About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Previously or currently diagnosed psychotic disorder.

Current substance use disorder.

Current suicidal crisis.

Depression is the primary diagnosis.

Trial design

Design model

Single group

Treatments tested in this trial

Trauma-Focused Cognitive Behavioral Therapy for complex presentation (TF-CBT-CP)
Behavioral
This TF-CBT-CP is a short-term intervention to treat outpatients. This will be carried out via videoconference.

Treatment groups

13 Participants

are divided into 1 treatment group

Group A: Trauma-Focused Cognitive Behavioral Therapy for complex presentation (TF-CBT-CP)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Eligibility rate as a feasibility indicator

Proportion of patients who meet eligibility criteria compared to the total number of patients registered in the community mental health care services and hospital referral system during the recruitment period.

Time frame

At the baseline assessment during the recruitment period.

2

Recruitment rate as a feasibility indicator.

The proportion of patients who accept the invitation to participate in the study with respect to those who meet the eligibility criteria.

Time frame

At the baseline assessment during the recruitment period.

3

Participation rate in the evaluation protocol as a feasibility indicator.

Proportion of patients who fully conclude activities in all 3 assessments: initial evaluation, at week 16 after the start of treatment (or end of treatment), and follow-up at week 20 after the start of treatment, with respect to the total number of people who agree to participate in the study.

Time frame

At baseline, 16-weeks and 20- week after the start of treatment.

4

Trauma-Focused Cognitive Behavioral Therapy for complex presentation (TF-CBT-CP) activities completion rate.

Percentage of participants who concluded all (100%) of the proposed activities in the 16 treatment sessions, as reported in the TF-CBT-CP patients' activities diary carried out inside or outside sessions.

Time frame

During the intervention period.

Secondary outcomes

1

Changes in PTSD symptoms, according to mean scores obtained with the International Trauma Questionnaire (ITQ).

The ITQ (International Trauma Questionnaire) is an 18-item self-report scale that assesses PTSD and complex PTSD (CPTSD) symptomatology based on the International Classification of Diseases 11 (ICD-11) and functional impairment. Each item is scored on a Likert scale ranging from 0 (not at all) to 4 points (extremely); the higher the score, the greater the symptomatology.

Time frame

At baseline, 16 weeks, and 20 weeks after the start of treatment.

2

Changes in CPTSD symptoms, according to mean scores obtained with the International Trauma Questionnaire (ITQ).

The ITQ (International Trauma Questionnaire) is an 18-item self-report scale that assesses PTSD and complex PTSD (CPTSD) symptomatology based on the International Classification of Diseases 11 (ICD-11) and functional impairment. Each item is scored on a Likert scale ranging from 0 (not at all) to 4 points (extremely); the higher the score, the greater the symptomatology.

Time frame

At baseline, 16 weeks, and 20 weeks after the start of treatment.

3

Changes in PTSD symptoms, according to mean scores obtained with the International Trauma Interview (ITI).

The ITI (International Trauma Interview) is a 16-item semi-structured interview that allows for determining the diagnosis of PTSD and CPTSD by assessing PTSD symptoms and Disturbances in Self-Organization symptoms. The interview takes between 45 and 60 minutes.

Time frame

At baseline, 16 weeks, and 20 weeks after the start of treatment.

4

Changes in CPTSD symptoms, according to mean scores obtained with the International Trauma Interview (ITI).

The ITI (International Trauma Interview) is a 16-item semi-structured interview that allows for determining the diagnosis of PTSD and CPTSD by assessing PTSD symptoms and Disturbances in Self-Organization symptoms. The interview takes between 45 and 60 minutes.

Time frame

At baseline, 16 weeks, and 20 weeks after the start of treatment.

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

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts