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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United Kingdom

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.

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 groups in NCT04576741
Study groupRoleWhat they receive
bMBI standard practiceExperimentalThis 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 practiceExperimentalThis 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.

  1. 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)
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  1. First posted6 Oct 2020
  2. Study start1 Mar 2021
  3. Primary completion1 May 2022
  4. Study completion27 May 2022

Resources

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)
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

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.

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