TF-CBT for Long-term PTSD, Major Depressive Disorder and Anxiety Disorders in Victims of Terrorism

NCT05516368 | Completed

• 1 other identifier: PSI 2011-26450
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study is to test the efficacy of a Trauma-Focused Cognitive-Behavioural Therapy (TF-CBT) adapted for use with victims of terrorism in Spain who are diagnosed with posttraumatic stress disorder (PTSD), major depressive disorder and/or anxiety disorders subsequent to direct or indirect exposure to a series of terrorist attacks that occurred 20 years prior to treatment on average. Spanish victims who meet the criteria for long-term posttraumatic stress disorder, major depressive disorder, and/or anxiety disorders related to direct or indirect exposure to terrorist attacks that occurred 20 years ago, on average, will be randomly assigned to 16 weekly sessions of TF-CBT (experimental group) or waiting list control (control group) conditions. Between groups comparisons related to diagnostic rates and posttraumatic, depressive and anxiety symptoms will be made immediately after the intervention. Pre- follow-up comparisons related to diagnostic rates and posttraumatic, depressive, and anxiety symptoms will be carried out for the experimental group. It is hypothesised that participants receiving TF-CBT will have significantly lower diagnostic rates and mean levels of posttraumatic, depressive and anxiety symptoms than the control group immediately after the intervention, and that they will experience significant pre-treatment to 6-month follow-up decreases in diagnostic rates and in posttraumatic, depressive and anxiety symptoms.

Conditions

Posttraumatic Stress Disorder; Major Depressive Disorder; Anxiety Disorders

Keywords

Terrorism; Cognitive Behavior Therapy; Posttraumatic Stress Disorder (PTSD); Major Depression; Anxiety Disorders; Randomized Clinical Trial

Outcome Measures

Primary Outcomes (1)

• Diagnosis of PTSD, depressive and anxiety disorders

  Percentage of PTSD, major depressive disorder and anxiety disorders, obtained by The Spanish version of the Structured Clinical Interview for DSM-IV, modules F and A (First et al., 1999).

  Immediately after the intervention

Secondary Outcomes (7)

• Post-traumatic stress symptoms

  Immediately after the intervention

• Major depressive disorder symptoms

  Immediately after the intervention

• Anxiety symptoms

  Immediately after the intervention

• Change from Baseline Diagnosis of PTSD, depressive and anxiety disorders at 6 months

  Baseline, 6 months

• Change from Baseline mean level of post-traumatic stress symptoms at 6 months

  Baseline, 6 months

Study Arms (2)

TF-CBT

EXPERIMENTAL

16 sessions of trauma-focused CBT adapted to victims of terrorism with long-term PTSD, major depressive disorder and/or anxiety disorders

Behavioral: TF-CBT

Waiting list control

NO INTERVENTION

4 months of waiting list condition

Interventions

TF-CBT BEHAVIORAL

Modular TF-CBT therapy programme of 16 weekly individual sessions, each lasting 60-90 minutes.

TF-CBT

Eligibility Criteria

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

You may qualify if:

• Being a direct victim of terrorism and/or a relative of someone killed or injured in a terrorist attack.
• Being of legal age
• Living in the same city or nearby
• Being diagnosed with PTSD, major depressive disorder, and/or anxiety disorders based on Diagnostic and Statistical Manual (DSM-IV) criteria (American Psychiatric Association, 2000).

You may not qualify if:

• Psychological condition unrelated to a terrorist attack
• Psychiatric emergency
• Declining to participate in the intervention before being diagnosed
• Medical contraindication(s) likely to interfere with treatment effectiveness, including organic brain syndrome, severe cognitive or sensor impairment, current substance use disorder, active psychotic or bipolar disorder, or severe dissociative amnesia
• Ongoing, in-process trauma-focused psychotherapy
• Inability to attend treatment sessions.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead
• Ministry of Science and Innovation, Spain: collaborator
• Spanish Association of Victims of Terrorism: collaborator

Related Publications (5)

• Paz Garcia-Vera M, Sanz J, Gutierrez S. A Systematic Review of the Literature on Posttraumatic Stress Disorder in Victims of Terrorist Attacks. Psychol Rep. 2016 Aug;119(1):328-59. doi: 10.1177/0033294116658243. Epub 2016 Jul 7.

  PMID: 27388691 BACKGROUND

• Garcia-Vera MP, Sanz J, Sanz-Garcia A. Ten Things Every Psychologist Should Know About Treating Psychological Disorders in Victims of Terrorism. Psicothema. 2021 May;33(2):177-187. doi: 10.7334/psicothema2021.33.

  PMID: 33879289 BACKGROUND

• Moreno N, Sanz J, Garcia-Vera MP, Gesteira C, Gutierrez S, Zapardiel A, Cobos B, Marotta-Walters S. Effectiveness of trauma-focused cognitive behavioral therapy for terrorism victims with very long-term emotional disorders. Psicothema. 2019 Nov;31(4):400-406. doi: 10.7334/psicothema2018.165.

  PMID: 31634084 BACKGROUND

• Garcia-Vera, M. P., Moreno, N., Sanz, J., Gutierrez, S., Gesteira, C., Zapardiel, A., & Marotta, S. (2015). Eficacia y utilidad clínica de los tratamientos para las víctimas adultas de atentados terroristas: una revisión sistemática. [Efficacy and clinical utility (effectiveness) of treatments for adult victims of terrorist attacks: A systematic review]. Psicología Conductual- Behavioral Psychology, 23, 215-244.

  BACKGROUND

• Gesteira, C., Garcia-Vera, M.P., & Sanz, J. (2028). Porque el Tiempo no lo Cura Todo Eficacia de la Terapia Cognitivo-conductual Centrada en el Trauma para el Estrés postraumático a muy Largo Plazo en Víctimas de Terrorismo. [Because time does not heal all wounds: Efficacy of trauma-focused cognitive behavioral therapy for very long-term posttraumatic stress in victims of terrorism]. Clínica y Salud, 29(1), 9-13.

  RESULT

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depressive Disorder, Major; Anxiety Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Depressive Disorder; Mood Disorders

Study Officials

• María Paz García Vera, Professor

  Universidad Complutense de Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full-professor

Study Record Dates

• First Submitted: August 19, 2022
• First Posted: August 25, 2022
• Study Start: March 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: August 25, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share