DepressionMINDFUL-PCNCT02972203
MINDFUL-PC: Integrating Mindfulness Into the Patient-Centered Medical Home
A study testing Mindfulness Training for Primary Care and Mindfulness Intro. +resources +waitlist in people with Depression and Anxiety, run by Cambridge Health Alliance at 1 site in United States.
Trial summary
Specific aims for this pilot study are: (Behavioral health outcomes aim): Among primary care patients, compare the effectiveness of an 8-week mindfulness-based intervention (Mindfulness Training for Primary Care[MTPC]) vs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety, Stress Related Disorder
- What is being tested?
- Mindfulness Training for Primary Care and Mindfulness Intro. +resources +waitlist
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to 30 Aug 2018
- 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, or adjustment disorder related to chronic illness, pain, etc.).
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
- Lack of insurance coverage for group psychotherapy may preclude 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 Center for Mindfulness and Compassion
Somerville, Massachusetts, 02143
About this study
Official title: MINDFUL-PC: Integrating Mindfulness Into the Patient-Centered Medical Home - A Pilot Study
Specific aims for this pilot study are:
(Behavioral health outcomes aim): Among primary care patients, compare the effectiveness of an 8-week mindfulness-based intervention (Mindfulness Training for Primary Care[MTPC]) vs. a 60-minute introduction to mindfulness plus referral to community resources on measures related to anxiety, depression, and stress, and self-management of chronic illness.
Read more
(Medical Regimen Adherence Aim): Among primary care patients, compare the effectiveness of MTPC vs. 60-minute introduction to mindfulness on the initiation and maintenance of an action plan.
(Patient-Provider Relationship Aim): To examine the effects of level of primary care provider mindfulness training on successful referral to program, patient-provider relationship measures, and on patient action plan initiation and maintenance.
Read the detailed description
This project aims evaluate the integration of mindfulness training into the heart of the standard healthcare delivery system.
The investigators and collaborators have developed an 8-week mindfulness-based intervention for primary care called Mindfulness Training for Primary Care (MTPC). MTPC combines common Mindfulness-Based Intervention skills with additional attention to patient/provider relationships, cultural and socio-economic diversity, coping with chronic illness, reducing unnecessary medical care, and encouraging self-management skills acquisition.
This project addresses important gaps in the current mindfulness research and delivery system by evaluating the integration of the novel MTPC model into a system of urban, community, multi-cultural, safety-net Patient-Centered Medical Homes.
In this pilot randomized controlled trial, the investigators compare the effectiveness of 8-week MTPC versus a 60-minute introduction to mindfulness plus referral to community mindfulness resources for primary care patients on behavioral health outcomes of anxiety, depression, stress, and self-management of chronic illness. The investigators are also testing the effect of MTPC on rates of initiation and maintenance of health action plans that patients collaborate on with their primary care provider during study Week 6 . This study also enrolls primary care providers who have participated in various levels of mindfulness training, i.e., 16-hour and 8-week mindfulness-based stress reduction and 10-month mindful communication vs. no training.
Outcome assessments are conducted at baseline and study week 8. An action-planning visit with PCPs occurs at week 6 with follow-up during week 8 (initiation) and interview at study week 24 (maintenance).
- Conditions
- Depression, Anxiety, Stress Related Disorder, Adjustment Disorder
- Being tested
- Mindfulness Training for Primary Care, Mindfulness Intro. +resources +waitlist
- Keywords
- Mindfulness, primary care, self-control, self-regulation, adherence
- Medical subject headings
- Depression, Anxiety Disorders, Adjustment Disorders, Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Training for Primary CareBehavioural
- MPTC is a primary care adaptation that includes core common Mindfulness-Based Intervention (MBI) elements. MTPC is a referral-based, insurance-reimbursable 8-week group psychotherapy delivered primarily by Patient-Centered Medical Home-integrated behavioral clinicians. MTPC groups are 2 hours long for 8 weeks, with a 7-hour day of silent group practice on a weekend. MTPC also emphasizes psychoeducational skills for self-regulation including a collaborative primary care provider (PCP) action-planning appointment during week 6.
Mindfulness Intro. +resources +waitlistBehavioural
Also called 6-month waitlist
Control 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 waitlist for a Cambridge Health Alliance mindfulness-based intervention group. All participants are scheduled to meet with their primary care provider during week 6 for a collaborative action planning visit.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Training for Primary Care | Experimental | • Mindfulness Training for Primary Care (MPTC) is a primary care adaptation that includes core common Mindfulness-Based Intervention (MBI) elements. MTPC is a referral-based, insurance-reimbursable 8-week group psychotherapy delivered primarily by Patient-Centered Medical Home-integrated behavioral clinicians. MTPC groups are 2 hours long for 8 weeks, with a 7-hour day of silent group practice on a weekend. MTPC also emphasizes psychoeducational skills for self-regulation including a collaborative primary care provider (PCP) action-planning appointment during week 6. Receives: Behavioral: Mindfulness Training for Primary Care |
| Mindfulness Intro. +resources +waitlist | Active comparator | Control 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 waitlist for a Cambridge Health Alliance (CHA) mindfulness-based intervention group. All participants are scheduled to meet with their primary care provider during week 6 for a collaborative action planning visit. Receives: Behavioral: Mindfulness Intro. +resources +waitlist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Perceived Stress Scale
The Perceived Stress Scale (PSS) (10 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
Change in 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). Ratings from baseline will be compared to ratings from 8 Weeks post-baseline.
Measured: Week 8
Change in 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). Ratings from baseline will be compared to ratings from 8 Weeks post-baseline.
Measured: Week 8
Change in 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
Action Plan Initiation Survey (APIS-5)
Patient self-reported Action Plan Initiation Survey (APIS-5) will be administered at post-treatment (PT Study Week 8). This 5-item questionnaire is adapted from a measure used by Guck et al. In this questionnaire, patients are asked to list their action plan goals generated with their PCP, and determine whether they met or did not meet each goal. For each unmet goal, patients are asked to rate the cause of not meeting the goal on an attributional rating scale using a 7-point format.
Measured: Week 8
Secondary outcomes (6)
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
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.
Measured: Week 8
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.
Measured: Week 8
Perceived Control Questionnaire (PCQ)
The Perceived Control Questionnaire (PCQ) is adapted from a 5-item perceived control measure from Jerant et al. and a previously validated survey from Armitage et al. This 5-item scale asks participants to rate their sense of control over chronic illness self-management on a 7-point scale from 1 (None) to 7 (Total).
Measured: Week 8
Patient Activation Measure (PAM)
The Patient Activation Measure (PAM) is a 13-item scale that is designed to evaluate a participant's ability to be an effective and informed manager of his or her own health and health care. Participants are asked to rate their agreement with each statement on a 0-100 metric where 0 = the lowest possible activation and 100 = the highest possible activation as measured by this set of items.
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2016 (estimated)
- Study startOct 2015
- Primary completion30 Aug 2018
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)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
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge Health Alliance
- Sponsor type
- University, hospital or other
- Collaborators
- The Arthur Vining Davis Foundations, The Arnold P. Gold Foundation
- Responsible party
- Principal investigator, Zev Schuman Olivier, Cambridge Health Alliance
- Investigators
- Zev D Schuman-Olivier, MD, MD, Principal investigator, Cambridge Health Alliance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02972203
- Sponsor's protocol ID
- IRB number: CHA-IRB-1002/08/14
- Acronym
- MINDFUL-PC
- Status last verified
- Dec 2018
- First submitted
- 4 Nov 2016
- Last updated
- 12 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Mccubbin 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 25662520Merkes M. Mindfulness-based stress reduction for people with chronic diseases. Aust J Prim Health. 2010;16(3):200-10. doi: 10.1071/PY09063.
PubMed 20815988Goyal M, Singh S, Sibinga EM, Gould NF, Rowland-Seymour A, Sharma R, Berger Z, Sleicher D, Maron DD, Shihab HM, Ranasinghe PD, Linn S, Saha S, Bass EB, Haythornthwaite JA. Meditation programs for psychological stress and well-being: a systematic review and meta-analysis. JAMA Intern Med. 2014 Mar;174(3):357-68. doi: 10.1001/jamainternmed.2013.13018.
PubMed 24395196Hofmann SG, Sawyer AT, Witt AA, Oh D. The effect of mindfulness-based therapy on anxiety and depression: A meta-analytic review. J Consult Clin Psychol. 2010 Apr;78(2):169-83. doi: 10.1037/a0018555.
PubMed 20350028Chiesa A, Serretti A. Mindfulness based cognitive therapy for psychiatric disorders: a systematic review and meta-analysis. Psychiatry Res. 2011 May 30;187(3):441-53. doi: 10.1016/j.psychres.2010.08.011. Epub 2010 Sep 16.
PubMed 20846726Holzel 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 26168376Lorig KR, Sobel DS, Ritter PL, Laurent D, Hobbs M. Effect of a self-management program on patients with chronic disease. Eff Clin Pract. 2001 Nov-Dec;4(6):256-62.
PubMed 11769298Schuman-Olivier Z, Hoeppner BB, Evins AE, Brewer JA. Finding the right match: mindfulness training may potentiate the therapeutic effect of nonjudgment of inner experience on smoking cessation. Subst Use Misuse. 2014 Apr;49(5):586-94. doi: 10.3109/10826084.2014.850254.
PubMed 24611853Alegria M, Sribney W, Perez D, Laderman M, Keefe K. The role of patient activation on patient-provider communication and quality of care for US and foreign born Latino patients. J Gen Intern Med. 2009 Nov;24 Suppl 3(Suppl 3):534-41. doi: 10.1007/s11606-009-1074-x.
PubMed 19842003Neff KD, Germer CK. A pilot study and randomized controlled trial of the mindful self-compassion program. J Clin Psychol. 2013 Jan;69(1):28-44. doi: 10.1002/jclp.21923. Epub 2012 Oct 15.
PubMed 23070875Wiegner L, Hange D, Bjorkelund C, Ahlborg G Jr. Prevalence of perceived stress and associations to symptoms of exhaustion, depression and anxiety in a working age population seeking primary care--an observational study. BMC Fam Pract. 2015 Mar 19;16:38. doi: 10.1186/s12875-015-0252-7.
PubMed 25880219Benzo RP. Mindfulness and motivational interviewing: two candidate methods for promoting self-management. Chron Respir Dis. 2013 Aug;10(3):175-82. doi: 10.1177/1479972313497372.
PubMed 23897933
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MINDFUL-PC: Integrating Mindfulness Into the Patient-Centered Medical Home - A Pilot Study
- ClinicalTrials.gov ID
- NCT02972203
- Acronym / sponsor ID
- MINDFUL-PC / IRB number: CHA-IRB-1002/08/14
- Conditions
- Depression, Anxiety, Stress Related Disorder, Adjustment Disorder
- Keywords
- Mindfulness, primary care, self-control, self-regulation, adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Cambridge Health AllianceUniversity, hospital or other
- Collaborators
- The Arthur Vining Davis Foundations, The Arnold P. Gold Foundation
- Study start
- Oct 2015 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 23 Nov 2016 (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.
Specific aims for this pilot study are:
(Behavioral health outcomes aim): Among primary care patients, compare the effectiveness of an 8-week mindfulness-based intervention (Mindfulness Training for Primary Care[MTPC]) vs. a 60-minute introduction to mindfulness plus referral to community resources on measures related to anxiety, depression, and stress, and self-management of chronic illness.
(Medical Regimen Adherence Aim): Among primary care patients, compare the effectiveness of MTPC vs. 60-minute introduction to mindfulness on the initiation and maintenance of an action plan.
(Patient-Provider Relationship Aim): To examine the effects of level of primary care provider mindfulness training on successful referral to program, patient-provider relationship measures, and on patient action plan initiation and maintenance.
Detailed description
This project aims evaluate the integration of mindfulness training into the heart of the standard healthcare delivery system.
The investigators and collaborators have developed an 8-week mindfulness-based intervention for primary care called Mindfulness Training for Primary Care (MTPC). MTPC combines common Mindfulness-Based Intervention skills with additional attention to patient/provider relationships, cultural and socio-economic diversity, coping with chronic illness, reducing unnecessary medical care, and encouraging self-management skills acquisition.
This project addresses important gaps in the current mindfulness research and delivery system by evaluating the integration of the novel MTPC model into a system of urban, community, multi-cultural, safety-net Patient-Centered Medical Homes.
In this pilot randomized controlled trial, the investigators compare the effectiveness of 8-week MTPC versus a 60-minute introduction to mindfulness plus referral to community mindfulness resources for primary care patients on behavioral health outcomes of anxiety, depression, stress, and self-management of chronic illness. The investigators are also testing the effect of MTPC on rates of initiation and maintenance of health action plans that patients collaborate on with their primary care provider during study Week 6 . This study also enrolls primary care providers who have participated in various levels of mindfulness training, i.e., 16-hour and 8-week mindfulness-based stress reduction and 10-month mindful communication vs. no training.
Outcome assessments are conducted at baseline and study week 8. An action-planning visit with PCPs occurs at week 6 with follow-up during week 8 (initiation) and interview at study week 24 (maintenance).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Training for Primary Care | Experimental | Behavioral: Mindfulness Training for Primary Care• Mindfulness Training for Primary Care (MPTC) is a primary care adaptation that includes core common Mindfulness-Based Intervention (MBI) elements. MTPC is a referral-based, insurance-reimbursable 8-week group psychotherapy delivered primarily by Patient-Centered Medical Home-integrated behavioral clinicians. MTPC groups are 2 hours long for 8 weeks, with a 7-hour day of silent group practice on a weekend. MTPC also emphasizes psychoeducational skills for self-regulation including a collaborative primary care provider (PCP) action-planning appointment during week 6. |
| Mindfulness Intro. +resources +waitlist | Active comparator | Behavioral: Mindfulness Intro. +resources +waitlistControl 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 waitlist for a Cambridge Health Alliance (CHA) mindfulness-based intervention group. All participants are scheduled to meet with their primary care provider during week 6 for a collaborative action planning visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 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, or adjustment disorder related to chronic illness, pain, 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 Care• MPTC is a primary care adaptation that includes core common Mindfulness-Based Intervention (MBI) elements. MTPC is a referral-based, insurance-reimbursable 8-week group psychotherapy delivered primarily by Patient-Centered Medical Home-integrated behavioral clinicians. MTPC groups are 2 hours long for 8 weeks, with a 7-hour day of silent group practice on a weekend. MTPC also emphasizes psychoeducational skills for self-regulation including a collaborative primary care provider (PCP) action-planning appointment during week 6. | Behavioural | Mindfulness Training for Primary Care |
| Mindfulness Intro. +resources +waitlistAlso: 6-month waitlistControl 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 waitlist for a Cambridge Health Alliance mindfulness-based intervention group. All participants are scheduled to meet with their primary care provider during week 6 for a collaborative action planning visit. | Behavioural | Mindfulness Intro. +resources +waitlist |
Primary outcome
Change in Perceived Stress Scale
Time frame: Week 8
The Perceived Stress Scale (PSS) (10 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).
Change in Patient Reported Outcomes Measurement Information System - Anxiety Short Form (PROMIS-ASF)
Time frame: Week 8
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). Ratings from baseline will be compared to ratings from 8 Weeks post-baseline.
Change in Patient Reported Outcomes Measurement Information System - Depression Short Form (PROMIS-DSF)
Time frame: Week 8
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). Ratings from baseline will be compared to ratings from 8 Weeks post-baseline.
Change in Self-Efficacy for Managing Chronic Disease (SECD-6)
Time frame: Week 8
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).
Action Plan Initiation Survey (APIS-5)
Time frame: Week 8
Patient self-reported Action Plan Initiation Survey (APIS-5) will be administered at post-treatment (PT Study Week 8). This 5-item questionnaire is adapted from a measure used by Guck et al. In this questionnaire, patients are asked to list their action plan goals generated with their PCP, and determine whether they met or did not meet each goal. For each unmet goal, patients are asked to rate the cause of not meeting the goal on an attributional rating scale using a 7-point format.
6 secondary outcomes
Five Facet Mindfulness Questionnaire (FFMQ)
Time frame: Week 8
Self-Compassion Scale-Short Form (SCS-SF)
Time frame: Week 8
Difficulty in Emotion Regulation Scale (DERS)
Time frame: Week 8
Multidimensional Assessment of Interoceptive Awareness (MAIA)
Time frame: Week 8
Perceived Control Questionnaire (PCQ)
Time frame: Week 8
Patient Activation Measure (PAM)
Time frame: Week 8
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 12 Dec 2018.
- 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 20815988Merkes M. Mindfulness-based stress reduction for people with chronic diseases. Aust J Prim Health. 2010;16(3):200-10. doi: 10.1071/PY09063.
- Background: PubMed 24395196Goyal M, Singh S, Sibinga EM, Gould NF, Rowland-Seymour A, Sharma R, Berger Z, Sleicher D, Maron DD, Shihab HM, Ranasinghe PD, Linn S, Saha S, Bass EB, Haythornthwaite JA. Meditation programs for psychological stress and well-being: a systematic review and meta-analysis. JAMA Intern Med. 2014 Mar;174(3):357-68. doi: 10.1001/jamainternmed.2013.13018.
- Background: PubMed 20350028Hofmann SG, Sawyer AT, Witt AA, Oh D. The effect of mindfulness-based therapy on anxiety and depression: A meta-analytic review. J Consult Clin Psychol. 2010 Apr;78(2):169-83. doi: 10.1037/a0018555.
- Background: PubMed 20846726Chiesa A, Serretti A. Mindfulness based cognitive therapy for psychiatric disorders: a systematic review and meta-analysis. Psychiatry Res. 2011 May 30;187(3):441-53. doi: 10.1016/j.psychres.2010.08.011. Epub 2010 Sep 16.
- 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 11769298Lorig KR, Sobel DS, Ritter PL, Laurent D, Hobbs M. Effect of a self-management program on patients with chronic disease. Eff Clin Pract. 2001 Nov-Dec;4(6):256-62.
- Background: PubMed 24611853Schuman-Olivier Z, Hoeppner BB, Evins AE, Brewer JA. Finding the right match: mindfulness training may potentiate the therapeutic effect of nonjudgment of inner experience on smoking cessation. Subst Use Misuse. 2014 Apr;49(5):586-94. doi: 10.3109/10826084.2014.850254.
- Background: PubMed 19842003Alegria M, Sribney W, Perez D, Laderman M, Keefe K. The role of patient activation on patient-provider communication and quality of care for US and foreign born Latino patients. J Gen Intern Med. 2009 Nov;24 Suppl 3(Suppl 3):534-41. doi: 10.1007/s11606-009-1074-x.
- Background: PubMed 23070875Neff KD, Germer CK. A pilot study and randomized controlled trial of the mindful self-compassion program. J Clin Psychol. 2013 Jan;69(1):28-44. doi: 10.1002/jclp.21923. Epub 2012 Oct 15.
- Background: PubMed 25880219Wiegner L, Hange D, Bjorkelund C, Ahlborg G Jr. Prevalence of perceived stress and associations to symptoms of exhaustion, depression and anxiety in a working age population seeking primary care--an observational study. BMC Fam Pract. 2015 Mar 19;16:38. doi: 10.1186/s12875-015-0252-7.
- Background: PubMed 23897933Benzo RP. Mindfulness and motivational interviewing: two candidate methods for promoting self-management. Chron Respir Dis. 2013 Aug;10(3):175-82. doi: 10.1177/1479972313497372.
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Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
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 D Schuman-Olivier, MD, 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 Mindfulness Intro. +resources +waitlist in people with Depression and Anxiety, 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 5 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: finished, as of the sponsor's last update on 12 Dec 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 Perceived Stress Scale (time frame: Week 8). The study lists 5 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 NCT02972203, which also lists 12 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 12 Dec 2018.