1) We examine whether individuals who binge eat, and their mental health care professionals value the ESM app as a useful tool in BED treatment; 2) We examine which emotional and situational factors and fluctuations of these factors immediately…
ID
Source
Brief title
Condition
- Eating disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Aim 1: Qualitative evaluations of the practical use and added value of the app
for treatment. Aim 2: Within-person mean-level changes in emotions and
situations and its bi-directional associations with binge eating episodes and
cravings will be examined with the data collected with the ESM application.
Secondary outcome
Not applicable.
Background summary
Binge eating disorder (BED) is the most common eating disorder. It has a
detrimental effect on individual*s health and well-being, as it may lead to
obesity, depressive symptoms and substance abuse. Research using the Experience
Sampling Method (ESM) which assesses daily emotions and activities suggests
that mood changes precede binge eating episodes among BED patients. Such
fine-grained information about modifiable behaviours and emotions can be used
to detect individualized treatment targets.
Study objective
1) We examine whether individuals who binge eat, and their mental health care
professionals value the ESM app as a useful tool in BED treatment;
2) We examine which emotional and situational factors and fluctuations of these
factors immediately precede and follow binge eating episodes and cravings.
Study design
Longitudinal intervention study, with 6 weeks of Experience Sampling (ESM)
integrated within a smartphone app. After 6 weeks, a qualitative,
semi-structured interview evaluates the practical use and added value of the
app.
Intervention
ESM app as an additional tool to TAU:
In the first week of treatment, participants are asked to download the app on
their phone and to start the monitoring. They receive 5 semi-random
notifications per day on their smartphone as an invite to fill out
micro-questionnaires. If a participants does not fill in the
micro-questionnaire, s/he will receive a notification after 30 minutes to
remind the participant to fill out the questionnaire.
Participants are also instructed to initiate an ESM report during a binge
eating episode, right after a binge eating episode or when they experience a
strong urge to binge eat. The reports of each participant are automatically
included in the personal graph in their app, which monitors daily fluctuations
in emotions and the occurrence of binge eating events. The participants can
evaluate their emotions and binge eating episodes in the graph any time and can
select the emotions of interest.
In the first 6 weeks of treatment, the therapist briefly discusses the graph
with the participants during each group treatment session. All assessments of
micro-questionnaires are included in the graph and may offer participants
insight in their pattern of binges and its triggers.
Study burden and risks
Data collection takes 6 weeks* time, during which participants receive
semi-random beeps on their smartphone at 5 random times during the day as an
invite to fill out 5 micro-questionnaires. Per beep, it takes a 1-2 minutes to
fill out the micro-questionnaire. Pilot studies with the app in the general
population indicated that the burden is minimal. In fact, as we want to offer
participants a tool to support them in overcoming their binge eating episodes,
we expect that participants will be motivated to use the app. The app prototype
has already been used by lead investigator Jansen in the Generation R Study,
and will be approved by the privacy and security office of the Erasmus
University Rotterdam. Collected data will be stored on a secured server.
Burgermeester Oudlaan 50
Rotterdam 3062 PA
NL
Burgermeester Oudlaan 50
Rotterdam 3062 PA
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet be an
adult aged 18 to 65 years old, known to have binge eating disorder according to
the DSM 5 classification and who are indicated to be treated with group
therapy.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
1. Inability to understand Dutch, inability to read or write Dutch
2. No internet access or no email or no cell phone.
3. Patients who do not fill out their baseline questionnaires
4. People who use medication that is known to trigger binges, such as
corticosteroids, antipsychotics and some antidepressants (e.g. mirtazapine) or
antihistamines (e.g. promethazine).
5. People who are suspected to have a monogenetic pathology as the cause of
their obesity and binges.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL75943.078.20 |