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

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ClinicalTrials.gov Identifier: NCT02483117
Recruitment Status : Completed
First Posted : June 26, 2015
Last Update Posted : June 26, 2015
Sponsor:
Collaborator:
Carlos III Health Institute
Information provided by (Responsible Party):
Josune Martin Corral, Hospital Galdakao-Usansolo

Tracking Information
First Submitted Date June 17, 2015
First Posted Date June 26, 2015
Last Update Posted Date June 26, 2015
Study Start Date January 2010
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 23, 2015)
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).
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 23, 2015)
  • 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.
  • 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).
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.

Condition Eating Disorders
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).
Study Groups/Cohorts Eating disorder patients by type of compensating behavior.
Data collection started in 2010; one year follow-ups were conducted through 2011-2012. Psychiatrists collaborating in the study informed personally their patients about the objectives of the study, and recorded the sociodemographic information, including age, gender, marital status, level of education, employment status, and people with whom the patient lived. Those who agreed to take part were also sent the questionnaires and informed consent form by mail. They were asked to return these by mail using an enclosed, pre-stamped envelope. Two reminders also were sent at intervals of 15 days to those who did not respond to the first mailing.
Intervention: Other: Adaptation of the CIA
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 23, 2015)
244
Original Actual Enrollment Same as current
Actual Study Completion Date January 2012
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02483117
Other Study ID Numbers PS09/02012
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Josune Martin Corral, Hospital Galdakao-Usansolo
Study Sponsor Hospital Galdakao-Usansolo
Collaborators Carlos III Health Institute
Investigators
Principal Investigator: Angel Padierna, MD Hospital Galdakao-Usansolo
PRS Account Hospital Galdakao-Usansolo
Verification Date June 2015