Mild-moderate Unipolar Depression; Persistent Negative AffectNCT01831362
Dismantling Mindfulness: Contributions of Attention vs. Acceptance
A study testing Mindfulness-Based Cognitive Therapy, Focused Attention (FA) and Open- Monitoring in people with Mild-moderate Unipolar Depression; Persistent Negative Affect, run by Brown University at 1 site in United States.
Trial summary
This study addresses NCCAM's request for research that investigates the neuropsychological mechanisms underlying mind-body therapies, and for precise criteria and better delineation of meditation practices. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mild-moderate Unipolar Depression; Persistent Negative Affect
- What is being tested?
- Mindfulness-Based Cognitive Therapy, Focused Attention (FA) and Open- Monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to 15 Mar 2016
- 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
- English-speaking
- ages 18-65
- mild-severe levels of depression or high level of negative affect
Who cannot join
- Current:
- age <18 or >65
- inability to read and write in English
- Extremely severe levels of depression
- active suicidal ideation
- presence of Axis I personality disorder
Show all 19Show fewer
- panic disorder
- post-traumatic stress disorder
- obsessive-compulsive disorder
- eating disorder, or substance abuse/dependence
- current psychotherapy
- change in antidepressant medication type or dosage in the last 8 weeks.
- Lifetime history exclusions:
- bipolar disorder
- psychotic disorders
- persistent antisocial behavior or repeated self-harm,
- borderline personality disorder,
- organic brain damage
- regular meditation practice
Trial locations and contacts
1 site in 1 country.
United States1 site
Brown University Clinical and Affective Neuroscience Laboratory
Providence, Rhode Island, 02912
About this study
This study addresses NCCAM's request for research that investigates the neuropsychological mechanisms underlying mind-body therapies, and for precise criteria and better delineation of meditation practices.
The purpose of this study is to assess the clinical efficacy and mechanism of action of 2 component practices of "mindfulness meditation", i.e. focused awareness (FA) and open monitoring (OM) in comparison to each other and to the standard package, Mindfulness-Based Cognitive Therapy (MBCT).
Read the detailed description
Meditation, particularly mindfulness meditation, is one of the most popular Complementary and Alternative Medicine (CAM) therapies for alleviating emotional stress, depression and anxiety. While standardized meditation-based treatment packages like Mindfulness Based Stress Reduction (MBSR) and Mindfulness-based Cognitive Therapy (MBCT) have reliably shown sustained improvements in emotional disturbances and wellbeing, they contain so many different components and practices that the active ingredient cannot be ascertained. What is commonly called "Mindfulness" meditation is actually comprised of two separate practices: 1) focused awareness practice (FA), and 2) open-monitoring practice (OM). This project aims to create separate 8 week programs for FA and OM meditations, compare their clinical efficacy and investigate their separate mechanisms of action in individuals with clinically significant levels of persistent negative affect and depression. The clinical benefit and mechanism of action of focused awareness (FA) vs open-monitoring (OM) vs MBCT will be examined with a 3-armed randomized control trial of these 8 week interventions. Outcome variables include negative affect (depression, anxiety, stress) and wellbeing. Hypothesized mediating processes include objectively measured attention, emotion regulation and the basic wakefulness on which they depend.
- Being tested
- Mindfulness-Based Cognitive Therapy, Focused Attention (FA), Open- Monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Cognitive TherapyBehavioural
Focused Attention (FA)Behavioural
Open- MonitoringBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Focused Attention (FA) | Experimental | This 8 week program consists solely of focused attention practices, i.e. selected attention to an object (breath etc) and deselection of other stimuli Receives: Behavioral: Focused Attention (FA) |
| Open-Monitoring (OM) | Experimental | This 8-week program consists solely of open monitoring practices, or noticing and/or labeling the contents of ongoing experience ( thoughts, body sensations, emotions, seeing, hearing etc) without focusing on or deselecting any stimuli Receives: Behavioral: Open- Monitoring |
| Mindfulness-Based Cognitive Therapy (MBCT) | Experimental | The 8 week MBCT program follows the 2nd Edition (2012) manual (Segal, Williams, Teasdale) and includes both focused attention and open- monitoring practices Receives: Behavioral: Mindfulness-Based Cognitive Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Inventory of Depressive Symptomatology
30-item clinician administered interview about unipolar depression symptoms
Measured: baseline, 8 weeks, 20 weeks
change in Depression, Anxiety Stress Scale (DASS)
42-item self-report questionnaire on depression, anxiety and stress symptoms
Measured: baseline, week 2,4,6,8, 20
change in Wellbeing Scale (WBS)
73-item self-report questionnaire of psychological wellbeing
Measured: baseline, 8 weeks, 20 weeks
Secondary outcomes (5)
Change in alpha-theta EEG power from baseline to 8 weeks
Resting/spontaneous EEG power in 5-9 Hz range
Measured: baseline and 8 weeks
Change in Facial EMG power from baseline to 8 weeks
Facial EMG response to emotional (IAPS) photos (reactivity + regulation)
Measured: baseline and 8 weeks
Sustained Attention to response Task (SART)
40 minuted sustained attention, go-no-go task
Measured: baseline, 8 weeks
Difficulties in Emotion Regulation Scale (DERS)
36-item self report of emotion regulation
Measured: baseline, 8 weeks, 20 weeks
Attention Control Questionnaire (Derryberry & Reed, 2002)
20-item self report measure of attentional abilities
Measured: baseline, 8 weeks, 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2013 (estimated)
- Study startFeb 2013
- Primary completion15 Mar 2016
- Study completion15 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mild-moderate Unipolar Depression; Persistent Negative AffectStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Willoughby Britton, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01831362
- Sponsor's protocol ID
- K23AT006328-01A1
- Status last verified
- Nov 2018
- First submitted
- 10 Apr 2013
- Last updated
- 5 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cullen B, Eichel K, Lindahl JR, Rahrig H, Kini N, Flahive J, Britton WB. The contributions of focused attention and open monitoring in mindfulness-based cognitive therapy for affective disturbances: A 3-armed randomized dismantling trial. PLoS One. 2021 Jan 12;16(1):e0244838. doi: 10.1371/journal.pone.0244838. eCollection 2021.
PubMed 33434227Canby NK, Eichel K, Peters SI, Rahrig H, Britton WB. Predictors of Out-of-Class Mindfulness Practice Adherence During and After a Mindfulness-Based Intervention. Psychosom Med. 2021 Jul-Aug 01;83(6):655-664. doi: 10.1097/PSY.0000000000000873.
PubMed 33038188Britton WB, Davis JH, Loucks EB, Peterson B, Cullen BH, Reuter L, Rando A, Rahrig H, Lipsky J, Lindahl JR. Dismantling Mindfulness-Based Cognitive Therapy: Creation and validation of 8-week focused attention and open monitoring interventions within a 3-armed randomized controlled trial. Behav Res Ther. 2018 Feb;101:92-107. doi: 10.1016/j.brat.2017.09.010. Epub 2017 Sep 28.
PubMed 29106898
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dismantling Mindfulness: Contributions of Attention vs. Acceptance
- ClinicalTrials.gov ID
- NCT01831362
- Acronym / sponsor ID
- K23AT006328-01A1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- 15 Mar 2016 (actual)
- Study completion
- 15 Mar 2016 (actual)
- First posted
- 15 Apr 2013 (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 study addresses NCCAM's request for research that investigates the neuropsychological mechanisms underlying mind-body therapies, and for precise criteria and better delineation of meditation practices.
The purpose of this study is to assess the clinical efficacy and mechanism of action of 2 component practices of "mindfulness meditation", i.e. focused awareness (FA) and open monitoring (OM) in comparison to each other and to the standard package, Mindfulness-Based Cognitive Therapy (MBCT).
Detailed description
Meditation, particularly mindfulness meditation, is one of the most popular Complementary and Alternative Medicine (CAM) therapies for alleviating emotional stress, depression and anxiety. While standardized meditation-based treatment packages like Mindfulness Based Stress Reduction (MBSR) and Mindfulness-based Cognitive Therapy (MBCT) have reliably shown sustained improvements in emotional disturbances and wellbeing, they contain so many different components and practices that the active ingredient cannot be ascertained. What is commonly called "Mindfulness" meditation is actually comprised of two separate practices: 1) focused awareness practice (FA), and 2) open-monitoring practice (OM). This project aims to create separate 8 week programs for FA and OM meditations, compare their clinical efficacy and investigate their separate mechanisms of action in individuals with clinically significant levels of persistent negative affect and depression. The clinical benefit and mechanism of action of focused awareness (FA) vs open-monitoring (OM) vs MBCT will be examined with a 3-armed randomized control trial of these 8 week interventions. Outcome variables include negative affect (depression, anxiety, stress) and wellbeing. Hypothesized mediating processes include objectively measured attention, emotion regulation and the basic wakefulness on which they depend.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Focused Attention (FA) | Experimental | Behavioral: Focused Attention (FA)This 8 week program consists solely of focused attention practices, i.e. selected attention to an object (breath etc) and deselection of other stimuli |
| Open-Monitoring (OM) | Experimental | Behavioral: Open- MonitoringThis 8-week program consists solely of open monitoring practices, or noticing and/or labeling the contents of ongoing experience ( thoughts, body sensations, emotions, seeing, hearing etc) without focusing on or deselecting any stimuli |
| Mindfulness-Based Cognitive Therapy (MBCT) | Experimental | Behavioral: Mindfulness-Based Cognitive TherapyThe 8 week MBCT program follows the 2nd Edition (2012) manual (Segal, Williams, Teasdale) and includes both focused attention and open- monitoring practices |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English-speaking
- ages 18-65
- mild-severe levels of depression or high level of negative affect
Key exclusion criteria (19 listed)
- Current:
- bipolar disorder
- psychotic disorders
- persistent antisocial behavior or repeated self-harm,
- borderline personality disorder,
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 Therapy | Behavioural | Mindfulness-Based Cognitive Therapy (MBCT) |
| Focused Attention (FA) | Behavioural | Focused Attention (FA) |
| Open- Monitoring | Behavioural | Open-Monitoring (OM) |
Primary outcome
Change in Inventory of Depressive Symptomatology
Time frame: baseline, 8 weeks, 20 weeks
30-item clinician administered interview about unipolar depression symptoms
change in Depression, Anxiety Stress Scale (DASS)
Time frame: baseline, week 2,4,6,8, 20
42-item self-report questionnaire on depression, anxiety and stress symptoms
change in Wellbeing Scale (WBS)
Time frame: baseline, 8 weeks, 20 weeks
73-item self-report questionnaire of psychological wellbeing
5 secondary outcomes
Change in alpha-theta EEG power from baseline to 8 weeks
Time frame: baseline and 8 weeks
Change in Facial EMG power from baseline to 8 weeks
Time frame: baseline and 8 weeks
Sustained Attention to response Task (SART)
Time frame: baseline, 8 weeks
Difficulties in Emotion Regulation Scale (DERS)
Time frame: baseline, 8 weeks, 20 weeks
Attention Control Questionnaire (Derryberry & Reed, 2002)
Time frame: baseline, 8 weeks, 20 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 Nov 2018.
- Derived from this study: PubMed 33434227Cullen B, Eichel K, Lindahl JR, Rahrig H, Kini N, Flahive J, Britton WB. The contributions of focused attention and open monitoring in mindfulness-based cognitive therapy for affective disturbances: A 3-armed randomized dismantling trial. PLoS One. 2021 Jan 12;16(1):e0244838. doi: 10.1371/journal.pone.0244838. eCollection 2021.
- Derived from this study: PubMed 33038188Canby NK, Eichel K, Peters SI, Rahrig H, Britton WB. Predictors of Out-of-Class Mindfulness Practice Adherence During and After a Mindfulness-Based Intervention. Psychosom Med. 2021 Jul-Aug 01;83(6):655-664. doi: 10.1097/PSY.0000000000000873.
- Derived from this study: PubMed 29106898Britton WB, Davis JH, Loucks EB, Peterson B, Cullen BH, Reuter L, Rando A, Rahrig H, Lipsky J, Lindahl JR. Dismantling Mindfulness-Based Cognitive Therapy: Creation and validation of 8-week focused attention and open monitoring interventions within a 3-armed randomized controlled trial. Behav Res Ther. 2018 Feb;101:92-107. doi: 10.1016/j.brat.2017.09.010. Epub 2017 Sep 28.
- Brown University's Clinical and Affective Neuroscience LaboratoryLink provided by the sponsor.
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, Focused Attention (FA) and Open- Monitoring in people with Mild-moderate Unipolar Depression; Persistent Negative Affect, run by Brown University at 1 site in United States.
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 3 inclusion and 19 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 Nov 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 States. 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 Inventory of Depressive Symptomatology (time frame: baseline, 8 weeks, 20 weeks). The study lists 3 primary outcomes in all. 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 NCT01831362, which also lists 3 linked publications.
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 Nov 2018.