Ignite Creation Date:
2024-10-25 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06554431
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
Assessing the Efficacy of Self-Driven Repetitive Artmaking Practice
Sponsor:
None
Organization:
None
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary purpose of this study is to assess the acceptability of self-directed art making for people with chronic pain and OUDopioid misuse or to state it another way whether people with chronic pain and OUDopioid 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
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 OUDopioid 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 OUDopioid 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 ie 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 OUDopioid 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 OUDopioid 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 OUDopioid 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 OUDopioid 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 OUDopioid 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 OUDopioid 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 OUDopioid 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 OUDopioid 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
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 OUDopioid 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 ie 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 OUDopioid 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 OUDopioid 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 OUDopioid 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 OUDopioid 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 OUDopioid 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 OUDopioid 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 OUDopioid 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 OUDopioid 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None