UnknownNot Applicable

Characteristics of Illness Awareness in Anorexia Nervosa

Spain80 participantsStarted 2022-12-01

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of bulimia nervosa, anorexia nervosa or atypical anorexia nervosa according to Diagnostic and Statistical Manual (DSM-5) criteria. * Age between 18 and 65 years. * Female sex. Exclusion Criteria: * Comorbid neurological disorder. * Clinical worsening requiring hospitalization. * Patients who do not give consent. * Patients who do not understand or speak Spanish or Catalan.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Insight impairment

Timeframe: Baseline and 6 months.

Trial details

NCT IDNCT06177262

SponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-08-01

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