N/A
N=136
Integrating Mindfulness Into the Patient-Centered Medical Home (Phase 2)
Depression · Anxiety · Stress Related Disorder · Adjustment Disorders
Bottom Line
View on ClinicalTrials.gov: NCT03265600 ↗Enrolled (actual)
136
Serious AEs
2.9%
Results posted
Dec 2019
Primary outcome: Primary: Action Plan Initiation Survey (APIS-5) — 53; 14 Participants — p=0.006
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mindfulness Training for Primary Care (Behavioral); 60-minute Introduction to Mindfulness (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cambridge Health Alliance
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Action Plan Initiation Survey (APIS-5) |
53; 14 | 0.006 sig |
| PRIMARY Perceived Stress Scale |
25.0; 24.3; 19.9; 20.9 | 0.19 |
| PRIMARY Patient Reported Outcomes Measurement Information System - Anxiety Short Form (PROMIS-ASF) |
63.9; 61.9; 58.5; 58.9 | 0.12 |
| PRIMARY Patient Reported Outcomes Measurement Information System - Depression Short Form (PROMIS-DSF) |
59.2; 58.0; 53.9; 55.6 | 0.08 |
| SECONDARY Five Facet Mindfulness Questionnaire (FFMQ) |
115.8; 115.6; 132.0; 119.4 | <0.001 sig |
| SECONDARY Self-Compassion Scale-Short Form (SCS-SF) |
2.6; 2.6; 3.1; 2.8 | 0.03 sig |
| SECONDARY Change in Self-Efficacy for Managing Chronic Disease (SECD-6) |
6.1; 6.2; 6.7; 6.5 | 0.31 |
| SECONDARY Perceived Control Questionnaire (PCQ) |
23.5; 23.0; 25.3; 23.8 | 0.26 |
| SECONDARY Difficulty in Emotion Regulation Scale (DERS) |
76.1; 72.2; 60.2; 68.8 | <0.001 sig |
| SECONDARY Multidimensional Assessment of Interoceptive Awareness (MAIA) |
2.4; 2.5; 3.1; 2.6 | <0.001 sig |
Summary
Among primary care patients, compare the effectiveness of an 8-week mindfulness-based intervention (Mindfulness Training for Primary Care[MTPC]) vs. a low-dose mindfulness introduction comparator on self-management of chronic illness and illness-related health behavior action plan initiation, as well as on measures related to anxiety, depression, and stress.
Eligibility Criteria
Inclusion Criteria
- 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.).
Exclusion Criteria
- 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT03265600). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.