Insight ImpairedNCT06177262
Characteristics of Illness Awareness in Anorexia Nervosa
An observational study of Insight Impaired, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
Objective: To study the characteristics of illness awareness, its dimensions and its evolution in relation to clinical, cognitive and psychosocial variables in patients with anorexia nervosa. Design: observational longitudinal design. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Insight Impaired
- What is being tested?
- cognitive behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2022to 1 Dec 2024
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The subjects of the initial cross-sectional study will be patients with anorexia or bulimia recruited consecutively from the Eating Disorder Unit of the Hospital de la Santa Creu i Sant Pau (HSCSP) and from the Hospital Universitari Mútua de Terrassa (HUMT). A sub-sample of the study patients diagnosed with anorexia or atypical anorexia will participate in the longitudinal follow-up.
Who may be able to join
- Diagnosis of bulimia nervosa, anorexia nervosa or atypical anorexia nervosa according to Diagnostic and Statistical Manual (DSM-5) criteria.
- Age between 18 and 65 years.
- Female sex.
Who cannot join
- Comorbid neurological disorder.
- Clinical worsening requiring hospitalization.
- Patients who do not give consent.
- Patients who do not understand or speak Spanish or Catalan.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
Cristina Carmona, Phd, +34935537813, CDelgadoE@santpau.cat
Cristina Carmona, Phd, 650003427, ccarmonaf@santpau.cat
About this study
Official title: Characteristics of Illness Awareness and Its Evolution in Relation to Clinical, Cognitive and Psychosocial Variables in Anorexia Nervosa
Objective: To study the characteristics of illness awareness, its dimensions and its evolution in relation to clinical, cognitive and psychosocial variables in patients with anorexia nervosa.
Design: observational longitudinal design. Method: First, the process of translating and culturally adapting the Schedule for the Assessment of Insight in Eating Disorders (SAI-ED) to Spanish will be carried out and, over 9 months, patients who are admitted to the Eating Disorders Unit of the Hospital de la Santa Creu I Sant Pau (HSCSP) and the Eating Disorders Unit of the H. Mutua de Terrassa will be offered to participate in the study. Through individual clinical interviews and self-reports, a first sample will be collected to allow the validation study of the scale in the Spanish population.
Read more
The sample will include patients with Anorexia Nervosa and Bulimia Nervosa who understand and speak Spanish or Catalan and sign the informed consent for participation. Participants will be recruited consecutively until N=80 is reached.
From a subsample of patients with anorexia nervosa, data related to illness awareness and other clinical, cognitive and psychosocial variables will be collected longitudinally in the 3 and 6 months after.
Finally, a quantitative analysis of the results obtained will be carried out.
Read the detailed description
Lack of illness awareness in patients suffering from eating disorders is a recognized phenomenon that has received abundant theoretical interest in recent decades. However, research on the subject is limited and has provided inconsistent results.
Illness denial rates reported in different studies have yielded discrepant figures ranging from 15% to 80% in anorexia nervosa. Attempts have been made to explain this variability between results by the use of dichotomous classifications and inconsistent or unspecified criteria to designate patients as deniers or admitters. Some authors suggest higher rates of impaired insight in eating disorders, assuming greater impairment in people who refuse or do not demand treatment and who were not included in these studies.
Moreover, the relationship between the lack of insight, the evolution of the disorder and the fluctuations of other clinical variables, such as affective symptomatology or body mass índex, cognitive and psychosocial variables, has not been clearly established. In a recent cross-sectional study, no relationship was found between insight and the duration of the disease in patients with anorexia nervosa, suggesting that there could be deterioration in both early and chronic phases.
To date, only two longitudinal studies have been conducted on insight in eating disorders. According to these studies, the variation in illness awareness remains relatively stable over time, but despite this, its relationship with changes in nutritional status is not clear.
Regarding the development of specific tools to assess insight in eating disorders, there is only one recently created scale in English, the Schedule for the Assessment of Insight in Eating Disorders (SAI-ED), by Konstantakopoulos (2020). This scale was initially created as an adaptation of the SAI-E for psychosis, it includes 8 items to be assessed by a clinician, easy to apply as it does not require prior training and it has been shown to have good psychometric properties. To date, no adaptation's study of this scale for the Spanish population was conducted.
Objective: To study the characteristics of illness awareness, its dimensions and its evolution in relation to clinical, cognitive and psychosocial variables in patients with anorexia nervosa.
Design: observational longitudinal design. Method: First, the process of translating and culturally adapting the SAI-ED scale to Spanish will be carried out and, over 9 months, patients who are admitted to the Eating Disorders Unit of the Hospital de la Santa Creu i Sant Pau (HSCSP) and the Eating Disorders Unit of the H. Mutua de Terrassa will be offered to participate in the study. Through individual clinical interviews and self-reports, a first sample will be collected to allow the validation study of the scale in the Spanish population.
The sample will include patients with Anorexia Nervosa and Bulimia Nervosa who understand and speak Spanish or Catalan and sign the informed consent for participation. Participants will be recruited consecutively until N=80 is reached.
From a subsample of patients with anorexia nervosa, data related to illness awareness and other clinical, cognitive and psychosocial variables will be collected longitudinally in the 3 and 6 months after.
Finally, a quantitative analysis of the results obtained will be carried out.
- Conditions
- Insight Impaired
- Being tested
- cognitive behavioral therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive behavioral therapyBehavioural
Cognitive behavioral therapy for eating disorders.
What is being measured
The primary outcome is the main question the study is designed to answer.
Insight impairment
Change from Baseline Illness awareness impairment in patients with an eating disorder measured at 6 months
Measured: Baseline and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start1 Dec 2022
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
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 Insight ImpairedStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Mutua de Terrassa
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06177262
- Sponsor's protocol ID
- IIBSP-INS-2021-122
- Status last verified
- Jun 2023
- First submitted
- 17 Nov 2022
- Last updated
- 20 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gawron LP, Garrido-Ribas I, Carmona-Farres C, Carril-Batuecas S, Carceller-Sindreu M, Avila-Parcet A, Amaro-Carriba MA, Hernandez-Molina M, Portella MJ, Pousa E; Insight Barcelona Work Group. Understanding the structure of insight in eating disorders: validation of the SAI-ED in a Spanish clinical sample. J Eat Disord. 2025 Aug 25;13(1):184. doi: 10.1186/s40337-025-01360-5.
PubMed 40855569
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of Illness Awareness and Its Evolution in Relation to Clinical, Cognitive and Psychosocial Variables in Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT06177262
- Acronym / sponsor ID
- IIBSP-INS-2021-122
- Conditions
- Insight Impaired
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Hospital Mutua de Terrassa
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 20 Dec 2023 (actual)
- 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.
Objective: To study the characteristics of illness awareness, its dimensions and its evolution in relation to clinical, cognitive and psychosocial variables in patients with anorexia nervosa.
Design: observational longitudinal design. Method: First, the process of translating and culturally adapting the Schedule for the Assessment of Insight in Eating Disorders (SAI-ED) to Spanish will be carried out and, over 9 months, patients who are admitted to the Eating Disorders Unit of the Hospital de la Santa Creu I Sant Pau (HSCSP) and the Eating Disorders Unit of the H. Mutua de Terrassa will be offered to participate in the study. Through individual clinical interviews and self-reports, a first sample will be collected to allow the validation study of the scale in the Spanish population.
The sample will include patients with Anorexia Nervosa and Bulimia Nervosa who understand and speak Spanish or Catalan and sign the informed consent for participation. Participants will be recruited consecutively until N=80 is reached.
From a subsample of patients with anorexia nervosa, data related to illness awareness and other clinical, cognitive and psychosocial variables will be collected longitudinally in the 3 and 6 months after.
Finally, a quantitative analysis of the results obtained will be carried out.
Detailed description
Lack of illness awareness in patients suffering from eating disorders is a recognized phenomenon that has received abundant theoretical interest in recent decades. However, research on the subject is limited and has provided inconsistent results.
Illness denial rates reported in different studies have yielded discrepant figures ranging from 15% to 80% in anorexia nervosa. Attempts have been made to explain this variability between results by the use of dichotomous classifications and inconsistent or unspecified criteria to designate patients as deniers or admitters. Some authors suggest higher rates of impaired insight in eating disorders, assuming greater impairment in people who refuse or do not demand treatment and who were not included in these studies.
Moreover, the relationship between the lack of insight, the evolution of the disorder and the fluctuations of other clinical variables, such as affective symptomatology or body mass índex, cognitive and psychosocial variables, has not been clearly established. In a recent cross-sectional study, no relationship was found between insight and the duration of the disease in patients with anorexia nervosa, suggesting that there could be deterioration in both early and chronic phases.
To date, only two longitudinal studies have been conducted on insight in eating disorders. According to these studies, the variation in illness awareness remains relatively stable over time, but despite this, its relationship with changes in nutritional status is not clear.
Regarding the development of specific tools to assess insight in eating disorders, there is only one recently created scale in English, the Schedule for the Assessment of Insight in Eating Disorders (SAI-ED), by Konstantakopoulos (2020). This scale was initially created as an adaptation of the SAI-E for psychosis, it includes 8 items to be assessed by a clinician, easy to apply as it does not require prior training and it has been shown to have good psychometric properties. To date, no adaptation's study of this scale for the Spanish population was conducted.
Objective: To study the characteristics of illness awareness, its dimensions and its evolution in relation to clinical, cognitive and psychosocial variables in patients with anorexia nervosa.
Design: observational longitudinal design. Method: First, the process of translating and culturally adapting the SAI-ED scale to Spanish will be carried out and, over 9 months, patients who are admitted to the Eating Disorders Unit of the Hospital de la Santa Creu i Sant Pau (HSCSP) and the Eating Disorders Unit of the H. Mutua de Terrassa will be offered to participate in the study. Through individual clinical interviews and self-reports, a first sample will be collected to allow the validation study of the scale in the Spanish population.
The sample will include patients with Anorexia Nervosa and Bulimia Nervosa who understand and speak Spanish or Catalan and sign the informed consent for participation. Participants will be recruited consecutively until N=80 is reached.
From a subsample of patients with anorexia nervosa, data related to illness awareness and other clinical, cognitive and psychosocial variables will be collected longitudinally in the 3 and 6 months after.
Finally, a quantitative analysis of the results obtained will be carried out.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The subjects of the initial cross-sectional study will be patients with anorexia or bulimia recruited consecutively from the Eating Disorder Unit of the Hospital de la Santa Creu i Sant Pau (HSCSP) and from the Hospital Universitari Mútua de Terrassa (HUMT). A sub-sample of the study patients diagnosed with anorexia or atypical anorexia will participate in the longitudinal follow-up.
Key inclusion criteria (3 listed)
- Diagnosis of bulimia nervosa, anorexia nervosa or atypical anorexia nervosa according to Diagnostic and Statistical Manual (DSM-5) criteria.
- Age between 18 and 65 years.
- Female sex.
Key exclusion criteria (4 listed)
- Comorbid neurological disorder.
- Clinical worsening requiring hospitalization.
- Patients who do not give consent.
- Patients who do not understand or speak Spanish or Catalan.
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 |
|---|---|---|
| cognitive behavioral therapyCognitive behavioral therapy for eating disorders. | Behavioural | – |
Primary outcome
Insight impairment
Time frame: Baseline and 6 months.
Change from Baseline Illness awareness impairment in patients with an eating disorder measured at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Derived from this study: PubMed 40855569Gawron LP, Garrido-Ribas I, Carmona-Farres C, Carril-Batuecas S, Carceller-Sindreu M, Avila-Parcet A, Amaro-Carriba MA, Hernandez-Molina M, Portella MJ, Pousa E; Insight Barcelona Work Group. Understanding the structure of insight in eating disorders: validation of the SAI-ED in a Spanish clinical sample. J Eat Disord. 2025 Aug 25;13(1):184. doi: 10.1186/s40337-025-01360-5.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insight Impaired, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insight impairment (time frame: Baseline and 6 months.). 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 NCT06177262, 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 20 Dec 2023.