Increasing Access to Evidence-based Treatment for Chronic Pain and Opioid Use Disorder: Adapting Acceptance and Commitment Therapy for Opioid Treatment Programs
NCT Number: NCT06581276
Acronym: OTP-ACT
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Opioid Use|Opioid Use Disorder|Chronic Pain
Interventions: BEHAVIORAL: Acceptance and Commitment Therapy (ACT)
Sponsor: Montefiore Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 7
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-06-23
Completion Date: 2024-04-09
Locations: Montefiore Medical Center Division of General Internal Medicine, Bronx, New York, 10467, United States

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.

Primary Outcome Measures: Change in Non-Prescription Opioid Use, Change in Non-Prescription Opioid Use from Pre-intervention to Post-intervention will be assessed by administration of the Addiction Severity Index (ASI) to OTP participants at enrollment and upon completion of the ACT session. The ASI is a structured clinical interview consisting of 7 statements asking patients about opioid use over the last 30 days and their lifetime. For this study, each item is scored such that if the patient answers "Yes" they may score 1; if they answer "No", they may score 0. For some items, the scoring may be reversed. A composite score is used to assign a severity rating. Basic descriptive statistics will be used to summarize group results. Negative group mean scores are associated with a lowered need for opioid treatment following intervention and positive group mean scores are associated with an increased need for opioid treatment following intervention., Pre-Intervention and Post-Intervention, approximately 12 weeks|Change in Overdose Risk Behavior, Change in Overdose Risk Behavior from Pre-intervention to Post-intervention will be assessed using a modification of the Opioid Risk Behavior Scale (ORBS2). This 26-item instrument tailored to each patient's use of substances selected from a screening question containing opioid and opioid-contraindicated categories. Concurrent use of opioids and other contraindicated substances are generated based on the specific drugs selected from the list and progress from combinations as indicated on the form. Pictures of the substances are included to aid participants in identifying the polysubstance combinations. Patients are asked to identify the number of days within the past 30 days they engaged in each activity. Scores are summarized for an overall possible score of 0-780. Basic descriptive statistics will be used to summarize group results. Negative group mean scores are associated with decreased overdose risk behavior following intervention and positive group mean scores are associated, Pre-Intervention and Post-Intervention, approximately 12 weeks|Change in Anxiety, Change in Anxiety from Pre-intervention to Post-intervention will be assessed using the General Anxiety Disorder (GAD-7) scale. The GAD-7 is a 7-item self-report anxiety scale consisting of 7 statements asking patients to rate how often they have been bothered by the problems identified within each statement over the prior 2 weeks. Each item is scored on a 4-point scale ranging from 0 ("Not at all sure") to 3 ("Nearly every day") yielding an overall possible score of 0-21. Basic descriptive statistics will be used to summarize group results. Negative group mean scores are associated with decreased severity of anxiety following intervention and positive group mean scores are associated with increased severity of anxiety following intervention., Pre-Intervention and Post-Intervention, approximately 12 weeks|Change in Depression, Change in Depression from Pre-intervention to Post-intervention will be assessed using the 9-item Patient Health Questionnaire (PHQ-9). The PHQ-9 is a 9-item self-report depression severity scale consisting of 9 statements asking patients to rate how often they have been bothered by the problems within each statement over the prior 2 weeks. Each item is scored on a 4-point scale ranging from 0 ("Not at all") to 3 ("Nearly every day") yielding an overall possible score of 0-27. Basic descriptive statistics will be used to summarize group results. Negative group mean scores are associated with lower depression severity following intervention and positive group mean scores are associated with greater depression severity following intervention.

The PHQ-9 also includes a single screening question about suicide risk however this question is not part of the Outcome Measures for this study., Pre-Intervention and Post-Intervention, approximately 12 weeks|Change in Pain Intensity and Interference - PEG, Change in Pain Interference from Pre-intervention to Post-intervention will be assessed using the Pain, Enjoyment, General Activity (PEG) scale. The PEG scale is a 3-item, patient-reported pain scale used to assess and monitor chronic pain intensity and interference. The scale is based on the Brief Pain Inventory and consists of three numerical scales (Pain on average over the past week'; 'Enjoyment of Life'; and 'Pain Interference of general activities') each ranging from 0 ("No Pain" or "Does not interfere") to 10 ("Pain as bad as you can imagine" or "Completely interferes"). Basic descriptive statistics will be used to summarize group results from the three scales for an overall possible range of 0-30. Negative group mean scores are associated with a reduction in pain intensity and interference following intervention and positive group mean scores are associated with an increase in pain intensity and interference following intervention., Pre-Intervention and Post-Intervention, approximately 12 weeks|Change in Pain Interference - Patient-Reported Outcomes Measurement Information System (PROMIS), Change in Pain Interference from Pre-intervention to Post-intervention will also be assessed using the PROMIS Pain Interference - Short Form 8a. This 8-item scale which measures the self-reported consequences of pain on relevant aspects of a person's life asks patients to respond how often pain interfered with universal activities over the prior 7 day period on a 5-point scale ranging from 1 ("Not at all") to 5 ("Very much") yielding an overall possible score of 8-40. Basic descriptive statistics will be used to summarize group results. Negative group mean scores are associated with a reduction in pain interference during the conduct of universal activities following intervention and positive group mean scores are associated with an increase in pain interference during the conduct of universal activities following intervention., Pre-Intervention and Post-Intervention, approximately 12 weeks|Change in Pain Catastrophizing, Change in Pain Catastrophizing from Pre-intervention to Post-intervention will be assessed using the Pain Catastrophizing Scale (PCS). The PCS is a 13-item self-report questionnaire that asks patients to rate how often they experience certain thoughts and feelings when in pain and span the categories of rumination, magnification, and helplessness. Each item is scored on a 5-point scale ranging from 0 ("Not at all") to 4 ("All the time") yielding an overall possible score of 0-52. Basic descriptive statistics will be used to summarize group results. Negative group mean scores are associated with a reduction in pain catastrophizing following intervention and positive group mean scores are associated with an increase in pain catastrophizing following intervention., Pre-Intervention and Post-Intervention, approximately 12 weeks|Change in Pain Acceptance, Change in Pain Acceptance from Pre-intervention to Post-intervention will be assessed using the Chronic Pain Acceptance Questionnaire - Revised (CPAQ-R). The CPAQ-R consists 20 of statements asking the patient to rate the truth of each statement on a 7-point Likert scale ranging from 0 ("Never true") to 6 ("Always true") for an overall possible range of 0-120. Basic descriptive statistics will be used to summarize group results. Positive group mean scores are associated with improvement in pain acceptance following intervention and negative group scores are associated with a decrease in pain acceptance following intervention., Pre-Intervention and Post-Intervention, approximately 12 weeks|Satisfaction with Treatment, Patient satisfaction with treatment was assessed using the Patients' Global Impression of Change (PGIC) Scale. The PGIC consists of a single question asking the patient how they would describe the change (if any) in Activity, Limitations, Symptoms, Emotions, and overall Quality of Life (QoL) related to their condition following the intervention. A response is provided based on a 7-point Likert scale ranging from 1 ("No Change") to 7 ("A great deal better") for an overall possible range of 1-7. Higher scores are associated with overall improvement in condition. Basic descriptive statistics will be used to summarize group results., Pre-Intervention and Post-Intervention, approximately 12 weeks|Problematic Substance Use, Change in problematic substance use was assessed using the Short Inventory of Problems Alcohol and Drugs (SID-AD), a fifteen-item instrument asking patients to rate how often they have experienced a range of problems related to alcohol and/or drug use during the past 30 days. Each item is scored on a 4-point scale ranging from 0 ("Never") to 3 ("Daily or almost daily"), yielding an overall possible score of 0-45. Basic descriptive statistics will be used to summarize group results. Negative group mean scores are associated with reductions in problematic substance use following intervention., Pre-Intervention and Post-Intervention, approximately 12 weeks|Psychological flexibility, Change in psychological flexibility was assessed using the Multidimensional Psychological Flexibility Inventory (MPFI-12). The MPFI-12 is a 12-item scale with six items assessing psychological flexibility, and six items assessing psychological inflexibility. Patients are asked about responses to thoughts, feelings, and actions aligned with their values on a 6-point scale ranging from 1 ("Never true") to 6 ("Always true"), yielding an overall possible score of 6-36 for flexibility and 6-36 for inflexibility. Basic descriptive statistics will be used to summarize group results. Positive group mean scores for flexibility and negative group mean scores for inflexibility are associated with improvement following intervention., Pre-Intervention and Post-Intervention, approximately 12 weeks|Committed Action, Change in committed action was assessed using the committed Action Questionnaire (CAQ). The CAQ is an 18-item measure asking patients to indicate agreement with statements about how they take goal-directed actions ranging from 0 ("never true") to 6 ("always true"), yielding a score of 0-108. Basic descriptive statistics will be used to summarize group results. Positive group mean scores for committed action are associated with improvement following the intervention., Pre-Intervention and Post-Intervention, approximately 12 weeks|Acceptance and Action Related to Substance Use, Change in acceptance and actions related to substance use were assessed using the Acceptance and Action Questionnaire for Substance Abuse (AAQSA). The AAQSA is an 18-item measure asking patients to indicate responses to thoughts and feelings about their substance use from 1 ("never true") to 7 ("always true"), yielding an overall possible score of 18- 126. Basic descriptive statistics will be used to summarize group results. Positive group mean scores for acceptance and action are associated with improvement following the intervention., Pre-Intervention and Post-Intervention, approximately 12 weeks