Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT05911334 |
| Other study ID # |
STUDY00006140 |
| Secondary ID |
AOTFIRG23Hardiso |
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2023 |
| Est. completion date |
April 19, 2024 |
Study information
| Verified date |
June 2024 |
| Source |
University of New Mexico |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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 (e.g., 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 (e.g. 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.
