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
presentation (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.
Thus, the present study aims to evaluate the feasibility, acceptability, and preliminary
effectiveness of TF-CBT-CP therapy in videoconference modality compared with the usual
treatment on the reduction of PTSD and CPTSD symptoms in adults diagnosed with PTSD or
CPTSD, who are treated at the community mental health care services (CMHCS) of the Maule
Region, Chile.
This pilot study will use a mixed design. The quantitative component will consist of
carrying out a randomized two-arm parallel superiority trial, blinded to the data
analyst. The study's sample will include 68 persons who have been diagnosed with either
PTSD or CPTSD and referred to care at community mental health care services (CMHCS) in
the Maule Region, Chile.
The investigators will randomly assign participants to the experimental (EG) or control
(CG) groups in a 1:1 ratio. Participants in the EG will receive 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. Two clinical psychologists, trained by the research team,
will apply 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. The CG will receive the usual care (TAU) provided by CMHCS for individuals
referred for PTSD symptoms or trauma-related issues. This could include waiting on a
list, getting medication, and/or going to regular non-specialized PTSD therapy sessions.
CMHCS professionals will provide this treatment.
CMHCS' intake professionals 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 o she will be
invited to an in-person interview at CMHCS or at a similar clinical care center 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 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.
The EG participants will engage in 16 weekly 60-minute sessions of trauma-focused
cognitive behavioral therapy (TF-CBT-CP) throughout videoconference. CG participants will
receive the usual care offered by their respective CMHCS. Participants from both groups
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 CMHCS' 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 psychologist will collect qualitative data related to the study's acceptability
through telephone interviews after the follow-up measurement in both groups. Trained
psychologist will apply an open-ended interview to a randomly select an initial sample of
six participants (3 in each group). Data collection will continue until 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 of preliminary
effectiveness consider the reduction of PTSD and CPTSD symptomatology, depression and
anxiety, and improvement of indicators of emotional regulation and psychological
well-being. The investigators expect the TF-CBT-CP treatment in the videoconferencing
modality to decrease symptoms of PTSD, CPTSD, depression, and anxiety and improve
indicators of emotional regulation and psychological well-being at 16 and 20 weeks after
the start of treatment. The investigators expect this effect to be greater in the EG than
in the CG.