Post-traumatic stress disorder (PTSD) is a mental health condition that's triggered by
the experience of potentially traumatic events. It is a disabling psychopathology with
high comorbidity, associated with problems of emotional regulation and low psychological
well-being. In addition, the World Health Organization (WHO) has recently proposed the
diagnosis of complex PTSD (CPTSD) to account for a type of PTSD that includes both
traditional and additional symptoms that account for a disturbance of self-organization
of the self.
Randomized controlled trials (RCT) have shown that trauma-focused cognitive behavioral
therapy (TF-CBT) is effective in reducing PTSD symptoms. However, additional clinical
studies are necessary to fully assess the effectiveness of TF-CBT for complex
presentations (TF-CBT-CP). Additionally, adapting PTSD therapy to a new population
requires prior knowledge of information that may affect the effects of the intervention,
e.g., history of traumatic events, variety and intensity of PTSD symptoms, and
comorbidities. Given the lack of knowledge of these characteristics in Chile and for the
purpose of subsequently implementing a large-scale randomized clinical trial in the
Chilean population, the CONSORT guidelines recommend developing a pilot RCT.
The present study aims to evaluate the feasibility and acceptability of TF-CBT-CP therapy
in a videoconference modality in adults diagnosed with PTSD or CPTSD who are treated at
community mental health care services (CMHCS) or hospitals in 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. Participants
will receive-by videoconference-TF-CBT-CP therapy, which consists of 16 weekly 60-minute
sessions of trauma-focused cognitive behavioral therapy for complex presentations.
The treatment includes a) conducting clinical assessment sessions; b) providing
psychoeducation on PTSD and CPTSD; c) facilitating the development of coping strategies
to manage distressing experiences; d) implementing behavioral activation techniques to
reintegrate into daily activities; e) fostering the acquisition of emotional regulation
strategies and interpersonal relationship skills; f) utilizing in-vivo (live) and
imaginal exposure methods to confront the traumatic memory; g) engaging in cognitive
interventions to address distorted thoughts; and h) implementing relapse prevention
strategies. Clinical psychologists, trained by the research team, will implement the
treatment. To ensure the fidelity of the TF-CBT-CP treatment, the project team will
conduct weekly supervisions and review compliance with the activities of each session
using a checklist based on the therapy protocol. The project team will provide
supervision.
Professionals designated by CMHCS or hospitals will present the study to eligible
individuals and ask if they are willing to be contacted by the study's research
assistant(s) via telephone as part of the initial recruitment process. The research
assistants will explain the study characteristics and the selection process, paying
particular attention to the study inclusion and exclusion criteria. If the person agrees
to participate, he or she will be invited to an in-person interview at the respective
health services to address any doubts about the study and to complete the informed
consent process.
Those who have agreed to participate and signed the informed consent form do the initial
evaluation. This initial assessment will be conducted via videoconference, where trained
psychologists will administer the Life Event Checklist-5 (LEC-5) and the International
Trauma Questionnaire (ITQ), a self-report questionnaire that assesses PTSD and CPTSD
symptoms. Trained psychologists administer the Mini-International Neuropsychiatric
Interview (MINI) to determine whether individuals at risk for PTSD or CPTSD on previous
instruments meet exclusion criteria. If the person is at risk of PTSD or CPTSD and does
not meet any exclusion criteria, trained psychologists administer additional
questionnaires to assess depressive (Patient Health Questionnaire, PHQ-9) and anxious
symptoms (Generalized Anxiety Disorder Questionnaire, GAD-7), suicidal ideation and
behavior (Columbia-Suicide Severity Rating Scale, C-SSRS), alcohol consumption and/or
dependence (Alcohol and Other Drugs Use Questionnaire, AUDIT), emotional regulation
problems (Spanish version of Difficulties in Emotion Regulation Scale, DERS-S), and
impaired functioning (Work and Social Adjustment Scale, WSAS, and Clinical Outcomes in
Routine Evaluation, CORE-10). In addition, another evaluation session is scheduled, where
the diagnosis of PTSD or CPTSD is established through the International Trauma Interview
(ITI). Participants who are excluded during this evaluation process will be invited to a
feedback interview via videoconference.
Participants who meet the inclusion criteria and do not present exclusion criteria will
engage in 16 weekly 60-minute sessions of trauma-focused cognitive behavioral therapy
(TF-CBT-CP) through videoconference.
Participants will be invited to an evaluation session via video conference at the end of
week 16 (final measurement) and week 20 (follow-up) after the start of treatment. During
this session, they will participate in the International Trauma Interview (ITI) and
complete the following questionnaires: ITQ, PHQ-9, GAD-7, C-SSRS, AUDIT, DERS-S, WSAS,
and CORE-10. Furthermore, the participants' satisfaction with the intervention will be
assessed using the Client Satisfaction Questionnaire (CSQ-8) at each of these measurement
points.
To guarantee access to a computer with connectivity for video conferencing and a
confidential space for TF-CBT-CP therapy, both the evaluation and treatment sessions will
take place in the respective health services' room or in a similar clinical care center,
where a notebook, internet connection, printer, camera, and microphone will be available
to be used by study participants.
Trained psychologists will collect qualitative data related to the study's acceptability
through telephone interviews after the follow-up measurement. They will apply an
open-ended interview to all participants. Data collection will continue until the
saturation point is reached. The thematic analysis will be done on the transcribed
interviews.
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 and dropout will be assessed. 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.
