Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06298526
Other study ID # 21C307
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 1, 2023
Est. completion date December 31, 2024

Study information

Verified date March 2024
Source Istituto Auxologico Italiano
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this observational cross-sectional study is to test the sensory attenuation effect with auditory stimuli comparing women affected by anorexia nervosa and healthy-weight women. Specifically, the study aims to test whether the sensory attenuation effect (i.e., the perceived loudness of a self-generated sound is weaker than when another person produces the same sound): i) is observed in anorexia nervosa ii) it can be modulated in interactive action contexts, as was previously observed in healthy participants. Participants will compare the loudness of target sound with a comparison tone, which can be prompt by the participant by pressing a button on their own will (i.e., individual context) or upon the experimenter's signal (i.e., interactive context); externally-generated sounds are produced in the opposite way.


Description:

The perceived loudness of a self-generated sound is generally weaker than when another person produces the same sound. This effect is known as sensory attenuation, and it is considered a proof of sense of agency (i.e., it relies on the anticipation of the sensory-motor effects of one's intentional action). Recently, it was suggested that this effect is enhanced in interactive action contexts in healthy individuals, meaning that sounds are produced as a consequence of cooperation between individuals. Participants will compare the loudness of target sound with a comparison tone, which could be generated in 4 different conditions: i) participants press a button ii) the experimenter press the button iii) participants press the button upon the experimenter's signal (i.e., who touch the participants' arm) iv) the experimenter presses the button upon the participants' signal (i.e., who touch the experimenter's arm). However, it is not clear whether the same effect of cooperation can be observed also when individuals experience difficulties in social interactions and relationships. To this purpose, the study compared the sensory attenuation effect for auditory stimuli in a traditional (i.e., individual) and interactive context, comparing women affected by anorexia nervosa with healthy-weight women. Indeed, relational difficulties and social withdrawal characterized this clinical condition.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 36
Est. completion date December 31, 2024
Est. primary completion date February 29, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - diagnosis of anorexia nervosa according to the DSM-V classification (experimental group) - BMI ranged between 19 - 25 kg/m2 (controls) - handedness: right Exclusion Criteria: - history of eating disorders (controls) - major psychiatric conditions (e.g., psychosis, personality disorders) - developmental disorders (e.g., autism spectrum disorders) - neurological or brain injuries disorders - motor impairments

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Italy IRCCS Istituto Auxologico Italiano, San Giuseppe Hospital Piancavallo VCO

Sponsors (1)

Lead Sponsor Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Colle L, Hilviu D, Boggio M, Toso A, Longo P, Abbate-Daga G, Garbarini F, Fossataro C. Abnormal sense of agency in eating disorders. Sci Rep. 2023 Aug 30;13(1):14176. doi: 10.1038/s41598-023-41345-5. — View Citation

Weiss C, Herwig A, Schutz-Bosbach S. The self in social interactions: sensory attenuation of auditory action effects is stronger in interactions with others. PLoS One. 2011;6(7):e22723. doi: 10.1371/journal.pone.0022723. Epub 2011 Jul 27. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary point of subjective equality (PSE) individual PSE in each experimental condition is obtained by fitting observed judgements of loudness, relative to seven possible comparison tones. The PSE represents the tone loudness that participants perceive as loud as the target sound (i.e., the sound intensity which records only 50% of correct judgments "which sounds was louder?") day 1
Secondary cognitive empathy Interpersonal Reactivity Index - IRI: 28-item self-report questionnaire on a 5-point Likert scale (from 1 -does not describe me well to 5 - describes me very well). Four components of cognitive empathy are measured: i) perspective taking (IRI-PT); ii) fantasy (IRI-F); iii) empathic concern (IRI-EC); iv) personal distress (IRI-PD); each subscale includes 7 items (total scores range from 1 to 35): the higher the score, the higher the expression of cognitive empathy described in each subscale. day 1
Secondary interpersonal pleasure Anticipatory and Consummatory Interpersonal Pleasure Scale - ACIPS: 17-item self-reported questionnaire scored on 6-point Likert scale (from 1 - very false for me to 6-very true for me). ACIPS total score ranges from 1 to 102: higher scores indicate higher anticipatory and consummatory interpersonal pleasure. day 1
See also
  Status Clinical Trial Phase
Recruiting NCT05531604 - Appetitive Conditioning in Anorexia Nervosa
Enrolling by invitation NCT04174703 - Preparing for Eating Disorders Treatment Through Compassionate Letter-Writing N/A
Active, not recruiting NCT04883554 - Impact of an Olfactory Sensory Therapeutic Group for Adolescent Patients With Restrictive Anorexia Nervosa , Pilot Study N/A
Recruiting NCT04213820 - TMS and Body Image Treatment for Anorexia Nervosa N/A
Completed NCT03414112 - The Impact of Oxytocin on the Neurobiology of Anorexia Nervosa Early Phase 1
Recruiting NCT06144905 - Norwegian Microbiota Study in Anorexia Nervosa
Not yet recruiting NCT06380257 - Anorexia Nervosa and Brain in Adolescence
Not yet recruiting NCT05682417 - Impact of Body Schema Distortion on Remission and Weight Regain in Anorexia Nervosa N/A
Not yet recruiting NCT05632497 - Alteration of Symbiosis Intestinal Microbiota on Patients With Anorexia Nervosa
Not yet recruiting NCT04804800 - Virtual Reality Place in the Management of Body Dysmorphia Disorders in Anorexia Nervosa N/A
Not yet recruiting NCT03600610 - Evaluation of CARdiac Abnormalities by Echocardiography and MRI in Malnourished Patients Suffering From Anorexia Nervosa N/A
Completed NCT02745067 - Effectiveness of Enhanced Cognitive Behavioral Therapy (CBT-E) in the Treatment of Anorexia Nervosa N/A
Completed NCT02382055 - Changing Habits in Anorexia Nervosa: Novel Treatment Development N/A
Completed NCT03075371 - Homeostatic and Non-homeostatic Processing of Food Cues in Anorexia Nervosa N/A
Terminated NCT02240797 - Kappa Opioid Receptor Imaging in Anorexia N/A
Completed NCT03144986 - Insula-coil Deep TMS for Treatment Resistant Anorexia Nervosa N/A
Unknown status NCT01761942 - Fatty Acids Omega -3 Diet Supplementation Efficiency and Safety Evaluation in Anorexia Nervosa Phase 2
Completed NCT02551445 - A fMRI Pilot Study of the Effects of Meal-support in Eating Disorders. N/A
Completed NCT01579682 - Adaptive Family Treatment for Adolescent Anorexia Nervosa N/A
Completed NCT00946816 - The Effects of Dietary Intervention on Gastrointestinal Function in Patients With Anorexia Nervosa and Obesity N/A