Affective Touch, Hedonia and Suicidal Behavior (TOUCH-S)
Primary Purpose
Major Depressive Episode, Suicidal and Self-injurious Behavior
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Tactile stimulation
Sponsored by
About this trial
This is an interventional other trial for Major Depressive Episode focused on measuring Suicide, Depression, Affective touch, Decision making
Eligibility Criteria
Inclusion Criteria:
- Being a woman
- Aged between 18 and 65
- Past major depressive episode according to the DSM-5 criteria
- Currently euthymic (Montgomery-Asberg Depression rating Scale (MADRS) < 12 and Young Mania Rating Scale (YMRS) < 6)
- Minimal psychotropic medication (as determined by the clinician)
- Able to understand experimental procedures
- Able to speak, read and understand French
- Having given written informed consent
- For suicide attempters only: Lifetime history of suicide attempt
- For affective controls only: No lifetime history of suicide attempt
Exclusion Criteria:
- Lifetime diagnosis of schizoaffective disorder, schizophrenia or autism spectrum disorder
- Severe alcohol or substance use disorder in the past 6 months
- Current anorexia nervosa
- Diagnosis of mental retardation or severe medical comorbidity that is unstable or could interfere with measures (HIV, diabetes, cancer, chronic inflammatory disease, neurological disorder, sensory or cognitive disability)
- Injury, scar, irritation/dermatological lesion or tattoo on the left forearm
- Pregnancy or breastfeeding
- Being in exclusion period for another study
- Not being affiliated to the French National Social Security System
- Being deprived of freedom (by judicial or administrative decision)
- Being protected by law (guardianship or curatorship)
- Having reached 4500€ annual compensation for participating to clinical trials
Sites / Locations
- Montpellier University Hospital, France (CHU)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Euthymic patients with history of suicide attempt (suicide attempters)
Euthymic patients without any history of suicide attempt (affective controls)
Arm Description
Currently euthymic patients with at least one lifetime major depressive episode and a history of suicide attempts
Currently euthymic patients with at least one lifetime major depressive episode and with no history of suicide attempts
Outcomes
Primary Outcome Measures
Pleasantness of the touch
Perceived pleasantness of the tactile stimulation, assessed with a numeric scale ranging from -5 (very unpleasant) to +5 (very pleasant)
Secondary Outcome Measures
Intensity of the touch
Perceived intensity of the tactile stimulation, assessed with a 10 points Likert scale (low intensity to high intensity).
Decision-making performance (Iowa Gambling Test)
Decision-making performance using the IG index from the Iowa Gambling Test (difference between the number of safe and risky choices)
Decision-making performance (Ultimatum Game)
Decision-making performance using the UG index from the Ultimatum Game (difference between the number of rejections of unfair and fair offers)
β-endorphin levels
Plasmatic levels of β-endorphin
Variation in the expression of opioidergic genes
Variation in mRNA levels of 6 genes coding for opioidergic receptors and peptides (OPRM1 (µ), OPRK1 (κ), OPRD1 (δ) and pro-opio-melanocortin, pro-enkephalin, pro-dynomorphin), before and after tactile stimulation
Full Information
NCT ID
NCT05182827
First Posted
December 22, 2021
Last Updated
March 7, 2022
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT05182827
Brief Title
Affective Touch, Hedonia and Suicidal Behavior
Acronym
TOUCH-S
Official Title
Affective Touch, Hedonia and Suicidal Behavior
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 11, 2022 (Actual)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Several elements suggest that suicidal vulnerability may be associated with an alteration in the perception of affective touch. On the one hand, anhedonia, characterized by a decrease in the pleasure felt, is strongly associated with suicidal ideation, independently of depression. However, the ability to feel pleasure is essential in the perception of affective touch. On the other hand, suicidal behaviors are associated with interpersonal difficulties, of which communication is an integral part, and communication is partly through touch.
The investigators therefore wish to explore the perception of affective touch in suicidal behavior by using an affective tactile stimulation in 72 subjects with and without a history of suicide attempts (SA).
Detailed Description
This study aims to compare the perceived hedonic nature of affective touch in euthymic subjects with a history of SA and euthymic subjects without a history of SA.
The investigators also aim to :
compare the perceived hedonic nature of non-affective touch in this population;
compare the perceived intensity of affective touch;
compare the perceived intensity of non-affective touch;
study the association between decision making performance and perceived pleasantness of affective vs. non-affective touch;
study the association between plasma beta-endorphin levels and the perceived pleasantness of affective vs. non-affective touch;
study the effect of the tactile stimulation on the expression of opioidergic genes, by comparing the mRNA levels of 6 genes coding for opioidergic receptors and peptides before and after tactile stimulation;
investigate the association between tactile stimulation-related opioidergic gene expression variation and the perception of the pleasantness of affective versus non-affective touch.
To do so, 72 euthymic women will be included and divided in two groups: 1) Euthymic patients with a lifetime history of major depressive episode and a history of suicidal behavior; 2) Euthymic patients with a lifetime history of a major depressive episode and no history of suicidal behavior.
Participants will be subjected to tactile stimulation (affective and non-affective), following a clinical and neurospychological assessment. During the experimental touch, participants will be asked to evaluate the pleasantness of the touch and its intensity. In addition, blood samples will be taken before and after the stimulation.
Participation will be done in one day or in two visits, up to 72 hours apart.
The investigators expect: 1) subjects with a history of TS to have a decreased perceived pleasantness of affective touch compared to subjects without a history of TS; 2) the difference between the perceived pleasantness of affective versus non-affective touch to be smaller in patients with a history of TS; 3) decision making to be related to the hedonic nature of affective touch; 4) a change in the expression of opioidergic genes.
This study will contribute to a better knowledge of the vulnerability to suicidal behaviors and to a better understanding of psychopathology in order to offer specific and more adapted prevention and management strategies.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Episode, Suicidal and Self-injurious Behavior
Keywords
Suicide, Depression, Affective touch, Decision making
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Euthymic patients with history of suicide attempt (suicide attempters)
Arm Type
Experimental
Arm Description
Currently euthymic patients with at least one lifetime major depressive episode and a history of suicide attempts
Arm Title
Euthymic patients without any history of suicide attempt (affective controls)
Arm Type
Experimental
Arm Description
Currently euthymic patients with at least one lifetime major depressive episode and with no history of suicide attempts
Intervention Type
Other
Intervention Name(s)
Tactile stimulation
Intervention Description
The experimental task aims to evaluate the hedonic nature of an affective touch by tactile stimulation.
It consists in stimulating two adjacent regions of the left forearm, delimited and marked, of 9 cm x 4 cm each. In order to limit habituation, the stimulation areas will be alternated.
To stimulate these areas, the investigator (previously trained) strokes the participant with a brush at an optimal speed to stimulate the C-fibers (3 cm/s; slow speed) or not (18 cm/s; fast speed).
Touch will consist of 30 seconds blocks of stimulation, performed on one of the two identified areas, from the elbow to the wrist. In total, 6 stimulation blocks will be done (3 slow and 3 fast), the order and location of which will be random in order to limit habituation.
This stimulation is completely painless. After each block, the participant will evaluate the intensity of the stimulation and its pleasantness.
Primary Outcome Measure Information:
Title
Pleasantness of the touch
Description
Perceived pleasantness of the tactile stimulation, assessed with a numeric scale ranging from -5 (very unpleasant) to +5 (very pleasant)
Time Frame
at inclusion
Secondary Outcome Measure Information:
Title
Intensity of the touch
Description
Perceived intensity of the tactile stimulation, assessed with a 10 points Likert scale (low intensity to high intensity).
Time Frame
at inclusion
Title
Decision-making performance (Iowa Gambling Test)
Description
Decision-making performance using the IG index from the Iowa Gambling Test (difference between the number of safe and risky choices)
Time Frame
at inclusion
Title
Decision-making performance (Ultimatum Game)
Description
Decision-making performance using the UG index from the Ultimatum Game (difference between the number of rejections of unfair and fair offers)
Time Frame
at inclusion
Title
β-endorphin levels
Description
Plasmatic levels of β-endorphin
Time Frame
at inclusion
Title
Variation in the expression of opioidergic genes
Description
Variation in mRNA levels of 6 genes coding for opioidergic receptors and peptides (OPRM1 (µ), OPRK1 (κ), OPRD1 (δ) and pro-opio-melanocortin, pro-enkephalin, pro-dynomorphin), before and after tactile stimulation
Time Frame
at inclusion
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Being a woman
Aged between 18 and 65
Past major depressive episode according to the DSM-5 criteria
Currently euthymic (Montgomery-Asberg Depression rating Scale (MADRS) < 12 and Young Mania Rating Scale (YMRS) < 6)
Minimal psychotropic medication (as determined by the clinician)
Able to understand experimental procedures
Able to speak, read and understand French
Having given written informed consent
For suicide attempters only: Lifetime history of suicide attempt
For affective controls only: No lifetime history of suicide attempt
Exclusion Criteria:
Lifetime diagnosis of schizoaffective disorder, schizophrenia or autism spectrum disorder
Severe alcohol or substance use disorder in the past 6 months
Current anorexia nervosa
Diagnosis of mental retardation or severe medical comorbidity that is unstable or could interfere with measures (HIV, diabetes, cancer, chronic inflammatory disease, neurological disorder, sensory or cognitive disability)
Injury, scar, irritation/dermatological lesion or tattoo on the left forearm
Pregnancy or breastfeeding
Being in exclusion period for another study
Not being affiliated to the French National Social Security System
Being deprived of freedom (by judicial or administrative decision)
Being protected by law (guardianship or curatorship)
Having reached 4500€ annual compensation for participating to clinical trials
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emilie OLIE, MD PhD
Phone
+33 4 67 33 85 81
Email
e-olie@chu-montpellier.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Lou LEFEVRE
Email
l-lefevre@chu-montpellier.fr
Facility Information:
Facility Name
Montpellier University Hospital, France (CHU)
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Myriam Benramdane
Phone
+ 33 4 67 99 61 45 75
Email
m-benramdane@chu-montpellier.fr
12. IPD Sharing Statement
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Affective Touch, Hedonia and Suicidal Behavior
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