Response to Social Rejection in Suicidal Behavior (SADS-CS)
Primary Purpose
Unipolar Depression
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Trier Social Stress Test (TSST)
smartphone
Sponsored by
About this trial
This is an interventional other trial for Unipolar Depression focused on measuring Psychiatry, Depressive disorder, Suicide
Eligibility Criteria
Inclusion Criteria:
- Non specifics
- Female
- Between 18 and 65 years
- Main diagnosis of unipolar major depressive episode (DSM-IV criteria)
- Having signed informed consent
- Able to understand nature, aims, and methodology oh the study
- Specifics :
- Having a personal history of suicidal behavior (group : depressed patient with history of SB) OR
- Not Having personal history of suicidal behavior (group : depressed patient without history of SB)
Exclusion criteria:
- Inflammatory or intercurrent pathology
- Lifetime history of schizophrenia, or schizoaffective or bipolar disorder, according to DSM-IV criteria;
- Current diagnosis of substance abuse or dependence in the last year (excluding tobacco)
- Current organic mental disorder or mental retardation, or severe comorbid medical condition
- Participation in another clinical trial
- Pregnancy
- Not able to speak, read and understand French
- Patient on protective measures (guardianship or trusteeship)
Sites / Locations
- University Hospital of Montpellier
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Depressive patients
Arm Description
Depressive patients with or without story of suicidal behavior will pass the TSST and will have a psychological assessment to complete with a questionnaire on their smartphone
Outcomes
Primary Outcome Measures
Psychological pain response to Trier Social Stress Test (TSST) assessed by visual analogic sale
comparaison of psychological pain response between group with personal history of suicid attempt and group without personal history of suicid attempt
Secondary Outcome Measures
Inflammatory response to TTST
comparaison of blood markers of inflammation between groups
Impact of loneliness and childhood abuse on inflammatory markers
comparaison of sacles scores (ESUL : loneliness scale and CTQ : childhood abuse scale) between groups on inflammatory markers
impact of neuropschychological function on psychological pain
comparaison of neuropsychological tests between groups on psychological pain assessed by visual analogic scale
Social rejection assessed by likert scale in real life condition with a smartphone
comparaison between groups whether inflammatory / psychological pain reactivity to a single experimental episode of social rejection in the laboratory relates to real-world social experience. It consists on self-assessments (with a smartphone) by Likert scales (feelings of social disconnection or rejection during their most recent social interaction, mood, negative affects, suicidal ideation, psychological pain), 5 times per day during 7 days
Full Information
NCT ID
NCT02710279
First Posted
March 11, 2016
Last Updated
August 2, 2022
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT02710279
Brief Title
Response to Social Rejection in Suicidal Behavior
Acronym
SADS-CS
Official Title
Response to Social Rejection in Suicidal Behavior
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Terminated
Why Stopped
difficulties in recruitment
Study Start Date
February 19, 2016 (Actual)
Primary Completion Date
February 15, 2018 (Actual)
Study Completion Date
February 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Suicide is a major health problem that causes annually a million death worldwild. In the stress-vulnerability model, suicidal behavior (SB) results from the interaction between an individual's predisposition and stressful condition. We hypothesized that the sensitivity to social exclusion may represent a core component of the suicidal vulnerability Recent evidence also suggest that inflammatory mediators plays a critical role in SB. Furthermore, social stressors are particulary strong and specific triggers of inflammatory response.
To sum up, patients carrying a suicidal vulnerability are expected to present greater responses to social rejection in terms of inflammatory activity and psychological pain.
The aim of the study is to evaluate the psychological and inflammatory responses to a social stressor validated, the Trier Social Stress Test (TSST) . We will also investigate the moderating effect of childhood abuse, attachment, trait rejection sensitivity and social isolation.
In the second part of the study, we will also investigate the prospective association between inflammatory responses induces by laboratory paradigms of social rejection and the occurrence of social distress, suicidal ideation and psychological pain in response to social exclusion events in real life (using ecological momentary assessment).
Detailed Description
Over one year, we will recruit 140 female outpatients suffering from a major depressive episode with (n=70) and without any history of suicide attempt (n=70) from a specialized clinic for mood disorders and SB.
First visit: clinical, biological and neuropsychological assessment Second visit: The TSST is a standardized laboratory psychosocial stress protocol that involves public speaking, role play, and mental arithmetic tasks in front of a panel of confederate judges. Blood samples will be obtained before the introduction to the TSST and immediately after and at + 30, + 60, + 90, and + 120 min. Self-ratings of emotional states, anxiety, anger and psychological pain will be completed at the same times.
Third visit: Participants will be instructed to carry a smartphone with them for one week, and to record at each alarm signal daily life events, negative emotions, psychological pain, suicidal ideas, and specific attributions to these events. Participants will be signalled five times a day during the period. Subjects will be contacted by telephone halfway through the assessment period to monitor and encourage compliance.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unipolar Depression
Keywords
Psychiatry, Depressive disorder, Suicide
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
79 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Depressive patients
Arm Type
Other
Arm Description
Depressive patients with or without story of suicidal behavior will pass the TSST and will have a psychological assessment to complete with a questionnaire on their smartphone
Intervention Type
Behavioral
Intervention Name(s)
Trier Social Stress Test (TSST)
Intervention Description
For the TSST the participants are instructed to imagine having applied for their "dream job" and that they are now invited to a job interview. Three successive phases: (1) A preparation period (3 min), (2) a free speech: explain why you are the best candidate for the job (5 min), (3) a mental arithmetic complex task (5 min). The two tasks (task 2 and 3) are performed in front of a selection committee, three persons dressed in white lab coats, acting in a reserved manner and providing no facial or verbal feedback. Additionally, participants are told that they are video-taped and told that their performance will be evaluated. (in fact, there is no video-tape, just a false camera). After the TSST, patients have to answer to a questionnaire on their smartphone, 5 times a day during 7 days.
Intervention Type
Device
Intervention Name(s)
smartphone
Primary Outcome Measure Information:
Title
Psychological pain response to Trier Social Stress Test (TSST) assessed by visual analogic sale
Description
comparaison of psychological pain response between group with personal history of suicid attempt and group without personal history of suicid attempt
Time Frame
up to one week
Secondary Outcome Measure Information:
Title
Inflammatory response to TTST
Description
comparaison of blood markers of inflammation between groups
Time Frame
up to one week
Title
Impact of loneliness and childhood abuse on inflammatory markers
Description
comparaison of sacles scores (ESUL : loneliness scale and CTQ : childhood abuse scale) between groups on inflammatory markers
Time Frame
up to one week
Title
impact of neuropschychological function on psychological pain
Description
comparaison of neuropsychological tests between groups on psychological pain assessed by visual analogic scale
Time Frame
up to one week
Title
Social rejection assessed by likert scale in real life condition with a smartphone
Description
comparaison between groups whether inflammatory / psychological pain reactivity to a single experimental episode of social rejection in the laboratory relates to real-world social experience. It consists on self-assessments (with a smartphone) by Likert scales (feelings of social disconnection or rejection during their most recent social interaction, mood, negative affects, suicidal ideation, psychological pain), 5 times per day during 7 days
Time Frame
7 days after the TSST
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:
Non specifics
Female
Between 18 and 65 years
Main diagnosis of unipolar major depressive episode (DSM-IV criteria)
Having signed informed consent
Able to understand nature, aims, and methodology oh the study
Specifics :
Having a personal history of suicidal behavior (group : depressed patient with history of SB) OR
Not Having personal history of suicidal behavior (group : depressed patient without history of SB)
Exclusion criteria:
Inflammatory or intercurrent pathology
Lifetime history of schizophrenia, or schizoaffective or bipolar disorder, according to DSM-IV criteria;
Current diagnosis of substance abuse or dependence in the last year (excluding tobacco)
Current organic mental disorder or mental retardation, or severe comorbid medical condition
Participation in another clinical trial
Pregnancy
Not able to speak, read and understand French
Patient on protective measures (guardianship or trusteeship)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Courtet, MD PhD
Organizational Affiliation
University Hospital, Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Response to Social Rejection in Suicidal Behavior
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