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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02483117
Other study ID # PS09/02012
Secondary ID
Status Completed
Phase N/A
First received June 17, 2015
Last updated June 23, 2015
Start date January 2010
Est. completion date January 2012

Study information

Verified date June 2015
Source Hospital Galdakao-Usansolo
Contact n/a
Is FDA regulated No
Health authority Spain: Ethics Committee
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 244
Est. completion date January 2012
Est. primary completion date January 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
Adaptation of the CIA
Adaptation of the CIA into Spanish was performed using the backward-forward translation process, which ensures conceptual. Forward translation into Spanish was carried out by two independent native Spanish speaking translators who were fluent in English. Two other independent translators, totally blind to the original version, whose native language was English and who were fluent in Spanish, back-translated the consensus version into English. After reaching consensus on a final translated version, it was sent to the CIA's original author (Dr. Bohn) who gave her approval. We undertook a cognitive debriefing process with a group of 5 ED patients to identify any problems with language. The pre-final version was administered to two small groups, one made up of patients (a sample of 5 respondents) and the other of clinical experts (2 psychiatrists and 2 psychologists who were experts on ED).

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Hospital Galdakao-Usansolo Carlos III Health Institute

References & Publications (1)

Martín J, Padierna A, Unzurrunzaga A, González 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary CIA questionnaire The CIA (v. 3.0) (Bohn et al., 2008) is a 16-item self-report measure of psychosocial impairment secondary to features of an eating disorder. This questionnaire measures three domains of impairment—personal, social, and cognitive—attributable to eating habits, exercising, or feelings about eating, shape, or weight over the previous 28 days. Items are rated on a four-point Likert scale, ranging from 0=''Not at all'' to 3=''A lot.'' A global CIA score ranging from 0 to 48 is calculated to provide a global index of the severity of psychosocial impairment due to eating disorder pathology during the past 28 days. A higher score indicates greater impairment. Subscale scores can be calculated to determine the three domains of impairment (personal, social, and cognitive). The original report of the CIA's psychometric properties supported adequate reliability and validity of the measure within a clinical sample of patients with eating disorders (Bohn et al., 2008). Up to 2 years No
Secondary Eating Attitudes Test-12 (EAT-12) Eating problems were measured by the EAT-12 (Lavik, Clause & Pedersen, 1991). It uses a 4-point scale, from never (score 0) to always (score 2). The EAT-12 yields three factors: dieting, bulimia and food preoccupation, and oral control. Previous studies have supported its validity as a measure of disordered eating (Wichstrøm, Skogen & Øia, 1994; Wichstrøm, 1995). The internal consistency was a 0.71. Up to 2 years No
Secondary Health-Related Quality of Life in ED-short form (HeRQoLED-s) ED patients' quality of life was evaluated using the Health-Related Quality of Life in ED-short form (HeRQoLED-s) (Las Hayas et al, 2007; Las Hayas, Quintana, Padierna, Bilbao & Munoz, 2010). This questionnaire consists of 20 items distributed into two domains: social maladjustment and mental (a=0.91) and functional health (a=0.90). The higher the score, the lower the quality of life. This measure has been used successfully with Spanish-speaking populations (González, Padierna, Martín, Aguirre & Quintana, 2012; Las Hayas et al., 2006; Martín et al., 2011; Muñoz, 2009; Padierna et al., 2012). Up to 2 years No
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