Assessing the Efficacy of Self-Driven Repetitive Artmaking Practice

NCT06554431 | Completed Results

• 2 other identifiers: 2023-154401RM1DA055437-01
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Opioid Use Disorder; Opioid Misuse; Opioid-Related Disorders

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  4 months

Secondary Outcomes (9)

• Mood Outcomes - Anxiety

  Before and after a microintervention within a 24 hour period, up to 4 months

• Mood Outcomes - Depression

  Before and after a microintervention within a 24 hour period, up to 4 months

• Current Level of Pain

  Before and after a microintervention within a 24 hour period, up to 4 months

• 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 Least

  Before the workshop and before each microintervention within a 24 hour period, up to 4 months

Study Arms (1)

Art Making

EXPERIMENTAL

Each patient will receive artmaking kits

Behavioral: Self-Driven Repetitive Artmaking

Interventions

Self-Driven Repetitive Artmaking BEHAVIORAL

Three (3) art kits which all use repetitive artmaking processes (e.g., materials for mandalas, stamp making kit, weaving kit)

Art Making

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Are not fluent in either English or Spanish

Sponsors & Collaborators

• Montefiore Medical Center: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Montefiore Wellness Center at Waters Place

The Bronx, New York, 10461, United States

Location

Related Publications (35)

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• 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

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MeSH Terms

Conditions

Chronic Pain; Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Limitations and Caveats

Because the small sample size restricts the statistical power and generalizability of the findings, the results of this pilot study should be interpreted with caution.

Results Point of Contact

• Title: Jenny Seham
• Organization: Montefiore Medical Center

jseham@montefiore.org

718-696-3040

Study Officials

• Jenny Seham, PhD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Repetitive Artmaking

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: August 15, 2024
• Study Start: July 2, 2024
• Primary Completion: January 5, 2025
• Study Completion: January 5, 2025
• Last Updated: March 3, 2026
• Results First Posted: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)