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Completed

NCT Number: NCT02483117

Adaptation and Validation of the Clinical Assessment Inventory for Eating Disorders (CIA)

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Adaptation of the CIA

Other

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).

Primary outcomes

  1. CIA questionnaire

    Time frame: Up to 2 years

    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).

Secondary outcomes

  1. Eating Attitudes Test-12 (EAT-12)

    Time frame: Up to 2 years

    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.

  2. Health-Related Quality of Life in ED-short form (HeRQoLED-s)

    Time frame: Up to 2 years

    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 (α=0.91) and functional health (α=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).

Sponsors and collaborators

Lead sponsor

Hospital Galdakao-Usansolo

Other Gov

Collaborators

  • Carlos III Health Institute

Registry information

Official study title

Adaptation and Validation of the Clinical Assessment Inventory (CIA) for Eating Disorders. Assessment of Its Relation With Other Clinical Measures

Acronym: CIA

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Jun 26, 2015
Registry last updated
Jun 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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