Persistent Depressive DisorderbMBINCT04576741
Blended Mindfulness-Based Intervention for Persistent Depression
A study testing bMBI standard practice and bMBI shorter more frequent practice in people with Persistent Depressive Disorder, run by University of Surrey at 1 site in United Kingdom.
Trial summary
We plan to share all IPD but not any personal information. 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?
- bMBI standard practice and bMBI shorter more frequent practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2021to 27 May 2022
- 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 Structured Clinical Interview for DSM IV (First, Spitzer, Gibbon, \& Williams, 2002).
- 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.
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 nonsuicidal 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 the medication has not been changed during the last four weeks before entry into the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Surrey and Borders Partnership NHS Foundation Trust
Guildford, Surrey, KT16 9FG
About this study
Official title: Testing the Feasibility and Acceptability of a Blended Mindfulness-Based Intervention for Persistent Depression
We plan to share all IPD but not any personal information.
- Conditions
- Persistent Depressive Disorder
- Being tested
- bMBI standard practice, bMBI shorter more frequent practice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bMBI standard practiceBehavioural
This is a 12-week online mindfulness-based course blended with therapist support via video link using standard practices for Mindfulness-Based Cognitive Therapy (30-minutes/day).
bMBI shorter more frequent practiceBehavioural
This is a 12-week online mindfulness-based course blended with therapist support via video link using shorter, more frequent practice than standard Mindfulness-Based Cognitive Therapy (2x15-minutes/day).
| Study group | Role | What they receive |
|---|---|---|
| bMBI standard practice | Experimental | This is a 12-week online mindfulness-based course blended with therapist support via video link using standard practices for Mindfulness-Based Cognitive Therapy (30-minutes/day). Receives: Behavioral: bMBI standard practice |
| bMBI shorter more frequent practice | Experimental | This is a 12-week online mindfulness-based course blended with therapist support via video link using shorter, more frequent practice than standard Mindfulness-Based Cognitive Therapy (2x15-minutes/day). Receives: Behavioral: bMBI shorter more frequent practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reductions in depression symptomatology as assessed using the Patient Health Questionnaire-9 (PHQ-9), change measured within 1 week of starting and finishing the course and in week 5 and 9.
The PHQ-9 has 9 questions to assess the presence and severity of depression according to DSM-IV criteria and takes less than 3 minutes to complete. The PHQ-9 asks about patients' experiences in the last 2 weeks in relation to depression. Responses range from "0" (not at all) to "3" (nearly every day). Presence and severity of depression is scored as follows: 0-4 = minimal, 5-9 = mild, 10-14 = moderate, 15-19 moderately severe, 20-27 = severe.
The PHQ-9 has been found to have a high level of validity and reliability (Kroenke, Spitzer, \& Williams, 2001).
Measured: Weeks 0, 5, 9,13.
Secondary outcomes (6)
Ability to decenter as assessed by self-report on the Experiences Questionnaire (EQ), change measured within 1 week of starting and finishing the course and in week 5 and 9.
The EQ is a questionnaire to assess the ability to decenter. Decentering is defined as 'the ability to observe one's thoughts and feelings as temporary, objective events in the mind, as opposed to reflections of the self that are necessarily true' (Fresco et al., 2007). Decentering is thought to be a key mechanism for mindfulness-based interventions (Bernstein et al., 2019). There are 20 items and responses are made on a 5-point Likert scale ranging from 1 (completely disagree) to 5 (completely agree). We expect to see an increase in patient's ability to decenter.
Convergent and discriminant validity has been shown in negative relationships with measures of depression symptoms, depressive rumination, experiential avoidance, and emotion regulation. Results have been replicated in clinical and non-clinical populations (Fresco et al., 2007).
Measured: Weeks 0, 5, 9,13.
Levels of mindfulness in daily life as assessed using the Five-Facet Mindfulness Questionnaire (FFMQ-15), change measured within 1 week of starting and finishing the course and in week 5 and 9.
The FFMQ-15 is a questionnaire to assess levels of mindfulness in daily life. It assesses five aspects (or facets) of mindfulness: observation (noticing our internal and external environment), description (verbally labelling our experiences), mindful actions (acting with awareness), non-judgmental (not being overly critical of ourselves and others) and non-reactivity (not reacting impulsively to thoughts and feelings). The FFMQ-15 is the short version and has 15 items, the original version has 39. Responses are made on a 5-point Likert scale and range from 1 (never or rarely true) to 5 (very often or always true). There is a combination of direct scoring (e.g. 5=5) and reverse scoring (e.g. 5=1) to reveal a score for each facet and an overall total.
The FFMQ-15 has been found to have high validity and reliability (Baer et al., 2006; Bohlmeijer et al., 2011).
Measured: Weeks 0, 5, 9,13.
Mind wandering and spontaneous thoughts as assessed by the Amsterdam Resting-State Questionnaire 2.0 (ARSQ 2.0), change measured within 1 week of starting and finishing the course and in week 5 and 9.
The ARSQ 2.0 is a questionnaire to assess patients' subjective experience of their thoughts and feelings at rest. The questions tap into 10-factors: Discontinuity of Mind, Theory of Mind, Self, Planning, Sleepiness, Comfort, Somatic Awareness, Health Concern, Visual Thought and Verbal Thought. The ARSQ 2.0 involves a 5-minute eyes closed rest period followed by 55 questions about thoughts and feeling that were experienced. Responses are made on a 5-point Likert scale ranging from 1 (completely disagree) to 5 (completely agree). We expect to see an increase in Comfort and a decrease in Discontinuity of Mind.
The test-retest correlations were found to be high for all 10-factors and mental health positively correlated with Comfort and negatively with Discontinuity of Mind (Diaz et al., 2013; Diaz et al., 2014).
Measured: Weeks 0, 5, 9,13.
Symptoms of anxiety as assessed using the Generalised Anxiety Disorder Assessment (GAD-7), change measured within 1 week of starting and finishing the course and in week 5 and 9.
The GAD-7 is a questionnaire to assess the presence and severity of generalized anxiety disorder (GAD). It asks about patients' experiences in the last 2 weeks in relation to anxiety. Responses range from "0" (Not at all) to "3" (nearly every day). Presence and severity of anxiety is scored as follows: 0-5 = mild, 6-10 = moderate, 11-15 = moderately severe, 15-21 severe.
The GAD-7 has been found to have good reliability, as well as criterion, construct, factorial, and procedural validity (sensitivity 89% and specificity 82%). Although anxiety and depression are closely related, factor analysis confirmed them as distinct dimensions. Also, good agreement was found between self-report and interviewer administered versions of the scale (Spitzer, Kroenke, Williams, \& Loewe, 2006).
Measured: Weeks 0, 5, 9,13.
Subjective levels of stress as assessed using the Perceived Stress Scale (PSS), change measured within 1 week of starting and finishing the course and in week 5 and 9.
The PSS is measure of the perception of stress and measures the degree to which situations in one's life are appraised as stressful. It is one of the most widely used measures of stress. There are 10 items that tap into how unpredictable, uncontrollable, and overloaded respondents find their lives. Questions ask about feelings and thoughts during the last month in relation to stress, enquiring how often they felt a certain way. Responses range from "0" (never) to "4" (very often). Scores are then reversed and summed to reveal at total between 0 and 40. Presence and severity of stress is scored as follows: 0-13 = low, 14-26 = moderate, 27-40 = high.
The PSS has been found to have a good level of validity and reliability. (Cohen, Karmack, \& Mermelstein, 1988; Roberti et al., 2006; Taylor, 2015).
Measured: Weeks 0, 5, 9,13.
Mental wellbeing as assessed using the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS), change measured within 1 week of starting and finishing the course and in week 5 and 9.
The WEMWBS is a measure of mental wellbeing. There are 14 items that enquire about both the feeling (e.g. I have been feeling cheerful) and functioning (e.g. I have been feeling useful) aspect of mental wellbeing. Responses range from "0" (none of the time) to "5" (all of the time). Scores are summed to reveal a total between 14 and 70. Based on UK population samples: 14-42 = low wellbeing, 43-59 = average wellbeing, 60-70 = high wellbeing.
The WEMWBS has been used extensively worldwide and has been found to have high validity and reliability (Clarke et al., 2011; Taggart et al., 2013; Maheswaran at al., 2012).
Measured: Weeks 0, 5, 9,13.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2020
- Study start1 Mar 2021
- Primary completion1 May 2022
- Study completion27 May 2022
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Surrey
- Sponsor type
- University, hospital or other
- Collaborators
- Mind and Life Europe, Surrey and Borders Partnership NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Jonathan Hamilton, Principal investigator, University of Surrey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04576741
- Sponsor's protocol ID
- SPON/2020/08/FHMS
- Acronym
- bMBI
- Status last verified
- Jan 2025
- First submitted
- 1 Sep 2020
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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
- Testing the Feasibility and Acceptability of a Blended Mindfulness-Based Intervention for Persistent Depression
- ClinicalTrials.gov ID
- NCT04576741
- Acronym / sponsor ID
- bMBI / SPON/2020/08/FHMS
- Conditions
- Persistent Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of SurreyUniversity, hospital or other
- Collaborators
- Mind and Life Europe, Surrey and Borders Partnership NHS Foundation Trust
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 27 May 2022 (actual)
- First posted
- 6 Oct 2020 (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.
We plan to share all IPD but not any personal information.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bMBI standard practice | Experimental | Behavioral: bMBI standard practiceThis is a 12-week online mindfulness-based course blended with therapist support via video link using standard practices for Mindfulness-Based Cognitive Therapy (30-minutes/day). |
| bMBI shorter more frequent practice | Experimental | Behavioral: bMBI shorter more frequent practiceThis is a 12-week online mindfulness-based course blended with therapist support via video link using shorter, more frequent practice than standard Mindfulness-Based Cognitive Therapy (2x15-minutes/day). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- A current diagnosis of Major Depression as assessed by Structured Clinical Interview for DSM IV (First, Spitzer, Gibbon, \& Williams, 2002).
- 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 (5 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 nonsuicidal 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 the 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 |
|---|---|---|
| bMBI standard practiceThis is a 12-week online mindfulness-based course blended with therapist support via video link using standard practices for Mindfulness-Based Cognitive Therapy (30-minutes/day). | Behavioural | bMBI standard practice |
| bMBI shorter more frequent practiceThis is a 12-week online mindfulness-based course blended with therapist support via video link using shorter, more frequent practice than standard Mindfulness-Based Cognitive Therapy (2x15-minutes/day). | Behavioural | bMBI shorter more frequent practice |
Primary outcome
Reductions in depression symptomatology as assessed using the Patient Health Questionnaire-9 (PHQ-9), change measured within 1 week of starting and finishing the course and in week 5 and 9.
Time frame: Weeks 0, 5, 9,13.
The PHQ-9 has 9 questions to assess the presence and severity of depression according to DSM-IV criteria and takes less than 3 minutes to complete. The PHQ-9 asks about patients' experiences in the last 2 weeks in relation to depression. Responses range from "0" (not at all) to "3" (nearly every day). Presence and severity of depression is scored as follows: 0-4 = minimal, 5-9 = mild, 10-14 = moderate, 15-19 moderately severe, 20-27 = severe. The PHQ-9 has been found to have a high level of validity and reliability (Kroenke, Spitzer, \& Williams, 2001).
6 secondary outcomes
Ability to decenter as assessed by self-report on the Experiences Questionnaire (EQ), change measured within 1 week of starting and finishing the course and in week 5 and 9.
Time frame: Weeks 0, 5, 9,13.
Levels of mindfulness in daily life as assessed using the Five-Facet Mindfulness Questionnaire (FFMQ-15), change measured within 1 week of starting and finishing the course and in week 5 and 9.
Time frame: Weeks 0, 5, 9,13.
Mind wandering and spontaneous thoughts as assessed by the Amsterdam Resting-State Questionnaire 2.0 (ARSQ 2.0), change measured within 1 week of starting and finishing the course and in week 5 and 9.
Time frame: Weeks 0, 5, 9,13.
Symptoms of anxiety as assessed using the Generalised Anxiety Disorder Assessment (GAD-7), change measured within 1 week of starting and finishing the course and in week 5 and 9.
Time frame: Weeks 0, 5, 9,13.
Subjective levels of stress as assessed using the Perceived Stress Scale (PSS), change measured within 1 week of starting and finishing the course and in week 5 and 9.
Time frame: Weeks 0, 5, 9,13.
Mental wellbeing as assessed using the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS), change measured within 1 week of starting and finishing the course and in week 5 and 9.
Time frame: Weeks 0, 5, 9,13.
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: Yes
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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 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 bMBI standard practice and bMBI shorter more frequent practice 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 6 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 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?
Reductions in depression symptomatology as assessed using the Patient Health Questionnaire-9 (PHQ-9), change measured within 1 week of starting and finishing the course and in week 5 and 9. (time frame: Weeks 0, 5, 9,13.). 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.