionnaires will be administered at baseline and after MBCT/8 week gap (8 weeks post baseline) and at subsequent follow-up visits (3,6,12 months).
Measured: measured at baseline and after the intervention/8 week gap (8 weeks post baseline) and at each follow-up visit (3 in total)
Changes in attention regulation following MBCT
Measured: measured at baseline and after the intervention/8 week gap (8 weeks post baseline)
Changes in brain structure following MBCT
Measured: measured at baseline and after the intervention (8 weeks post baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2016
- Study completionOct 2017
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 Depression (in Remission)Studies of the same condition, open and under way.
- More trials run by University of ManchesterThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kate Williams, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02226042
- Sponsor's protocol ID
- MBCTMechanisms
- Status last verified
- May 2018
- First submitted
- 21 Aug 2014
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Williams K, Hartley S, Anderson IM, Birtwell K, Dowson M, Elliott R, Taylor P. An ongoing process of reconnection: A qualitative exploration of mindfulness-based cognitive therapy for adults in remission from depression. Psychol Psychother. 2022 Mar;95(1):173-190. doi: 10.1111/papt.12357. Epub 2021 Jul 17.
PubMed 34272797
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Neuropsychological Mechanisms Underlying Mindfulness-based Cognitive Therapy
- ClinicalTrials.gov ID
- NCT02226042
- Acronym / sponsor ID
- MBCTMechanisms
- Conditions
- Major Depression (in Remission)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 26 Aug 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.
This research will investigate the neuropsychological mechanisms underlying the eight-week Mindfulness-based Cognitive Therapy (MBCT) programme.
Participants in remission from depression will be seen pre- and post-MBCT to assess the underlying neuropsychological mechanisms. All will be followed-up over 12 months to assess the relationship of these neuropsychological changes with relapse risk.
The research will focus primarily on changes in self-compassion, rumination, attention and structural brain changes, with secondary focus on other mechanisms of emotional processing and memory.
Detailed description
There will be three groups in total.
- The first group will take 36 participants in remission from major depression (rMDD) through the 8 week MBCT program.
- A control group of 36 rMDD participants will not receive the intervention.
- A group of never depressed healthy control participants will also be recruited.
Research visits for participants not undergoing MBCT will be separated by an 8 week gap.
All participants will be seen before and after the 8 weeks for completion of neuropsychological assessments and questionnaires.
rMDD participants will be followed up over the following 12 months to identify any predictors of relapse.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based Cognitive Therapy | Experimental | Behavioral: Mindfulness-based Cognitive TherapyIndividuals currently in remission from depression will choose to enter the Mindfulness-based Cognitive Therapy (MBCT) arm and undergo the 8 week MBCT group programme |
| Non-MBCT arm | No intervention | –Individuals currently in remission from depression will choose not to undergo the 8 week MBCT group programme |
| Healthy volunteers | No intervention | –Individuals who have never experienced major depression |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- At least two previous episodes of DSM-IV major depression in adulthood, diagnosed using the Mini International Neuropsychiatric Interview (M.I.N.I).
- Full or partial remission for at least three months with two depressive episodes within the last five years.
- A score of less than or equal to 12 on the Montgomery Asberg Depression Rating Scale (MADRS) mood assessment.
- If on medication, no recent or planned major changes
- In good psychological health screened with the M.I.N.I
Key exclusion criteria (5 listed)
- Any current mental health diagnosis (DSM-IV diagnosis including current major depression, bipolar disorder, psychosis, Obsessive Compulsive Disorder (OCD), substance abuse or dependence, eating disorders)
- Physical health or neurological disorders that might interfere with the interpretation of the tasks, including a history of significant head injury.
- In addition healthy volunteers will be without a history mental health disorders (DSM-IV)
- Current or previous experience of mindfulness-based treatments or extensive cognitive behavioural treatment, or planned participation in psychological treatments during the key time for the study (between pre and post visits).
- Planned major alteration in drug treatment for depression between pre and post visits.
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 TherapyAlso: MBCTMBCT: Mindfulness-based Cognitive Therapy is an 8 week group-based programme consisting of approximately 12 participants per group. There is also a full one day of practice around week 6. MBCT was initially designed for individuals in remission from depression and at risk of relapsing. The intervention is a mix of mindfulness meditation, cognitive behavioural therapy exercises and psychoeducation. MBCT has been shown to be effective in reducing relapse risk over 12 months. | Behavioural | Mindfulness-based Cognitive Therapy |
Primary outcome
Changes in self-compassion following MBCT measured by both neuropsychological and self-report measures
Time frame: measured at baseline and post intervention (8 weeks post baseline) and at each follow-up visit (3 in total)
Two neuropsychological measures of self-compassion have been developed and will be administerat baseline and after MBCT/8 week gap (8 weeks post baseline). Self-report questionnaires will be administered before and after MBCT/8 week gap and at subsequent follow-up visits (3, 6, 12 months).
3 secondary outcomes
Changes in levels of rumination following MBCT measured through both neuropsychological and self-report measures
Time frame: measured at baseline and after the intervention/8 week gap (8 weeks post baseline) and at each follow-up visit (3 in total)
Changes in attention regulation following MBCT
Time frame: measured at baseline and after the intervention/8 week gap (8 weeks post baseline)
Changes in brain structure following MBCT
Time frame: measured at baseline and after the intervention (8 weeks post baseline)
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 3 May 2018.
- Derived from this study: PubMed 34272797Williams K, Hartley S, Anderson IM, Birtwell K, Dowson M, Elliott R, Taylor P. An ongoing process of reconnection: A qualitative exploration of mindfulness-based cognitive therapy for adults in remission from depression. Psychol Psychother. 2022 Mar;95(1):173-190. doi: 10.1111/papt.12357. Epub 2021 Jul 17.
- Individual participant dataSharing planned: No
Related trials for Major Depression (in Remission)
Recruiting
A Randomized, 52-Week Extension Study to Evaluate the Maintenance of Remission, Relapse Prevention, and Long-Term Safety of CreNeuroS™ in Patients With Major Depressive Disorder Who Achieved Remission Following an 8-Week Parent Study
Adjunct in the Treatment of Depressive Disorder
Active, not recruitingObservational study
Pharmaco-Neuroimaging Studies of Approach/Avoidance Behaviors and Post-Mortem Studies: Study 1.2 (Stress Manipulation)
Major Depression in Remission
Active, not recruitingPhase 2/3
Low Amplitude Pulse Seizure Therapy Versus Standard Ultra-Brief Right Unilateral Electroconvulsive Therapy
Suicidal Ideation, Major Depressive Disorder
Recruiting
Mindfulness-Based Cognitive Therapy (MBCT) for the Prevention of Depression Relapse or Recurrence Using Videoconference
Major Depressive Disorder, Recurrent, in Remission, Major Depressive Disorder, Recurrent, Mild
RecruitingObservational study
Predictors of Relapse in Major Depressive Disorder (PERFORM-D)
Major Depressive Disorder (MDD)
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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Major Depression (in Remission), run by University of Manchester at 1 site in United Kingdom.
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 12 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 3 May 2018. 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 United Kingdom. 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?
Changes in self-compassion following MBCT measured by both neuropsychological and self-report measures (time frame: measured at baseline and post intervention (8 weeks post baseline) and at each follow-up visit (3 in total)). 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 NCT02226042, 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 3 May 2018.