It will be investigated whether a new form of exposure therapy, aiming at the reduction of anxiety by the disconfirmation of expectancies and learning of new inhibitory associations will lead to less AN symptoms, better acceptance of weight gain and…
ID
Source
Brief title
Condition
- Eating disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• Eating disorder symptoms (Eating Disorder Examination Questionnaire; EDEQ;
Global Score en Subscale Scores)
• Body weight and length (BMI)
• Anxiety in different situations or tasks (State Anxiety; Visual Analog Scale;
VAS)
• Probability and credibility of the frightening thoughts different situations
or tasks
• Acceptance of body weight (scale test and VR)
• Food intake (lab breakfast)
• Body image (VR)
• Body image (lichaamswaarderingslijst)
Secondary outcome
• General anxiety (Trait Anxiety)
• Intolerance of uncertainty
• Depression
• Personality disorders
• Expectance of the therapy
• Number of exposure sessions
• Content of exposure sessions
• Therapist per exposure session
• Number of sessions and duration of regular treatment
Background summary
Anorexia nervosa is an eating disorder that often takes a chronic course and
potentially becomes life threatening: the mortality rate amongst all
psychiatric disorders is highest in AN. Up until now, treatment is mostly
unsuccessful. Therefore, it is important to develop better treatment for AN;
especially personalized treatment, targeting factors that maintain the disorder
is necessary. Anxiety plays a central role in AN and it is suggested that
specifically anxiety and associated avoidance behaviors maintain the disorder.
In common praxis, however, anxieties that patients with AN face are not
targeted, which may reduce treatment success and heighten the relapse rate. We
expect that targeting and reducing AN specific anxieties will improve treatment
outcomes in AN.
Study objective
It will be investigated whether a new form of exposure therapy, aiming at the
reduction of anxiety by the disconfirmation of expectancies and learning of new
inhibitory associations will lead to less AN symptoms, better acceptance of
weight gain and higher body weight. The intervention will be offered to parts
of the AN patients at the MUMC+ and Youz Maastricht in addition to their
regular treatment. Also, patients who are not currently in treatment are asked
to participate.
Study design
Because the current intervention is *personalized treatment* we will
predominantly study effects in a within subjects clinical case series design.
To assess the additional value of our intervention we will compare outcomes
with a group of AN patients who will not receive our intervention but only
their regular treatment/ no treatment.
Intervention
Some participants will receive regular treatment that is offered at the section
for eating disorders. Also, patients who are not currently in treatment are
asked to participate. We will randomly assign 30 participants to the condition
where the additional exposure intervention is offered. They will receive a
minimum of 30 and a maximum of 40 individual exposure sessions. In this group
the exposure will thus be offered in addition to the regular treatment/ no
treatment.
Study burden and risks
Risks: participation can be burdensome in a sense that it requires time and
energy to conduct the measurements and exposure sessions. Moreover,
participation can cause a temporary rise of anxiety. Other than this no risks
are known.
Benefits: the participants receive a reward for participating at the
measurements. Patients who receive our new exposure intervention will more
likely experience a stronger reduction in eating disorder symptomatology than
patients who will not receive the intervention. Further, our additional
intervention is gratis.
Universiteitssingel 40
Maastricht 6229 ET
NL
Universiteitssingel 40
Maastricht 6229 ET
NL
Listed location countries
Age
Inclusion criteria
1)Primary diagnosis: Anorexia Nervosa according to DSM5 (307.1)
2) participant is or will be in treatment for Anorexia Nervosa at the MUMC+ or
Youz Maastricht or is not currently in treatment
3) age: 16 years and older
4)Body Mass Index between 13 and 18,5
5)Patient is able to give Informed Consent
Exclusion criteria
Patients with a primary diagnosis of Anorexia nervosa (DSM5: 307.1) who fulfill
one or more of the following criteria will be excluded from participation:
1) Body Mass Index below 13
2) Regular treatment is not predominately focusing on AN but a on secondary
diagnosis
3) Acute danger of suicide
4) Serious medical or psychological condition that makes participation
impossible or dangerous
5) Patient is not able to give Informed Consent
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 |
|---|---|
| Other | Het onderzoek wordt bij www.asPredicted.org geregistreerd zodra het door de METC goedgekeurd is |
| CCMO | NL72174.068.20 |