Exploring the Changes in Social Interaction and Its Protective Features in Anorexia Nervosa (SOCINTERACAN)

Anorexia Nervosa (AN) is an eating disorder often characterised by restriction of food intake, being underweight, body image uneasiness, and the possibility of binge eating, purging, fasting behaviours, and excessive exercising. Despite weight and eating habits being one, and perhaps the most recognizable, components of AN, AN is a multidimensional disease. For example, individuals affected by AN might show psychological suffering, such as depression and anxiety. For example, social anxiety disorder/social phobia is the first or second most common comorbid anxiety in AN (i.e. prevalence rates ranging from 16% to 88.2% in AN against 12% in the general population). Moreover, the highest the level of social anxiety the highest the severity of the eating disorder psychopathology. This latter component resonates with findings on the difficulties observed in people affected by AN in creating and maintaining satisfactory relationships with others. These evidences tell us the importance to take into account the social components/skills of people affected by AN.

The development of social components/skills of people affected by AN during their recovery can be considered as a protective factor for future relapse. This would be of relevance for the creation of rehabilitative programs.

Study Overview

• Status: Completed
• Conditions: Anorexia Nervosa
• Intervention / Treatment: Other: Participants will be asked to complete a series of questionnaires at t0, t1 and t2

Detailed Description

Anorexia Nervosa (AN) is an eating disorder often characterised by restriction of food intake, being underweight, body image uneasiness, and the possibility of binge eating, purging, fasting behaviours, and excessive exercising. AN is of relevance for the health care system because of the high mortality rates, high psychiatric comorbidity, high suicide risk, and because of the high costs for the health system. Despite weight and eating habits being one, and perhaps the most recognizable, components of AN, AN is a multidimensional disease. For example, individuals affected by AN might show psychological suffering, such as depression and anxiety. For example, social anxiety disorder/social phobia is the first or second most common comorbid anxiety in AN (i.e. prevalence rates ranging from 16% to 88.2% in AN against 12% in the general population). Moreover, the highest the level of social anxiety the highest the severity of the eating disorder psychopathology. This latter component resonates with findings on the difficulties observed in people affected by AN in creating and maintaining satisfactory relationships with others. These evidences tell us the importance to take into account the social components/skills of people affected by AN. Therefore, we believe it would be relevant to understand whether our treatments change the social components/skills of the people affected by AN who access our ward's multidisciplinary inpatient intensive rehabilitation treatment. Moreover, it would be important to evaluate the protective role of participants' social components/skills in the changes in their psychopathology. Despite our rehabilitative activities not having a specific focus on sociality, the activities are conducted on a 1:1 or group basis. This means that our activities have an intrinsic relational and socializing value.

The purpose of the study lays on two outcomes:

• Primary outcome: evaluation of the short-term effects (T0 vs T1) of the multidisciplinary inpatient intensive rehabilitation treatment on the social components/skills of people affected by AN.
• Secondary outcome: evaluation of the long-term effects (T0 vs T2) of the multidisciplinary inpatient intensive rehabilitation treatment on the social components/skills of people affected by AN.

The development of social components/skills of people affected by AN during their recovery can be considered as a protective factor for future relapse. This would be of relevance for the creation of rehabilitative programs

• Study Type: Observational
• Enrollment (Actual): 68

Contacts and Locations

Study Locations

• Italy
  • MI
    • Milano, MI, Italy, 20145
      • istituto Auxologico italiano IRCSS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Individuals of both biological sexes affected by AN who will take part in the multidisciplinary inpatient intensive rehabilitation treatment as offered by the U.O. dei Disturbi del Comportamento Alimentare, San Giuseppe Hospital, Piancavallo (VCO), Italy.

Description

Inclusion Criteria:

• age between 18 and 65 years old;
• diagnosis of AN, as per DSM V criteria (APA, 2013);
• BMI ≤ 17 Kg/m2;
• adherence to the rehabilitation program, meaning participating at the 75% of the proposed activities.

Exclusion criteria:

• presence of other pathologies not associated with AN (i.e., neurodegenerative diseases);
• severe psychopathologies other than AN (i.e., schizophrenia);
• spontaneous dropout from the multidisciplinary inpatient intensive rehabilitation treatment.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

anorexia nervosa/AN; Individuals of both biological sexes affected by AN who will take part in the multidisciplinary inpatient intensive rehabilitation treatment as offered by the U.O. dei Disturbi del Comportamento Alimentare, San Giuseppe Hospital, Piancavallo (VCO), Italy. Inclusion Criteria: i) age between 18 and 65 years old; ii) diagnosis of AN, as per DSM V criteria (APA, 2013); iii) BMI ≤ 17 Kg/m2; iv) adherence to the rehabilitation program, meaning participating at the 75% of the proposed activities. Exclusion criteria: i) presence of other pathologies not associated with AN (i.e., neurodegenerative diseases); ii) severe psychopathologies other than AN (i.e., schizophrenia); iii) spontaneous dropout from the multidisciplinary inpatient intensive rehabilitation treatment.

Other: Participants will be asked to complete a series of questionnaires at t0, t1 and t2; Individuals will be people who voluntarily will take part in a residential three to six weeks multidisciplinary inpatient intensive rehabilitation treatment targeting the improvement of psychological well-being, body image, and psychopathology for anorexia nervosa. Therefore, at T0 (at the beginning of the treatment) and T1 (at the end of the rehabilitation programme), participants will fill out some self-report questionnaires to evaluate the effect of the multidisciplinary inpatient intensive rehabilitation treatment on different outcomes (i.e. psychological well-being, eating pathology, body image, and comorbidities), among which their social components/skills. Moreover, we will ask participants to complete 3 months after discharge the questionnaires related to the social components/skills only. Participants will be contacted by email, within the email participants will find a link to click on for the completion of the questionnaires.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS)	Social anhedonia will be evaluated by the Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS). This self-report questionnaire is made up of 17-item for measuring individuals' tendency to look forward to interactions with others (anticipatory interpersonal pleasure - 7 items) and the experienced pleasure in social interactions (consummatory interpersonal pleasure - 10 items). The ACIPS is scored on a six-point Likert scale ranging from 1 (very false for me) to 6 (very true for me).	Through study completion, an average of 4 months
The Social Appearance Anxiety Scale (SAAS)	The scale will be used to assess anxiety about being negatively evaluated by others because of one's overall appearance, including body shape (e.g., "I am concerned people would not like me because of the way I look and I am afraid that people find me unattractive"). The scale contains 16 items rated on a 5-points Likert scale ranging from 1 = not at all to 5 = extremely, with higher scores reflecting a higher social appearance anxiety scale.	Through study completion, an average of 4 months
The Social Interaction Anxiety Scale (SIAS)	The scale will be used to assess the fear of interacting in dyads and groups (e.g., ''I have difficulty talking with other people''). The scale contains 20 items rated on a 5-points Likert scale ranging from 0 = not at all to 4 = extremely, with a higher score indicating greater social interaction anxiety	Through study completion, an average of 4 months
Social Phobia Scale (SPS)	We will administer the scale to evaluate the fear of being scrutinized by others during routine activities, such as eating, drinking, or writing (e.g., ''I become anxious if I have to write in front of other people''). The scale is made up of 20 items rated on a five-points Likert scale ranging from 0 = not at all to 4 = extremely, with a higher score indicating greater fear of scrutiny.	Through study completion, an average of 4 months

Collaborators and Investigators

• Sponsor: Istituto Auxologico Italiano
• Collaborators: Catholic University of the Sacred Heart; University of Turin, Italy

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2024
• Primary Completion (Actual): October 31, 2024
• Study Completion (Actual): October 31, 2024

Study Registration Dates

• First Submitted: May 20, 2024
• First Submitted That Met QC Criteria: May 31, 2024
• First Posted (Actual): June 3, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2025
• Last Update Submitted That Met QC Criteria: April 29, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Rehabilitation; Anorexia nervosa; Social interaction
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Anorexia; Anorexia Nervosa
• Other Study ID Numbers: 49C401

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No