Chronic PainNCT06554431
Assessing the Efficacy of Self-Driven Repetitive Artmaking Practice
A study testing Self-Driven Repetitive Artmaking in people with Chronic Pain and Opioid Use Disorder, run by Montefiore Medical Center at 1 site in United States.
Trial summary
The primary purpose of this study is to assess the acceptability of self-directed art making for people with chronic pain and OUD/opioid misuse, or to state it another way, whether people with chronic pain and OUD/opioid misuse will realistically do this artistic practice on their own. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Opioid Use Disorder, Opioid Misuse
- What is being tested?
- Self-Driven Repetitive Artmaking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2024to 5 Jan 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Experience chronic pain
- Have received medication for OUD in the past 30 days or meet criteria for opioid misuse
- Are aged 18 or older
- Are fluent in English and/or Spanish
Who cannot join
- Are not fluent in either English or Spanish
- Are unable to participate in and complete the introductory workshop due to language or other barriers - physical disabilities are not exclusionary
- Do not otherwise meet the inclusion criteria for age, OUD, Opioid misuse, and chronic pain.
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Wellness Center at Waters Place
The Bronx, New York, 10461
About this study
Official title: Assessing the Efficacy of Self-Driven Repetitive Artmaking Practice on Pain and Mood States for Patients With Chronic Pain, Opioid Use Disorder, and Opioid Misuse
The primary purpose of this study is to assess the acceptability of self-directed art making for people with chronic pain and OUD/opioid misuse, or to state it another way, whether people with chronic pain and OUD/opioid misuse will realistically do this artistic practice on their own.
A secondary question of this study is to explore whether doing this art practice can help minimize pain during the artistic process, lessen depression and anxiety, and improve feelings of social connection.
Read the detailed description
The pilot is an exploratory evaluation of whether repetitive artmaking in home environments is acceptable for chronic pain self-management in individuals with OUD/opioid misuse, and whether self-driven repetitive artmaking can offer respite from pain, depression, and anxiety, and improve social connectivity.
The study will recruit 40 individuals living with chronic pain with an OUD diagnosis or opioid misuse from a Montefiore-led methadone clinic. The Principal Investigators (PIs) will collaborate with an Art Therapist to develop three (3) simple art kits. Patients will participate in an in-person art workshop, to be held in English with the support of a Spanish translator, and complete pre- and post-surveys assessing in-the moment pain, anxiety, depression, and social connectivity. Patients will be given all three (3) kits to take home and to complete the same pre- and post-surveys and art kits at home up to four (4) times within a four-month period to assess real-world adoptability and efficacy. The art kits will not include any visible information about Montefiore or the study in the front of the packets; paper versions of the survey will be enclosed within the kits, to support confidentiality. A subset of patients will be invited to a virtual meaning making group to capture qualitative feedback. The study staff will not share the names of patients with anyone outside the core research team - the co-PIs, Study Coordinator, Patient Advocate, Biostatistician, Art Therapist, and Photographer and Exhibit Coordinator. All patients will be invited to have their art photographed and share their experience of the artmaking process and how it relates to their chronic pain and opioid use.
Photographs and stories will be shared on the Montefiore campus as an art exhibit, and the layperson audience will be surveyed to assess any resultant alteration in feelings of stigma toward the population of those living with chronic pain and OUD/opioid misuse. Patients who share their artwork will be able to decide if their name (or a portion of their name) or a pseudonym will be included in the exhibit alongside their artwork, or whether maintaining anonymity is preferred.
Implementation:
In-Person Workshop: An Art Therapist, will lead three (3) two-hour in-person workshops, with all patients required to attend one (1) in-person workshop as part of this study. Spanish translation will be available at all workshops. The purpose of these workshops are twofold: gather patient characteristic data (demographics, Pain Catastrophizing Survey, questions on experience with art and openness to mindfulness) and orient patients to the use of the art kits available to them to take and use at home. The art therapist will develop three (3) repetitive artmaking kit options and will develop enough for patients to leave the workshop with one of each kit. Options include mandala painting, weaving, and stamp making kits. As previously stated, the art kits will be compiled to minimize visual identification from others that are part of a research study, with all survey materials asking sensitive questions buried in the middle of the packet. At the start of the in-person workshop, PI will orient patients to the pilot goals and activities, answer all questions, collect consent forms, and provide the link to the pre-survey assessing pain and mood as well as paper versions of the survey. The art therapist will provide an engaging overview of the three available kits, and patients will select a kit to try for the in-person workshop. PI will be present to provide Spanish translation and explanation as necessary. The last 15 minutes of the workshop will be saved for patients to complete the post-survey on pain and mood. Finally, patients will be informed that they will be invited to bring their artistic outputs to be photographed by a professional photographer at the end of the four month period and to share their experiences of making the art, so that they can share what they have made with the broader community.
It will be made it clear that displaying their art and sharing their experiences is not mandatory, that patients do not need to decide during the workshop if they will want to share their artwork, and that they will be able to use full, part, or none of their name in the event.
At-Home Artmaking: Patients will be invited to take home all three (3) art kits at the end of the in-person workshop, each of which will allow them to make multiple versions of the type of art in question (i.e., materials for multiple mandalas). Each kit will include printed copies of the pre and post-survey assessing pain and mood, along with a reminder to complete the pre- and post-survey when doing the kits (the end date will be included in the art kits).
Communication from the Survey Coordinator will also include the links to the pre- and post surveys. The instructions will prompt patients to complete the survey immediately before starting the art kit and immediately after concluding. Patients will further be prompted to include a photo of their art in the post-survey and can text their photo to the Study Coordinator if they have phone-based photography capacity. All instructions will be in English and Spanish. This implementation process is designed to assess real-world use of the art kits.
The pilot study is an exploratory implementation and mixed methods evaluation of self-guided repetitive art-making to assess the impact of this artistic practice on:
- self-reported pain levels,
- self-reported mood states including anxiety and depression, and
- self-reported feelings of connection for patients living with chronic pain and opioid use disorder (OUD) or documented misuse of opioids.
A secondary research focus will be to assess whether viewing art made by patients with chronic pain and OUD/opioid misuse diminishes stigma towards these populations for the broader population.
Aim 1 (Acceptability): Develop three (3) self-guided repetitive artmaking kits for patients with chronic pain and OUD/opioid misuse to use on their own, with instructions in English and Spanish, and train the patients on the use of these artmaking kits through three (3) in person workshops in English and Spanish.
Hypothesis 1: Simple art kits that offer repetitive artmaking practices will be acceptable for and interesting to patients with chronic pain and OUD/opioid misuse. Acceptability will be measured as described in the Outcome Measures. Brief questions will be asked at the workshops to assess patients' previous experience with art and openness to mindfulness activities, along with a brief demographic questionnaire, to provide a baseline.
Aim 2 (Efficacy): Evaluate whether the self-guided repetitive artmaking kits significantly impact patients' self-reported experiences of pain, mood (inclusive of depression and anxiety), and social isolation.
Hypothesis 2: Repetitive artmaking will reduce experiences of pain for patients with both chronic pain and OUD/opioid misuse. Significant pain reduction during artmaking practice as captured using the first three questions of the Brief Pain Inventory (BPI) Reduced Minus Peg Questions 8-item questionnaire - questions one and two will be only asked in the pre-survey as these questions ask about pain over the last week and will therefore not change before and after a solo artmaking experience. Patients will also complete the 6-item Pain Catastrophizing Questionnaire as described in the Outcome Measures. This data will be supplemented with qualitative data from the meaning making session and storytelling content, for those who participate.
Hypothesis 3: Repetitive artmaking will reduce depression and anxiety and improve mood for patients with chronic pain and OUD/opioid misuse as described in the Outcome Measures. This data will be supplemented with qualitative data from the meaning making session and storytelling content, for those who participate.
Hypothesis 4: Supporting patients with chronic pain and OUD/opioid misuse in making art will result in higher ratings of social connectivity. Significant improvement in social connectivity during artmaking practice will be captured using the IOS-CC and assessed as described in the Outcome Measures.
Hypothesis 5: Repetitive artmaking will reduce opioid misuse in patients. Any reduction in non-prescribed opioid use as captured as described in the Outcome Measures. This data will be supplemented with qualitative data from the meaning making session and storytelling content, for those who participate.
Aim 3 (Community Intervention): Prepare an exhibit of art made by patients and stories of their experiences and evaluate whether this exhibit impacts stigma regarding chronic pain and opioid use in the broader population (audience).
Hypothesis 6: Laypersons viewing photographs of the art paired with patients' descriptions of their art and the artmaking process, will lessen stigma towards people with chronic pain and OUD/opioid misuse. Laypersons who view the exhibit and who complete a retroactive pre-post survey will self-report lessened stigma towards persons with chronic pain and OUD/opioid misuse through positive appraisal of the artists. This data will be supplemented with qualitative data from the meaning making session and storytelling content, for those who participate.
- Being tested
- Self-Driven Repetitive Artmaking
- Medical subject headings
- Chronic Pain, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Driven Repetitive ArtmakingBehavioural
Three (3) art kits which all use repetitive artmaking processes (e.g., materials for mandalas, stamp making kit, weaving kit)
| Study group | Role | What they receive |
|---|---|---|
| Art Making | Experimental | Each patient will receive artmaking kits Receives: Behavioral: Self-Driven Repetitive Artmaking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the Intervention
Feasibility of the intervention will be measured quantitatively by the number of patients who complete the pre- and post-survey up to four (4) times. Results are summarized.
Measured: 4 months
Acceptability of the Intervention
Acceptability of the intervention was assessed as a composite measure. Specifically, acceptability was assessed based on the number of participants who both responded affirmatively during training sessions as to whether they used the art kits at home AND also similarly reported to the Study Coordinator (SC) during monthly check-ins they engaged with the art kits on their own time. The number of participants who both responded 'Yes' on the survey and reported home use during monthly check-ins is summarized.
Measured: 4 months
Secondary outcomes (9)
Mood Outcomes - Anxiety
Anxiety before and after the workshop and each instance of repetitive art making (up to 4 sessions) will be assessed based on a single question administered during the survey: "How anxious are you feeling right now?" Patient responses will be scored on a 5-point Likert scale ranging from 0 ("Extremely") to 4 ("Not at all"). In this context, higher scores are associated with reduced levels of worrying and fearfulness regarding everyday situations. Group results will be summarized using basic descriptive statistics.
Measured: Before and after a microintervention within a 24 hour period, up to 4 months
Mood Outcomes - Depression
Depression before and after the workshop and each instance of repetitive art making (up to 4 sessions) will be assessed based on a single question administered during the survey: "How sad are you feeling right now?" Patient responses will be scored on a 5-point Likert scale ranging from 0 ("Extremely") to 4 ("Not at all"). In this context, higher scores are associated with reduced levels of feeling down or hopelessness and increased pleasure in daily activities. Group results will be summarized using basic descriptive statistics.
Measured: Before and after a microintervention within a 24 hour period, up to 4 months
Current Level of Pain
Current level of pain before and after the workshop and each instance of repetitive art making (up to 4 sessions) will be assessed based on a single question administered during the survey. Patients will be asked to rate the severity of their current pain on a scale ranging from 0 ("No Pain") to 10 = ("Pain as bad as you can imagine") with higher scores being associated increased pain severity. Group results will be summarized using basic descriptive statistics.
Measured: Before and after a microintervention within a 24 hour period, up to 4 months
Previous Week Pain - at Its Worst
Previous week pain (at its worst) will be assessed before the workshop and before each instance of repetitive art making (up to 4 sessions) by asking patients a single question to describe the least and most pain they have experienced over past week (7 days) on a scale ranging from 0 ("No Pain") to 10 ("Pain as bad as you can imagine") with higher scores being associated increased pain severity. Group results will be summarized using basic descriptive statistics.
Measured: Before the workshop and before each microintervention within a 24 hour period, up to 4 months
Previous Week Pain - at Its Least
Previous week pain (at its least) will be assessed before the workshop and before each instance of repetitive art making (up to 4 sessions) by asking patients a single question to describe the least and most pain they have experienced over past week (7 days) on a scale ranging from 0 ("No Pain") to 10 ("Pain as bad as you can imagine") with higher scores being associated increased pain severity. Group results will be summarized using basic descriptive statistics.
Measured: Before the workshop and before each microintervention within a 24 hour period, up to 4 months
Pain Catastrophizing Experience
Pain Catastrophizing experience before the workshop will be assessed based on patient responses on the 6-item Pain Catastrophizing Scale (PCS-6) conducted during the in-person workshop. The PCS-6, a short form of the PCS questionnaire, consists of six statements (Items 4, 5, 6, 10, 11, and 13 from the 13-item PCS questionnaire) which ask about the degree of pain catastrophizing on a 5-point Likert scale ranging from 0 ("Not at all") to 4 ("All the time") for an overall possible scoring range of 0-24. Higher scores are associated with increased perceptions of helplessness regarding their pain, magnification of their pain, and pain-related rumination. Group results will be summarized using basic descriptive statistics.
Measured: Before the workshop, within 24 hours
Social Connectivity
Social Connectivity before and after the workshop and each instance of repetitive art making (up to 4 sessions) will be assessed using the Inclusion of Other in the Self Scale to assess Communal Coping (IOS-CC). Patients are presented with seven pairs of circles that range from just touching to almost completely overlapping. One circle in each pair is labeled "self," and the second circle is labeled "other." Patients are asked to choose the pair of circles that best describe their relationship to their community. Responses are scored as: 1 = no overlap; 2 = little overlap; 3 = some overlap; 4 = equal overlap; 5 = strong overlap; 6 = very strong overlap; 7 = most overlap such that the higher the score the stronger the bond with their community. Group results will be summarized using basic descriptive statistics.
Measured: Before and after a microintervention within a 24 hour period, up to 4 months
Non-prescribed Opioid Use
Non-prescribed opioid use during the past 24 hours prior to the workshop as well as each instance of repetitive art making (up to 4 sessions) will be assessed based on a response to a binary question (modified from the Addiction Severity Index) as to whether the patient has used non-prescription opioids during the past 24 hours. "No" responses will be assigned a score of 0; "Yes" responses will be assigned a score of 1. The number of participants who responded affirmatively is summarized for each instance.
Measured: Before the workshop and before each microintervention within a 24-hour period, up to 4 months
Level of Intoxication
Level of intoxication before and after the workshop and each instance of repetitive art making (up to 4 sessions) will be assessed based on a single question derived from the modified, Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis Use (DFAQ-CU) inventory with the exception that the question is focused on opioids not cannabis. Patients will be asked to share how high they are at the time of the survey on a 5-point Likert scale ranging from 0 ("I am not high") to 4 ("I am very high") such that higher scores are associated with increased states of being high. Group results will be summarized using basic descriptive statistics.
Measured: Before and after a microintervention within a 24 hour period, up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start2 Jul 2024
- Primary completion5 Jan 2025
- Study completion5 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Repetitive Artmaking
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Jenny Seham, PhD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06554431
- Sponsor's protocol ID
- 2023-15440
- Other IDs
- 1RM1DA055437-01, 2023
- Status last verified
- Feb 2026
- First submitted
- 25 Jul 2024
- Last updated
- 3 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yong RJ, Mullins PM, Bhattacharyya N. Prevalence of chronic pain among adults in the United States. Pain. 2022 Feb 1;163(2):e328-e332. doi: 10.1097/j.pain.0000000000002291.
PubMed 33990113Rikard SM, Strahan AE, Schmit KM, Guy GP Jr. Chronic Pain Among Adults - United States, 2019-2021. MMWR Morb Mortal Wkly Rep. 2023 Apr 14;72(15):379-385. doi: 10.15585/mmwr.mm7215a1.
PubMed 37053114Lerman SF, Rudich Z, Brill S, Shalev H, Shahar G. Longitudinal associations between depression, anxiety, pain, and pain-related disability in chronic pain patients. Psychosom Med. 2015 Apr;77(3):333-41. doi: 10.1097/PSY.0000000000000158.
PubMed 25849129Fishbain DA, Cutler R, Rosomoff HL, Rosomoff RS. Chronic pain-associated depression: antecedent or consequence of chronic pain? A review. Clin J Pain. 1997 Jun;13(2):116-37. doi: 10.1097/00002508-199706000-00006.
PubMed 9186019Allen SF, Gilbody S, Atkin K, van der Feltz-Cornelis C. The associations between loneliness, social exclusion and pain in the general population: A N=502,528 cross-sectional UK Biobank study. J Psychiatr Res. 2020 Nov;130:68-74. doi: 10.1016/j.jpsychires.2020.06.028. Epub 2020 Aug 1.
PubMed 32791383McCaffrey R, Frock TL, Garguilo H. Understanding chronic pain and the mind-body connection. Holist Nurs Pract. 2003 Nov-Dec;17(6):281-7; quiz 288-9. doi: 10.1097/00004650-200311000-00002.
PubMed 14650569Angheluta A-M., & Lee, B. L. (2011). Art therapy for chronic pain: Applications and future directions. Canadian Journal of Counselling and Psychotherapy, 45(2), 112-131.
Dahlhamer JM, Connor EM, Bose J, Lucas JL, Zelaya CE. Prescription Opioid Use Among Adults With Chronic Pain: United States, 2019. Natl Health Stat Report. 2021 Aug;(162):1-9.
PubMed 34524076Keyes KM, Rutherford C, Hamilton A, Barocas JA, Gelberg KH, Mueller PP, Feaster DJ, El-Bassel N, Cerda M. What is the prevalence of and trend in opioid use disorder in the United States from 2010 to 2019? Using multiplier approaches to estimate prevalence for an unknown population size. Drug Alcohol Depend Rep. 2022 Jun;3:100052. doi: 10.1016/j.dadr.2022.100052. Epub 2022 Apr 8.
PubMed 35783994Substance Abuse and Mental Health Services Administration (SAMHSA). (2021). Highlights for the 2021 National Survey on Drug Use and Health. Retrieved May 22, 2023 from https://www.samhsa.gov/datasites/default/files/2022- 12/2021NSDUHFFRHighlights092722.pdf
Premier, Inc. (2019, January 30). Opioid overdoses costing U.S. hospitals an estimated $11 billion annually. Retrieved May 22, 2023 from https://www.premierinc.com/newsroom/press-reoleases/opioid-overdoses/costing-u-shospitals-an-estimated-11-billion-annually
Florence C, Luo F, Rice K. The economic burden of opioid use disorder and fatal opioid overdose in the United States, 2017. Drug Alcohol Depend. 2021 Jan 1;218:108350. doi: 10.1016/j.drugalcdep.2020.108350. Epub 2020 Oct 27.
PubMed 33121867Shella, T. A. (2018). Art therapy improves mood, and reduces pain and anxiety when offered at bedside during acute hospital treatment. The Arts in Psychotherapy, 57, 59-64.
Hass-Cohen N., Bokoch, R., Goodman, K., & Conover, K. J. (2021). Art therapy drawing protocols for chronic pain: Quantitative results from a mixed method pilot study. The Arts in Psychotherapy, 73, 101479.
Angheluta A-M., & Lee, B. L. (2011). Art therapy for chronic pain: Applications and future directions. Canadian Journal of Counselling and Psychotherapy, 45(2), 112-131
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Efficacy of Self-Driven Repetitive Artmaking Practice on Pain and Mood States for Patients With Chronic Pain, Opioid Use Disorder, and Opioid Misuse
- ClinicalTrials.gov ID
- NCT06554431
- Acronym / sponsor ID
- 2023-15440
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 2 Jul 2024 (actual)
- Primary completion
- 5 Jan 2025 (actual)
- Study completion
- 5 Jan 2025 (actual)
- First posted
- 15 Aug 2024 (actual)
- Results
- Posted 3 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to assess the acceptability of self-directed art making for people with chronic pain and OUD/opioid misuse, or to state it another way, whether people with chronic pain and OUD/opioid misuse will realistically do this artistic practice on their own.
A secondary question of this study is to explore whether doing this art practice can help minimize pain during the artistic process, lessen depression and anxiety, and improve feelings of social connection.
Detailed description
The pilot is an exploratory evaluation of whether repetitive artmaking in home environments is acceptable for chronic pain self-management in individuals with OUD/opioid misuse, and whether self-driven repetitive artmaking can offer respite from pain, depression, and anxiety, and improve social connectivity.
The study will recruit 40 individuals living with chronic pain with an OUD diagnosis or opioid misuse from a Montefiore-led methadone clinic. The Principal Investigators (PIs) will collaborate with an Art Therapist to develop three (3) simple art kits. Patients will participate in an in-person art workshop, to be held in English with the support of a Spanish translator, and complete pre- and post-surveys assessing in-the moment pain, anxiety, depression, and social connectivity. Patients will be given all three (3) kits to take home and to complete the same pre- and post-surveys and art kits at home up to four (4) times within a four-month period to assess real-world adoptability and efficacy. The art kits will not include any visible information about Montefiore or the study in the front of the packets; paper versions of the survey will be enclosed within the kits, to support confidentiality. A subset of patients will be invited to a virtual meaning making group to capture qualitative feedback. The study staff will not share the names of patients with anyone outside the core research team - the co-PIs, Study Coordinator, Patient Advocate, Biostatistician, Art Therapist, and Photographer and Exhibit Coordinator. All patients will be invited to have their art photographed and share their experience of the artmaking process and how it relates to their chronic pain and opioid use.
Photographs and stories will be shared on the Montefiore campus as an art exhibit, and the layperson audience will be surveyed to assess any resultant alteration in feelings of stigma toward the population of those living with chronic pain and OUD/opioid misuse. Patients who share their artwork will be able to decide if their name (or a portion of their name) or a pseudonym will be included in the exhibit alongside their artwork, or whether maintaining anonymity is preferred.
Implementation:
In-Person Workshop: An Art Therapist, will lead three (3) two-hour in-person workshops, with all patients required to attend one (1) in-person workshop as part of this study. Spanish translation will be available at all workshops. The purpose of these workshops are twofold: gather patient characteristic data (demographics, Pain Catastrophizing Survey, questions on experience with art and openness to mindfulness) and orient patients to the use of the art kits available to them to take and use at home. The art therapist will develop three (3) repetitive artmaking kit options and will develop enough for patients to leave the workshop with one of each kit. Options include mandala painting, weaving, and stamp making kits. As previously stated, the art kits will be compiled to minimize visual identification from others that are part of a research study, with all survey materials asking sensitive questions buried in the middle of the packet. At the start of the in-person workshop, PI will orient patients to the pilot goals and activities, answer all questions, collect consent forms, and provide the link to the pre-survey assessing pain and mood as well as paper versions of the survey. The art therapist will provide an engaging overview of the three available kits, and patients will select a kit to try for the in-person workshop. PI will be present to provide Spanish translation and explanation as necessary. The last 15 minutes of the workshop will be saved for patients to complete the post-survey on pain and mood. Finally, patients will be informed that they will be invited to bring their artistic outputs to be photographed by a professional photographer at the end of the four month period and to share their experiences of making the art, so that they can share what they have made with the broader community.
It will be made it clear that displaying their art and sharing their experiences is not mandatory, that patients do not need to decide during the workshop if they will want to share their artwork, and that they will be able to use full, part, or none of their name in the event.
At-Home Artmaking: Patients will be invited to take home all three (3) art kits at the end of the in-person workshop, each of which will allow them to make multiple versions of the type of art in question (i.e., materials for multiple mandalas). Each kit will include printed copies of the pre and post-survey assessing pain and mood, along with a reminder to complete the pre- and post-survey when doing the kits (the end date will be included in the art kits).
Communication from the Survey Coordinator will also include the links to the pre- and post surveys. The instructions will prompt patients to complete the survey immediately before starting the art kit and immediately after concluding. Patients will further be prompted to include a photo of their art in the post-survey and can text their photo to the Study Coordinator if they have phone-based photography capacity. All instructions will be in English and Spanish. This implementation process is designed to assess real-world use of the art kits.
The pilot study is an exploratory implementation and mixed methods evaluation of self-guided repetitive art-making to assess the impact of this artistic practice on:
- self-reported pain levels,
- self-reported mood states including anxiety and depression, and
- self-reported feelings of connection for patients living with chronic pain and opioid use disorder (OUD) or documented misuse of opioids.
A secondary research focus will be to assess whether viewing art made by patients with chronic pain and OUD/opioid misuse diminishes stigma towards these populations for the broader population.
Aim 1 (Acceptability): Develop three (3) self-guided repetitive artmaking kits for patients with chronic pain and OUD/opioid misuse to use on their own, with instructions in English and Spanish, and train the patients on the use of these artmaking kits through three (3) in person workshops in English and Spanish.
Hypothesis 1: Simple art kits that offer repetitive artmaking practices will be acceptable for and interesting to patients with chronic pain and OUD/opioid misuse. Acceptability will be measured as described in the Outcome Measures. Brief questions will be asked at the workshops to assess patients' previous experience with art and openness to mindfulness activities, along with a brief demographic questionnaire, to provide a baseline.
Aim 2 (Efficacy): Evaluate whether the self-guided repetitive artmaking kits significantly impact patients' self-reported experiences of pain, mood (inclusive of depression and anxiety), and social isolation.
Hypothesis 2: Repetitive artmaking will reduce experiences of pain for patients with both chronic pain and OUD/opioid misuse. Significant pain reduction during artmaking practice as captured using the first three questions of the Brief Pain Inventory (BPI) Reduced Minus Peg Questions 8-item questionnaire - questions one and two will be only asked in the pre-survey as these questions ask about pain over the last week and will therefore not change before and after a solo artmaking experience. Patients will also complete the 6-item Pain Catastrophizing Questionnaire as described in the Outcome Measures. This data will be supplemented with qualitative data from the meaning making session and storytelling content, for those who participate.
Hypothesis 3: Repetitive artmaking will reduce depression and anxiety and improve mood for patients with chronic pain and OUD/opioid misuse as described in the Outcome Measures. This data will be supplemented with qualitative data from the meaning making session and storytelling content, for those who participate.
Hypothesis 4: Supporting patients with chronic pain and OUD/opioid misuse in making art will result in higher ratings of social connectivity. Significant improvement in social connectivity during artmaking practice will be captured using the IOS-CC and assessed as described in the Outcome Measures.
Hypothesis 5: Repetitive artmaking will reduce opioid misuse in patients. Any reduction in non-prescribed opioid use as captured as described in the Outcome Measures. This data will be supplemented with qualitative data from the meaning making session and storytelling content, for those who participate.
Aim 3 (Community Intervention): Prepare an exhibit of art made by patients and stories of their experiences and evaluate whether this exhibit impacts stigma regarding chronic pain and opioid use in the broader population (audience).
Hypothesis 6: Laypersons viewing photographs of the art paired with patients' descriptions of their art and the artmaking process, will lessen stigma towards people with chronic pain and OUD/opioid misuse. Laypersons who view the exhibit and who complete a retroactive pre-post survey will self-report lessened stigma towards persons with chronic pain and OUD/opioid misuse through positive appraisal of the artists. This data will be supplemented with qualitative data from the meaning making session and storytelling content, for those who participate.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Repetitive Artmaking
| Arm | Type | Receives |
|---|---|---|
| Art Making | Experimental | Behavioral: Self-Driven Repetitive ArtmakingEach patient will receive artmaking kits |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Experience chronic pain
- Have received medication for OUD in the past 30 days or meet criteria for opioid misuse
- Are aged 18 or older
- Are fluent in English and/or Spanish
Key exclusion criteria (3 listed)
- Are not fluent in either English or Spanish
- Are unable to participate in and complete the introductory workshop due to language or other barriers - physical disabilities are not exclusionary
- Do not otherwise meet the inclusion criteria for age, OUD, Opioid misuse, and chronic pain.
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 |
|---|---|---|
| Self-Driven Repetitive ArtmakingThree (3) art kits which all use repetitive artmaking processes (e.g., materials for mandalas, stamp making kit, weaving kit) | Behavioural | Art Making |
Primary outcome
Feasibility of the Intervention
Time frame: 4 months
Feasibility of the intervention will be measured quantitatively by the number of patients who complete the pre- and post-survey up to four (4) times. Results are summarized.
Acceptability of the Intervention
Time frame: 4 months
Acceptability of the intervention was assessed as a composite measure. Specifically, acceptability was assessed based on the number of participants who both responded affirmatively during training sessions as to whether they used the art kits at home AND also similarly reported to the Study Coordinator (SC) during monthly check-ins they engaged with the art kits on their own time. The number of participants who both responded 'Yes' on the survey and reported home use during monthly check-ins is summarized.
9 secondary outcomes
Mood Outcomes - Anxiety
Time frame: Before and after a microintervention within a 24 hour period, up to 4 months
Mood Outcomes - Depression
Time frame: Before and after a microintervention within a 24 hour period, up to 4 months
Current Level of Pain
Time frame: Before and after a microintervention within a 24 hour period, up to 4 months
Previous Week Pain - at Its Worst
Time frame: Before the workshop and before each microintervention within a 24 hour period, up to 4 months
Previous Week Pain - at Its Least
Time frame: Before the workshop and before each microintervention within a 24 hour period, up to 4 months
Pain Catastrophizing Experience
Time frame: Before the workshop, within 24 hours
Social Connectivity
Time frame: Before and after a microintervention within a 24 hour period, up to 4 months
Non-prescribed Opioid Use
Time frame: Before the workshop and before each microintervention within a 24-hour period, up to 4 months
Level of Intoxication
Time frame: Before and after a microintervention within a 24 hour period, up to 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 33990113Yong RJ, Mullins PM, Bhattacharyya N. Prevalence of chronic pain among adults in the United States. Pain. 2022 Feb 1;163(2):e328-e332. doi: 10.1097/j.pain.0000000000002291.
- Background: PubMed 37053114Rikard SM, Strahan AE, Schmit KM, Guy GP Jr. Chronic Pain Among Adults - United States, 2019-2021. MMWR Morb Mortal Wkly Rep. 2023 Apr 14;72(15):379-385. doi: 10.15585/mmwr.mm7215a1.
- Background: PubMed 25849129Lerman SF, Rudich Z, Brill S, Shalev H, Shahar G. Longitudinal associations between depression, anxiety, pain, and pain-related disability in chronic pain patients. Psychosom Med. 2015 Apr;77(3):333-41. doi: 10.1097/PSY.0000000000000158.
- Background: PubMed 9186019Fishbain DA, Cutler R, Rosomoff HL, Rosomoff RS. Chronic pain-associated depression: antecedent or consequence of chronic pain? A review. Clin J Pain. 1997 Jun;13(2):116-37. doi: 10.1097/00002508-199706000-00006.
- Background: PubMed 32791383Allen SF, Gilbody S, Atkin K, van der Feltz-Cornelis C. The associations between loneliness, social exclusion and pain in the general population: A N=502,528 cross-sectional UK Biobank study. J Psychiatr Res. 2020 Nov;130:68-74. doi: 10.1016/j.jpsychires.2020.06.028. Epub 2020 Aug 1.
- Background: PubMed 14650569McCaffrey R, Frock TL, Garguilo H. Understanding chronic pain and the mind-body connection. Holist Nurs Pract. 2003 Nov-Dec;17(6):281-7; quiz 288-9. doi: 10.1097/00004650-200311000-00002.
- BackgroundAngheluta A-M., & Lee, B. L. (2011). Art therapy for chronic pain: Applications and future directions. Canadian Journal of Counselling and Psychotherapy, 45(2), 112-131.
- Background: PubMed 34524076Dahlhamer JM, Connor EM, Bose J, Lucas JL, Zelaya CE. Prescription Opioid Use Among Adults With Chronic Pain: United States, 2019. Natl Health Stat Report. 2021 Aug;(162):1-9.
- Background: PubMed 35783994Keyes KM, Rutherford C, Hamilton A, Barocas JA, Gelberg KH, Mueller PP, Feaster DJ, El-Bassel N, Cerda M. What is the prevalence of and trend in opioid use disorder in the United States from 2010 to 2019? Using multiplier approaches to estimate prevalence for an unknown population size. Drug Alcohol Depend Rep. 2022 Jun;3:100052. doi: 10.1016/j.dadr.2022.100052. Epub 2022 Apr 8.
- BackgroundSubstance Abuse and Mental Health Services Administration (SAMHSA). (2021). Highlights for the 2021 National Survey on Drug Use and Health. Retrieved May 22, 2023 from https://www.samhsa.gov/datasites/default/files/2022- 12/2021NSDUHFFRHighlights092722.pdf
- BackgroundPremier, Inc. (2019, January 30). Opioid overdoses costing U.S. hospitals an estimated $11 billion annually. Retrieved May 22, 2023 from https://www.premierinc.com/newsroom/press-reoleases/opioid-overdoses/costing-u-shospitals-an-estimated-11-billion-annually
- Background: PubMed 33121867Florence C, Luo F, Rice K. The economic burden of opioid use disorder and fatal opioid overdose in the United States, 2017. Drug Alcohol Depend. 2021 Jan 1;218:108350. doi: 10.1016/j.drugalcdep.2020.108350. Epub 2020 Oct 27.
- 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.
Jenny Seham, PhD 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 Self-Driven Repetitive Artmaking in people with Chronic Pain 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 3 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 Mar 2026. 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?
Yes. Results are posted in the registry (first posted 3 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Feasibility of the Intervention (time frame: 4 months). The study lists 2 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 NCT06554431, 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 Mar 2026.