Persistent Depressive DisorderNCT05650177
Effects of Mindfulness on Brain Functioning in Depressed Patients
A study testing blended Mindfulness-Based Intervention (bMBI) in people with Persistent Depressive Disorder, run by University of Surrey at 1 site in United Kingdom.
Trial summary
Depression is a common disorder that often takes a recurrent or chronic course. Recent research has indicated that such courses are associated with significant changes in brain functioning including changes in strength of functional connectivity between regions of the default mode network, a large-scale brain network… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Persistent Depressive Disorder
- What is being tested?
- blended Mindfulness-Based Intervention (bMBI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Jun 2022to 31 Oct 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A current diagnosis of Major Depression as assessed by SAGE-SR (Series of Assessments to Guide Evaluation Self Report (Brodey et al., 2018).
- A chronic or recurrent lifetime history of depression, with either chronic persistence of symptoms or a history of at least three previous episodes of depression, two of which needed to have occurred during the last two years.
- Self-reported severity of current symptoms on a clinical level as indicated by a PHQ-9 score of 10 or more.
- Age 18 to 65 thus excluding cases of late life depression given that such cases might differ in aetiology.
- Fluency in spoken and written English.
- Have individual access to a computer or mobile device with internet connection and video link.
- Fully committed to the intervention and assessments as assessed by the Participation Form.
Who cannot join
- History of schizophrenia, schizoaffective disorder, bipolar disorder, current abuse of alcohol or other substances, organic mental disorder, pervasive developmental delay, primary diagnosis of obsessive-compulsive disorder or eating disorder, or regular non-suicidal self-injury.
- Current treatment with CBT more than once a month.
- Regular meditation practice (meditating more than once per week).
- Inability to complete research assessments through difficulty with English, visual impairment, or cognitive difficulties.
- We will allow patients who are currently taking antidepressants into the study provided that their medication has not been changed during the last four weeks before entry into the study.
- People with heart pacemakers and clips or other metal items, which have been implanted into the body by a surgeon. This is because they would not safe in the brain scanner.
- Suffer from claustrophobia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating Effects of Mindfulness Training on DMN Connectivity and Dynamics
Depression is a common disorder that often takes a recurrent or chronic course. Recent research has indicated that such courses are associated with significant changes in brain functioning including changes in strength of functional connectivity between regions of the default mode network, a large-scale brain network involved in spontaneous thinking and rumination, and the ability to suppress this network.
Training in mindfulness has been found to be an effective treatment for patients with recurrent and chronic courses of depression and there is evidence for beneficial effects on brain structure and functioning. However, it remains unclear whether and in how far the training may serve to reverse brain changes in recurrent and chronic courses of depression. The aim of this research is to test the effects of sustained training in mindfulness meditation on default mode network connectivity and suppression in patients suffering from recurrent or chronic depression.
The investigators will invite currently depressed patients with a recurrent or chronic course of the disorder (N = 36) to take part in a 6-month mindfulness intervention and investigate changes in default-mode network connectivity and suppression over repeated assessments. Building on our previous research, the intervention will use a blended format that combines an online app offering psychoeducational materials and meditation guidance with brief individual therapy sessions delivered via videoconference. Eligible participants will be asked to complete questionnaires and take part in brain scans before the start of the treatment, 3 months after the start of the treatment and after the end of treatment.
Read the detailed description
Background and rationale
Major Depression is one of the leading contributors to the burden of disease world-wide. While there are established treatments, a considerable proportion of patients do not respond sufficiently. About a third of people who suffer from depression develop an increasingly chronic and recurrent course that is accompanied by progressive changes in brain structure and functioning. These changes act to prevent recovery and play an important role in conferring an increased risk for associated physical and neurodegenerative disorders.
Training in mindfulness helps patients recognize and disengage from the maladaptive and habitual patterns of thinking that maintain the disorder and has been shown to have promising effects in the treatment of such persistent courses. Mindfulness-Based Cognitive Therapy (MBCT), a standard MBI consisting of eight weekly sessions, is now a recommended treatment for the prevention of relapse in highly recurrent courses of depression.
However, recent research indicates that beneficial effects are contingent on sustained practice and utilization of mindfulness skills beyond the actual intervention periods. There is now an increasing awareness of the need to support patients in establishing a sustained practice of mindfulness. Yet despite the fact that this need is now widely acknowledged, there are currently no established approaches to support patients in sustained practice and it remains unclear in how far, and at what levels, sustained practice may lead to visible changes in underlying neurobiological vulnerabilities. While standard MBIs have been shown to have significant beneficial effects in patients with persistent forms of depression, there is still a considerable proportion of patients who do not respond sufficiently - current trials suggest a response rate of about 50%. Few studies have investigated reversibility of neurobiological vulnerabilities in depression. However, research in healthy meditators suggests that sustained practice in mindfulness may have promising potential for this purpose. Establishing approaches to support patients in sustained practice and understanding its effects on neurobiological vulnerabilities therefore represents an important step in improving MBIs for this group.
Previous research has indicated that the psychological maintenance mechanisms that hold persistent forms of depression in place are associated with significant changes in the connectivity and dynamics of the DMN, a large distributed network of interacting brain regions that serves to imbue present moment experience with memory content and becomes active when people engage in mind wandering and other forms of task-unrelated thinking such as rumination. Research in patients with depression has shown that depression is characterised by significant deficits in suppressing DMN activity during performance of common working memory and other executive tasks. Furthermore, there is now considerable evidence for aberrations in connectivity within and from this network to other regions of the brain that are relevant in the regulation of attention and emotions.
This study is the second stage of the project. In the first stage, the investigators tested the feasibility and acceptability of a blended Mindfulness-Based Intervention (bMBI) over a period of 3-months. The bMBI is an online course 'blended' with therapist support via video link. The online course comprises of 9 themed sessions each involving: video instructions, written information, exercises, and practices. The therapist sessions are biweekly and help participants overcome any problems they experience. In this stage, the investigators will investigate the effects of engaging in the bMBI over an extended period of 6-months on brain functioning using brain imaging techniques. The investigators will specifically look at the effects of the intervention on DMN suppression and connectivity in a sample of patients suffering from persistent depression.
- Conditions
- Persistent Depressive Disorder
- Being tested
- blended Mindfulness-Based Intervention (bMBI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blended Mindfulness-Based Intervention (bMBI)Behavioural
The blended Mindfulness-Based Intervention (bMBI) is a 24-week online course 'blended' with therapist support via video link. The entire course is completed online and requires no in person contact. The bMBI follows the general structure of Mindfulness-Based Cognitive Therapy (MBCT) with an added emphasis on the cultivation of self-compassion. The bMBI comprises of 9-themed sessions spread out over the 24-weeks. Each session involves: video instructions, written information, psycho-educational exercises, and guided meditation practices. Participants meditate for 30-minutes each day. Additional homework involves short daily activities designed to incorporate mindfulness into daily life and keeping a journal about experiences within and around the practices and exercises. The therapist sessions are every two weeks and last for 45-minutes and help participants overcome any problems they experience.
| Study group | Role | What they receive |
|---|---|---|
| Receiving intervention. | Experimental | Patients with persistent depression who are receiving the intervention. Receives: Behavioral: blended Mindfulness-Based Intervention (bMBI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in activity within the brain's 'default mode network'.
The primary outcome measure is changes in activity within the brain's 'default mode network', measured during a working memory task. The default mode network (DMN) refers to an interconnected group of brain structures (including medial prefrontal cortex, posterior cingulate cortex, and the inferior parietal lobule) that is more active when we are not involved in any specific mental exercise, e.g. just daydreaming, recalling memories or thinking about the future. Research has found links between activity in the DMN and mental disorders including depression and anxiety, while mindfulness practise has been shown to influence DMN activity.
Measured: 0 months, 3 months, and 6 months.
Secondary outcomes (7)
Patient Health Questionnaire-9 (PHQ-9)
Reductions in depression symptomatology as assessed using the Patient Health Questionnaire-9 (PHQ-9).
Measured: 0 months, 3 months, and 6 months.
Experiences Questionnaire (EQ)
Ability to decenter as assessed by self-report on the Experiences Questionnaire (EQ). The ability to decenter from thoughts and feelings (to see them as events that arise in the mind rather than being involved in them) is a key mechanism for which mindfulness has been found to be effective for mental health disorders.
Measured: 0 months, 3 months, and 6 months.
Five-Facet Mindfulness Questionnaire (FFMQ-15)
Levels of mindfulness in daily life as assessed using the Five-Facet Mindfulness Questionnaire (FFMQ-15).
Measured: 0 months, 3 months, and 6 months.
Amsterdam Resting-State Questionnaire 2.0 (ARSQ 2.0)
Mind wandering and spontaneous thoughts as assessed by the Amsterdam Resting-State Questionnaire 2.0 (ARSQ 2.0).
Measured: 0 months, 3 months, and 6 months.
Generalised Anxiety Disorder Assessment (GAD-7)
Symptoms of anxiety as assessed using the Generalised Anxiety Disorder Assessment (GAD-7).
Measured: 0 months, 3 months, and 6 months.
Perceived Stress Scale (PSS)
Subjective levels of stress as assessed using the Perceived Stress Scale (PSS).
Measured: 0 months, 3 months, and 6 months.
Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
Mental wellbeing as assessed using the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS).
Measured: 0 months, 3 months, and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start6 Jun 2022
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Depressive DisorderStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Surrey
- Sponsor type
- University, hospital or other
- Collaborators
- Surrey and Borders Partnership NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Jonathan D Hamilton, Principal investigator, University of Surrey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05650177
- Sponsor's protocol ID
- USurrey
- Status last verified
- Jan 2025
- First submitted
- 30 Nov 2022
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Effects of Mindfulness Training on DMN Connectivity and Dynamics
- ClinicalTrials.gov ID
- NCT05650177
- Acronym / sponsor ID
- USurrey
- Conditions
- Persistent Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of SurreyUniversity, hospital or other
- Collaborators
- Surrey and Borders Partnership NHS Foundation Trust
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 14 Dec 2022 (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.
Depression is a common disorder that often takes a recurrent or chronic course. Recent research has indicated that such courses are associated with significant changes in brain functioning including changes in strength of functional connectivity between regions of the default mode network, a large-scale brain network involved in spontaneous thinking and rumination, and the ability to suppress this network.
Training in mindfulness has been found to be an effective treatment for patients with recurrent and chronic courses of depression and there is evidence for beneficial effects on brain structure and functioning. However, it remains unclear whether and in how far the training may serve to reverse brain changes in recurrent and chronic courses of depression. The aim of this research is to test the effects of sustained training in mindfulness meditation on default mode network connectivity and suppression in patients suffering from recurrent or chronic depression.
The investigators will invite currently depressed patients with a recurrent or chronic course of the disorder (N = 36) to take part in a 6-month mindfulness intervention and investigate changes in default-mode network connectivity and suppression over repeated assessments. Building on our previous research, the intervention will use a blended format that combines an online app offering psychoeducational materials and meditation guidance with brief individual therapy sessions delivered via videoconference. Eligible participants will be asked to complete questionnaires and take part in brain scans before the start of the treatment, 3 months after the start of the treatment and after the end of treatment.
Detailed description
Background and rationale
Major Depression is one of the leading contributors to the burden of disease world-wide. While there are established treatments, a considerable proportion of patients do not respond sufficiently. About a third of people who suffer from depression develop an increasingly chronic and recurrent course that is accompanied by progressive changes in brain structure and functioning. These changes act to prevent recovery and play an important role in conferring an increased risk for associated physical and neurodegenerative disorders.
Training in mindfulness helps patients recognize and disengage from the maladaptive and habitual patterns of thinking that maintain the disorder and has been shown to have promising effects in the treatment of such persistent courses. Mindfulness-Based Cognitive Therapy (MBCT), a standard MBI consisting of eight weekly sessions, is now a recommended treatment for the prevention of relapse in highly recurrent courses of depression.
However, recent research indicates that beneficial effects are contingent on sustained practice and utilization of mindfulness skills beyond the actual intervention periods. There is now an increasing awareness of the need to support patients in establishing a sustained practice of mindfulness. Yet despite the fact that this need is now widely acknowledged, there are currently no established approaches to support patients in sustained practice and it remains unclear in how far, and at what levels, sustained practice may lead to visible changes in underlying neurobiological vulnerabilities. While standard MBIs have been shown to have significant beneficial effects in patients with persistent forms of depression, there is still a considerable proportion of patients who do not respond sufficiently - current trials suggest a response rate of about 50%. Few studies have investigated reversibility of neurobiological vulnerabilities in depression. However, research in healthy meditators suggests that sustained practice in mindfulness may have promising potential for this purpose. Establishing approaches to support patients in sustained practice and understanding its effects on neurobiological vulnerabilities therefore represents an important step in improving MBIs for this group.
Previous research has indicated that the psychological maintenance mechanisms that hold persistent forms of depression in place are associated with significant changes in the connectivity and dynamics of the DMN, a large distributed network of interacting brain regions that serves to imbue present moment experience with memory content and becomes active when people engage in mind wandering and other forms of task-unrelated thinking such as rumination. Research in patients with depression has shown that depression is characterised by significant deficits in suppressing DMN activity during performance of common working memory and other executive tasks. Furthermore, there is now considerable evidence for aberrations in connectivity within and from this network to other regions of the brain that are relevant in the regulation of attention and emotions.
This study is the second stage of the project. In the first stage, the investigators tested the feasibility and acceptability of a blended Mindfulness-Based Intervention (bMBI) over a period of 3-months. The bMBI is an online course 'blended' with therapist support via video link. The online course comprises of 9 themed sessions each involving: video instructions, written information, exercises, and practices. The therapist sessions are biweekly and help participants overcome any problems they experience. In this stage, the investigators will investigate the effects of engaging in the bMBI over an extended period of 6-months on brain functioning using brain imaging techniques. The investigators will specifically look at the effects of the intervention on DMN suppression and connectivity in a sample of patients suffering from persistent depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Receiving intervention. | Experimental | Behavioral: blended Mindfulness-Based Intervention (bMBI)Patients with persistent depression who are receiving the intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- A current diagnosis of Major Depression as assessed by SAGE-SR (Series of Assessments to Guide Evaluation Self Report (Brodey et al., 2018).
- A chronic or recurrent lifetime history of depression, with either chronic persistence of symptoms or a history of at least three previous episodes of depression, two of which needed to have occurred during the last two years.
- Self-reported severity of current symptoms on a clinical level as indicated by a PHQ-9 score of 10 or more.
- Age 18 to 65 thus excluding cases of late life depression given that such cases might differ in aetiology.
- Fluency in spoken and written English.
Key exclusion criteria (7 listed)
- History of schizophrenia, schizoaffective disorder, bipolar disorder, current abuse of alcohol or other substances, organic mental disorder, pervasive developmental delay, primary diagnosis of obsessive-compulsive disorder or eating disorder, or regular non-suicidal self-injury.
- Current treatment with CBT more than once a month.
- Regular meditation practice (meditating more than once per week).
- Inability to complete research assessments through difficulty with English, visual impairment, or cognitive difficulties.
- We will allow patients who are currently taking antidepressants into the study provided that their medication has not been changed during the last four weeks before entry into 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 |
|---|---|---|
| blended Mindfulness-Based Intervention (bMBI)The blended Mindfulness-Based Intervention (bMBI) is a 24-week online course 'blended' with therapist support via video link. The entire course is completed online and requires no in person contact. The bMBI follows the general structure of Mindfulness-Based Cognitive Therapy (MBCT) with an added emphasis on the cultivation of self-compassion. The bMBI comprises of 9-themed sessions spread out over the 24-weeks. Each session involves: video instructions, written information, psycho-educational exercises, and guided meditation practices. Participants meditate for 30-minutes each day. Additional homework involves short daily activities designed to incorporate mindfulness into daily life and keeping a journal about experiences within and around the practices and exercises. The therapist sessions are every two weeks and last for 45-minutes and help participants overcome any problems they experience. | Behavioural | Receiving intervention. |
Primary outcome
Changes in activity within the brain's 'default mode network'.
Time frame: 0 months, 3 months, and 6 months.
The primary outcome measure is changes in activity within the brain's 'default mode network', measured during a working memory task. The default mode network (DMN) refers to an interconnected group of brain structures (including medial prefrontal cortex, posterior cingulate cortex, and the inferior parietal lobule) that is more active when we are not involved in any specific mental exercise, e.g. just daydreaming, recalling memories or thinking about the future. Research has found links between activity in the DMN and mental disorders including depression and anxiety, while mindfulness practise has been shown to influence DMN activity.
7 secondary outcomes
Patient Health Questionnaire-9 (PHQ-9)
Time frame: 0 months, 3 months, and 6 months.
Experiences Questionnaire (EQ)
Time frame: 0 months, 3 months, and 6 months.
Five-Facet Mindfulness Questionnaire (FFMQ-15)
Time frame: 0 months, 3 months, and 6 months.
Amsterdam Resting-State Questionnaire 2.0 (ARSQ 2.0)
Time frame: 0 months, 3 months, and 6 months.
Generalised Anxiety Disorder Assessment (GAD-7)
Time frame: 0 months, 3 months, and 6 months.
Perceived Stress Scale (PSS)
Time frame: 0 months, 3 months, and 6 months.
Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
Time frame: 0 months, 3 months, and 6 months.
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 6 Jan 2025.
- 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.
Jonathan D Hamilton principal investigator
University of Surrey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blended Mindfulness-Based Intervention (bMBI) in people with Persistent Depressive Disorder, run by University of Surrey 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 7 inclusion and 7 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 6 Jan 2025. 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 activity within the brain's 'default mode network'. (time frame: 0 months, 3 months, and 6 months.). 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 6 Jan 2025.