Opioid UseOTP-ACTNCT06581276
Increasing Access to Evidence-based Treatment for Chronic Pain and Opioid Use Disorder: Adapting Acceptance and Commitment Therapy for Opioid Treatment Programs
A study testing Acceptance and Commitment Therapy (ACT) in people with Opioid Use and Opioid Use Disorder, run by Montefiore Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use, Opioid Use Disorder, Chronic Pain
- What is being tested?
- Acceptance and Commitment Therapy (ACT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2023to 9 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center Division of General Internal Medicine
The Bronx, New York, 10467
About this study
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.
Read the 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.
- Conditions
- Opioid Use, Opioid Use Disorder, Chronic Pain
- Being tested
- Acceptance and Commitment Therapy (ACT)
- Medical subject headings
- Opioid-Related Disorders, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment Therapy (ACT)Behavioural
Acceptance and Commitment Therapy (ACT) is an evidence-based behavioral pain treatment intervention for Chronic Pain, anxiety and depression, and substance use disorders, being studied as a group-based therapy delivered by substance use counselors in an opioid treatment program.
| Study group | Role | What they receive |
|---|---|---|
| OTP Intervention | Other | Evidence-based behavioral pain treatment integrated into OTP model of care Receives: Behavioral: Acceptance and Commitment Therapy (ACT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre-Intervention and Post-Intervention, approximately 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start23 Jun 2023
- Primary completion9 Apr 2024
- Study completion9 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Jakubowski, MD, MS, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06581276
- Sponsor's protocol ID
- 2022-14272
- Acronym
- OTP-ACT
- Status last verified
- Aug 2024
- First submitted
- 27 Aug 2024
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hser YI, Mooney LJ, Saxon AJ, Miotto K, Bell DS, Huang D. Chronic pain among patients with opioid use disorder: Results from electronic health records data. J Subst Abuse Treat. 2017 Jun;77:26-30. doi: 10.1016/j.jsat.2017.03.006. Epub 2017 Mar 9.
PubMed 28476267Rosenblum A, Joseph H, Fong C, Kipnis S, Cleland C, Portenoy RK. Prevalence and characteristics of chronic pain among chemically dependent patients in methadone maintenance and residential treatment facilities. JAMA. 2003 May 14;289(18):2370-8. doi: 10.1001/jama.289.18.2370.
PubMed 12746360Ellis MS, Kasper Z, Cicero T. Assessment of Chronic Pain Management in the Treatment of Opioid Use Disorder: Gaps in Care and Implications for Treatment Outcomes. J Pain. 2021 Apr;22(4):432-439. doi: 10.1016/j.jpain.2020.10.005. Epub 2020 Nov 14.
PubMed 33197581Han BH, Doran KM, Krawczyk N. National trends in substance use treatment admissions for opioid use disorder among adults experiencing homelessness. J Subst Abuse Treat. 2022 Jan;132:108504. doi: 10.1016/j.jsat.2021.108504. Epub 2021 May 29.
PubMed 34102461Lee C, Crawford C, Swann S; Active Self-Care Therapies for Pain (PACT) Working Group. Multimodal, integrative therapies for the self-management of chronic pain symptoms. Pain Med. 2014 Apr;15 Suppl 1:S76-85. doi: 10.1111/pme.12408.
PubMed 24734863Hughes LS, Clark J, Colclough JA, Dale E, McMillan D. Acceptance and Commitment Therapy (ACT) for Chronic Pain: A Systematic Review and Meta-Analyses. Clin J Pain. 2017 Jun;33(6):552-568. doi: 10.1097/AJP.0000000000000425.
PubMed 27479642Coto-Lesmes R, Fernandez-Rodriguez C, Gonzalez-Fernandez S. Acceptance and Commitment Therapy in group format for anxiety and depression. A systematic review. J Affect Disord. 2020 Feb 15;263:107-120. doi: 10.1016/j.jad.2019.11.154. Epub 2019 Dec 2.
PubMed 31818766Lee EB, An W, Levin ME, Twohig MP. An initial meta-analysis of Acceptance and Commitment Therapy for treating substance use disorders. Drug Alcohol Depend. 2015 Oct 1;155:1-7. doi: 10.1016/j.drugalcdep.2015.08.004. Epub 2015 Aug 13.
PubMed 26298552Purgato M, Carswell K, Tedeschi F, Acarturk C, Anttila M, Au T, Bajbouj M, Baumgartner J, Biondi M, Churchill R, Cuijpers P, Koesters M, Gastaldon C, Ilkkursun Z, Lantta T, Nose M, Ostuzzi G, Papola D, Popa M, Roselli V, Sijbrandij M, Tarsitani L, Turrini G, Valimaki M, Walker L, Wancata J, Zanini E, White R, van Ommeren M, Barbui C. Effectiveness of Self-Help Plus in Preventing Mental Disorders in Refugees and Asylum Seekers in Western Europe: A Multinational Randomized Controlled Trial. Psychother Psychosom. 2021;90(6):403-414. doi: 10.1159/000517504. Epub 2021 Jul 20.
PubMed 34350902Acarturk C, Uygun E, Ilkkursun Z, Carswell K, Tedeschi F, Batu M, Eskici S, Kurt G, Anttila M, Au T, Baumgartner J, Churchill R, Cuijpers P, Becker T, Koesters M, Lantta T, Nose M, Ostuzzi G, Popa M, Purgato M, Sijbrandij M, Turrini G, Valimaki M, Walker L, Wancata J, Zanini E, White RG, van Ommeren M, Barbui C. Effectiveness of a WHO self-help psychological intervention for preventing mental disorders among Syrian refugees in Turkey: a randomized controlled trial. World Psychiatry. 2022 Feb;21(1):88-95. doi: 10.1002/wps.20939.
PubMed 35015365Mercer, D. E., D, P. & Woody, G. E. Individual Drug Counseling. in Therapy Manuals for Drug Addiction Series 1-77 (U.S. Department of Health and Human Services, NIH, NIDA, 1999)
McKleroy VS, Galbraith JS, Cummings B, Jones P, Harshbarger C, Collins C, Gelaude D, Carey JW; ADAPT Team. Adapting evidence-based behavioral interventions for new settings and target populations. AIDS Educ Prev. 2006 Aug;18(4 Suppl A):59-73. doi: 10.1521/aeap.2006.18.supp.59.
PubMed 16987089Bernal G, Bonilla J, Bellido C. Ecological validity and cultural sensitivity for outcome research: issues for the cultural adaptation and development of psychosocial treatments with Hispanics. J Abnorm Child Psychol. 1995 Feb;23(1):67-82. doi: 10.1007/BF01447045.
PubMed 7759675Alderks CE. Trends in the Use of Methadone, Buprenorphine, and Extended-Release Naltrexone at Substance Abuse Treatment Facilities: 2003-2015 (Update). 2017 Aug 22. In: The CBHSQ Report. Rockville (MD): Substance Abuse and Mental Health Services Administration (US); 2013-. Available from http://www.ncbi.nlm.nih.gov/books/NBK469748/
PubMed 29200242Heimer R, Zhan W, Grau LE. Prevalence and experience of chronic pain in suburban drug injectors. Drug Alcohol Depend. 2015 Jun 1;151:92-100. doi: 10.1016/j.drugalcdep.2015.03.007. Epub 2015 Mar 19.
PubMed 25841984
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Access to Evidence-based Treatment for Chronic Pain and Opioid Use Disorder: Adapting Acceptance and Commitment Therapy for Opioid Treatment Programs
- ClinicalTrials.gov ID
- NCT06581276
- Acronym / sponsor ID
- OTP-ACT / 2022-14272
- Conditions
- Opioid Use, Opioid Use Disorder, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- 23 Jun 2023 (actual)
- Primary completion
- 9 Apr 2024 (actual)
- Study completion
- 9 Apr 2024 (actual)
- First posted
- 3 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OTP Intervention | Other | Behavioral: Acceptance and Commitment Therapy (ACT)Evidence-based behavioral pain treatment integrated into OTP model of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and Commitment Therapy (ACT)Acceptance and Commitment Therapy (ACT) is an evidence-based behavioral pain treatment intervention for Chronic Pain, anxiety and depression, and substance use disorders, being studied as a group-based therapy delivered by substance use counselors in an opioid treatment program. | Behavioural | OTP Intervention |
Primary outcome
Change in Non-Prescription Opioid Use
Time frame: Pre-Intervention and Post-Intervention, approximately 12 weeks
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.
Change in Overdose Risk Behavior
Time frame: Pre-Intervention and Post-Intervention, approximately 12 weeks
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
Change in Anxiety
Time frame: Pre-Intervention and Post-Intervention, approximately 12 weeks
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.
Change in Depression
Time frame: Pre-Intervention and Post-Intervention, approximately 12 weeks
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.
Change in Pain Intensity and Interference - PEG
Time frame: Pre-Intervention and Post-Intervention, approximately 12 weeks
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.
Change in Pain Interference - Patient-Reported Outcomes Measurement Information System (PROMIS)
Time frame: Pre-Intervention and Post-Intervention, approximately 12 weeks
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.
Change in Pain Catastrophizing
Time frame: Pre-Intervention and Post-Intervention, approximately 12 weeks
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.
Change in Pain Acceptance
Time frame: Pre-Intervention and Post-Intervention, approximately 12 weeks
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.
Satisfaction with Treatment
Time frame: Pre-Intervention and Post-Intervention, approximately 12 weeks
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.
Problematic Substance Use
Time frame: Pre-Intervention and Post-Intervention, approximately 12 weeks
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.
Psychological flexibility
Time frame: Pre-Intervention and Post-Intervention, approximately 12 weeks
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.
Committed Action
Time frame: Pre-Intervention and Post-Intervention, approximately 12 weeks
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.
Acceptance and Action Related to Substance Use
Time frame: Pre-Intervention and Post-Intervention, approximately 12 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Background: PubMed 28476267Hser YI, Mooney LJ, Saxon AJ, Miotto K, Bell DS, Huang D. Chronic pain among patients with opioid use disorder: Results from electronic health records data. J Subst Abuse Treat. 2017 Jun;77:26-30. doi: 10.1016/j.jsat.2017.03.006. Epub 2017 Mar 9.
- Background: PubMed 12746360Rosenblum A, Joseph H, Fong C, Kipnis S, Cleland C, Portenoy RK. Prevalence and characteristics of chronic pain among chemically dependent patients in methadone maintenance and residential treatment facilities. JAMA. 2003 May 14;289(18):2370-8. doi: 10.1001/jama.289.18.2370.
- Background: PubMed 33197581Ellis MS, Kasper Z, Cicero T. Assessment of Chronic Pain Management in the Treatment of Opioid Use Disorder: Gaps in Care and Implications for Treatment Outcomes. J Pain. 2021 Apr;22(4):432-439. doi: 10.1016/j.jpain.2020.10.005. Epub 2020 Nov 14.
- Background: PubMed 34102461Han BH, Doran KM, Krawczyk N. National trends in substance use treatment admissions for opioid use disorder among adults experiencing homelessness. J Subst Abuse Treat. 2022 Jan;132:108504. doi: 10.1016/j.jsat.2021.108504. Epub 2021 May 29.
- Background: PubMed 24734863Lee C, Crawford C, Swann S; Active Self-Care Therapies for Pain (PACT) Working Group. Multimodal, integrative therapies for the self-management of chronic pain symptoms. Pain Med. 2014 Apr;15 Suppl 1:S76-85. doi: 10.1111/pme.12408.
- Background: PubMed 27479642Hughes LS, Clark J, Colclough JA, Dale E, McMillan D. Acceptance and Commitment Therapy (ACT) for Chronic Pain: A Systematic Review and Meta-Analyses. Clin J Pain. 2017 Jun;33(6):552-568. doi: 10.1097/AJP.0000000000000425.
- Background: PubMed 31818766Coto-Lesmes R, Fernandez-Rodriguez C, Gonzalez-Fernandez S. Acceptance and Commitment Therapy in group format for anxiety and depression. A systematic review. J Affect Disord. 2020 Feb 15;263:107-120. doi: 10.1016/j.jad.2019.11.154. Epub 2019 Dec 2.
- Background: PubMed 26298552Lee EB, An W, Levin ME, Twohig MP. An initial meta-analysis of Acceptance and Commitment Therapy for treating substance use disorders. Drug Alcohol Depend. 2015 Oct 1;155:1-7. doi: 10.1016/j.drugalcdep.2015.08.004. Epub 2015 Aug 13.
- Background: PubMed 34350902Purgato M, Carswell K, Tedeschi F, Acarturk C, Anttila M, Au T, Bajbouj M, Baumgartner J, Biondi M, Churchill R, Cuijpers P, Koesters M, Gastaldon C, Ilkkursun Z, Lantta T, Nose M, Ostuzzi G, Papola D, Popa M, Roselli V, Sijbrandij M, Tarsitani L, Turrini G, Valimaki M, Walker L, Wancata J, Zanini E, White R, van Ommeren M, Barbui C. Effectiveness of Self-Help Plus in Preventing Mental Disorders in Refugees and Asylum Seekers in Western Europe: A Multinational Randomized Controlled Trial. Psychother Psychosom. 2021;90(6):403-414. doi: 10.1159/000517504. Epub 2021 Jul 20.
- Background: PubMed 35015365Acarturk C, Uygun E, Ilkkursun Z, Carswell K, Tedeschi F, Batu M, Eskici S, Kurt G, Anttila M, Au T, Baumgartner J, Churchill R, Cuijpers P, Becker T, Koesters M, Lantta T, Nose M, Ostuzzi G, Popa M, Purgato M, Sijbrandij M, Turrini G, Valimaki M, Walker L, Wancata J, Zanini E, White RG, van Ommeren M, Barbui C. Effectiveness of a WHO self-help psychological intervention for preventing mental disorders among Syrian refugees in Turkey: a randomized controlled trial. World Psychiatry. 2022 Feb;21(1):88-95. doi: 10.1002/wps.20939.
- BackgroundMercer, D. E., D, P. & Woody, G. E. Individual Drug Counseling. in Therapy Manuals for Drug Addiction Series 1-77 (U.S. Department of Health and Human Services, NIH, NIDA, 1999)
- Background: PubMed 16987089McKleroy VS, Galbraith JS, Cummings B, Jones P, Harshbarger C, Collins C, Gelaude D, Carey JW; ADAPT Team. Adapting evidence-based behavioral interventions for new settings and target populations. AIDS Educ Prev. 2006 Aug;18(4 Suppl A):59-73. doi: 10.1521/aeap.2006.18.supp.59.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Jakubowski, MD, MS principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy (ACT) in people with Opioid Use and Opioid Use Disorder, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Non-Prescription Opioid Use (time frame: Pre-Intervention and Post-Intervention, approximately 12 weeks). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06581276, which also lists 35 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2024.