Trial Outcomes & Findings for Assessing the Efficacy of Self-Driven Repetitive Artmaking Practice (NCT NCT06554431)

Ethnicity data is missing for 2 participants on study.

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 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.

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.

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 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) 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.

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.

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.

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 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.

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.