- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05756530
The Experience of Affective Touch in Anorexia Nervosa (AffTouch_AN)
The Experience of Affective Touch in Obesity: the Role of Social Anhedonia and Lifespan Experiences
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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VCO
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Piancavallo, VCO, Italy, 28824
- IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Participants with AN were consecutively recruited during their rehabilitative treatment at the Istituto Auxologico Italiano, IRCCS, San Giuseppe Hospital (Italy).
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Description
Inclusion criteria:
- Right-handed
- diagnosis of restricting type or binge-eating/purging type AN, according to the Diagnostic and Statistical Manual of Mental Disorders (5th Edition)'s criteria (DSM, American Psychiatric Association, 2013).
Exclusion Criteria:
- Concurrent neurological, neurodevelopmental (e.g., autism), motor, somatosensory and/or psychiatric disorders
- Evidence of any skin-related condition possibly affecting sensitivity on the participants' forearm (e.g., eczema, scars).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Cases
Right-handed women diagnosed with restricting type or binge-eating/purging type AN, according to the Diagnostic and Statistical Manual of Mental Disorders (5th Edition)'s criteria (DSM, American Psychiatric Association, 2013), will be consecutively recruited during their rehabilitative treatment at the Istituto Auxologico Italiano, IRCCS, San Giuseppe Hospital (Italy).
Concurrent neurological, neurodevelopmental (e.g., autism), motor, somatosensory and/or psychiatric disorders will be the exclusion criteria, as well as the evidence of any skin-related condition possibly affecting sensitivity on the participants' forearm (e.g., eczema, scars)
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Affective touch paradigm: experimental stimuli will include the touch of a soft cosmetic, a hand, which will be both expected to resemble affective pleasant stimulations, and a plastic stick with a rounded tip, as a control (non-affective) condition. Two speeds of stimulation will be adopted i) slow affective stimuli delivered at 3 cm/s and fast non-affective stimuli, delivered at non-optimal speed (18 cm/s). An imagery version of the task will be also administered: blindfolded participants will be asked to image the touches on their left forearm. After each (actual or imagined) tactile stimulus, individuals will rate the experience level of pleasantness. As part of the protocol, they will fill out two psychological questionnaires, assessing the level of social anhedonia and the amount and characteristics of the lifespan experiences of affective touch in close relationships. |
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Controls
Age-matched, right-handed, healthy women (i.e., with no history of eating disorders) will be recruited outside the hospital through personal contacts of the researchers and word-of-mouth.
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Affective touch paradigm: experimental stimuli will include the touch of a soft cosmetic, a hand, which will be both expected to resemble affective pleasant stimulations, and a plastic stick with a rounded tip, as a control (non-affective) condition. Two speeds of stimulation will be adopted i) slow affective stimuli delivered at 3 cm/s and fast non-affective stimuli, delivered at non-optimal speed (18 cm/s). An imagery version of the task will be also administered: blindfolded participants will be asked to image the touches on their left forearm. After each (actual or imagined) tactile stimulus, individuals will rate the experience level of pleasantness. As part of the protocol, they will fill out two psychological questionnaires, assessing the level of social anhedonia and the amount and characteristics of the lifespan experiences of affective touch in close relationships. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Rating of subjective pleasantness
Time Frame: Baseline
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Behavioural outcome associated with the experimental paradigm: participants will be asked to rate the pleasantness of the tactile stimuli after each stimulation with a score ranging from zero not pleasant at all) to 100 (extremely pleasant).
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Social Anhedonia Score
Time Frame: Baseline
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Social anhedonia will be evaluated with the Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS, Gooding and Pflum, 2014); this is a 17-item self-report measure of individuals' tendency to look forward to interactions with others (anticipatory interpersonal pleasure - 7 items) and experienced pleasure in social interactions (consummatory interpersonal pleasure - 10 items).
The ACIPS is scored on a Likert scale ranging from 1 (very false for me) to 6 (very true for me); higher scores indicate higher anticipatory and consummatory interpersonal pleasure.the
assessment
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Baseline
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Affective experience Score
Time Frame: Baseline
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The lifespan experience of affective touch in close relationships will be assessed with the Tactile Biography questionnaire (TBIO, Beltrán et al., 2020).
This includes a 29-item self-report measure scored on a Likert scale ranging from 1 (e.g., not at all true for me) to 5 (e.g., extremely true) that evaluate four independent components: the frequency of and satisfaction for affective touch i) in childhood/adolescence and ii) adulthood, iii) comfort with and iv) fondness for interpersonal touch in close relationships.
However, the experience of affective touch in adulthood was not included in the analyses since most of our participants did not have long experience in adult relationships since their age.
Three additional items allow the recording of the feelings experienced in bodily affective interactions, the presence of negative/unpleasant experiences involving interpersonal touch and the preference for giving and/or receiving affective touch.affective
touch in close relationships.
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Baseline
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Federica Scarpina, PhD, IRCCS Istituto Auxologico Italiano
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21C127
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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