Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06516874
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-02
Brief Title:
A Pilot Clinical Trial of Trauma-Focused Cognitive-Behavioral Therapy for Treatment of Post-traumatic Stress in Adults
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Pilot Clinical Trial of Feasibility Acceptability and Preliminary Effectiveness of Videoconference-Delivered Trauma-Focused Cognitive Behavioral Therapy for Treatment of PTSD and C-PTSD in Adults of Community Mental Health Services
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Post-traumatic stress disorder PTSD is a mental health condition thats triggered by the experience of potentially traumatic events A 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 acceptability and preliminary effectiveness of TF-CBT therapy for complex presentation TF-CBT-CP in videoconference modality compared with the usual treatment for 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 COSAM in spanish of the Maule Region Chile
This pilot study will use a mixed design The quantitative component will consist of a randomized two-arm parallel superiority trial blinded to the data analyst which will include 68 adults diagnosed with PTSD or CPTSD referred to care at CMHCS of the Maule Region Chile The collection of qualitative data related to the studys acceptability will be done through telephone interviews
Participants will be randomized into experimental EG or control CG groups in a 11 ratio Participants in the EG will receive TF-CBT-CP therapy It consists of 16 weekly 60-minute sessions of trauma-focused cognitive behavioral therapy for complex presentations People who take part in the CG will get the same treatment TAU that CMHCS gives to people who are referred for PTSD symptoms or problems related to traumatic events This could mean waiting on a list getting medication andor going to regular non-specialized PTSD therapy sessions
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 Secondary outcomes of preliminary effectiveness consider the reduction of PTSD and CPTSD symptomatology depression anxiety and improvement of indicators of emotional regulation and psychological well-being
The present study aims to evaluate the feasibility acceptability and preliminary effectiveness of TF-CBT therapy for complex presentation TF-CBT-CP in videoconference modality compared with the usual treatment for 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 COSAM in spanish of the Maule Region Chile
This pilot study will use a mixed design The quantitative component will consist of a randomized two-arm parallel superiority trial blinded to the data analyst which will include 68 adults diagnosed with PTSD or CPTSD referred to care at CMHCS of the Maule Region Chile The collection of qualitative data related to the studys acceptability will be done through telephone interviews
Participants will be randomized into experimental EG or control CG groups in a 11 ratio Participants in the EG will receive TF-CBT-CP therapy It consists of 16 weekly 60-minute sessions of trauma-focused cognitive behavioral therapy for complex presentations People who take part in the CG will get the same treatment TAU that CMHCS gives to people who are referred for PTSD symptoms or problems related to traumatic events This could mean waiting on a list getting medication andor going to regular non-specialized PTSD therapy sessions
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 Secondary outcomes of preliminary effectiveness consider the reduction of PTSD and CPTSD symptomatology depression anxiety and improvement of indicators of emotional regulation and psychological well-being
Detailed Description:
Post-traumatic stress disorder PTSD is a mental health condition thats 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 eg 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 studys 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 11 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 andor 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 studys research assistants 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 andor 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 studys 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
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 eg 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 studys 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 11 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 andor 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 studys research assistants 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 andor 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 studys 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None