Response to Social Rejection in Suicidal Behavior

NCT02710279 | Terminated

• 2 other identifiers: 96152015-A01308-41
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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).

Conditions

Unipolar Depression

Keywords

Psychiatry; Depressive disorder; Suicide

Outcome Measures

Primary Outcomes (1)

• 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

  up to one week

Secondary Outcomes (4)

• Inflammatory response to TTST

  up to one week

• Impact of loneliness and childhood abuse on inflammatory markers

  up to one week

• impact of neuropschychological function on psychological pain

  up to one week

• Social rejection assessed by likert scale in real life condition with a smartphone

  7 days after the TSST

Study Arms (1)

Depressive patients

OTHER

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

Interventions

Trier Social Stress Test (TSST) BEHAVIORAL

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.

Depressive patients

smartphone DEVICE

Depressive patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

University Hospital of Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Depressive Disorder; Suicide

Interventions

Psychological Tests

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

• Philippe Courtet, MD PhD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2016
• First Posted: March 16, 2016
• Study Start: February 19, 2016
• Primary Completion: February 15, 2018
• Study Completion: February 15, 2018
• Last Updated: August 3, 2022

Record last verified: 2021-12

Locations

FR (1)