Clinical trial NCT02483117: Adaptation and Validation of the Clinical Assessment Inventory for Eating Disorders (CIA)
Official title: Adaptation and Validation of the Clinical Assessment Inventory (CIA) for Eating Disorders. Assessment of Its Relation With Other Clinical Measures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eating Disorders
Lead sponsor: Hospital Galdakao-Usansolo
Sponsor class: OTHER_GOV
Collaborators: name: Carlos III Health Institute
First posted: 2015-06-26
Enrollment: 244
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We conducted a prospective study of all patients diagnosed with and treated for an ED in the Eating Disorders Outpatient Clinic of the Psychiatric Services at the Galdakao-Usansolo Hospital, in Bizkaia, Spain. This institution, which serves a population of 300,000 inhabitants, is part of the Basque Health Care Service, which provides free, unrestricted care to nearly 100% of the population. The diagnosis was verified via chart review. Throughout the 2-year study period, each patient received a psychopharmacologic and psychotherapeutic treatment program consisting of cognitive-behavioural treatment; nutritional orientation and counselling; psycho-education; motivational therapy; social skills training; and therapy to modify distorted perception of body image.

Sample size was calculated according to the recommended 10:1 ratio of the number of subjects to the number of test items (Kline, 1998). The study was approved by the institutional review board of Galdakao-Usansolo Hospital.

Brief summary: The Clinical Impairment Assessment (CIA) assesses psychosocial impairment secondary to an eating disorder. The aim of this study was to create and validate a Spanish-language version of the CIA. Using a forward-backward translation methodology, we translated the CIA into Spanish and evaluated its psychometric characteristics in a clinical sample of 178 ED patients. Cronbach's alpha values, confirmatory factor analysis (CFA), and correlations between the CIA and the Eating Attitudes Test-12 and the Health-Related Quality of Life in ED-short form questionnaires evaluated the reliability, construct validity, and convergent validity, respectively. Known-groups validity was also studied comparing the CIA according to different groups; responsiveness was assessed by means of effect sizes.


Eligibility criteria: Inclusion Criteria:

* Outpatients were eligible for the study if they had been diagnosed with anorexia nervosa, bulimia nervosa, or an eating disorder not otherwise specified (EDNOS) by psychiatrists based on criteria established in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) (American Psychiatric Association, 1994), and provided written informed consent to participate.

Exclusion Criteria:

* Patients were excluded if they had a malignant, severe organic disease, could not complete the questionnaires because of language barriers, or did not give written informed consent to participate in the study.

Primary outcomes:
measure: CIA questionnaire
timeFrame: Up to 2 years
Secondary outcomes:
measure: Eating Attitudes Test-12 (EAT-12)
timeFrame: Up to 2 years
measure: Health-Related Quality of Life in ED-short form (HeRQoLED-s)
timeFrame: Up to 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Galdakao-Usansolo
name: Angel Padierna, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Martin J, Padierna A, Unzurrunzaga A, Gonzalez N, Berjano B, Quintana JM. Adaptation and validation of the Spanish version of the Clinical Impairment Assessment Questionnaire. Appetite. 2015 Aug;91:20-7. doi: 10.1016/j.appet.2015.03.031. Epub 2015 Apr 1.