Clinical trial NCT06439160: Exploring the Changes in Social Interaction and Its Protective Features in Anorexia Nervosa
Official title: Exploring the Changes in Social Interaction and Its Protective Features in Anorexia Nervosa
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anorexia Nervosa
Keywords: Anorexia nervosa
Social interaction
Rehabilitation
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
Collaborators: name: University of Turin, Italy
name: Catholic University of the Sacred Heart
First posted: 2024-06-03
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS)
timeFrame: Through study completion, an average of 4 months
measure: The Social Appearance Anxiety Scale (SAAS)
timeFrame: Through study completion, an average of 4 months
measure: The Social Interaction Anxiety Scale (SIAS)
timeFrame: Through study completion, an average of 4 months
measure: Social Phobia Scale (SPS)
timeFrame: Through study completion, an average of 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: istituto Auxologico italiano IRCSS
state: MI
Study officials:
References: