Eating DisordersCIANCT02483117
Adaptation and Validation of the Clinical Assessment Inventory for Eating Disorders (CIA)
An observational study of Eating Disorders, run by Hospital Galdakao-Usansolo.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Eating Disorders
- What is being tested?
- Adaptation of the CIA
- How many people
- 244 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Jan 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Adaptation and Validation of the Clinical Assessment Inventory (CIA) for Eating Disorders. Assessment of Its Relation With Other Clinical Measures
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.
- Conditions
- Eating Disorders
- Being tested
- Adaptation of the CIA
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptation of the CIAOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Adaptation of the CIA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 2 years
Secondary outcomes (2)
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.
Measured: Up to 2 years
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 (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).
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2015 (estimated)
- Study startJan 2010
- Primary completionJan 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Galdakao-Usansolo
- Sponsor type
- Other government
- Collaborators
- Carlos III Health Institute
- Responsible party
- Principal investigator, Josune Martin Corral, Hospital Galdakao-Usansolo
- Investigators
- Angel Padierna, MD, Principal investigator, Hospital Galdakao-Usansolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02483117
- Sponsor's protocol ID
- PS09/02012
- Acronym
- CIA
- Status last verified
- Jun 2015
- First submitted
- 17 Jun 2015
- Last updated
- 26 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25839732
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation and Validation of the Clinical Assessment Inventory (CIA) for Eating Disorders. Assessment of Its Relation With Other Clinical Measures
- ClinicalTrials.gov ID
- NCT02483117
- Acronym / sponsor ID
- CIA / PS09/02012
- Conditions
- Eating Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- Hospital Galdakao-UsansoloOther government
- Collaborators
- Carlos III Health Institute
- Study start
- Jan 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 26 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eating disorder patients by type of compensating behavior. | – | Other: Adaptation of the CIAData 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adaptation of the CIAAdaptation 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). | Other | Eating disorder patients by type of compensating behavior. |
Primary outcome
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).
2 secondary outcomes
Eating Attitudes Test-12 (EAT-12)
Time frame: Up to 2 years
Health-Related Quality of Life in ED-short form (HeRQoLED-s)
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2015.
- Results publication: PubMed 25839732Martin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angel Padierna, MD principal investigator
Hospital Galdakao-Usansolo
Questions about this trial
What is this clinical trial studying?
An observational study of Eating Disorders, run by Hospital Galdakao-Usansolo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CIA questionnaire (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02483117, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2015.