Clinical trial NCT06554431: Assessing the Efficacy of Self-Driven Repetitive Artmaking Practice
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Opioid Use Disorder
Opioid Misuse
Opioid-Related Disorders
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-08-15
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Repetitive Artmaking
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of the Intervention
timeFrame: 4 months
measure: Acceptability of the Intervention
timeFrame: 4 months
Secondary outcomes:
measure: Mood outcomes - Anxiety
timeFrame: Before and after a microintervention within a 24 hour period, up to 4 months
measure: Mood outcomes - Depression
timeFrame: Before and after a microintervention within a 24 hour period, up to 4 months
measure: Current Level of Pain
timeFrame: Before and after a microintervention within a 24 hour period, up to 4 months
measure: Previous week pain - at its worst
timeFrame: Before the workshop and before each microintervention within a 24 hour period, up to 4 months
measure: Previous week pain - at its least
timeFrame: Before the workshop and before each microintervention within a 24 hour period, up to 4 months
measure: Pain Experiences
timeFrame: Before the workshop, within 24 hours
measure: Social Connectivity
timeFrame: Before and after a microintervention within a 24 hour period, up to 4 months
measure: Non-prescribed Opioid Use
timeFrame: Before and after a microintervention within a 24 hour period, up to 4 months
measure: Level of Opioid Highness
timeFrame: Before and after a microintervention within a 24 hour period, up to 4 months
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Wellness Center at Waters Place
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Jenny Seham, PhD
role: PRINCIPAL_INVESTIGATOR
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