RecruitingNot ApplicableNCT06516874

A Pilot Study of Trauma-Focused Cognitive-Behavioral Therapy for Treatment of Post-traumatic Stress in Adults.

A Pilot Study of Feasibility and Acceptability of Videoconference-Delivered Trauma-Focused Cognitive Behavioral Therapy for Treatment of PTSD and C-PTSD in Adults of Community and Hospitals Mental Health Services


Sponsor

University of Talca

Enrollment

13 participants

Start Date

Oct 22, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Post-traumatic stress disorder (PTSD) is a mental health condition that's triggered by the experience of potentially traumatic events. Complex PTSD (CPTSD) includes additional symptoms that account for a disturbance of the organization of the self. Randomized controlled trials have shown that trauma-focused cognitive behavioral therapy (TF-CBT) is effective in reducing PTSD symptoms; however, there is insufficient evidence to support the effectiveness of this intervention for CPTSD. The present study aims to evaluate the feasibility and acceptability of TF-CBT therapy for complex presentation (TF-CBT-CP) in a videoconference modality in adults diagnosed with PTSD or CPTSD who are treated at community mental health care services (CMHCS, COSAM in Spanish) and the Hospital of the Maule Region, Chile. This pilot study will use a mixed design. The quantitative component will consist of a one-group pre-post-follow-up design, which will include 13 adults diagnosed with PTSD or CPTSD referred to care at CMHCS or hospitals of the Maule Region, Chile. Telephone interviews will collect qualitative data relevant to the study's acceptability. Participants will receive TF-CBT-CP therapy. It consists of 16 weekly 60-minute sessions of trauma-focused cognitive behavioral therapy for complex presentations. To determine the feasibility of TF-CBT-CP therapy, eligibility, recruitment, participation, activity completion, retention, exit, and dropout rates will be considered. To establish the acceptability of the protocol, participant satisfaction with the recruitment, assessment, and treatment process and reporting of reasons for non-participation or dropout will be assessed. Furthermore, secondary outcomes consider the reduction of PTSD and CPTSD symptomatology, depression, and anxiety and the improvement of indicators of emotional regulation and psychological well-being.


Eligibility

Min Age: 18 YearsMax Age: 64 Years

Inclusion Criteria9

  • Eligibility criteria:
  • Men and women over 18 years of age.
  • Referred to a community mental health care service (CMHCS) or hospital in the Maule Region for difficulties associated with the experience of traumatic events, symptomatology, or diagnosis of Post-Traumatic Stress Disorder (PTSD) or the complex form of Post-Traumatic Stress Disorder (CPTSD).
  • Not being treated for PTSD or C-PTSD at the time of recruitment
  • Men and women over 18 years of age.
  • Referred to a community mental health care service (CMHCS) or hospital in the Maule Region for difficulties associated with the experience of traumatic events, symptomatology, or diagnosis of Post-Traumatic Stress Disorder (PTSD) or Complex Post-Traumatic Stress Disorder (CPTSD).
  • Having the diagnosis of Post-Traumatic Stress Disorder (PTSD) or Complex Post-Traumatic Stress Disorder (CPTSD) by International Trauma Interview (ITI).
  • Fluent in oral and written Spanish language.
  • Access to telephone.

Exclusion Criteria8

  • Previously or currently diagnosed psychotic disorder.
  • Current substance use disorder.
  • Current suicidal crisis.
  • Depression is the primary diagnosis.
  • Participation in a PTSD psychological treatment parallel to the study.
  • Study's exit criteria:
  • Initiation of a psychological or pharmacological treatment for PTSD parallel to the study.
  • Change of medication dose in the case of participants with pharmacological treatment prior to the study.

Interventions

BEHAVIORALTrauma-Focused Cognitive Behavioral Therapy for complex presentation (TF-CBT-CP)

This TF-CBT-CP is a short-term intervention to treat outpatients. This will be carried out via videoconference.


Locations(5)

Centro Comunitario de Salud Mental de Curicó (COSAM)

Curicó, Maule Region, Chile

Centro Comunitario de Salud Mental de Linares (COSAM)

Linares, Maule Region, Chile

Hospital de Linares

Linares, Maule Region, Chile

Centro Comunitario de Salud Mental de Maule (COSAM)

Maule, Maule Region, Chile

Centro Comunitario de Salud Mental de Talca (COSAM)

Talca, Maule Region, Chile

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NCT06516874


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