Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06177262 |
| Other study ID # |
IIBSP-INS-2021-122 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2022 |
| Est. completion date |
December 1, 2024 |
Study information
| Verified date |
June 2023 |
| Source |
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Objective: To study the characteristics of illness awareness, its dimensions and its
evolution in relation to clinical, cognitive and psychosocial variables in patients with
anorexia nervosa.
Design: observational longitudinal design. Method: First, the process of translating and
culturally adapting the Schedule for the Assessment of Insight in Eating Disorders (SAI-ED)
to Spanish will be carried out and, over 9 months, patients who are admitted to the Eating
Disorders Unit of the Hospital de la Santa Creu I Sant Pau (HSCSP) and the Eating Disorders
Unit of the H. Mutua de Terrassa will be offered to participate in the study. Through
individual clinical interviews and self-reports, a first sample will be collected to allow
the validation study of the scale in the Spanish population.
The sample will include patients with Anorexia Nervosa and Bulimia Nervosa who understand and
speak Spanish or Catalan and sign the informed consent for participation. Participants will
be recruited consecutively until N=80 is reached.
From a subsample of patients with anorexia nervosa, data related to illness awareness and
other clinical, cognitive and psychosocial variables will be collected longitudinally in the
3 and 6 months after.
Finally, a quantitative analysis of the results obtained will be carried out.
Description:
Lack of illness awareness in patients suffering from eating disorders is a recognized
phenomenon that has received abundant theoretical interest in recent decades. However,
research on the subject is limited and has provided inconsistent results.
Illness denial rates reported in different studies have yielded discrepant figures ranging
from 15% to 80% in anorexia nervosa. Attempts have been made to explain this variability
between results by the use of dichotomous classifications and inconsistent or unspecified
criteria to designate patients as deniers or admitters. Some authors suggest higher rates of
impaired insight in eating disorders, assuming greater impairment in people who refuse or do
not demand treatment and who were not included in these studies.
Moreover, the relationship between the lack of insight, the evolution of the disorder and the
fluctuations of other clinical variables, such as affective symptomatology or body mass
índex, cognitive and psychosocial variables, has not been clearly established. In a recent
cross-sectional study, no relationship was found between insight and the duration of the
disease in patients with anorexia nervosa, suggesting that there could be deterioration in
both early and chronic phases.
To date, only two longitudinal studies have been conducted on insight in eating disorders.
According to these studies, the variation in illness awareness remains relatively stable over
time, but despite this, its relationship with changes in nutritional status is not clear.
Regarding the development of specific tools to assess insight in eating disorders, there is
only one recently created scale in English, the Schedule for the Assessment of Insight in
Eating Disorders (SAI-ED), by Konstantakopoulos (2020). This scale was initially created as
an adaptation of the SAI-E for psychosis, it includes 8 items to be assessed by a clinician,
easy to apply as it does not require prior training and it has been shown to have good
psychometric properties. To date, no adaptation's study of this scale for the Spanish
population was conducted.
Objective: To study the characteristics of illness awareness, its dimensions and its
evolution in relation to clinical, cognitive and psychosocial variables in patients with
anorexia nervosa.
Design: observational longitudinal design. Method: First, the process of translating and
culturally adapting the SAI-ED scale to Spanish will be carried out and, over 9 months,
patients who are admitted to the Eating Disorders Unit of the Hospital de la Santa Creu i
Sant Pau (HSCSP) and the Eating Disorders Unit of the H. Mutua de Terrassa will be offered to
participate in the study. Through individual clinical interviews and self-reports, a first
sample will be collected to allow the validation study of the scale in the Spanish
population.
The sample will include patients with Anorexia Nervosa and Bulimia Nervosa who understand and
speak Spanish or Catalan and sign the informed consent for participation. Participants will
be recruited consecutively until N=80 is reached.
From a subsample of patients with anorexia nervosa, data related to illness awareness and
other clinical, cognitive and psychosocial variables will be collected longitudinally in the
3 and 6 months after.
Finally, a quantitative analysis of the results obtained will be carried out.
