Primary Objective: To assess AET*s effectiveness concerning eating disorder symptoms, autonomy-connectedness (primary outcome measures), general psychopathology, self-esteem and quality of life (secondary outcome measures). Secondary Objective(s):…
ID
Source
Brief title
Condition
- Eating disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Multiple Baseline Design
The Eating Disorder Examination Questionnaire - Short (Gideon et al., 2016) is
a brief, reliable and valid measure of eating disorder symptom severity. It
consists of 12 items and was developed for routine, including
session-by-session and outcome assessment. Gideon et al. found that it performs
similarly to the EDE-Q lending itself for the use of sessional outcome
monitoring in treatment and research (2016).
The Autonomy-Connectedness Scale (revised) (ACS-30) is an amended version of
the Autonomy-Connectedness measure, the ACS-30 (Bekker & van Assen, 2006). As
the ACS-30 does not allow for measuring short-term changes, we adapted it to
the ACS-30-S. The ACS-30-S instruction asks about participants* experiences
during the past week (instead of *Usually*, as in the original ACS-30).
Existing questions have been rephrased where timing is concerned (e.g. *I often
long for** has been changed to *I have longed for**).
The ACS-30-S has been reviewed by a convenience sample to assess acceptability
and feasibility, after which a few changes were made, concerning questions that
were hard to answer on a weekly basis (e.g. *When making important decisions
about my life, I leave other peoples* opinions and wishes out of consideration*
was changed to *When making decisions I leave other peoples* opinions and
wishes out of consideration*.) This process was repeated until the
questionnaire was easy to use. Psychometric properties of the ACS-30-S will be
conducted in the course of this study.)
Repeated Measures design
The Autonomy-Connectedness Scale (ACS-30) (Bekker & van Assen, 2006) consists
of 30 items and three subscales: Self-awareness, Sensitivity to others, and
Capacity for managing new situations. All items are measured on a 5-point
Likert scale, running from 1 (disagree) to 5 (agree). The ACS-30 has been shown
to have good psychometric properties. Norm scores are available and, agreeing
with ACs gender-sensitivity, separate SO norm scores exist for both sexes.
The EDE-Q (Luce & Crowther, 1999) assesses eating disorder pathology. It
measures four eating attitudes during the previous 28 days, using four
subscales: Restraint, Eating Concerns, Shape Concerns and Weight Concerns. The
scale consists of 36 items and has shown excellent internal consistency and
test-retest reliability.
Secondary outcome
The SCL-90 (Derogatis, 1994) consists of 90 items and 8 subscales. Norm scores
are available for the general population and psychiatric patients. The
reliability and validity of the SCL-90 are reported to be good.
Self-esteem is measured with the RSES (Sinclair et al., 2010), which consists
of 10 items and assesses global self-esteem. All items, containing positive and
negative statements about the self, are rated on a 4-point Likert scale ranging
from *strongly agree* to *strongly disagree*. The reliability and validity of
the RSES are reported to be good (Schmitt & Allik, 2005).
Quality of life is measured with the WHOQOL-BREF (The Whoqol Group, 1998),
which consists of 26 items, including four Quality of life domains: physical
health, psychological health, social relationships and environment.
Additionally, two items examine general Quality of life. All items are rated on
a 5-point Likert scale with 0 meaning *not at all*, *never*, *very poor*, or
*very dissatisfied*, and 4 meaning *completely*, *always*, *very good*, or
*very satisfied*. Psychometric properties have been studied in psychiatric
outpatients and are reported to be good (Trompenaars et al., 2005)
Background summary
Eating disorders are among the most serious but least successfully treated
mental disorders. In fact, to date, no evidence-based treatment for adults with
Anorexia Nervosa (AN) exist. Global eating disorder prevalence increased from
3.4% to 7.8% between 2000 and 2018, and there are reports of further increasing
rates worldwide (Galmiche et al., 2019). Due to COVID-19, child and adolescent
eating disorder services have seen almost a doubling in the number of urgent
and routine referrals, making eating disorders the fifth most prominent mental
health condition by August 2020 (FAIR health, 2021).
Eating disorders are associated with great functional impairment, morbidity and
mortality, with AN having the highest mortality rate of any psychiatric
disorder (Arcelus et al., 2011). At present, only approximately 50% of patients
recover after treatment (Hay et al., 2014) and even after successful treatment,
relapse is high, ranging from 22% to 51%.
Because of the major role of transdiagnostic factors in causing and keeping
eating disorders (Connan et al., 2003; Fairburn et al., 2003; Treasure et al.,
2012), we propose to investigate the innovative and gender-sensitive
Autonomy-Enhancing Treatment (AET). AET focuses on underlying transdiagnostic
autonomy deficits. Autonomy deficits characterise many psychiatric disorders,
including eating disorders (Bachrach et al., 2013; Bekker et al., 2007; Bekker
& Belt, 2006; Bekker & Croon, 2010; van Assen & Bekker, 2009), and are
reflected by a strong focus on the needs and wishes of others and a poor
ability to acknowledge and communicate one's own needs. AET has recently been
established as a(n) (cost-)effective treatment for anxiety disorders (Kunst et
al., 2022), and autonomy was one of the strongest predictors of recovery from
eating disorders in previous research (Kuipers et al., 2017).
Currently, AET is already implemented in the final phase of treatment at our
Centre for Eating Disorders (GGZ Oost-Brabant, Helmond). Patients enter the
final phase of treatment when the eating disorder is under control on a
behavioural level. It is based on further stabilisation, re-integration, and
relapse prevention. AET seems to fit very well in this phase of treatment, as
in this stage, patients struggle with who they are without the eating disorder.
They start learning more about their identity, become aware of, and act on
boundaries, needs and emotions, and learn to prioritise themselves instead of
only others in relationships. Practice-based evidence shows that patients value
this person-centred approach, as they feel AET penetrates the core of their
psychological problems. Given the alarming rise of ED prevalence, the current
lack of evidence-based treatment for adults with anorexia nervosa, and the
promising results for the effectiveness of AET for, e.g., anxiety disorders,
the natural next step is to investigate AET*s effectiveness for eating
disorders.
Study objective
Primary Objective: To assess AET*s effectiveness concerning eating disorder
symptoms, autonomy-connectedness (primary outcome measures), general
psychopathology, self-esteem and quality of life (secondary outcome measures).
Secondary Objective(s): To investigate if autonomy will mediate the decrease in
eating disorder symptoms.
Study design
We propose a multiple baseline design to investigate the effectiveness of AET
in the final phase of multidisciplinary treatment. Participants will be
patients at the GGZ Oost Brabant multidisciplinary centre from the AN and BN
group (this group is combined, for further details on treatment infrastructure
and context, see below) in the final phase of treatment.
A multiple baseline design will be used, with short-term eating disorder
symptoms and short-term autonomy connectedness as primary parameters.
Additionally, a repeated measures design will be used with long-term eating
disorder symptoms and long-term autonomy connectedness as primary parameters
and quality of life, self-esteem, depression and anxiety as secondary
parameters.
Intervention
Baseline consists of 5 to 13 weeks of treatment as usual in stage two of
treatment.
The investigational treatment, AET, consists of weekly 2-hour sessions
following the AET-protocol (Bekker et al., 2016). AET groups have an average of
8 participating patients (range 4-9). Sessions consist of psycho-education
about autonomy-connectedness, its relation to eating disorders and setting
autonomy-related personal goals. Each group member, supported by the
therapists, also acts as chairperson once, which entails keeping time and
structuring the group discussion to practice assertiveness. Sessions feature
different autonomy-related themes each week, serving as psycho-education as
well as grounds for discussion about autonomy-related difficulties (e.g.
relationships, boundaries, body and sexuality, emotions). The goal of the
treatment is to enhance understanding, feelings and behaviours of autonomy by
working on personal, autonomy-related goals.
Study burden and risks
Patients who participate in this study receive treatment offered in a centre
with expertise in treating eating disorders. The only difference between taking
part and not taking part in the study is the filling out of questionnaires. On
a weekly basis, this is expected to take less than fifteen minutes, and will be
done within sessions. On a three-monthly basis, this is expected to take +- 30
minutes.
AET is part of standard treatment. We do not anticipate any risks to patients
through participation.
Wesselmanlaan 25/A
Helmond 5707 HA
NL
Wesselmanlaan 25/A
Helmond 5707 HA
NL
Listed location countries
Age
Inclusion criteria
Being in the final phase of treatment at the Multidisciplinary Center of Eating
disorders after completing the AN or BN daycare treatment track.
Exclusion criteria
Patients who have not given informed consent to use their data for scientific
purposes.
No patients with a BMI lower than 15 are found in the final stage of treatment,
excluding them naturally from this study as well.
No patients younger than 18 years old are found in the final stage of
treatment, excluding them naturally from this study as well.
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 | NL83503.018.23 |