Skip to content

Response to Social Rejection in Suicidal Behavior

Response to Social Rejection in Suicidal Behavior

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02710279
Acronym
SADS-CS
Enrollment
79
Registered
2016-03-16
Start date
2016-02-19
Completion date
2018-02-15
Last updated
2022-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unipolar Depression

Keywords

Psychiatry, Depressive disorder, Suicide

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.

Interventions

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.

DEVICEsmartphone

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Psychological pain response to Trier Social Stress Test (TSST) assessed by visual analogic saleup to one weekcomparaison of psychological pain response between group with personal history of suicid attempt and group without personal history of suicid attempt

Secondary

MeasureTime frameDescription
Inflammatory response to TTSTup to one weekcomparaison of blood markers of inflammation between groups
Impact of loneliness and childhood abuse on inflammatory markersup to one weekcomparaison of sacles scores (ESUL : loneliness scale and CTQ : childhood abuse scale) between groups on inflammatory markers
impact of neuropschychological function on psychological painup to one weekcomparaison 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 smartphone7 days after the TSSTcomparaison 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026