Clinical trial NCT06581276: Increasing Access to Evidence-based Treatment for Chronic Pain and Opioid Use Disorder: Adapting Acceptance and Commitment Therapy for Opioid Treatment Programs
Official title: Increasing Access to Evidence-based Treatment for Chronic Pain and Opioid Use Disorder: Adapting Acceptance and Commitment Therapy for Opioid Treatment Programs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use
Opioid Use Disorder
Chronic Pain
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2024-09-03
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The overarching goal of this study was to provide patient-centered treatment for chronic pain in opioid treatment programs (OTPs). Chronic pain (CP) is highly prevalent among people with opioid use disorder (OUD) who attend OTPs, with 64% of OTP patients experiencing CP and 37% reporting severe CP. OTP patients are required to attend programs frequently for medication administration, which makes the OTP an ideal location to deliver pain treatment; however, in a large national survey of people entering OUD treatment, only one-third of patients had CP treated in their program. People with OUD attending OTPs are highly marginalized and may lack access to multimodal pain management and mental health services. Integrating evidence-based treatments for CP and its associated comorbidities (such as anxiety and depression) into OTPs could have broad impact.

Detailed description: Training OTP counselors to deliver evidence-based pain interventions may be the ideal way to integrate pain and OUD treatment. There is a strong tradition of OTP counselors providing individual and group counseling, but it is typically focused on substance use recovery. Acceptance and Commitment Therapy (ACT), an evidence-based intervention for CP, anxiety and depression, and substance use disorders, is being studied in the IMPOWR-ME center as a group-based therapy combined with outpatient buprenorphine treatment for delivery in the primary care setting. Successful delivery of ACT in OTPs would require modifying its content and format to meet the needs of the OTP setting and patients. IMPOWR-ME's ACT is a 12-session, psychologist-led intervention. ACT has been effectively delivered by lay-person facilitators and many OTP counselors are accustomed to on-the-job training. However one modifiable barrier is that OTP counselors primarily work from an abstinence-based model, which is in conflict with ACT principles (i.e. patients identifying their own values and goals). Although OTPs have a longstanding commitment to running groups, group ACT, with its structured and sequential content, may run counter to OTP norms of open attendance and unstructured discussion. Notable OTP attendance barriers such as transportation and competing priorities may also hinder completion of 12-session protocols like that of the IMPOWR-ME trial.

To address these challenges, the investigator team: 1) Trained OTP counselors to deliver ACT and provided ongoing supervision; 2) Increased OTP counselors' familiarity and technical skill in harm reduction counseling strategies (patient-identified goal setting and monitoring) to complement ACT principles; 3) Adapted ACT's format and content to be culturally aligned with OTP patients (including language, concepts and metaphors) and responsive to the needs and preferences of OTP patients for group therapy (number of sessions, use of sequential content). Perspectives of OTP patients and staff were incorporated. The 12-month pilot study consisted of the following 3 Aims:

Aim 1: Adapted the IMPOWR-ME high-intensity ACT intervention to meet the needs of an OTP. Guided by the Center for Disease Control and Prevention (CDC) framework for adapting evidence-based interventions and Bernal's ecological validity model, the investigator team developed a modified ACT protocol in collaboration with the IMPOWR-ME ACT team, content experts, and OTP stakeholders. Two stakeholder studios (1 with OTP staff, 1 with OTP patients) provided input on how to adapt ACT for optimal feasibility and acceptability for OTP patients. With the IMPOWR-ME ACT team and content experts, the investigator team systematically modified ACT structure and content to address stakeholder studio recommendations. Then, 4 OTP counselors interested in serving as ACT group leaders were recruited and trained in the adapted ACT protocol.

Aim 2: Examined feasibility and acceptability of adapted ACT in an OTP and study OTP counselor fidelity to the intervention: 15 patients were recruited and enrolled to pilot the adapted ACT intervention during one of two, 12-session groups. To assess feasibility, the study team used qualitative data from in-depth interviews with OTP ACT group leaders on time, skills, and other resources required to deliver the intervention. To assess the acceptability of the intervention, the study team conducted questionnaires and in-depth interviews with patients to examine their experiences with and attitudes toward the intervention and suggestions for modifications (N=15). The investigator team examined the acceptability of the intervention to the ACT group leaders during in-depth qualitative interviews at the end of the study (N=3). ACT group leader fidelity to key principles of ACT facilitation and harm reduction principles was rated for 6 video recorded group sessions.

Aim 3, the basis of this registration, was conducted to examine changes in patient non-prescription opioid use, overdose risk behavior, anxiety, depression, pain interference, pain catastrophizing and pain acceptance pre and post-intervention. The study team administered baseline and follow-up questionnaires upon completion of the ACT intervention to assess changes in clinical outcomes. Completion of these aims provides a manual for group-based ACT for CP and OUD in OTPs and data on the feasibility and acceptability of providing ACT in OTPs. This data is going to be used to apply for a National Institute on Drug Abuse (NIDA) R34 grant to plan a Randomized Control Trial (RCT) studying the effectiveness of ACT for CP and OUD outcomes among OTP participants.

Eligibility criteria: Inclusion Criteria:

* Opioid Treatment Program (OTP) patients;
* Patient self-report of at least moderate Chronic Pain of any duration;
* Willingness to participate in video-recorded ACT group sessions to be viewed by the study team
* Fluent in English

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: Change in Non-Prescription Opioid Use
timeFrame: Pre-Intervention and Post-Intervention, approximately 12 weeks
measure: Change in Overdose Risk Behavior
timeFrame: Pre-Intervention and Post-Intervention, approximately 12 weeks
measure: Change in Anxiety
timeFrame: Pre-Intervention and Post-Intervention, approximately 12 weeks
measure: Change in Depression
timeFrame: Pre-Intervention and Post-Intervention, approximately 12 weeks
measure: Change in Pain Intensity and Interference - PEG
timeFrame: Pre-Intervention and Post-Intervention, approximately 12 weeks
measure: Change in Pain Interference - Patient-Reported Outcomes Measurement Information System (PROMIS)
timeFrame: Pre-Intervention and Post-Intervention, approximately 12 weeks
measure: Change in Pain Catastrophizing
timeFrame: Pre-Intervention and Post-Intervention, approximately 12 weeks
measure: Change in Pain Acceptance
timeFrame: Pre-Intervention and Post-Intervention, approximately 12 weeks
measure: Satisfaction with Treatment
timeFrame: Pre-Intervention and Post-Intervention, approximately 12 weeks
measure: Problematic Substance Use
timeFrame: Pre-Intervention and Post-Intervention, approximately 12 weeks
measure: Psychological flexibility
timeFrame: Pre-Intervention and Post-Intervention, approximately 12 weeks
measure: Committed Action
timeFrame: Pre-Intervention and Post-Intervention, approximately 12 weeks
measure: Acceptance and Action Related to Substance Use
timeFrame: Pre-Intervention and Post-Intervention, approximately 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center Division of General Internal Medicine
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Andrea Jakubowski, MD, MS
role: PRINCIPAL_INVESTIGATOR
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