An interventional study of Trier Social Stress Test (TSST) and smartphone in Unipolar Depression, sponsored by University Hospital, Montpellier. Terminated at 1 site in France. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-08-03.
Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Other
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).
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.
4,847 studies on the registry are indexed under Depressive Disorder; 509 are open to participants now.
This study's enrollment of 79 is close to the median of 80 across 3,997 interventional studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →University Hospital, Montpellier is the lead sponsor of 1,261 studies on the registry; 227 are open to participants now.
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Exclusion criteria:
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
Behavioral: Trier Social Stress Test (TSST) · Device: smartphone
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.
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
Time frame: up to one week
Inflammatory response to TTST
comparaison of blood markers of inflammation between groups
Time frame: up to one week
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
Time frame: up to one week
impact of neuropschychological function on psychological pain
comparaison of neuropsychological tests between groups on psychological pain assessed by visual analogic scale
Time frame: up to one week
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
Time frame: 7 days after the TSST
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Feb 2016 to primary completion in Feb 2018, 23 months.
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This study is terminated, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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