Investigating disruptive, healthy and brain electrical activity responses to effective psychological trauma treatments
| ISRCTN | ISRCTN91146045 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91146045 |
| Secondary identifying numbers | IRAS 1190578, FONDECYT-Chile 1190578 |
- Submission date
- 26/04/2021
- Registration date
- 21/05/2021
- Last edited
- 06/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
What is the aim of the study?
A trauma is a difficult life event, which causes upset to the present day and can be difficult to talk about. Fortunately, there are psychotherapies that work to understand what happened, in order for patients to feel at peace and be better. This study aims to understand how patients respond to effective psychological treatment for trauma and why they respond that way.
Who can participate?
Patients from the Center of Applied Psychology of the University of Talca, between 18 and 59 years old and who have been exposed to at least one difficult or traumatic event.
What does the study involve?
Each participant will receive one of two therapies that work for psychological trauma. The participant will be allocated to receive either EMDR therapy or conventional therapy provided by the center, with an equal chance of receiving either treatment (like tossing a coin). In all cases, participants will attend one session per week lasting between 60 and 90 min. Depending on the complexity of each case, the therapies range from 40 to 63 weeks in duration, including any evaluations. A screening and a follow-up evaluation will take place two and four months after the end of therapy.
What are the possible benefits and risks of participating?
It is possible that after therapy participates will be able to feel better personally and will improve their family, friendship, or work relationships. These positive effects are very likely to be permanent after therapy is completed. In addition, this study benefits the mental health of people and communities currently affected by events such as disasters, unemployment, abuse, and pandemics.
Although all procedures are painless and do not cause physical harm, the evaluations and therapies address issues related to difficult experiences. Therefore, it could be that whoever participates may feel bad. In the event that discomfort prevents further participation, the procedure can be paused or suspended. In addition, participants may request help from the research team if they need it, up to six months after participation. Information is also provided to contact the most appropriate health service in case a referral is required. In the event of an emergency situation (eg. suicide risk), the center also has protocols for referral.
The funding for this study ensures that the participant does not have to pay for any of the project procedures.
Where is the study run from?
The study is managed by the Laboratory of Methodology for Behavioral and Neurosciences team, University of Talca (Chile) in collaboration with the Center of Applied Psychology, University of Talca
When is the study starting and how long is it expected to run for?
From May 2021 to June 2024
Who is funding the study?
The Chilean Scientific and Technological Development Fund (FONDECYT-Chile) (Chile)
Who is the main contact?
Dr. Marcelo Leiva Bianchi
marcleiva@utalca.cl.
Contact information
Scientific
Faculty of Psychology
Lircay Av. n/n
Talca
3460000
Chile
 ORCID ID |
0000-0001-6135-9226 |
|---|---|
| Phone | +56712201654 |
| marcleiva@utalca.cl |
Study information
| Study design | Single-center interventional single-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community, Other |
| Study type | Treatment, Efficacy |
| Participant information sheet | No participant information sheet available |
| Scientific title | Adult patients from a health center specialized in the treatment of psychological trauma; eye movement desensitization and reprocessing therapy or EMDR; conventional therapy given by the center; electroencephalographic or EEG response, symptoms of post-traumatic stress or PTSD, complex PTSD or CPTSD, borderline personality disorder or BPD, and post-traumatic growth or PTG (TEEPCBG) |
| Study acronym | TEEPCBG |
| Study objectives | Without effective therapies, pre (e.g. abuse during childhood) and peri-traumatic risk factors (e.g. intensity of one traumatic event) produce an increase in the amplitude of waves (Alpha, Beta, Delta, Theta) of the cerebral cortex. This is at the base of the increase in disruptive responses (e.g. post-traumatic stress disorder) and the slight increase in healthy responses (e.g. post-traumatic growth). However, effective therapies like EMDR similarly mitigate the effect of these factors, decreasing the amplitude of these waves. This would decrease disruptive responses and increase healthy ones. |
| Ethics approval(s) | Approved 19/06/2019, Scientific Ethics Committee of the University of Talca (Lircay Av. n/n, Casilla 747, Talca, Chile; +56712203065; cec@utalca.cl), ref: 10-2019 |
| Health condition(s) or problem(s) studied | Disruptive and healthy responses related to psychological trauma: post-traumatic stress disorder (PTSD), complex post-traumatic stress disorder (cPTSD), borderline personality disorder (BPD), post-traumatic growth (PTG) |
| Intervention | Patients from the Center for Applied Psychology of the University of Talca will be randomly included in one of the 2 clinical trial groups: 1. EMDR treatment 2. Conventional center treatment Both groups will be matched according to risk factors (sex, educational level, belonging to minorities, psychiatric comorbidities, and history of child abuse). To control the effect of the therapist, each one will deliver the two psychotherapies according to random assignment. The selection will be made by the responsible researcher for the project, using the Excel formula "RANDBETWEEN(1;2)". The responsible researcher will also be the one who matches both groups of therapies according to risk factors (sex, educational level, belonging to minorities, psychiatric comorbidities, and history of child abuse). Subsequently, the result of the draw will be communicated to each therapist. Each therapist is expected to see at least 20 patients a year, 60 by the end of the clinical trial. At least three therapists will work on the project. Before starting, each patient will sign the informed consent approved by the Scientific Ethics Committee of the University of Talca, explaining the general conditions of their participation (e.g. voluntary, anonymity, absence of costs, evaluations). Treatment sessions will begin once per week, with each session lasting between 60 and 90 min, depending on the complexity of the case and the stage at which treatment is. Treatment will begin with 3 sessions of therapeutic framing and move on to 4 sessions of baseline evaluation, then the treatment itself will begin, and will last a maximum of 44 (EMDR) to 55 (conventional therapy) sessions. At the start of the study, in the middle of treatment, at the end of treatment, and 4 months after the end of treatment, evaluation sessions will be carried out. All evaluations include a clinical interview, application of EEG procedure and test to evaluate PTG, PTSD, CPTSD and BPD. Where not able to perform face-to-face procedures due to health security issues (e.g. COVID-19), the online versions of therapies will be applied. The evaluations can also be performed online, except for the EEG procedure, which is face-to-face and would not be performed. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Electrical activity of the brain measured using the Biosemi 64-channel electroencephalography (EEG) system at baseline, in the middle of treatment, at the end of treatment, and 4 months after treatment 2. Post-traumatic Stress Disorder (PTSD) measured using the Post-traumatic Stress Disorder Checklist-Civilian version (PCL-C) at baseline, in the middle of treatment, at the end of treatment, and 4 months after treatment 3. Complex Post-traumatic Stress Disorder (cPTSD) measured using the International Trauma Questionnaire (ITQ) at baseline, in the middle of treatment, at the end of treatment, and 4 months after treatment 4. Borderline Personality Disorder (BPD) measured using the Personality Assessment Inventory-Borderline Scale (PAI-BOR) at baseline, in the middle of treatment, at the end of treatment, and 4 months after treatment 5. Post-traumatic growth measured using the Post-Traumatic Growth Inventory (PTGI) at baseline, in the middle of treatment, at the end of treatment, and 4 months after treatment |
| Secondary outcome measures | 1. Disturbance measured using the Subjective Units of Disturbance Scale (SUD) at baseline, in the middle of treatment, at the end of treatment, and 4 months after treatment 2. Dissociation measured using the Dissociation Experiences Scale (DES) at baseline, in the middle of treatment, at the end of treatment, and 4 months after treatment 3. Traumatic events measured using the Life Events Checklist for DSM-5 (LEC-5) at baseline, in the middle of treatment, at the end of treatment, and 4 months after treatment 4. Depression measured using the Patient Health Questionnaire (PHQ-9) at baseline, in the middle of treatment, at the end of treatment, and 4 months after treatment |
| Overall study start date | 02/05/2021 |
| Completion date | 30/06/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 59 Years |
| Sex | Both |
| Target number of participants | 108 |
| Total final enrolment | 76 |
| Key inclusion criteria | Current participant inclusion criteria as of 05/04/2024: 1. Aged between 18 and 59 years 2. Exposed to at least one traumatic event Previous participant inclusion criteria: 1. Aged between 18 and 70 years 2. Exposed to at least one traumatic event |
| Key exclusion criteria | 1. Recent (within the previous 6 months) suicide attempt 2. Severe psychiatric comorbidities (such as schizophrenia) 3. Requiring hospitalization 4. Problem drug or alcohol use 5. High dissociation |
| Date of first enrolment | 02/05/2021 |
| Date of final enrolment | 30/05/2023 |
Locations
Countries of recruitment
- Chile
Study participating centres
Talca
3460000
Chile
Talca
3460000
Chile
Sponsor information
University/education
1 Poniente 1141
Talca
3460000
Chile
| Phone | +56965709700 |
|---|---|
| rodrigo.garcia@utalca.cl | |
| Website | https://www.utalca.cl/ |
"ROR" |
https://ror.org/01s4gpq44 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Fund for Scientific and Technological Development, El Fondo Nacional de Desarrollo Científico y Tecnológico, FONDECYT
- Location
- Chile
Results and Publications
| Intention to publish date | 01/07/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | The project protocols are available at https://www.dropbox.com/sh/dsdsu9xhmytnro3/AABSMnByNa0FyVM6pokZ3GMRa?dl=0. The baseline study (initial evaluation before the treatments) will be sent to "Biological Psychology" (Q1), following the discussion raised there by Kemp et al. (2010). The final study (two groups with treatment and four evaluations) will be sent to the "American Journal of Psychiatry" (Q1), continuing the discussions by Brunet et al. (2018), Markowitz et al. (2015), and Rudd et al. (2015). |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to ethical considerations given by the Scientific Ethics Committee of the University of Talca. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 28/04/2025 | 06/06/2025 | Yes | No |
Editorial Notes
06/06/2025: Publication reference and total final enrolment added.
05/04/2024: The following changes were made:
1. Community was added as a study setting.
2. Efficacy was added as a study type.
3. Participant inclusion criteria were changed.
4. Upper age limit number and unit were added.
5. The recruitment end date was changed from 30/05/2021 to 30/05/2023.
6. Laboratory of Methodology, Behavior and Neuroscience, University of Talca was added as a study participating study centre.
19/01/2023: Internal review.
12/05/2021: Trial’s existence confirmed by Scientific Ethics Committee of the University of Talca.
