An interventional study of Mindfulness Training for Primary Care and Mindfulness Intro. +resources +waitlist in Depression, Anxiety and Stress Related Disorder, sponsored by Cambridge Health Alliance. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-12.
Sponsored by Cambridge Health Alliance · Not applicable, Interventional, and Treatment
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.
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).
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's enrollment of 87 is close to the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →Cambridge Health Alliance is the lead sponsor of 52 studies on the registry; 10 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
• 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.
Behavioral: Mindfulness Training for Primary Care
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.
Behavioral: Mindfulness Intro. +resources +waitlist
• 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.
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.
Also known as: 6-month waitlist
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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Week 8
Action Plan Assessment (APA-10)
Action Plan Assessment (APA-10) (10 items) - this is a questionnaire to be completed after the PCP Visit, at PT Study Week 6. This 10-item scale evaluates patient behavior in the domains of self-determination, motivation, shared decision-making, and barrier appraisal. Participants are asked to rate their agreement with a statement on a 7-point scale from 1 (Strongly Disagree) to 7 (Strongly Agree).
Time frame: Week 6
Action Plan Follow-Up Interviews
Action Plan Follow-Up Interviews will be conducted by a blinded member of the MINDFUL-PC study staff at Follow-Up (6-months post-baseline). This staff member will contact patients after 6 months to ask about the status of the specific primary behavior focused on in the action plan. Staff members will rate patient behavior on a scale from -1 (Behavior is worse than baseline) to 3 (Behavior has exceeded the original expectations and other health behaviors have also improved).
Time frame: Week 24
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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