Efficacy of Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT) in Individuals With Chronic Pain and Opioid Use Disorder: Protocol for a Randomized Clinical Trial of a Digital Cognitive Behavioral Treatment
BackgroundChronic pain is common among individuals with opioid use disorder (OUD) who are maintained on medications for OUD (MOUD; eg, buprenorphine or methadone). Chronic pain is associated with worse retention and higher levels of substance use. Treatment of individuals wit...
| Main Authors: | , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
JMIR Publications
2024-03-01
|
| Series: | JMIR Research Protocols |
| Online Access: | https://www.researchprotocols.org/2024/1/e54342 |
| _version_ | 1797255058074632192 |
|---|---|
| author | R Ross MacLean Brett Ankawi Mary A Driscoll Melissa A Gordon Tami L Frankforter Charla Nich Sara K Szollosy Jennifer M Loya Larissa Brito Margaridha I P Ribeiro Sara N Edmond William C Becker Steve Martino Mehmet Sofuoglu Alicia A Heapy |
| author_facet | R Ross MacLean Brett Ankawi Mary A Driscoll Melissa A Gordon Tami L Frankforter Charla Nich Sara K Szollosy Jennifer M Loya Larissa Brito Margaridha I P Ribeiro Sara N Edmond William C Becker Steve Martino Mehmet Sofuoglu Alicia A Heapy |
| author_sort | R Ross MacLean |
| collection | DOAJ |
| description |
BackgroundChronic pain is common among individuals with opioid use disorder (OUD) who are maintained on medications for OUD (MOUD; eg, buprenorphine or methadone). Chronic pain is associated with worse retention and higher levels of substance use. Treatment of individuals with chronic pain receiving MOUD can be challenging due to their increased clinical complexity. Given the acute and growing nature of the opioid crisis, MOUD is increasingly offered in a wide range of settings, where high-quality, clinician-delivered, empirically validated behavioral treatment for chronic pain may not be available. Therefore, digital treatments that support patient self-management of chronic pain and OUD have the potential for wider implementation to fill this gap.
ObjectiveThis study aims to evaluate the efficacy of Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT), an interactive digital treatment program with asynchronous coach feedback, compared to treatment as usual (TAU) in individuals with chronic pain and OUD receiving MOUD.
MethodsAdult participants (n=160) receiving MOUD and reporting bothersome or high-impact chronic pain will be recruited from outpatient opioid treatment programs in Connecticut (United States) and randomized 1:1 to either IMPACT+TAU or TAU only. Participants randomized to IMPACT+TAU will complete an interactive digital treatment that includes 9 modules promoting training in pain and addiction coping skills and a progressive walking program. The program is augmented with a weekly personalized voice message from a trained coach based on daily participant-reported pain intensity and interference, craving to use opioids, sleep quality, daily steps, pain self-efficacy, MOUD adherence, and engagement with IMPACT collected through digital surveys. Outcomes will be assessed at 3, 6, and 9 months post randomization. The primary outcome is MOUD retention at 3 months post randomization (ie, post treatment). Secondary outcomes include pain interference, physical functioning, MOUD adherence, substance use, craving, pain intensity, sleep disturbance, pain catastrophizing, and pain self-efficacy. Semistructured qualitative interviews with study participants (n=34) randomized to IMPACT (completers and noncompleters) will be conducted to evaluate the usability and quality of the program and its outcomes.
ResultsThe study has received institutional review board approval and began recruitment at 1 site in July 2022. Recruitment at a second site started in January 2023, with a third and final site anticipated to begin recruitment in January 2024. Data collection is expected to continue through June 2025.
ConclusionsEstablishing efficacy for a digital treatment for addiction and chronic pain that can be integrated into MOUD clinics will provide options for individuals with OUD, which reduce barriers to behavioral treatment. Participant feedback on the intervention will inform updates or modifications to improve engagement and efficacy.
Trial RegistrationClinicalTrials.gov NCT05204576; https://clinicaltrials.gov/ct2/show/NCT05204576
International Registered Report Identifier (IRRID)DERR1-10.2196/54342 |
| first_indexed | 2024-04-24T21:59:48Z |
| format | Article |
| id | doaj.art-3cb39b16979e4706b8c32dc5eb1d0e6a |
| institution | Directory Open Access Journal |
| issn | 1929-0748 |
| language | English |
| last_indexed | 2024-04-24T21:59:48Z |
| publishDate | 2024-03-01 |
| publisher | JMIR Publications |
| record_format | Article |
| series | JMIR Research Protocols |
| spelling | doaj.art-3cb39b16979e4706b8c32dc5eb1d0e6a2024-03-20T12:45:55ZengJMIR PublicationsJMIR Research Protocols1929-07482024-03-0113e5434210.2196/54342Efficacy of Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT) in Individuals With Chronic Pain and Opioid Use Disorder: Protocol for a Randomized Clinical Trial of a Digital Cognitive Behavioral TreatmentR Ross MacLeanhttps://orcid.org/0000-0001-8067-7828Brett Ankawihttps://orcid.org/0000-0001-5420-8972Mary A Driscollhttps://orcid.org/0000-0001-7807-6118Melissa A Gordonhttps://orcid.org/0009-0006-8458-1413Tami L Frankforterhttps://orcid.org/0000-0002-8925-8408Charla Nichhttps://orcid.org/0000-0001-9769-259XSara K Szollosyhttps://orcid.org/0000-0002-9668-0308Jennifer M Loyahttps://orcid.org/0000-0002-9807-2234Larissa Britohttps://orcid.org/0009-0004-9744-0420Margaridha I P Ribeirohttps://orcid.org/0009-0003-8703-769XSara N Edmondhttps://orcid.org/0000-0002-6042-0053William C Beckerhttps://orcid.org/0000-0002-0788-1467Steve Martinohttps://orcid.org/0000-0002-7308-6592Mehmet Sofuogluhttps://orcid.org/0000-0002-5401-4681Alicia A Heapyhttps://orcid.org/0000-0003-1284-8263 BackgroundChronic pain is common among individuals with opioid use disorder (OUD) who are maintained on medications for OUD (MOUD; eg, buprenorphine or methadone). Chronic pain is associated with worse retention and higher levels of substance use. Treatment of individuals with chronic pain receiving MOUD can be challenging due to their increased clinical complexity. Given the acute and growing nature of the opioid crisis, MOUD is increasingly offered in a wide range of settings, where high-quality, clinician-delivered, empirically validated behavioral treatment for chronic pain may not be available. Therefore, digital treatments that support patient self-management of chronic pain and OUD have the potential for wider implementation to fill this gap. ObjectiveThis study aims to evaluate the efficacy of Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT), an interactive digital treatment program with asynchronous coach feedback, compared to treatment as usual (TAU) in individuals with chronic pain and OUD receiving MOUD. MethodsAdult participants (n=160) receiving MOUD and reporting bothersome or high-impact chronic pain will be recruited from outpatient opioid treatment programs in Connecticut (United States) and randomized 1:1 to either IMPACT+TAU or TAU only. Participants randomized to IMPACT+TAU will complete an interactive digital treatment that includes 9 modules promoting training in pain and addiction coping skills and a progressive walking program. The program is augmented with a weekly personalized voice message from a trained coach based on daily participant-reported pain intensity and interference, craving to use opioids, sleep quality, daily steps, pain self-efficacy, MOUD adherence, and engagement with IMPACT collected through digital surveys. Outcomes will be assessed at 3, 6, and 9 months post randomization. The primary outcome is MOUD retention at 3 months post randomization (ie, post treatment). Secondary outcomes include pain interference, physical functioning, MOUD adherence, substance use, craving, pain intensity, sleep disturbance, pain catastrophizing, and pain self-efficacy. Semistructured qualitative interviews with study participants (n=34) randomized to IMPACT (completers and noncompleters) will be conducted to evaluate the usability and quality of the program and its outcomes. ResultsThe study has received institutional review board approval and began recruitment at 1 site in July 2022. Recruitment at a second site started in January 2023, with a third and final site anticipated to begin recruitment in January 2024. Data collection is expected to continue through June 2025. ConclusionsEstablishing efficacy for a digital treatment for addiction and chronic pain that can be integrated into MOUD clinics will provide options for individuals with OUD, which reduce barriers to behavioral treatment. Participant feedback on the intervention will inform updates or modifications to improve engagement and efficacy. Trial RegistrationClinicalTrials.gov NCT05204576; https://clinicaltrials.gov/ct2/show/NCT05204576 International Registered Report Identifier (IRRID)DERR1-10.2196/54342https://www.researchprotocols.org/2024/1/e54342 |
| spellingShingle | R Ross MacLean Brett Ankawi Mary A Driscoll Melissa A Gordon Tami L Frankforter Charla Nich Sara K Szollosy Jennifer M Loya Larissa Brito Margaridha I P Ribeiro Sara N Edmond William C Becker Steve Martino Mehmet Sofuoglu Alicia A Heapy Efficacy of Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT) in Individuals With Chronic Pain and Opioid Use Disorder: Protocol for a Randomized Clinical Trial of a Digital Cognitive Behavioral Treatment JMIR Research Protocols |
| title | Efficacy of Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT) in Individuals With Chronic Pain and Opioid Use Disorder: Protocol for a Randomized Clinical Trial of a Digital Cognitive Behavioral Treatment |
| title_full | Efficacy of Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT) in Individuals With Chronic Pain and Opioid Use Disorder: Protocol for a Randomized Clinical Trial of a Digital Cognitive Behavioral Treatment |
| title_fullStr | Efficacy of Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT) in Individuals With Chronic Pain and Opioid Use Disorder: Protocol for a Randomized Clinical Trial of a Digital Cognitive Behavioral Treatment |
| title_full_unstemmed | Efficacy of Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT) in Individuals With Chronic Pain and Opioid Use Disorder: Protocol for a Randomized Clinical Trial of a Digital Cognitive Behavioral Treatment |
| title_short | Efficacy of Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT) in Individuals With Chronic Pain and Opioid Use Disorder: Protocol for a Randomized Clinical Trial of a Digital Cognitive Behavioral Treatment |
| title_sort | efficacy of integrating the management of pain and addiction via collaborative treatment impact in individuals with chronic pain and opioid use disorder protocol for a randomized clinical trial of a digital cognitive behavioral treatment |
| url | https://www.researchprotocols.org/2024/1/e54342 |
| work_keys_str_mv | AT rrossmaclean efficacyofintegratingthemanagementofpainandaddictionviacollaborativetreatmentimpactinindividualswithchronicpainandopioidusedisorderprotocolforarandomizedclinicaltrialofadigitalcognitivebehavioraltreatment AT brettankawi efficacyofintegratingthemanagementofpainandaddictionviacollaborativetreatmentimpactinindividualswithchronicpainandopioidusedisorderprotocolforarandomizedclinicaltrialofadigitalcognitivebehavioraltreatment AT maryadriscoll efficacyofintegratingthemanagementofpainandaddictionviacollaborativetreatmentimpactinindividualswithchronicpainandopioidusedisorderprotocolforarandomizedclinicaltrialofadigitalcognitivebehavioraltreatment AT melissaagordon efficacyofintegratingthemanagementofpainandaddictionviacollaborativetreatmentimpactinindividualswithchronicpainandopioidusedisorderprotocolforarandomizedclinicaltrialofadigitalcognitivebehavioraltreatment AT tamilfrankforter efficacyofintegratingthemanagementofpainandaddictionviacollaborativetreatmentimpactinindividualswithchronicpainandopioidusedisorderprotocolforarandomizedclinicaltrialofadigitalcognitivebehavioraltreatment AT charlanich efficacyofintegratingthemanagementofpainandaddictionviacollaborativetreatmentimpactinindividualswithchronicpainandopioidusedisorderprotocolforarandomizedclinicaltrialofadigitalcognitivebehavioraltreatment AT sarakszollosy efficacyofintegratingthemanagementofpainandaddictionviacollaborativetreatmentimpactinindividualswithchronicpainandopioidusedisorderprotocolforarandomizedclinicaltrialofadigitalcognitivebehavioraltreatment AT jennifermloya efficacyofintegratingthemanagementofpainandaddictionviacollaborativetreatmentimpactinindividualswithchronicpainandopioidusedisorderprotocolforarandomizedclinicaltrialofadigitalcognitivebehavioraltreatment AT larissabrito efficacyofintegratingthemanagementofpainandaddictionviacollaborativetreatmentimpactinindividualswithchronicpainandopioidusedisorderprotocolforarandomizedclinicaltrialofadigitalcognitivebehavioraltreatment AT margaridhaipribeiro efficacyofintegratingthemanagementofpainandaddictionviacollaborativetreatmentimpactinindividualswithchronicpainandopioidusedisorderprotocolforarandomizedclinicaltrialofadigitalcognitivebehavioraltreatment AT saranedmond efficacyofintegratingthemanagementofpainandaddictionviacollaborativetreatmentimpactinindividualswithchronicpainandopioidusedisorderprotocolforarandomizedclinicaltrialofadigitalcognitivebehavioraltreatment AT williamcbecker efficacyofintegratingthemanagementofpainandaddictionviacollaborativetreatmentimpactinindividualswithchronicpainandopioidusedisorderprotocolforarandomizedclinicaltrialofadigitalcognitivebehavioraltreatment AT stevemartino efficacyofintegratingthemanagementofpainandaddictionviacollaborativetreatmentimpactinindividualswithchronicpainandopioidusedisorderprotocolforarandomizedclinicaltrialofadigitalcognitivebehavioraltreatment AT mehmetsofuoglu efficacyofintegratingthemanagementofpainandaddictionviacollaborativetreatmentimpactinindividualswithchronicpainandopioidusedisorderprotocolforarandomizedclinicaltrialofadigitalcognitivebehavioraltreatment AT aliciaaheapy efficacyofintegratingthemanagementofpainandaddictionviacollaborativetreatmentimpactinindividualswithchronicpainandopioidusedisorderprotocolforarandomizedclinicaltrialofadigitalcognitivebehavioraltreatment |