Characteristics of Illness Awareness in Anorexia Nervosa

NCT06177262 | Unknown

• 1 other identifier: IIBSP-INS-2021-122
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Insight Impaired

Outcome Measures

Primary Outcomes (1)

• Insight impairment

  Change from Baseline Illness awareness impairment in patients with an eating disorder measured at 6 months

  Baseline and 6 months.

Interventions

cognitive behavioral therapy BEHAVIORAL

Cognitive behavioral therapy for eating disorders.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The subjects of the initial cross-sectional study will be patients with anorexia or bulimia recruited consecutively from the Eating Disorder Unit of the Hospital de la Santa Creu i Sant Pau (HSCSP) and from the Hospital Universitari Mútua de Terrassa (HUMT). A sub-sample of the study patients diagnosed with anorexia or atypical anorexia will participate in the longitudinal follow-up.

You may qualify if:

• 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.

You may not qualify if:

• Comorbid neurological disorder.
• Clinical worsening requiring hospitalization.
• Patients who do not give consent.
• Patients who do not understand or speak Spanish or Catalan.

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead
• Hospital Mutua de Terrassa: collaborator

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

RECRUITING

MeSH Terms

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2022
• First Posted: December 20, 2023
• Study Start: December 1, 2022
• Primary Completion: August 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 20, 2023

Record last verified: 2023-06

Locations

ES (1)