DepressionMINDFUL-PC-3NCT03609450
Integrating Mindfulness Into the Patient-Centered Medical Home (Phase 3)
A study testing Mindfulness Training for Primary Care and Low-Dose Comparator in people with Depression and Anxiety Disorders, run by Cambridge Health Alliance at 1 site in United States.
Trial summary
This study compares the effectiveness of an 8-week mindfulness-based intervention (Mindfulness Training for Primary Care[MTPC]) vs. a low-dose mindfulness comparator on self-regulation targets, specifically the primary outcome of emotion regulation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety Disorders, Stress Related Disorder
- What is being tested?
- Mindfulness Training for Primary Care and Low-Dose Comparator
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2019to 1 Aug 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current CHA patient with an enrolled CHA primary care doctor.
- CHA patients 18 years of age and older.
- Able to tolerate and participate in interviews and engage in all procedures.
- Able to give written consent in English OR willing and able to provide consent and complete assessments through a professional language translator when necessary.
- Diagnosis eligible to be covered by insurance for group visits (e.g., anxiety disorder, depression, stress disorders including adjustment disorder related to chronic illness, pain, insomnia, etc.).
- Must have access to a smartphone that is compatible with the activity tracker application.
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- Must be willing to use the smartphone application and/or wear a wristband device every day during the study collection periods
- Must be able to fill out the study questionnaires daily on a computer or compatible mobile device.
- Must be willing to attend the two computer task sessions.
Who cannot join
- Any cognitive impairment that precludes informed consent.
- Patients who, in the opinion of the Principal Investigator, pose an imminent risk of suicide or danger to self or others.
- Likelihood of potential incarceration such as a conviction or pending charges that may potentially result in imprisonment.
- Previous enrollment or randomization of treatment in the present study within the 12 months.
- Behaviors that may cause disruption to a mindfulness group.
- Patients with symptoms of psychosis, thought disorder, and/or severe mental illness, including schizophrenia, schizoaffective, bipolar disorder, or a current severe episode of major depressive disorder.
Show all 9Show fewer
- Refusal of insurance to cover group psychotherapy treatment may lead to exclusion from participation in groups.
- Patients in their third trimester of pregnancy who foresee conflicts that preclude their commitment to completing all activities.
- Patients with highly unstable medical problems that put them at a high risk of hospitalization.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cambridge Health Alliance
Somerville, Massachusetts, 02143
About this study
Official title: Mindfulness Influences on Self-regulation: Mental and Physical Health Implications -- Integrating Mindfulness Into the Patient-Centered Medical Home (Phase 3)
This study compares the effectiveness of an 8-week mindfulness-based intervention (Mindfulness Training for Primary Care[MTPC]) vs. a low-dose mindfulness comparator on self-regulation targets, specifically the primary outcome of emotion regulation. Secondary outcomes include sustained attention/response inhibition and interoceptive awareness. A secondary analysis will investigate the extent to which these self-regulation targets mediate the impact of MTPC group on action plan initiation.
Read the detailed description
The current Phase 3 comparative effectiveness randomized controlled trial examines impact of MTPC on specific mechanisms of change such as emotion regulation (primary outcome), interoceptive awareness and sustained attention/response inhibition (secondary outcomes). This study will also investigate the extent to which these self-regulation targets mediate the impact of MTPC group on action plan initiation. Participants randomized to 8-week MTPC are compared with participants randomized to a low-dose mindfulness comparator condition, in which they receive a 1-hour introduction to mindfulness with a referral to community mindfulness resources. Outcome assessments are conducted at baseline and study weeks 8-10. This study builds on the Phase 2 study, which demonstrated that Mindfulness Training for Primary Care enhanced chronic illness self-management action plan initiation among primary care patients receiving care in an urban, community, multi-cultural safety net healthcare system.
- Conditions
- Depression, Anxiety Disorders, Stress Related Disorder, Adjustment Disorders, Chronic Illness
- Being tested
- Mindfulness Training for Primary Care, Low-Dose Comparator
- Medical subject headings
- Depression, Anxiety Disorders, Adjustment Disorders, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Training for Primary CareBehavioural
MTPC is a referral-based, insurance-reimbursable 8-week program delivered as group psychotherapy by Patient-Centered Medical Home-integrated behavioral clinicians or as an 8-week primary care group visit delivered by a primary care provider. MTPC groups are 2 hours for 8 weeks with a 7-hour weekend day of silent practice. MTPC emphasizes mindfulness-oriented skills for self-regulation, self-management of chronic illness, and health behavior change. All participants complete an action plan during Week 7. Participants are called every two weeks for the first eight weeks for 5-10 minute engagement calls which focus helping participants cultivate a relationship with study staff, giving participants a place to ask questions, and supporting participants in completing study visits.
Low-Dose ComparatorBehavioural
Participants in the low-dose comparator arm receive a 60-minute introduction to mindfulness. Participants are introduced to the definition(s) of mindfulness, brief mindfulness practices, and discussion. They are also given a list of leading community, online, print, and smartphone mindfulness resources. Participants are called every two weeks for the first eight weeks for 5-10 minute engagement calls which focus helping participants cultivate a relationship with study staff, giving participants a place to ask questions, and supporting participants in completing study visits.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Training for Primary Care | Active comparator | Mindfulness Training for Primary Care (MTPC) is a primary care adaptation that includes core common Mindfulness-Based Intervention (MBI) elements integrated with novel mindfulness-oriented behavior change elements into a format that is adaptable to delivery in primary care health centers. Receives: Behavioral: Mindfulness Training for Primary Care |
| Low-Dose Comparator | Other | Comparator arm: Participants receive a 60-minute introduction to mindfulness group plus referral to a list of community mindfulness resources such as private-pay community mindfulness classes, mobile mindfulness applications, books, and online recordings. These participants are added to a 6-month wait-list for a Cambridge Health Alliance mindfulness-based intervention group, but are allowed to receive behavioral, psychiatric, and medical treatments that are consistent with treatment as usual. All participants complete an action planning protocol during Week 7. Receives: Behavioral: Low-Dose Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difficulty in Emotion Regulation Scale (DERS)
The Difficulties in Emotion Regulation (DERS) Scale is a 36-item self-report scale designed to assess emotional dysregulation using a 5 point Likert scale. The scale assesses 6 aspects of emotional dysregulation: non-acceptance of emotional responses, difficulties engaging in goal directed behavior, impulse control difficulties, lack of emotional awareness, limited access to emotion regulation strategies, and lack of emotional clarity. Subscales are summed and a lower total score represents a better outcome.
Measured: Week 8
Secondary outcomes (14)
Multidimensional Assessment of Interoceptive Awareness (MAIA)
The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a 32-item self-report scale designed to assess multiple aspects of interoception and interoceptive awareness. The 6 point Likert scale (ranging from 0-6) assesses 8 aspects of interoceptive awareness: noticing, not-distracting, not-worrying, attention regulation, emotional awareness, self-regulation, body listening, and trusting. Subscales are averaged, and a higher total score represents a better outcome.
Measured: Week 8
Sustained Attention to Response Task (SART)
Participants complete a computerized test measuring sustained attention and response inhibition. They are asked to press a key in response to rapidly displayed integers (1-9) and withhold a response to a designated "no-go" integer.
Measured: Week 8
Action Plan Initiation Survey (APIS-5)
Patient self-reported Action Plan Initiation is based on two-item in the APIS-5 self-report survey in which patients are asked to list their action plan SMART goal, if they met the goal and how much control they had over meeting the goal. The main outcome is a single-item response determining whether they met or did not meet the goal using a 7-point Likert scale (ranging from 1-7) with scores >=5 representing self-reported initiation of the goal.
Measured: Weeks 8 - 10
Hypothetical Delay Discounting Task (HDDT)
This is a brief delay discounting task performed on a computer that presents a series of 5 discrete choice questions between delayed larger reward and smaller sooner reward in dollars.
Measured: Week 8
Heart Beat Detection Task (HBDT)
This is a behavioral measure of interoceptive awareness. Participants are asked to count their heartbeat during three varying time intervals ranging from 30 to 60 seconds. In parallel, individuals' heart-rate will be measured by Kardia Mobile technology.
Measured: Week 8
Perceived Stress Scale (PSS-14)
The Perceived Stress Scale (PSS-14) (14 items) measures the degree to which situations in life are stressful. Items are designed to evaluate how overloaded, unpredictable, and uncontrollable one finds one's life. Each item is scored on a 5 point Likert scale from 0 (Never) to 4 (Very often).
Measured: Week 8
Five Facet Mindfulness Questionnaire (FFMQ)
The Five Facet Mindfulness Questionnaire (FFMQ) is a 39-item scale that examines five factors that represent aspects of the current empirical conception of mindfulness. These five facets include: "observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience." Participants rate their degree of agreement with each of the items on a Likert-type scale ranging from 1 (Never or very rarely true) to 5 (Very often or always true), with higher scores indicating higher experience of mindfulness.
Measured: Week 8
Self-Compassion Scale-Short Form (SCS-SF)
The short-form Self-Compassion Scale (SCS-SF) is an abbreviated 12-item form of the original 26-item Self-Compassion Scale. The scale is scored on a 5 point Likert scale (1 = Almost never; 5 = Almost always), and negative subscale items are reverse scored.
Measured: Week 8
Self-Efficacy for Managing Chronic Disease (SECD-6)
The Self-Efficacy for Managing Chronic Disease Scale (SECD-6) is a 6-item scale that is used to evaluate a participant's ability to self-manage care for a chronic disease. SECD-6 asks participants to rate their confidence in their own ability to do certain activities, on a scale from 1 (not at all confident) to 10 (totally confident).
Measured: Week 8
Patient Reported Outcomes Measurement Information System - Anxiety Short Form (PROMIS-ASF)
The Patient Reported Outcomes Measurement Information System - Anxiety Short Form 8a (PROMIS-ASF) is an 8-item scale used to assess patient-reported health status for anxiety. PROMIS instruments are funded by the National Institutes of Health (NIH) and used to reliably and validly measure patient-reported outcomes for clinical research and practice. Participants are asked to rate their experience of the item in the past seven days on a 5-point scale from 1 (Never) to 5 (Always).
Measured: Week 8
Patient Reported Outcomes Measurement Information System - Depression Short Form (PROMIS-DSF)
The Patient Reported Outcomes Measurement Information System - Depression Short Form 8a (PROMIS-DSF) is an 8-item scale used to assess patient-reported health status for depression. PROMIS instruments are funded by the National Institutes of Health (NIH) and used to reliably and validly measure patient-reported outcomes for clinical research and practice. Participants are asked to rate their experience of the item in the past seven days on a 5-point scale from 1 (Never) to 5 (Always).
Measured: Week 8
Three Factor Eating Questionnaire -Revised 18 (TFEQ-R18) emotional eating subscale
The Three Factor Eating Questionnaire is an 18-item scale measuring eating behavior with 4-point Likert scale (1-4). The questionnaire refers to current dietary practice and measures three different aspects of eating-related behavior: cognitive restraint of eating (CR: 6 items), uncontrolled eating (UE: 9 items) and emotional eating (EE: 3 items). Each score ranges from 0 to 100, with higher score and this study is primarily investigating emotional and uncontrolled eating subscales.
indicative of greater level in the eating behavior of interest.
Measured: Week 8
Food, Activity, and Sleep Tracking (FAST) Questionnaire
The Food, Activity, and Sleep Tracking (FAST) is a questionnaire with responsive logic, including up to 45-items. The questionnaire assesses daily sleep behavior, daily activity and exercise, and daily nutritional intake, using validated items from the National Cancer Institute (ASA-24) and National Sleep Foundation Sleep diary. Responses to individual items will be tracked daily and increases in health-promoting activity and decreases in harmful behavior will represent a better outcome.
Measured: Weeks 7-8
Mobile Device Accelerometer-Based Activity
Mobile device activity tracking with accelerometry, measuring overall activity, median daily activity count, and minutes of Moderate-to-Vigorous Physical Activity (MVPA)
Measured: Weeks 7-8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start30 Jan 2019
- Primary completion15 Apr 2020
- Study completion1 Aug 2020
Why it stopped: COVID-19 Pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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
- Model description
- Two arms, intervention and low-dose comparator, which are randomly assigned at the same time and are implemented in parallel.
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge Health Alliance
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Zev Schuman-Olivier, MD, Principal investigator, Cambridge Health Alliance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03609450
- Sponsor's protocol ID
- CHA-IRB-1002/08/14_3
- Other IDs
- UH3AT009145
- Acronym
- MINDFUL-PC-3
- Status last verified
- Nov 2020
- First submitted
- 25 Jul 2018
- Last updated
- 20 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Demarzo MM, Montero-Marin J, Cuijpers P, Zabaleta-del-Olmo E, Mahtani KR, Vellinga A, Vicens C, Lopez-del-Hoyo Y, Garcia-Campayo J. The Efficacy of Mindfulness-Based Interventions in Primary Care: A Meta-Analytic Review. Ann Fam Med. 2015 Nov;13(6):573-82. doi: 10.1370/afm.1863.
PubMed 26553897Loucks EB, Schuman-Olivier Z, Britton WB, Fresco DM, Desbordes G, Brewer JA, Fulwiler C. Mindfulness and Cardiovascular Disease Risk: State of the Evidence, Plausible Mechanisms, and Theoretical Framework. Curr Cardiol Rep. 2015 Dec;17(12):112. doi: 10.1007/s11886-015-0668-7.
PubMed 26482755Guendelman S, Medeiros S, Rampes H. Mindfulness and Emotion Regulation: Insights from Neurobiological, Psychological, and Clinical Studies. Front Psychol. 2017 Mar 6;8:220. doi: 10.3389/fpsyg.2017.00220. eCollection 2017.
PubMed 28321194Farb NA, Anderson AK, Segal ZV. The mindful brain and emotion regulation in mood disorders. Can J Psychiatry. 2012 Feb;57(2):70-7. doi: 10.1177/070674371205700203.
PubMed 22340146Holzel BK, Lazar SW, Gard T, Schuman-Olivier Z, Vago DR, Ott U. How Does Mindfulness Meditation Work? Proposing Mechanisms of Action From a Conceptual and Neural Perspective. Perspect Psychol Sci. 2011 Nov;6(6):537-59. doi: 10.1177/1745691611419671.
PubMed 26168376Mccubbin T, Dimidjian S, Kempe K, Glassey MS, Ross C, Beck A. Mindfulness-based stress reduction in an integrated care delivery system: one-year impacts on patient-centered outcomes and health care utilization. Perm J. 2014 Fall;18(4):4-9. doi: 10.7812/TPP/14-014.
PubMed 25662520Hallion LS, Steinman SA, Tolin DF, Diefenbach GJ. Psychometric Properties of the Difficulties in Emotion Regulation Scale (DERS) and Its Short Forms in Adults With Emotional Disorders. Front Psychol. 2018 Apr 19;9:539. doi: 10.3389/fpsyg.2018.00539. eCollection 2018.
PubMed 29725312Mehling WE, Price C, Daubenmier JJ, Acree M, Bartmess E, Stewart A. The Multidimensional Assessment of Interoceptive Awareness (MAIA). PLoS One. 2012;7(11):e48230. doi: 10.1371/journal.pone.0048230. Epub 2012 Nov 1.
PubMed 23133619Jha AP, Morrison AB, Dainer-Best J, Parker S, Rostrup N, Stanley EA. Minds "at attention": mindfulness training curbs attentional lapses in military cohorts. PLoS One. 2015 Feb 11;10(2):e0116889. doi: 10.1371/journal.pone.0116889. eCollection 2015.
PubMed 25671579Gawande R, To MN, Pine E, Griswold T, Creedon TB, Brunel A, Lozada A, Loucks EB, Schuman-Olivier Z. Mindfulness Training Enhances Self-Regulation and Facilitates Health Behavior Change for Primary Care Patients: a Randomized Controlled Trial. J Gen Intern Med. 2019 Feb;34(2):293-302. doi: 10.1007/s11606-018-4739-5. Epub 2018 Dec 3.
PubMed 30511291Gawande R, Smith L, Comeau A, Creedon TB, Wilson CL, Griswold T, Cook BL, Loucks EB, Schuman-Olivier Z. Impact of warm mindfulness on emotion regulation: A randomized controlled effectiveness trial. Health Psychol. 2023 Oct;42(10):699-711. doi: 10.1037/hea0001303. Epub 2023 Jul 6.
PubMed 37410421
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Influences on Self-regulation: Mental and Physical Health Implications -- Integrating Mindfulness Into the Patient-Centered Medical Home (Phase 3)
- ClinicalTrials.gov ID
- NCT03609450
- Acronym / sponsor ID
- MINDFUL-PC-3 / CHA-IRB-1002/08/14_3
- Conditions
- Depression, Anxiety Disorders, Stress Related Disorder, Adjustment Disorders, Chronic Illness
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 Pandemic
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Cambridge Health AllianceUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 30 Jan 2019 (actual)
- Primary completion
- 15 Apr 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 1 Aug 2018 (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.
This study compares the effectiveness of an 8-week mindfulness-based intervention (Mindfulness Training for Primary Care[MTPC]) vs. a low-dose mindfulness comparator on self-regulation targets, specifically the primary outcome of emotion regulation. Secondary outcomes include sustained attention/response inhibition and interoceptive awareness. A secondary analysis will investigate the extent to which these self-regulation targets mediate the impact of MTPC group on action plan initiation.
Detailed description
The current Phase 3 comparative effectiveness randomized controlled trial examines impact of MTPC on specific mechanisms of change such as emotion regulation (primary outcome), interoceptive awareness and sustained attention/response inhibition (secondary outcomes). This study will also investigate the extent to which these self-regulation targets mediate the impact of MTPC group on action plan initiation. Participants randomized to 8-week MTPC are compared with participants randomized to a low-dose mindfulness comparator condition, in which they receive a 1-hour introduction to mindfulness with a referral to community mindfulness resources. Outcome assessments are conducted at baseline and study weeks 8-10. This study builds on the Phase 2 study, which demonstrated that Mindfulness Training for Primary Care enhanced chronic illness self-management action plan initiation among primary care patients receiving care in an urban, community, multi-cultural safety net healthcare system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two arms, intervention and low-dose comparator, which are randomly assigned at the same time and are implemented in parallel.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Training for Primary Care | Active comparator | Behavioral: Mindfulness Training for Primary CareMindfulness Training for Primary Care (MTPC) is a primary care adaptation that includes core common Mindfulness-Based Intervention (MBI) elements integrated with novel mindfulness-oriented behavior change elements into a format that is adaptable to delivery in primary care health centers. |
| Low-Dose Comparator | Other | Behavioral: Low-Dose ComparatorComparator arm: Participants receive a 60-minute introduction to mindfulness group plus referral to a list of community mindfulness resources such as private-pay community mindfulness classes, mobile mindfulness applications, books, and online recordings. These participants are added to a 6-month wait-list for a Cambridge Health Alliance mindfulness-based intervention group, but are allowed to receive behavioral, psychiatric, and medical treatments that are consistent with treatment as usual. All participants complete an action planning protocol during Week 7. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Current CHA patient with an enrolled CHA primary care doctor.
- CHA patients 18 years of age and older.
- Able to tolerate and participate in interviews and engage in all procedures.
- Able to give written consent in English OR willing and able to provide consent and complete assessments through a professional language translator when necessary.
- Diagnosis eligible to be covered by insurance for group visits (e.g., anxiety disorder, depression, stress disorders including adjustment disorder related to chronic illness, pain, insomnia, etc.).
Key exclusion criteria (9 listed)
- Any cognitive impairment that precludes informed consent.
- Patients who, in the opinion of the Principal Investigator, pose an imminent risk of suicide or danger to self or others.
- Likelihood of potential incarceration such as a conviction or pending charges that may potentially result in imprisonment.
- Previous enrollment or randomization of treatment in the present study within the 12 months.
- Behaviors that may cause disruption to a mindfulness group.
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 Training for Primary CareMTPC is a referral-based, insurance-reimbursable 8-week program delivered as group psychotherapy by Patient-Centered Medical Home-integrated behavioral clinicians or as an 8-week primary care group visit delivered by a primary care provider. MTPC groups are 2 hours for 8 weeks with a 7-hour weekend day of silent practice. MTPC emphasizes mindfulness-oriented skills for self-regulation, self-management of chronic illness, and health behavior change. All participants complete an action plan during Week 7. Participants are called every two weeks for the first eight weeks for 5-10 minute engagement calls which focus helping participants cultivate a relationship with study staff, giving participants a place to ask questions, and supporting participants in completing study visits. | Behavioural | Mindfulness Training for Primary Care |
| Low-Dose ComparatorParticipants in the low-dose comparator arm receive a 60-minute introduction to mindfulness. Participants are introduced to the definition(s) of mindfulness, brief mindfulness practices, and discussion. They are also given a list of leading community, online, print, and smartphone mindfulness resources. Participants are called every two weeks for the first eight weeks for 5-10 minute engagement calls which focus helping participants cultivate a relationship with study staff, giving participants a place to ask questions, and supporting participants in completing study visits. | Behavioural | Low-Dose Comparator |
Primary outcome
Difficulty in Emotion Regulation Scale (DERS)
Time frame: Week 8
The Difficulties in Emotion Regulation (DERS) Scale is a 36-item self-report scale designed to assess emotional dysregulation using a 5 point Likert scale. The scale assesses 6 aspects of emotional dysregulation: non-acceptance of emotional responses, difficulties engaging in goal directed behavior, impulse control difficulties, lack of emotional awareness, limited access to emotion regulation strategies, and lack of emotional clarity. Subscales are summed and a lower total score represents a better outcome.
14 secondary outcomes
Multidimensional Assessment of Interoceptive Awareness (MAIA)
Time frame: Week 8
Sustained Attention to Response Task (SART)
Time frame: Week 8
Action Plan Initiation Survey (APIS-5)
Time frame: Weeks 8 - 10
Hypothetical Delay Discounting Task (HDDT)
Time frame: Week 8
Heart Beat Detection Task (HBDT)
Time frame: Week 8
Perceived Stress Scale (PSS-14)
Time frame: Week 8
Five Facet Mindfulness Questionnaire (FFMQ)
Time frame: Week 8
Self-Compassion Scale-Short Form (SCS-SF)
Time frame: Week 8
Self-Efficacy for Managing Chronic Disease (SECD-6)
Time frame: Week 8
Patient Reported Outcomes Measurement Information System - Anxiety Short Form (PROMIS-ASF)
Time frame: Week 8
Patient Reported Outcomes Measurement Information System - Depression Short Form (PROMIS-DSF)
Time frame: Week 8
Three Factor Eating Questionnaire -Revised 18 (TFEQ-R18) emotional eating subscale
Time frame: Week 8
Food, Activity, and Sleep Tracking (FAST) Questionnaire
Time frame: Weeks 7-8
Mobile Device Accelerometer-Based Activity
Time frame: Weeks 7-8
Results and safety
The study was stopped early (reason given: COVID-19 Pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
- Background: PubMed 26553897Demarzo MM, Montero-Marin J, Cuijpers P, Zabaleta-del-Olmo E, Mahtani KR, Vellinga A, Vicens C, Lopez-del-Hoyo Y, Garcia-Campayo J. The Efficacy of Mindfulness-Based Interventions in Primary Care: A Meta-Analytic Review. Ann Fam Med. 2015 Nov;13(6):573-82. doi: 10.1370/afm.1863.
- Background: PubMed 26482755Loucks EB, Schuman-Olivier Z, Britton WB, Fresco DM, Desbordes G, Brewer JA, Fulwiler C. Mindfulness and Cardiovascular Disease Risk: State of the Evidence, Plausible Mechanisms, and Theoretical Framework. Curr Cardiol Rep. 2015 Dec;17(12):112. doi: 10.1007/s11886-015-0668-7.
- Background: PubMed 28321194Guendelman S, Medeiros S, Rampes H. Mindfulness and Emotion Regulation: Insights from Neurobiological, Psychological, and Clinical Studies. Front Psychol. 2017 Mar 6;8:220. doi: 10.3389/fpsyg.2017.00220. eCollection 2017.
- Background: PubMed 22340146Farb NA, Anderson AK, Segal ZV. The mindful brain and emotion regulation in mood disorders. Can J Psychiatry. 2012 Feb;57(2):70-7. doi: 10.1177/070674371205700203.
- Background: PubMed 26168376Holzel BK, Lazar SW, Gard T, Schuman-Olivier Z, Vago DR, Ott U. How Does Mindfulness Meditation Work? Proposing Mechanisms of Action From a Conceptual and Neural Perspective. Perspect Psychol Sci. 2011 Nov;6(6):537-59. doi: 10.1177/1745691611419671.
- Background: PubMed 25662520Mccubbin T, Dimidjian S, Kempe K, Glassey MS, Ross C, Beck A. Mindfulness-based stress reduction in an integrated care delivery system: one-year impacts on patient-centered outcomes and health care utilization. Perm J. 2014 Fall;18(4):4-9. doi: 10.7812/TPP/14-014.
- Background: PubMed 29725312Hallion LS, Steinman SA, Tolin DF, Diefenbach GJ. Psychometric Properties of the Difficulties in Emotion Regulation Scale (DERS) and Its Short Forms in Adults With Emotional Disorders. Front Psychol. 2018 Apr 19;9:539. doi: 10.3389/fpsyg.2018.00539. eCollection 2018.
- Background: PubMed 23133619Mehling WE, Price C, Daubenmier JJ, Acree M, Bartmess E, Stewart A. The Multidimensional Assessment of Interoceptive Awareness (MAIA). PLoS One. 2012;7(11):e48230. doi: 10.1371/journal.pone.0048230. Epub 2012 Nov 1.
- Background: PubMed 25671579Jha AP, Morrison AB, Dainer-Best J, Parker S, Rostrup N, Stanley EA. Minds "at attention": mindfulness training curbs attentional lapses in military cohorts. PLoS One. 2015 Feb 11;10(2):e0116889. doi: 10.1371/journal.pone.0116889. eCollection 2015.
- Background: PubMed 30511291Gawande R, To MN, Pine E, Griswold T, Creedon TB, Brunel A, Lozada A, Loucks EB, Schuman-Olivier Z. Mindfulness Training Enhances Self-Regulation and Facilitates Health Behavior Change for Primary Care Patients: a Randomized Controlled Trial. J Gen Intern Med. 2019 Feb;34(2):293-302. doi: 10.1007/s11606-018-4739-5. Epub 2018 Dec 3.
- Derived from this study: PubMed 37410421Gawande R, Smith L, Comeau A, Creedon TB, Wilson CL, Griswold T, Cook BL, Loucks EB, Schuman-Olivier Z. Impact of warm mindfulness on emotion regulation: A randomized controlled effectiveness trial. Health Psychol. 2023 Oct;42(10):699-711. doi: 10.1037/hea0001303. Epub 2023 Jul 6.
- 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.
Zev Schuman-Olivier, MD principal investigator
Cambridge Health Alliance
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 Training for Primary Care and Low-Dose Comparator in people with Depression and Anxiety Disorders, run by Cambridge Health Alliance 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 9 inclusion and 9 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: stopped early, as of the sponsor's last update on 20 Nov 2020. 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 was stopped early (reason given: COVID-19 Pandemic). Results are not available in the source record.
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?
Difficulty in Emotion Regulation Scale (DERS) (time frame: Week 8). 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 NCT03609450, which also lists 11 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 20 Nov 2020.