The primary objective of the study is to determine the feasibility of concurrent treatment for AN and PTSD. This study aims to determine whether (a) participants are able to complete the trauma sessions while staying adherent to the AN inpatient…
ID
Source
Brief title
Condition
- Other condition
- Psychiatric disorders
Synonym
Health condition
post-traumatische stress-stoornis
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Feasibility will be assessed by examining by assessing attrition rate and by
assessing trauma treatment acceptability.
The primary outcome measure is attrition rate (percentage of participants who
stop out or are withdrawn of the trauma-focused treatment due to negative
effect on the course of AN treatment. Negative effects on the AN treatment can
be not being able to stick to agreed daily meal plans anymore or for stopping
regaining weight. If attrition is attrition is <= 40%, indicating the completion
rate is equal to or over 60%, it is assumed synchronous trauma treatment is
feasible..
Secondary outcome
The secondary outcomes in this study are factors that may moderate attrition,
including duration of anorexia, AN subtype and AN onset, baseline BMI (kg/m2),
somatic disorders and emotion regulation measured using the Difficulties in
Emotion Regulation Scale (DERS; Gratz & Roemer, 2004). It is suspected that
these factors may moderate attrition.
Other secondary outcomes include treatment effects such as changes in eating
disorder pathology measured using the Eating Disorder Examination Interview
(Cooper &; Fairburn, 1987) and changes in trauma pathology measured using the
PTSD Checklist for DSM-5 (PCL-5).
In addition, other measures will assess the acceptability of combined
treatment. To measure the acceptability of the AN-PTSD treatment, a qualitative
interview will take place in which patients will be asked about their
experiences. Practitioners are also interviewed about their experiences before
and after treatment. Client satisfaction will be measured using the client
satisfaction questionnaire (CSQ-8; de Brey, 1983) at the end of the IE
treatment and at the end of the AN treatment. Finally, the Working Alliance
Inventory (WAI; Hatcher & Gillaspy, 2016) will be used to examine patients'
therapeutic alliance.
Background summary
Childhood maltreatment is a known risk factor for developing AN, a debilitating
disorder with poor treatment response (Waller, 2016) and high associated
treatment costs (Van den Berg et al., 2022). According to the self-medication
hypothesis AN pathology as starvation serves as a coping mechanism for dealing
with trauma-related intrusive symptoms (Brewerton, 2018). Childhood
maltreatment can also lead to the development of PTSD. Although guidelines
recommend an integrated treatment approach when dealing with AN and PTSD (Ten
Napel et al., 2022), up till now no integrated approaches have been developed
as severely underweight AN patients are not offered trauma treatment. The
present feasibility study is a necessary first step in building high quality
knowledge on an integrated treatment approach for severely underweight patients
with significant important PTSD symptoms.
Study objective
The primary objective of the study is to determine the feasibility of
concurrent treatment for AN and PTSD. This study aims to determine whether (a)
participants are able to complete the trauma sessions while staying adherent to
the AN inpatient treatment and (b) whether trauma treatment is acceptable for
both participants and AN therapists.
Once this feasibility study indicates that trauma treatment can be completed
while receiving and staying adherent to co-occurring AN treatment, an
integrated AN-PTSD treatment approach can be developed. Next, the longterm
efficacy and cost-effectiveness of such an approach can be examined in a high
quality, sufficiently powered randomized controlled trial.
Study design
The study design of this feasibility study is a pre-experimental cohort study.
Due to the 12-months duration of this grant, a limited number of eligible
patients will be available. Therefore, findings on feasibility will be
preliminary and warrant a study design with a longer inclusion period and an
additional follow up period, in order to have sufficient power for findings to
be robust.
The inpatient unit of Novarum consists of 12 beds and serves between 57 and 60
inpatients during a 12-months period, around 80% of hospitalized
inpatients have a AN diagnosis. At Novarum, all AN inpatients have a body mass
index under 17.5 kg/m2.
Assuming a 23% rate of co-occuring PTSD, around 11 patients might be eligible.
We expect 5-10% of inpatients who are not willing to participate (Ten
Napel, 2022). As we aim to examine feasibility of the trauma-focused
intervention within a real-world clinical AN population, minimal exclusion
criteria will be applied. Inclusion is aimed at around 10-11 patients.
When completion rate is equal to or over 60%, it is assumed synchronous trauma
treatment is feasible. Due to the modest number of eligible patients,
statistical findings will not be robust and will be more qualitative by nature.
"The Journal Article Reporting Standards" and the "Strengthening the Reporting
of Observational Studies in Epidemiology"statement will be used for study
design and reporting of the results.
Intervention
Individual CBT-based trauma-focused treatment (IE) for 8 weeks, twice a week,
will be offered by specialized trauma therapists, during a 12-weeks
hospitalization period for AN in a specialized eating disorder clinic. After
two weeks of hospitalization, trauma treatment will start.
The inpatient AN stay has a duration of 12 weeks and aims at regaining
psychiatric and physical stability in order for outpatient psychotherapy to
start
following hospitalization. During AN hospitalization, interventions are offered
on a voluntary basis by a multidisciplinary group of psychiatrists, medical
doctors, dieticians, nurses, and psychologists.
Study burden and risks
When participants are processing their trauma through imaginal exposure, they
may experience temporarily increased emotional distress which may present
through increased AN or PTSD symptoms, particularly directly after imaginal
exposure sessions.
Klaprozenweg 111
Amsterdam 1033 NN
NL
Klaprozenweg 111
Amsterdam 1033 NN
NL
Listed location countries
Age
Inclusion criteria
The study sample consists of consecutive referrals by general practitioners or
general hospitals with adult patients with severe anorexia nervosa (AN) and
(subthreshold) posttraumatic stress disorder (PTSD). Patients are eligible if
they meet all of the following criteria:
•Being over 18 years of age
•A DSM-5 diagnosis of AN with a body mass index under 17.5 kg/m2 , as assessed
by a psychiatrist or clinical psychologist. These AN patients have been offered
and accepted inpatient treatment
•Being exposed to childhood maltreatment prior to the onset of the eating
disorder, as assessed by the Dutch version of the Childhood Trauma
Questionnaire (CTQ; Thombs et al., 2009)
•Having a diagnosis of PTSD or sub-threshold PTSD as assessed by the Dutch
version of the Clinical-Administered PTSD Scale for DSM-5 (CAPS; Boeschoten et
al., 2018) defined as having two or three of the DSM-5 criteria B - E
•Agrees to terms and conditions of the study and has provided informed consent
•Dutch speaking
Exclusion criteria
Acute suicidal or psychotic decompensation
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 | NL84705.100.23 |