Ignite Creation Date:
2024-05-06 @ 7:10 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05911334
Status:
TERMINATED
Last Update Posted:
2024-06-18
First Post:
2023-06-09
Brief Title:
Feasibility of the ROADE Program
Sponsor:
University of New Mexico
Organization:
University of New Mexico
Study Overview
Official Title:
Assessing the Feasibility of the Restorative Occupational Approaches for Disordered Eating ROADE Program
Status:
TERMINATED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The ROADE grant was terminated early by CG and the PI left the institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Occupational therapy is uniquely poised to help address chronic Eating Disorders EDs because of our holistic approach to client care The complex and serious nature of EDs spans so many areas of life and wellbeing it requires an intervention strategy that addresses the whole person across mental physical social and spiritual realms Unfortunately specialized care for EDs can be difficult to find - especially for those not sick enough to be admitted to an inpatient facility but who are still struggling to thrive in daily life For example in New Mexico there is only one inpatient treatment center for EDs and no specialized outpatient services This leaves many people suffering from EDs without options for care because they are not yet sick enough There is a need for novel interventions in this setting that go beyond the traditional weight and food-focused medical interventions and seek to help empower individuals work around challenges and live their lives to the fullest
To meet this need in our community the study team is developing a preliminary outpatient treatment program The ROADE Restorative Occupational Approaches for Disordered Eating Program is an 8-week structured multimodal intervention seeking to reduce psychosocial symptoms and improve self-management skills for disordered eating The intervention strategies range from 1 wellness activities like mindfulness meditation to improve interoception self-acceptance and as a self-guided coping tool 2 adaptation of health management and self-care occupations to improve daily functioning while navigating ongoing disordered eating symptoms and 3 light exercise like Yoga and lymphatic drainage exercises to reconnect in a positive way with the body improve digestion promote relaxation and reduce muscle tension The current research investigates the feasibility and acceptability of this intervention while testing preliminary effects on eating disorder symptoms
To meet this need in our community the study team is developing a preliminary outpatient treatment program The ROADE Restorative Occupational Approaches for Disordered Eating Program is an 8-week structured multimodal intervention seeking to reduce psychosocial symptoms and improve self-management skills for disordered eating The intervention strategies range from 1 wellness activities like mindfulness meditation to improve interoception self-acceptance and as a self-guided coping tool 2 adaptation of health management and self-care occupations to improve daily functioning while navigating ongoing disordered eating symptoms and 3 light exercise like Yoga and lymphatic drainage exercises to reconnect in a positive way with the body improve digestion promote relaxation and reduce muscle tension The current research investigates the feasibility and acceptability of this intervention while testing preliminary effects on eating disorder symptoms
Detailed Description:
Eating Disorders ED are pervasive long-lasting conditions that are exceptionally destructive to wellbeing and many areas of occupational performance In the United States an estimated 29 million individuals will suffer from an eating disorder across their lifespan Academy for Eating Disorders 2020 with the most common diagnoses being Anorexia Nervosa Binge Eating Disorder Bulimia Nervosa and Avoidant Restrictive Food Intake Disorder ARFID Though distinct each of these diagnoses share a feature of individuals developing a dysfunctional relationship with food that is rigid and ritualized The point prevalence of all eating disorders combined appears to be on the rise worldwide increasing from an estimated 4 to 8 of the population starting in the year 2000 through 2018 Galmiche 2019 Often this is accompanied with compulsive routines that exhaust many hours a day Beyond disrupted eating symptoms span almost all areas of occupation eg hygiene social functioning work rest and affect both mental health and physical health Bradford et al 2015
Unfortunately with current treatments for eating disorders the long-term outcomes are poor Recovery can be a long process often taking 6 years or more Franco 2017 but this is likely an underestimate due to the limited length of research follow up Arcelus et al 2011 Estimates of recovery and mortality range greatly depending on the source with as much as half of individuals not recovering fully and up to an astounding 5 of those afflicted with Anorexia Nervosa dying from the disorder Franko et al 2013 Sadly 1 in 5 deaths from Anorexia Nervosa result from suicide while predictors of higher mortality include alcohol misuse and other comorbid mental health diagnoses Arcelus et al 2011 Multiple systematic reviews report that current interventions have yet to demonstrate strong effect sizes and there is no one specific approach that has emerged as best practice Kotilahti et al 2020 Murray et al 2018 Peat et al 2017 Zeeck et al 2018 There is a call to move beyond a simplistic treatment model that over-emphasizes weight gain or loss and instead more fully addresses personal and social effects of the disorder uses harm reduction strategies and strives to empower clients Hay et al 2012
The present project addresses the serious complex and enduring nature of eating disorders Occupational therapy is uniquely poised to help address chronic EDs because of our holistic approach to client care As eating disorders affect myriad areas of health and wellbeing they require intervention strategies that addresses the whole person across mental physical and social realms Specialized care for EDs can be difficult to find This is especially true for those not sick enough to be admitted to an inpatient facility but who are still struggling to thrive in daily life Specific to the state of New Mexico where the project will be conducted there are currently no outpatient mental health services that specialize in treating eating disorders Individuals may succeed in graduating from the single in-patient eating disorder clinic in our state but are discharged without a strong outpatient program to follow their care This presents a large risk of relapse Our hope is that ROADE Program will eventually grow into a resource for the community and help bridge this gap in services More broadly the present project has the opportunity to build a role for occupational therapists in treating eating disorders and expand our role in chronic illness management
Occupational therapy interventions in this setting to our knowledge have yet been evaluated experimentally Much of the publications in occupational therapy about eating disorder treatment is older evidence or relies on expert opinion and nonsystematic literature review to describe potential avenues for intervention eg Bradford et al 2015 Clark Nayar 2012 Gardener Brown 2010 Horner 2006 One occupational therapy text in mental health Crouch Alers 2014 one survey of occupational therapists working in mental health settings Klockzko Ikiugu 2006 and a small subjective study that polled participants opinion about the helpfulness of the intervention Biddiscombe et al 2018 demonstrate that occupational therapy self-identifies as having a role in treating eating disorders Key points of interest for from these perspectives are that occupational therapists should work in a collaborative model with other healthcare providers use a holistic approach to care and focus on the areas of occupation that are affected by the disorder With this emerging level of evidence the study team has developed one such program from the ground up Our preliminary take on developing an intervention used best available evidence from within occupational therapy but also draws from outside the profession We focused on restorative approaches fitting within the occupational therapy practice area based on the OT Practice Framework AOTA 2020 This became the ROADE Restorative Occupational Approaches for Disordered Eating Program
The ROADE Program is to our knowledge the first of its kind being an occupational-therapy-specific intervention for disordered eating In its current form it is an 8-week structured multimodal intervention seeking to reduce psychosocial symptoms and improve self-management skills for disordered eating The intervention strategies range from 1 Light exercises and Yoga to improve lymphatic drainage improve digestion promote relaxation and reduce muscle tension Gibson Mehler 2019 Moser 2020 Sim et al 2017 Souza et al 2018 2 mindfulness meditation to improve interoception self-acceptance and as a self-guided coping tool Sala et al 2020 and 3 adaptation of health management and self-care occupations to improve daily functioning while navigating ongoing disordered eating symptoms Crouch Alers 2014 Sørlie et al 2020 It is our hope to further hone this program into a manualized intervention track the preliminary effects of the intervention collect feasibility data points and then seek funding for an efficacy trial These objectives will be explored in the form of three specific aims
Specific Aim 1 To establish the feasibility of implementing the ROADE Program in a research setting Specific Aim 2 To determine the preliminary effects the ROADE Program intervention has on disordered eating symptoms
Specific Aim 3 To hone the ROADE Program protocol by leveraging expert guidance training and experience
Unfortunately with current treatments for eating disorders the long-term outcomes are poor Recovery can be a long process often taking 6 years or more Franco 2017 but this is likely an underestimate due to the limited length of research follow up Arcelus et al 2011 Estimates of recovery and mortality range greatly depending on the source with as much as half of individuals not recovering fully and up to an astounding 5 of those afflicted with Anorexia Nervosa dying from the disorder Franko et al 2013 Sadly 1 in 5 deaths from Anorexia Nervosa result from suicide while predictors of higher mortality include alcohol misuse and other comorbid mental health diagnoses Arcelus et al 2011 Multiple systematic reviews report that current interventions have yet to demonstrate strong effect sizes and there is no one specific approach that has emerged as best practice Kotilahti et al 2020 Murray et al 2018 Peat et al 2017 Zeeck et al 2018 There is a call to move beyond a simplistic treatment model that over-emphasizes weight gain or loss and instead more fully addresses personal and social effects of the disorder uses harm reduction strategies and strives to empower clients Hay et al 2012
The present project addresses the serious complex and enduring nature of eating disorders Occupational therapy is uniquely poised to help address chronic EDs because of our holistic approach to client care As eating disorders affect myriad areas of health and wellbeing they require intervention strategies that addresses the whole person across mental physical and social realms Specialized care for EDs can be difficult to find This is especially true for those not sick enough to be admitted to an inpatient facility but who are still struggling to thrive in daily life Specific to the state of New Mexico where the project will be conducted there are currently no outpatient mental health services that specialize in treating eating disorders Individuals may succeed in graduating from the single in-patient eating disorder clinic in our state but are discharged without a strong outpatient program to follow their care This presents a large risk of relapse Our hope is that ROADE Program will eventually grow into a resource for the community and help bridge this gap in services More broadly the present project has the opportunity to build a role for occupational therapists in treating eating disorders and expand our role in chronic illness management
Occupational therapy interventions in this setting to our knowledge have yet been evaluated experimentally Much of the publications in occupational therapy about eating disorder treatment is older evidence or relies on expert opinion and nonsystematic literature review to describe potential avenues for intervention eg Bradford et al 2015 Clark Nayar 2012 Gardener Brown 2010 Horner 2006 One occupational therapy text in mental health Crouch Alers 2014 one survey of occupational therapists working in mental health settings Klockzko Ikiugu 2006 and a small subjective study that polled participants opinion about the helpfulness of the intervention Biddiscombe et al 2018 demonstrate that occupational therapy self-identifies as having a role in treating eating disorders Key points of interest for from these perspectives are that occupational therapists should work in a collaborative model with other healthcare providers use a holistic approach to care and focus on the areas of occupation that are affected by the disorder With this emerging level of evidence the study team has developed one such program from the ground up Our preliminary take on developing an intervention used best available evidence from within occupational therapy but also draws from outside the profession We focused on restorative approaches fitting within the occupational therapy practice area based on the OT Practice Framework AOTA 2020 This became the ROADE Restorative Occupational Approaches for Disordered Eating Program
The ROADE Program is to our knowledge the first of its kind being an occupational-therapy-specific intervention for disordered eating In its current form it is an 8-week structured multimodal intervention seeking to reduce psychosocial symptoms and improve self-management skills for disordered eating The intervention strategies range from 1 Light exercises and Yoga to improve lymphatic drainage improve digestion promote relaxation and reduce muscle tension Gibson Mehler 2019 Moser 2020 Sim et al 2017 Souza et al 2018 2 mindfulness meditation to improve interoception self-acceptance and as a self-guided coping tool Sala et al 2020 and 3 adaptation of health management and self-care occupations to improve daily functioning while navigating ongoing disordered eating symptoms Crouch Alers 2014 Sørlie et al 2020 It is our hope to further hone this program into a manualized intervention track the preliminary effects of the intervention collect feasibility data points and then seek funding for an efficacy trial These objectives will be explored in the form of three specific aims
Specific Aim 1 To establish the feasibility of implementing the ROADE Program in a research setting Specific Aim 2 To determine the preliminary effects the ROADE Program intervention has on disordered eating symptoms
Specific Aim 3 To hone the ROADE Program protocol by leveraging expert guidance training and experience
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AOTFIRG23Hardison | OTHER_GRANT | American Occupational Therapy Foundation | None |