Assessing the Efficacy of Self-Driven Repetitive Artmaking Practice

Not Applicable

Completed

• Conditions: Opioid-Related Disorders; Opioid Use Disorder; Chronic Pain; Opioid Misuse

• Registration Number: NCT06554431
• Lead Sponsor: Montefiore Medical Center

Brief 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.

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:

1. self-reported pain levels,

2. self-reported mood states including anxiety and depression, and

3. 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 Timeline

• Study Start: 2024-07-02
• Study First Submitted: 2024-07-25
• Study First Submitted QC: 2024-08-13
• Study First Posted: 2024-08-15
• Primary Completion: 2025-01-05
• Study Completion: 2025-01-05
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-05
• Last Update Posted: 2025-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

1. Experience chronic pain
2. Have received medication for OUD in the past 30 days or meet criteria for opioid misuse
3. Are aged 18 or older
4. Are fluent in English and/or Spanish

Exclusion Criteria

1. Are not fluent in either English or Spanish
2. Are unable to participate in and complete the introductory workshop due to language or other barriers - physical disabilities are not exclusionary
3. Do not otherwise meet the inclusion criteria for age, OUD, Opioid misuse, and chronic pain.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility of the Intervention	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. Group mean results will be summarized.
Acceptability of the Intervention	4 months	Acceptability of the intervention will be measured during listening sessions with participants responding to questions regarding whether they used the art kits at home AND whether they report to the Study Coordinator (SC) during monthly check-ins to confirm that they have engaged with the art kits on their own. Group mean results will be summarized using basic descriptive statistics.

Secondary Outcome Measures

Name	Time	Method
Previous week pain - at its least	Before the workshop and before each microintervention within a 24 hour period, up to 4 months	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.
Social Connectivity	Before and after a microintervention within a 24 hour period, up to 4 months	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.
Non-prescribed Opioid Use	Before and after a microintervention within a 24 hour period, up to 4 months	Non-prescribed opioid use before and after the workshop and 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. Group results will be summarized.
Level of Opioid Highness	Before and after a microintervention within a 24 hour period, up to 4 months	Level of opioid highness 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.
Mood outcomes - Anxiety	Before and after a microintervention within a 24 hour period, up to 4 months	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.
Mood outcomes - Depression	Before and after a microintervention within a 24 hour period, up to 4 months	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.
Current Level of Pain	Before and after a microintervention within a 24 hour period, up to 4 months	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.
Previous week pain - at its worst	Before the workshop and before each microintervention within a 24 hour period, up to 4 months	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.
Pain Experiences	Before the workshop, within 24 hours	Pain experiences 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.

Trial Locations

Locations (1)

Montefiore Wellness Center at Waters Place; 🇺🇸 Bronx, New York, United States