Brief Summary
The proposed IMPOWR Research Center at Montefiore-Einstein (IMPOWR-ME) will create a multidisciplinary and synergistic program of research to test multimodal treatments that address both chronic pain and opioid use disorder. IMPOWR-ME will generate critical knowledge about the effectiveness, implementation, and cost effectiveness of providing Acceptance and Commitment Therapy and/or a care management smartphone app for individuals in primary care-based buprenorphine treatment. Patients with lived experience with chronic pain and/or opioid use disorder, patient and policy advocates, payors, and health system partners will be engaged in all stages of the research. IMPOWR-ME is well-positioned to become a long-lasting hub for stakeholder-engaged research with multidisciplinary senior and early stage investigators focused on reducing overdose through better treatments for OUD and CP.
Brief Title
Randomized Trial of ACT and a Care Management App in Primary Care-based Buprenorphine Treatment
Detailed Description
Chronic pain (CP) and opioid use disorder (OUD) are leading causes of morbidity and mortality in the United States. Despite being commonly comorbid, there is a striking lack of integrated treatments accessible to people in need. This is particularly true for Black and Hispanic individuals living and seeking care in under-resourced settings like The Bronx, New York, one of the poorest and most racially diverse counties in the U.S. Submitted in response to the HEAL Initiative: Integrative Management of Chronic Pain and OUD for Whole Recovery (IMPOWR) (Request For Applications ID: RFA-DA-21-030), the overall goal of this proposal is to create the IMPOWR Research Center at Montefiore/Einstein ("IMPOWR-ME"), in the high-impact county of The Bronx New York. IMPOWR-ME is a synergistic multidisciplinary research center that leverages exceptional research infrastructure in CP and OUD and existing relationships with people living with CP and OUD, advocates, policymakers and payers, and health system stakeholders. The aims of IMPOWR-ME are to: 1) create a robust and sustainable research infrastructure to rigorously test and disseminate integrated and cost-effective evidence-based practices for people with CP and OUD; 2) partner with people with lived experience with CP, OUD, or both, and diverse stakeholders in all stages of the research; and 3) provide opportunities for multidisciplinary early stage investigators to become independent researchers focusing on CP and OUD. This innovative hybrid type 1 effectiveness-implementation trial is proposed to rigorously examine multi-modal evidence-based practices in diverse health care settings and populations of people with comorbid CP and OUD. Specifically, the investigators propose a 2x2 factorial trial to test Acceptance and Commitment Therapy and a care management smartphone app for individuals in primary-care based buprenorphine treatment. Participants will have both CP and OUD or opioid misuse, and specific aims will examine CP, OUD, implementation, and cost-effectiveness outcomes; additional patient-centered outcomes will be driven by people with lived experience. This project improves access to care for Black and Hispanic individuals in under-resourced settings by bringing integrated treatment of CP and OUD to them, and the interventions have high potential for dissemination and sustainability. An innovative program for pilot studies achieves a dual aim of catalyzing stakeholder-driven research and training early stage and new investigators. An exceptional team of investigators and clinical experts focused on CP and OUD, a longstanding history of collaboration with stakeholders and people with lived experience, and a high-impact population make Montefiore-Einstein an ideal site for an IMPOWR research center.
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
718-920-5756
Central Contact Email
heperez@montefiore.org
Central Contact Role
Contact
Central Contact Email
joanna.starrels@einsteinmed.edu
Completion Date
Completion Date Type
Estimated
Conditions
Opioid-use Disorder
Chronic Pain
Eligibility Criteria
Inclusion Criteria:
1. 18 years old or older;
2. English or Spanish proficiency;
3. receiving BUP treatment for OUD for at least 14 days (thus a stabilized BUP dose); and
4. CP with at least moderate pain severity (score greater than or equal to 4 on Pain, Enjoyment of Life and General Activity (PEG) scale). Comorbid psychiatric conditions and use of psychotropic medications will be allowed
Exclusion Criteria:
1. Acute exacerbation of psychiatric conditions precluding the ability to participate in the study (e.g., acute mania, active suicidality/homicidality, psychosis);
2. psychotropic medication changes within the past three months prior to enrollment;
3. CP related to malignancy;
4. received ACT or similar therapeutic intervention in the past;
5. initiated psychotherapy within the past three months;
6. neurocognitive conditions that may prevent participants from accessing telehealth services;
7. current use of a smartphone health platform similar to the Valera app;
8. are unable or unwilling to provide signed consent for participation
1. 18 years old or older;
2. English or Spanish proficiency;
3. receiving BUP treatment for OUD for at least 14 days (thus a stabilized BUP dose); and
4. CP with at least moderate pain severity (score greater than or equal to 4 on Pain, Enjoyment of Life and General Activity (PEG) scale). Comorbid psychiatric conditions and use of psychotropic medications will be allowed
Exclusion Criteria:
1. Acute exacerbation of psychiatric conditions precluding the ability to participate in the study (e.g., acute mania, active suicidality/homicidality, psychosis);
2. psychotropic medication changes within the past three months prior to enrollment;
3. CP related to malignancy;
4. received ACT or similar therapeutic intervention in the past;
5. initiated psychotherapy within the past three months;
6. neurocognitive conditions that may prevent participants from accessing telehealth services;
7. current use of a smartphone health platform similar to the Valera app;
8. are unable or unwilling to provide signed consent for participation
Inclusion Criteria
Inclusion Criteria:
1. 18 years old or older;
2. English or Spanish proficiency;
3. receiving BUP treatment for OUD for at least 14 days (thus a stabilized BUP dose); and
4. CP with at least moderate pain severity (score greater than or equal to 4 on Pain, Enjoyment of Life and General Activity (PEG) scale). Comorbid psychiatric conditions and use of psychotropic medications will be allowed
1. 18 years old or older;
2. English or Spanish proficiency;
3. receiving BUP treatment for OUD for at least 14 days (thus a stabilized BUP dose); and
4. CP with at least moderate pain severity (score greater than or equal to 4 on Pain, Enjoyment of Life and General Activity (PEG) scale). Comorbid psychiatric conditions and use of psychotropic medications will be allowed
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT05039554
Org Class
Other
Org Full Name
Albert Einstein College of Medicine
Org Study Id
2021-13325
Overall Status
Recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Randomized Trial of Acceptance and Commitment Therapy (ACT) and a Care Management App in Primary Care-based Buprenorphine Treatment
Primary Outcomes
Outcome Description
Change in Pain Interference on average over the prior 7-day period will be assessed using the Brief Pain Inventory (BPI) pain interference subscale. The BPI pain interference subscale consists of 7 items which asks patients to rate how much pain has interfered with mood, walking ability, work, relations with others, sleep, enjoyment of life, and general activity using a 0-10 numeric rating scale (NRS), where 0 represents "Does not interfere" and 10 represents "Completely interferes" such that higher scores are associate with greater pain interference. Scores from the seven items are averaged to obtain a mean score. Higher scores are indicative of more interference with daily life. Results will be summarized by study arm using basic descriptive statistics.
Outcome Measure
Change in Pain Interference
Outcome Time Frame
Baseline, 6 weeks, 12 weeks, 24 weeks, and 36 weeks
Outcome Description
Illicit opioid use will be a composite outcome defined by self-reported opioid use days over the past 30 days using items from a modified Addiction Severity Index questionnaire. It is defined by the maximum number of days of use of: a) heroin, b) fentanyl \[unprescribed\], and c) prescription opioids or analgesics \[unprescribed\]. The possible range of days is 0-30. Results will be summarized by study arm using basic descriptive statistics.
Outcome Measure
Illicit Opioid Use
Outcome Time Frame
Baseline, 6 weeks, 12 weeks, 24 weeks, and 36 weeks
Secondary Ids
Secondary Id
RM1DA055437
Secondary Outcomes
Outcome Description
Psychological flexibility is measured using the Multidimensional Psychological Flexibility Inventory - Short (MPFI-S) flexibility subscale, which consists of 12 items. Responses range from 1 ("Never true") to 6 ("Always true"). There are two subscales measuring psychological flexibility and inflexibility across key areas. A global composite score for flexibility uses the first 12 answers and divides scores by 12 to obtain a mean score. Higher scores reflect higher levels of psychological flexibility.
Outcome Time Frame
Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks
Outcome Measure
Psychological Flexibility
Outcome Description
Psychological inflexibility is measured using the Multidimensional Psychological Flexibility Inventory - Short (MPFI-S) inflexibility scale, which consists of 12 items. Responses range from 1 ("Never true") to 6 ("Always true"). There are two subscales measuring psychological flexibility and inflexibility across key areas. A global composite score for inflexibility uses the last 12 answers and divides scores by 12 to obtain a mean score. Higher scores reflect higher levels of psychological inflexibility.
Outcome Time Frame
Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks
Outcome Measure
Psychological Inflexibility
Outcome Description
Psychological inflexibility related to substance use is measured using the Acceptance and Action Questionnaire-Substance Abuse (AAQ-SA), a self-report scale. The AAQ-SA assesses the degree to which individuals avoid or struggle with substance-related thoughts, urges, and emotions, and the extent to which these experiences interfere with values-consistent behavior over recent weeks. Items are rated on a 7-point Likert scale ranging from 1 ("Never true") to 7 ("Always true"). Several items are reverse scored so that item responses can be summed to yield a total score, with lower scores indicating greater psychological flexibility (i.e., less experiential avoidance) in the context of substance use.
Outcome Time Frame
Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks
Outcome Measure
Psychological Flexibility Related to Substance Use
Outcome Description
Committed action is measured using the Committed Action Questionnaire (CAQ), an 18-item self-report scale. Each item assesses the degree to which individuals persist in values-directed actions in the face of discomfort over the past several weeks and is rated on a 7-point scale ranging from 0 ("Never true") to 6 ("Always true"). Item scores are summed to produce a total score ranging from 0 to 108, with higher scores indicating greater levels of committed action.
Outcome Time Frame
Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks
Outcome Measure
Committed Action
Outcome Description
Pain acceptance is measured using a 20-item scale called the Chronic Pain Acceptance Questionnaire--Revised (CPAQ-R). This is designed to measure acceptance of pain. It is measured on a scale of 0 ("Never true") to 6 ("Always true"). There are two subscales: (1) activity engagement, (2) pain willingness. Total score for pain acceptance is derived from mean scores on each of the subscales. Higher scores indicate higher levels of acceptance.
Outcome Time Frame
Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks
Outcome Measure
Pain Acceptance
Outcome Description
Pain catastrophizing is assessed via the 6-item Pain Catastrophizing Scale (PCS-6). The PCS-6 is a shortened version of the full 13-item Pain Catastrophizing Scale, designed to assess pain-related catastrophic thinking. Each items assesses maladaptive, cognitive, and emotional responses to pain experiences. Responses to items 4, 5, 6, 10, 11, and 13 from the original 13 item scale are rated on a 5-point scale ranging from 0 ("Not al all") to 4 ("All the time"). Item scores are summed to produce a total score ranging from 0-24, with higher scores indicating greater levels of pain catastrophizing. Scores will be summarized by study arm using basic descriptive statistics.
Outcome Time Frame
Baseline, 12 weeks, 36 weeks
Outcome Measure
Pain Catastrophizing
Outcome Description
Change in pain intensity on average over the prior 7-day period will be assessed using the Brief Pain Inventory (BPI) pain intensity subscale. The BPI pain intensity subscale consists of 4 items which asks patients to rate their worst pain, least pain, average pain, and current pain using a 0-10 numeric rating scale (NRS), where 0 represents "No pain" and 10 represents "Pain as bad as you can imagine," such that higher scores are associated with greater pain intensity. Scores from the four items are averaged to obtain a mean score. Results will be summarized by study arm using basic descriptive statistics.
Outcome Time Frame
Baseline, 6 weeks, 12 weeks, 24 weeks, and 36 weeks
Outcome Measure
Change in Pain Intensity
Outcome Description
Heroin use will be defined by self-reported heroin use days of the past 30 days using an item from a modified Addiction Severity Index questionnaire. The possible range of days is 0-30. Results will be summarized by study arm using basic descriptive statistics.
Outcome Time Frame
Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks
Outcome Measure
Heroin Use
Outcome Description
Fentanyl use will be defined by self-reported fentanyl use days of the past 30 days that is not prescribed, using items from a modified Addiction Severity Index questionnaire. The possible range of days is 0-30. Results will be summarized by study arm using basic descriptive statistics.
Outcome Time Frame
Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks
Outcome Measure
Fentanyl Use
Outcome Description
Prescription opioid analgesic use will be defined by self-reported number of days of prescription opioid analgesic use that is not prescribed, over the past 30 days, using items from a modified Addiction Severity Index questionnaire. The possible range of days is 0-30. Results will be summarized by study arm using basic descriptive statistics.
Outcome Time Frame
Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks
Outcome Measure
Unprescribed Prescription Opioid Analgesic Use
Outcome Description
HRQoL will be assessed using a utility score from the Patient-Reported Outcomes Measurement Information System (PROMIS)-Preference (PROPr) scoring system. PROPr summarizes several PROMIS domains into a single, preference-based score. PROPr is a health utility score which aggregates scores from 7 PROMIS domains: Cognitive Function/Abilities, Depression, Fatigue, Pain Interference, Physical Function, Sleep Disturbance, and Ability to Participate in Social Roles and Activities. PROPr scores are calculated using a multiplicative multiattribute utility function that combines the individual PROMIS domain scores into a single score. The PROPr score is expressed as a health utility index value on a scale between 0 (the utility of being dead) and 1 (utility of full health) such that higher scores are indicative of better perceived overall health utility. Scores will be summarized by study arm using basic descriptive statistics.
Outcome Time Frame
Baseline, 12 weeks, 24 weeks, and 36 weeks
Outcome Measure
Heatlh Related Quality of Life (HRQoL)
Outcome Description
Global Impression of change from the beginning of the study will be evaluated using the Patient Global Impression of Change (PGIC) assessment. The PGIC consists of a single item which asks the participant "Since the start of the study (treatment), my overall pain is..." and asks the participant to rate their pain on a 7-point Likert scale ranging from 0 ("Very much improved") to 6 ("Very much worse"), such that lower scores are associated with an overall impression of improvement since the start of the study. Results will be summarized by study arm using basic descriptive statistics.
Outcome Time Frame
12 weeks and 36 weeks
Outcome Measure
Global Impression of Change
Outcome Description
Depressive symptoms are measured using the Beck Depression Inventory (BDI), a 21-item self-report scale. Each item assesses the severity of a depressive symptom experienced over the past two weeks and is scored on a 4-point scale ranging from 0 ("Symptom not present") to 3 ("Severe symptom"). Item scores are summed to produce a total score ranging from 0 to 63, with higher scores indicating greater severity of depressive symptoms. Scores will be summarized by study arm using basic descriptive statistics.
Outcome Time Frame
Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks
Outcome Measure
Depressive Symptoms
Outcome Description
Anxiety symptoms are measured using the Beck Anxiety Inventory (BAI), a 21-item self-report scale. Each item assesses the severity of common anxiety symptoms experienced over the past week and is scored on a 4-point scale ranging from 0 ("Not at all") to 3 ("Severely; it bothered me a lot"). Item scores are summed to produce a total score ranging from 0 to 63, with higher scores indicating greater severity of anxiety symptoms. Scores will be summarized by study arm using basic descriptive statistics.
Outcome Time Frame
Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks
Outcome Measure
Anxiety Symptoms
Outcome Description
Positive urine for non-prescribed opioids will be assessed using point of care urine drug testing. Results of the test will be reported using a dichotomous variable ("Yes"/"No") where "Yes" is is indicated by positive oxycodone, fentanyl, or other opiates that were not indicated by participant as prescribed.
Outcome Time Frame
Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks
Outcome Measure
Positive Urine for Non-prescribed Opioids
Outcome Description
Anhedonia will be assessed via the Snaith-Hamilton Pleasure Scale (SHAPS), a 14-item self-report scale. Each item assesses the ability to experience pleasure over the past few days and is rated on a 4-point scale consisting of "Strongly disagree," "Disagree", "Agree," or "Strongly agree". For scoring, responses will be dichotomized such that "Strongly disagree" and "Disagree" are scored as 1 point and "Strongly agree" and "Agree" are scored as 0 points. Scores are summed to yield a total score ranging from 0 to 14. Higher total scores indicate greater levels of anhedonia.
Outcome Time Frame
Baseline, 24 weeks, 36 weeks
Outcome Measure
Anhedonia
Outcome Description
Psychiatric diagnoses are assessed using the Mini International Neuropsychiatric Interview (MINI), a structured diagnostic interview based on Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria. The MINI is administered by trained study personnel to determine the presence or absence of current psychiatric disorders. Diagnoses are assessed at multiple time points to evaluate changes in diagnostic status over the course of the study. The total number of diagnoses at each timepoint will be reported. A higher number reflects higher burden of psychiatric disease.
Outcome Time Frame
Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks
Outcome Measure
Psychiatric Diagnoses
Outcome Description
Retention with buprenorphine will be measured by a dichotomous measure of whether a buprenorphine prescription occurred within 1 week of the time of a study visit. This is measured using pharmacy data obtained through I-stop, a NY State controlled substance monitoring program. Results will be summarized by study arm.
Outcome Time Frame
Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks
Outcome Measure
Retention with Buprenorphine
Outcome Description
For participants enrolled into the ACT arm, satisfaction with ACT is measured using the Satisfaction With Therapy Scale (STS), a 14-item self-report questionnaire. The scale assesses participants' satisfaction with various aspects of their therapeutic experience. Each item is rated on a 5-point Likert scale ranging from 1 to 5, and item responses are summed to yield a total score ranging from 14-70. Higher total scores indicate greater satisfaction with ACT.
Outcome Time Frame
12 weeks
Outcome Measure
Satisfaction with ACT
Outcome Description
For participants enrolled into one of the Valera smartphone application arms, satisfaction with Valera is measured is measured using a novel scale measuring overall satisfaction along with satisfaction with three different components: (1) Educational articles, (2) Appointment Reminders, and (3) Messaging Care Team. Each is measured along a Likert-type scale from 1-5, with higher scores reflecting higher satisfaction or usefulness, of Valera.
Outcome Time Frame
12 weeks
Outcome Measure
Satisfaction with Valera
Outcome Description
For participants enrolled into one of the Valera smartphone application arms, Valera Engagement with articles is a dichotomous measure assessing whether participants opened up each of 24 articles sent to participants twice weekly across the 12 week intervention. Each measure is measured as "Yes" or "No." Total engagement will be reflected as a percentage of total yes answers over the 24 articles. Higher percentages reflect higher engagement with articles.
Outcome Time Frame
12 weeks
Outcome Measure
Valera Engagement with Articles
Outcome Description
For participants enrolled into the ACT arm, ACT attendance is a measure of attendance of each of 12 ACT sessions. These will be reported as percentages. Higher percentages indicates higher attendance.
Outcome Time Frame
12 weeks
Outcome Measure
ACT Attendance
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Hector Perez
Investigator Email
heperez@montefiore.org
Investigator Department
Medicine
Investigator Division
General Internal Medicine
Investigator Sponsor Organization
Einstein
Study Department
Medicine
Study Division
General Internal Medicine
Categories Mesh Debug
Substance Use and Addiction --- OPIOID-RELATED DISORDERS
Substance Use and Addiction --- CHRONIC PAIN
Substance Use and Addiction --- NARCOTIC-RELATED DISORDERS
Substance Use and Addiction --- SUBSTANCE-RELATED DISORDERS
Substance Use and Addiction --- CHEMICALLY-INDUCED DISORDERS
Child Development & Autism --- MENTAL DISORDERS
Mental Health & Behavioral Research --- MENTAL DISORDERS
Psychiatry & Behavioral Sciences --- MENTAL DISORDERS
Substance Use and Addiction --- MENTAL DISORDERS
Brain, Spinal Cord & Nervous System --- PAIN
Headaches & Migraine --- PAIN
Brain, Spinal Cord & Nervous System --- NEUROLOGIC MANIFESTATIONS
Headaches & Migraine --- NEUROLOGIC MANIFESTATIONS
Substance Use and Addiction --- NEUROLOGIC MANIFESTATIONS
MeSH Terms
OPIOID-RELATED DISORDERS
CHRONIC PAIN
NARCOTIC-RELATED DISORDERS
SUBSTANCE-RELATED DISORDERS
CHEMICALLY-INDUCED DISORDERS
MENTAL DISORDERS
PAIN
NEUROLOGIC MANIFESTATIONS
SIGNS AND SYMPTOMS
PATHOLOGICAL CONDITIONS, SIGNS AND SYMPTOMS
ACCEPTANCE AND COMMITMENT THERAPY
THERAPEUTICS
COGNITIVE BEHAVIORAL THERAPY
BEHAVIOR THERAPY
PSYCHOTHERAPY
BEHAVIORAL DISCIPLINES AND ACTIVITIES