Identification of the Clinical Specificities of Complex Posttraumatic Stress Disorder

NCT05592652 | Completed

• 2 other identifiers: DR220118-IDPLEX2022-A01206-37
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Identification of the clinical specificities of complex post-traumatic stress disorder post-traumatic stress disorder

Conditions

Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (4)

• Dissociation

  The Dissociation questionnaire (DIS-Q; Vanderlinden et al., 1993) is used to scan dissociative experience and disruptions, and to measure their severity. It can be used for psychiatric patients, individuals with traumatic experience, and for scanning purposes. Its instructions are available in the introduction section of the scale and patients are asked to mark the most appropriate option for their condition. It consists of a total of 63 questions and the subject marks one option for each of these questions. Each item is scored between 1 and 5 points, mean score is obtained by dividing total scores by 63. High scores reflect high dissociative experience and disruptions. This scale can distinguish the subjects with dissociative disorder from healthy individuals or from patients with schizophrenia or bipolar mood disorder.

  baseline

• Emotional dysregulation

  The Difficulties in Emotion Regulation Scale (DERS; Gratz \& Roemer, 2004) is a 36-item self-report questionnaire assessing emotion regulation difficulties. A typical item is "I am clear about my feelings". Items are rated from 1 (almost never) to 5 (almost always). The French version has good internal consistency for all the sub-dimensions, with Cronbach alpha values of 0.84 to 0.90 (Dan-Glauser \& Scherer, 2013). The DERS provides a total score and higher values are associated with a stronger emotion regulation difficulties.

  5 minutes for questionnaire completion

• PTSD

  The Posttraumatic stress disorder Checklist Scale PCL-5 (Weathers et al., 2013) is a self-administered questionnaire to assess the severity of PTSD in the clinic and research according to DSM-5 criteria. This scale translated and validated in French (Ashbaugh et al., 2016) is composed of 20 items, rated from 1 (not at all) to 5 (very often) according to the intensity and frequency of symptoms in the past month. When adding the scores for each of the 20 items, a total score greater than or equal to 33 indicates probable PTSD. The PCL-5 has good psychometric qualities as it demonstrates strong internal consistency (α = .94) as well as good convergent (rs = .74 to .85) and divergent validity (rs = .31 to .60) (Blevins et al., 2015). This tool is also sensitive to therapeutic change and can be used in repeated measures as evidenced by strong test-retest reliability (r = .82) (Blevins et al., 2015).

  baseline

• Complex PTSD

  The International Trauma Questionnaire (ITQ; Cloitre et al., 2018) is a self-report measure of PTSD and CPTSD severity assessing the following symptoms : reeexperiencing, avoidance, sense of threat, affective dysregulation, negative self- concept and disturbances in relationships. Participants are asked to select on a Likert scale how much a symptom has been bothersome in the past month or how true certain statements are of them, with scores ranging from 0 ("not at all") to 4 ("extremely"). Diagnosis of PTSD requires the endorsement of one of two symptoms from each PTSD cluster, while CPTSD diagnosis requires the endorsement of one of two symptoms from both PTSD and 'Disturbances in Self-organization' clusters. Both diagnoses require the presence of functional impairment. The ITQ is the only validated measure for ICD-11 PTSD and CPTSD.

  baseline

Secondary Outcomes (10)

• Early Maladaptive Schema

  10 minutes for questionnaire completion

• Personality Disorders

  baseline

• Depressive symptoms

  baseline

• Anxiety State and Trait

  baseline

• Peritraumatic Dissociation

  Less than five minutes for questionnaire completion

Study Arms (4)

simple post-traumatic stress disorder

OTHER

Patients suffering from PTSD according to DSM-5 diagnostic features

Other: Survey

complex post-traumatic stress disorder

OTHER

Patients suffering from CPTSD according to CIM-11 diagnostic features

Other: Survey

volonteer trauma +

OTHER

non clinical volunteer with traumatic exposure

Other: Survey

volonteer trauma -

OTHER

non clinical volunteer without traumatic exposure

Other: Survey

Interventions

Survey OTHER

Survey including demographic, clinical and psychopathological questions

complex post-traumatic stress disorder; simple post-traumatic stress disorder; volonteer trauma +; volonteer trauma -

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Free, informed and signed consent
• Affiliated to a social security scheme
• Age ≥ 18 years
• Free, informed and signed consent
• Affiliated to a social security scheme

You may not qualify if:

• Under legal protection (curatorship, guardianship, safeguard of justice)
• Present a former or current psychotic disorder, a former or current neurological disease, a history of head trauma (loss of consciousness of more than 10 minutes)

Sponsors & Collaborators

• University Hospital, Tours: lead
• University of Bordeaux: collaborator

Study Sites (1)

UHTours

Tours, 37000, France

Location

Related Publications (13)

• Arntz A, Jacob GA, Lee CW, Brand-de Wilde OM, Fassbinder E, Harper RP, Lavender A, Lockwood G, Malogiannis IA, Ruths FA, Schweiger U, Shaw IA, Zarbock G, Farrell JM. Effectiveness of Predominantly Group Schema Therapy and Combined Individual and Group Schema Therapy for Borderline Personality Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2022 Apr 1;79(4):287-299. doi: 10.1001/jamapsychiatry.2022.0010.

  PMID: 35234828 BACKGROUND

• Bandelow B, Krause J, Wedekind D, Broocks A, Hajak G, Ruther E. Early traumatic life events, parental attitudes, family history, and birth risk factors in patients with borderline personality disorder and healthy controls. Psychiatry Res. 2005 Apr 15;134(2):169-79. doi: 10.1016/j.psychres.2003.07.008.

  PMID: 15840418 BACKGROUND

• Brewin CR, Cloitre M, Hyland P, Shevlin M, Maercker A, Bryant RA, Humayun A, Jones LM, Kagee A, Rousseau C, Somasundaram D, Suzuki Y, Wessely S, van Ommeren M, Reed GM. A review of current evidence regarding the ICD-11 proposals for diagnosing PTSD and complex PTSD. Clin Psychol Rev. 2017 Dec;58:1-15. doi: 10.1016/j.cpr.2017.09.001. Epub 2017 Sep 6.

  PMID: 29029837 BACKGROUND

• Cloitre M, Garvert DW, Brewin CR, Bryant RA, Maercker A. Evidence for proposed ICD-11 PTSD and complex PTSD: a latent profile analysis. Eur J Psychotraumatol. 2013 May 15;4. doi: 10.3402/ejpt.v4i0.20706. Print 2013.

  PMID: 23687563 BACKGROUND

• Gilbar O, Hyland P, Cloitre M, Dekel R. ICD-11 complex PTSD among Israeli male perpetrators of intimate partner violence: Construct validity and risk factors. J Anxiety Disord. 2018 Mar;54:49-56. doi: 10.1016/j.janxdis.2018.01.004. Epub 2018 Jan 31.

  PMID: 29421372 BACKGROUND

• Karatzias T, Hyland P, Bradley A, Cloitre M, Roberts NP, Bisson JI, Shevlin M. Risk factors and comorbidity of ICD-11 PTSD and complex PTSD: Findings from a trauma-exposed population based sample of adults in the United Kingdom. Depress Anxiety. 2019 Sep;36(9):887-894. doi: 10.1002/da.22934. Epub 2019 Jul 3.

  PMID: 31268218 BACKGROUND

• Karatzias T, Shevlin M, Fyvie C, Hyland P, Efthymiadou E, Wilson D, Roberts N, Bisson JI, Brewin CR, Cloitre M. An initial psychometric assessment of an ICD-11 based measure of PTSD and complex PTSD (ICD-TQ): Evidence of construct validity. J Anxiety Disord. 2016 Dec;44:73-79. doi: 10.1016/j.janxdis.2016.10.009. Epub 2016 Oct 17.

  PMID: 27776256 BACKGROUND

• Kilpatrick DG, Resnick HS, Milanak ME, Miller MW, Keyes KM, Friedman MJ. National estimates of exposure to traumatic events and PTSD prevalence using DSM-IV and DSM-5 criteria. J Trauma Stress. 2013 Oct;26(5):537-47. doi: 10.1002/jts.21848.

  PMID: 24151000 BACKGROUND

• Lanius RA, Brand B, Vermetten E, Frewen PA, Spiegel D. The dissociative subtype of posttraumatic stress disorder: rationale, clinical and neurobiological evidence, and implications. Depress Anxiety. 2012 Aug;29(8):701-8. doi: 10.1002/da.21889. Epub 2012 Mar 16.

  PMID: 22431063 BACKGROUND

• Maercker A, Brewin CR, Bryant RA, Cloitre M, Reed GM, van Ommeren M, Humayun A, Jones LM, Kagee A, Llosa AE, Rousseau C, Somasundaram DJ, Souza R, Suzuki Y, Weissbecker I, Wessely SC, First MB, Saxena S. Proposals for mental disorders specifically associated with stress in the International Classification of Diseases-11. Lancet. 2013 May 11;381(9878):1683-5. doi: 10.1016/S0140-6736(12)62191-6. Epub 2013 Apr 11. No abstract available.

  PMID: 23583019 BACKGROUND

• Powers A, Fani N, Carter S, Cross D, Cloitre M, Bradley B. Differential predictors of DSM-5 PTSD and ICD-11 complex PTSD among African American women. Eur J Psychotraumatol. 2017 Jun 15;8(1):1338914. doi: 10.1080/20008198.2017.1338914. eCollection 2017.

  PMID: 28649302 BACKGROUND

• Resick PA, Bovin MJ, Calloway AL, Dick AM, King MW, Mitchell KS, Suvak MK, Wells SY, Stirman SW, Wolf EJ. A critical evaluation of the complex PTSD literature: implications for DSM-5. J Trauma Stress. 2012 Jun;25(3):241-51. doi: 10.1002/jts.21699.

  PMID: 22729974 BACKGROUND

• van der Kolk BA, Pelcovitz D, Roth S, Mandel FS, McFarlane A, Herman JL. Dissociation, somatization, and affect dysregulation: the complexity of adaptation of trauma. Am J Psychiatry. 1996 Jul;153(7 Suppl):83-93. doi: 10.1176/ajp.153.7.83.

  PMID: 8659645 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Géraldine TAPIA, PhD

  University of Bordeaux

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: patients and volunteers will undergo a series of psychometric scales

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: October 25, 2022
• Study Start: January 25, 2023
• Primary Completion: July 18, 2025
• Study Completion: July 18, 2025
• Last Updated: December 1, 2025

Record last verified: 2025-11

Locations

FR (1)