Posttraumatic Stress DisorderNCT04813224
Intervention Through EMDR and CBT With Women Victim of Childhood Sexual Abuse. A Randomized Controlled Trial.
A study testing TRAUMA CENTERED EMDR-BASED TREATMENT and TRAUMA-FOCUSED CBT-BASED TREATMENT in people with Posttraumatic Stress Disorder and Somatization, run by Universidad Internacional de Valencia at 1 site in Spain.
Trial summary
This study evaluates the effectiveness of two types of therapy for the treatment of sexual abuse psychological impact on a sample of Spanish women. The participants will receive first Trauma-Focused Cognitive Behavioral Therapy and Eye Movement Desensitization and Reprocessing treatments in order to observe the impact… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Posttraumatic Stress Disorder, Somatization, Obsessive-Compulsive Disorder
- What is being tested?
- TRAUMA CENTERED EMDR-BASED TREATMENT and TRAUMA-FOCUSED CBT-BASED TREATMENT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 16 Apr 2021to 16 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- present symptoms related to the post-traumatic sequelae of having had an experience of sexual abuse in childhood.
- The traumatic experience is accessible to explicit memory.
- The participant has shared her experience at least in a context of containment and is able to talk about it.
Who cannot join
- Enfermedad mental grave.
- Extreme scores on both the personality questionnaire and the Psychopathology questionnaire in the indicator of global severity, paranoid ideation, and psychoticism.
- Any problem of addiction to alcohol or other substances at the time of the evaluation, etc. that may interfere with adherence to treatment and group dynamics.
- Being currently in treatment to treat the traumatic experience.
- Present severe dissociative symptoms, beyond those typical of the PTSD diagnosis.
- Extreme scores on the dissociation scale in the pathological ideation items.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Asociación Contra los Abusos Sexuales en la Infancia (ACASI)
Valencia, 46200
Inmaculada García Ortiz, BD, 634567050´, inma.garcia@acasi.org
About this study
Official title: Psychological Intervention in Women Victims of Childhood Sexual Abuse: A Randomized Clinical Trial Comparing EMDR Psychotherapy and Trauma-Based Cognitive Therapy.
This study evaluates the effectiveness of two types of therapy for the treatment of sexual abuse psychological impact on a sample of Spanish women. The participants will receive first Trauma-Focused Cognitive Behavioral Therapy and Eye Movement Desensitization and Reprocessing treatments in order to observe the impact on symptoms of Posttraumatic Stress Disorder, somatization, obsessive-compulsive symptoms, anxiety, aggressiveness and dissociate symptoms.
Read the detailed description
The experience of sexual abuse in childhood is one of the forms of interpersonal victimization most associated with the development of psychological problems since it involves a serious violation of the rights and sexual and affective freedom of children and adolescents. The different types of child abuse and neglect are, in turn, associated with moderately severe psychological sequelae in adulthood. Its effects in adult life can affect physical, psychological, and social functioning and generate psychopathological alterations, being the most frequent consequences. Women who were abused in childhood, in their adult life more frequently presented sexual dysfunction and less perceived sexual satisfaction, less trust, and more difficulties in communicating with the partner.
Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) is an evidence-based treatment model designed to help patients (children, adolescents, youth) and their families overcome the symptoms resulting from exposure to a traumatic experience. Numerous investigations that support it, today it is considered a well-established intervention for the treatment of post-traumatic stress and associated symptoms.
Desensitization and reprocessing psychotherapy using eye movements. It is one of the transdiagnostic psychotherapeutic models of choice in international guidelines for dealing with the sequelae of traumatic life experiences. Trauma-focused treatment carried out with the EMDR therapeutic approach is feasible and safe for patients with PTSD derived from childhood sexual abuse.
A Randomized Clinical Trial is proposed, without a control group, and assignment to two types of treatment 1) TF -CBT, 2) EMDR.
After the initial evaluation, the participants will be randomly assigned to one of the two treatments. Subsequently, and after allowing the same time period that the intervention protocols will last, they will be evaluated again to measure changes without having received treatment. After this second evaluation, they will receive the treatment protocol to which they have been assigned after randomization. After receiving the first treatment, they will be evaluated again. After this evaluation, they will receive the other protocol of the intervention. Finally, after finishing the second intervention, they will be evaluated again. Thus, for example, participants who first received TF-CBT will subsequently receive the EMDR intervention, and participants who first received the EMDR intervention will subsequently receive the TF-CBT intervention. In this way, it will be possible to evaluate both the effectiveness of each of the protocols separately (intragroup comparison of each treatment condition), as well as the level of effectiveness obtained by comparing both treatment groups (intergroup comparison, after the application of each type of intervention ).
The subjective measures will include the following Psychometrics:
Satisfaction with life scale Rosenberg Self-Esteem Scale Symptom Checklist-90-Revised Post-Traumatic Stress Disorder Symptom Severity Scale according to DSM-5 (EGS-R) DSM-5 Personality Inventory - Short Version (PID-5-BF) Adults Scale of emotional regulation difficulties Dissociative Symptom Scale Satisfaction scale with received treatment Satisfaction scale with received treatment
- Conditions
- Posttraumatic Stress Disorder, Somatization, Obsessive-Compulsive Disorder, Depression, Anxiety, Hostility
- Being tested
- TRAUMA CENTERED EMDR-BASED TREATMENT and TRAUMA-FOCUSED CBT-BASED TREATMENT
- Medical subject headings
- Stress Disorders, Post-Traumatic, Obsessive-Compulsive Disorder, Depression, Anxiety Disorders, Dissociative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRAUMA CENTERED EMDR-BASED TREATMENT and TRAUMA-FOCUSED CBT-BASED TREATMENTBehavioural
Psychological evidence-based intervention for the reduction of the impact of childhood sexual abuse.
| Study group | Role | What they receive |
|---|---|---|
| TRAUMA CENTERED EMDR-BASED TREATMENT | Experimental | Phase 1) Client history before session 1 Phase 2) Preparation for the treatment of the traumatic event, with psycho education and regulation strategies.
Phases 3 to 6) Gives the sense of Safety (safe place, past resource, desired future-PC, timeline) control structure, order, differentiation of past \& present (move concretely between past danger to present safety) EMD strategy gives containment boundaries to current T-Episode.
Phase 7) Session closure A group debriefing of the experience will take place, and some of the stabilization exercises Phase 8) Re-Evaluation This phase will take place immediately after the group intervention. It assesses which participants may need individual attention and which may need further evaluation to identify the nature and extent of their symptoms. Receives: Behavioral: TRAUMA CENTERED EMDR-BASED TREATMENT and TRAUMA-FOCUSED CBT-BASED TREATMENT |
| TRAUMA-FOCUSED CBT-BASED TREATMENT | Active comparator | TF-CBT is an evidence-based therapeutic approach to improve symptoms of PTSD as well as affective or cognitive and behavioral problems. The treatment will consist of three phases that will include: Psychoeducation, Relaxation-Mindfulness, Emotional regulation skills, Cognitive coping skills, Narration and processing of trauma, Exposure / Desensitization of memories of the trauma, Self-esteem and future goals. The treatment is composed by 3 phases: 1) Phase 1: TF-CBT Coping Skills for Complex Traumas. Phase 2: Narration of trauma and processing of complicated trauma. Phase 3: Consolidation and closure of the treatment. Each case is delivered to the participants in a maximum of 3 sessions per phase. Receives: Behavioral: TRAUMA CENTERED EMDR-BASED TREATMENT and TRAUMA-FOCUSED CBT-BASED TREATMENT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in the scores of the Post-Traumatic Stress Disorder Symptom Severity Scale according to the DSM-5 (EGS-R)
The Revised Symptom Severity Scale for Post-Traumatic Stress Disorder (PTSD) consists of 21 items, based on the DSM-5 diagnostic criteria, and is used to assess the severity of the symptoms of this clinical picture. It is a structured assessment instrument, with responses measured with a Likert-type scale from 0 to 3 according to the frequency and intensity of the symptoms.
This scale has a nuclear part (EGS-R) and a complementary part. The core part consists of 21 central items (range: 0-63 points) in correspondence with the diagnostic criteria of the DSM-5 (APA, 2013): 5 refer to intrusion (range: 0-15), 3 to avoidance behavioral / cognitive (range: 0-9), 7 to cognitive disturbances and negative mood (AC / EAN) (range: 0-21) and 6 to hyperarousal (range: 0-18), as well as 4 additional ones referred to dissociation (range: 0-12).
It is expected that in all these subscales they will be significantly reduced (P <0.05) scores by patients after the treatments.
Measured: 4.5 months, after receiving both interventions.
Decrease in the scores of the clinical symptoms measured using the Symptom Checklist-90-Revised (SCL-R)
The SCL-90-R is a self-administered questionnaire that presents 90 elements that describe symptoms and requires the individual to indicate through a Likert-type scale graduated between 0 (not at all) and 4 (a lot or extremely) to what extent they have annoying feeling for each of the symptoms described.
The questionnaire allows obtaining three global indices and 10 symptomatic dimensions: 1) Global Severity Index, 2) Total Positive Symptoms, 3) Positive Discomfort Index, 4) Somatization, 5) Obsession-compulsion, 6) Interpersonal sensitivity, 7) Depression, 8) Anxiety, 9) Hostility, 10) Phobic anxiety, 11) Paranoid ideation, 12) Psychoticism, 13) Additional scale (ADI). It collects seven symptoms that have a relevant factorial weight on different scales. A clinically significant reduction (P <0.05) is expected in the Global Severity index, in the Total of positive symptoms, in the positive index of discomfort, in depression and anxiety.
Measured: 4.5 months, after receiving both interventions.
Decrease in the scores on the Dissociative Symptom Scale.
It is a 28-item self-administered scale, developed by Bernstein and Putnam (1986), designed to measure dissociative symptomatology. Items are scored, according to the frequency of each dissociative experience, in a range of 0 to 100, where 0 represents "never" and 100 "always." The center points represent 50% of the time. The global score is the sum of the score assigned to each item, divided by 28. The higher the global score, the more severe the dissociative symptoms, therefore improvement is indicated by a decrease in the DES score.
A clinically significant reduction (P <0.05) in the total score of this scale is expected after the treatments.
Measured: 4.5 months, after receiving both interventions.
Secondary outcomes (3)
Increase in the scores of the Satisfaction with Life Scale (SWLS)
This instrument consists of 5 items in which the participants must indicate how much they agree with each question, with response options in Likert format from 1 (totally disagree) to 7 (totally agree) ). Scores range from a minimum of 5 to a maximum of 35, where higher scores indicate greater satisfaction with life. A clinically significant increase (P <0.05) in the global score of this scale is expected after the treatments.
Measured: 4.5 months, after receiving both interventions.
Increase in the scores of the Rosenberg Self-Esteem Scale
This instrument assesses the feeling of satisfaction that a person has about himself. The questionnaire is made up of 10 items (half of the items are positively stated and the other half negatively) whose contents focus on the general feelings of respect and acceptance towards oneself. The items are answered in a four-point Likert format (1 = Strongly agree, 2 = Agree, 3 = Disagree, 4 = Strongly disagree) depending on the degree of agreement with the statement made. The total score ranges from 10 to 40 points, distinguishing between low self-esteem (scores less than or equal to 25), medium (from 26 to 29) and high (equal to or greater than 30).
A clinically significant increase (P <0.05) in the global score of this scale is expected after the treatments.
Measured: 4.5 months, after receiving both interventions.
Increase in the scores of the Emotional Regulation Difficulties Scale (DERS)
This scale assesses different aspects of the emotional regulation process in which there may be difficulties: emotional lack of control, daily interference, emotional inattention, emotional confusion and emotional rejection. The first factor, "Emotional lack of control", includes items from two scales of the original version: "Difficulty in impulse control" and "Limited access to regulation strategies". The rest of the factors correspond to the remaining subscales of the original version, although the labels were slightly modified with respect to the originals for reasons of simplification and adaptation to Spanish: "Emotional rejection", "Everyday interference", "Emotional neglect", "Emotional confusion." A clinically significant decrease (P <0.05) is expected in the scores of the factors: "Emotional lack of control", "Emotional rejection", "Daily interference", "Emotional inattention" and "Emotional confusion"
Measured: 4.5 months, after receiving both interventions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start16 Apr 2021
- Primary completion16 Dec 2022 (estimated)
- Study completion16 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Internacional de Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Valencia
- Responsible party
- Principal investigator, María Teresa Mitjans Lafont, Universidad Internacional de Valencia
- Investigators
- Milagros Molero Zafra, MD, Study chair, Universidad Internacional de ValenciaAlejandro Domínguez Rodríguez, PhD, Study chair, Universidad Internacional de ValenciaMarian Pérez Marín, PhD, Study chair, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04813224
- Sponsor's protocol ID
- VIU-EMDR-TFCBT
- Status last verified
- Jul 2021
- First submitted
- 20 Mar 2021
- Last updated
- 19 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The information will be available in a private server or in a server of the journal(s) that we will publish the articles that will be the result of this study. The protocol of the study is currently in progress to be published, in this article will be included such study protocol, the informed consent is already shared in the register of clinical trials.
Publications
Bisson JI, Roberts NP, Andrew M, Cooper R, Lewis C. Psychological therapies for chronic post-traumatic stress disorder (PTSD) in adults. Cochrane Database Syst Rev. 2013 Dec 13;2013(12):CD003388. doi: 10.1002/14651858.CD003388.pub4.
PubMed 24338345Canton-Cortes D, Canton J, Cortes MR. The interactive effect of blame attribution with characteristics of child sexual abuse on posttraumatic stress disorder. J Nerv Ment Dis. 2012 Apr;200(4):329-35. doi: 10.1097/NMD.0b013e31824cc078.
PubMed 22456587Cohen JA, Mannarino AP, Kliethermes M, Murray LA. Trauma-focused CBT for youth with complex trauma. Child Abuse Negl. 2012 Jun;36(6):528-41. doi: 10.1016/j.chiabu.2012.03.007. Epub 2012 Jun 30.
PubMed 22749612Davidson PR, Parker KC. Eye movement desensitization and reprocessing (EMDR): a meta-analysis. J Consult Clin Psychol. 2001 Apr;69(2):305-16. doi: 10.1037//0022-006x.69.2.305.
PubMed 11393607De Jongh A, Groenland GN, Sanches S, Bongaerts H, Voorendonk EM, Van Minnen A. The impact of brief intensive trauma-focused treatment for PTSD on symptoms of borderline personality disorder. Eur J Psychotraumatol. 2020 Feb 14;11(1):1721142. doi: 10.1080/20008198.2020.1721142. eCollection 2020.
PubMed 32128048Deblinger E, Pollio E, Dorsey S. Applying Trauma-Focused Cognitive-Behavioral Therapy in Group Format. Child Maltreat. 2016 Feb;21(1):59-73. doi: 10.1177/1077559515620668. Epub 2015 Dec 23.
PubMed 26701151Deblinger E, Mannarino AP, Cohen JA, Runyon MK, Steer RA. Trauma-focused cognitive behavioral therapy for children: impact of the trauma narrative and treatment length. Depress Anxiety. 2011 Jan;28(1):67-75. doi: 10.1002/da.20744. Epub 2010 Sep 9.
PubMed 20830695Karadag M, Gokcen C, Sarp AS. EMDR therapy in children and adolescents who have post-traumatic stress disorder: a six-week follow-up study. Int J Psychiatry Clin Pract. 2020 Mar;24(1):77-82. doi: 10.1080/13651501.2019.1682171. Epub 2019 Oct 30.
PubMed 31663396Lee CW, Cuijpers P. A meta-analysis of the contribution of eye movements in processing emotional memories. J Behav Ther Exp Psychiatry. 2013 Jun;44(2):231-9. doi: 10.1016/j.jbtep.2012.11.001. Epub 2012 Nov 20.
PubMed 23266601Ostacoli L, Carletto S, Cavallo M, Baldomir-Gago P, Di Lorenzo G, Fernandez I, Hase M, Justo-Alonso A, Lehnung M, Migliaretti G, Oliva F, Pagani M, Recarey-Eiris S, Torta R, Tumani V, Gonzalez-Vazquez AI, Hofmann A. Comparison of Eye Movement Desensitization Reprocessing and Cognitive Behavioral Therapy as Adjunctive Treatments for Recurrent Depression: The European Depression EMDR Network (EDEN) Randomized Controlled Trial. Front Psychol. 2018 Feb 13;9:74. doi: 10.3389/fpsyg.2018.00074. eCollection 2018.
PubMed 29487548Horst F, Den Oudsten B, Zijlstra W, de Jongh A, Lobbestael J, De Vries J. Cognitive Behavioral Therapy vs. Eye Movement Desensitization and Reprocessing for Treating Panic Disorder: A Randomized Controlled Trial. Front Psychol. 2017 Aug 18;8:1409. doi: 10.3389/fpsyg.2017.01409. eCollection 2017.
PubMed 28868042Bernstein EM, Putnam FW. Development, reliability, and validity of a dissociation scale. J Nerv Ment Dis. 1986 Dec;174(12):727-35. doi: 10.1097/00005053-198612000-00004.
PubMed 3783140Blevins CA, Weathers FW, Davis MT, Witte TK, Domino JL. The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5): Development and Initial Psychometric Evaluation. J Trauma Stress. 2015 Dec;28(6):489-98. doi: 10.1002/jts.22059. Epub 2015 Nov 25.
PubMed 26606250Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. doi: 10.1207/s15327752jpa4901_13.
PubMed 16367493Elhai JD, Gray MJ, Kashdan TB, Franklin CL. Which instruments are most commonly used to assess traumatic event exposure and posttraumatic effects?: A survey of traumatic stress professionals. J Trauma Stress. 2005 Oct;18(5):541-5. doi: 10.1002/jts.20062.
PubMed 16281252
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Intervention in Women Victims of Childhood Sexual Abuse: A Randomized Clinical Trial Comparing EMDR Psychotherapy and Trauma-Based Cognitive Therapy.
- ClinicalTrials.gov ID
- NCT04813224
- Acronym / sponsor ID
- VIU-EMDR-TFCBT
- Conditions
- Posttraumatic Stress Disorder, Somatization, Obsessive-Compulsive Disorder, Depression, Anxiety, Hostility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universidad Internacional de ValenciaUniversity, hospital or other
- Collaborators
- University of Valencia
- Study start
- 16 Apr 2021 (actual)
- Primary completion
- 16 Dec 2022 (estimated)
- Study completion
- 16 Dec 2022 (estimated)
- First posted
- 24 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the effectiveness of two types of therapy for the treatment of sexual abuse psychological impact on a sample of Spanish women. The participants will receive first Trauma-Focused Cognitive Behavioral Therapy and Eye Movement Desensitization and Reprocessing treatments in order to observe the impact on symptoms of Posttraumatic Stress Disorder, somatization, obsessive-compulsive symptoms, anxiety, aggressiveness and dissociate symptoms.
Detailed description
The experience of sexual abuse in childhood is one of the forms of interpersonal victimization most associated with the development of psychological problems since it involves a serious violation of the rights and sexual and affective freedom of children and adolescents. The different types of child abuse and neglect are, in turn, associated with moderately severe psychological sequelae in adulthood. Its effects in adult life can affect physical, psychological, and social functioning and generate psychopathological alterations, being the most frequent consequences. Women who were abused in childhood, in their adult life more frequently presented sexual dysfunction and less perceived sexual satisfaction, less trust, and more difficulties in communicating with the partner.
Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) is an evidence-based treatment model designed to help patients (children, adolescents, youth) and their families overcome the symptoms resulting from exposure to a traumatic experience. Numerous investigations that support it, today it is considered a well-established intervention for the treatment of post-traumatic stress and associated symptoms.
Desensitization and reprocessing psychotherapy using eye movements. It is one of the transdiagnostic psychotherapeutic models of choice in international guidelines for dealing with the sequelae of traumatic life experiences. Trauma-focused treatment carried out with the EMDR therapeutic approach is feasible and safe for patients with PTSD derived from childhood sexual abuse.
A Randomized Clinical Trial is proposed, without a control group, and assignment to two types of treatment 1) TF -CBT, 2) EMDR.
After the initial evaluation, the participants will be randomly assigned to one of the two treatments. Subsequently, and after allowing the same time period that the intervention protocols will last, they will be evaluated again to measure changes without having received treatment. After this second evaluation, they will receive the treatment protocol to which they have been assigned after randomization. After receiving the first treatment, they will be evaluated again. After this evaluation, they will receive the other protocol of the intervention. Finally, after finishing the second intervention, they will be evaluated again. Thus, for example, participants who first received TF-CBT will subsequently receive the EMDR intervention, and participants who first received the EMDR intervention will subsequently receive the TF-CBT intervention. In this way, it will be possible to evaluate both the effectiveness of each of the protocols separately (intragroup comparison of each treatment condition), as well as the level of effectiveness obtained by comparing both treatment groups (intergroup comparison, after the application of each type of intervention ).
The subjective measures will include the following Psychometrics:
Satisfaction with life scale Rosenberg Self-Esteem Scale Symptom Checklist-90-Revised Post-Traumatic Stress Disorder Symptom Severity Scale according to DSM-5 (EGS-R) DSM-5 Personality Inventory - Short Version (PID-5-BF) Adults Scale of emotional regulation difficulties Dissociative Symptom Scale Satisfaction scale with received treatment Satisfaction scale with received treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| TRAUMA CENTERED EMDR-BASED TREATMENT | Experimental | Behavioral: TRAUMA CENTERED EMDR-BASED TREATMENT and TRAUMA-FOCUSED CBT-BASED TREATMENTPhase 1) Client history before session 1 Phase 2) Preparation for the treatment of the traumatic event, with psycho education and regulation strategies. Phases 3 to 6) Gives the sense of Safety (safe place, past resource, desired future-PC, timeline) control structure, order, differentiation of past \& present (move concretely between past danger to present safety) EMD strategy gives containment boundaries to current T-Episode. Phase 7) Session closure A group debriefing of the experience will take place, and some of the stabilization exercises Phase 8) Re-Evaluation This phase will take place immediately after the group intervention. It assesses which participants may need individual attention and which may need further evaluation to identify the nature and extent of their symptoms. |
| TRAUMA-FOCUSED CBT-BASED TREATMENT | Active comparator | Behavioral: TRAUMA CENTERED EMDR-BASED TREATMENT and TRAUMA-FOCUSED CBT-BASED TREATMENTTF-CBT is an evidence-based therapeutic approach to improve symptoms of PTSD as well as affective or cognitive and behavioral problems. The treatment will consist of three phases that will include: Psychoeducation, Relaxation-Mindfulness, Emotional regulation skills, Cognitive coping skills, Narration and processing of trauma, Exposure / Desensitization of memories of the trauma, Self-esteem and future goals. The treatment is composed by 3 phases: 1) Phase 1: TF-CBT Coping Skills for Complex Traumas. Phase 2: Narration of trauma and processing of complicated trauma. Phase 3: Consolidation and closure of the treatment. Each case is delivered to the participants in a maximum of 3 sessions per phase. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- present symptoms related to the post-traumatic sequelae of having had an experience of sexual abuse in childhood.
- The traumatic experience is accessible to explicit memory.
- The participant has shared her experience at least in a context of containment and is able to talk about it.
Key exclusion criteria (6 listed)
- Enfermedad mental grave.
- Extreme scores on both the personality questionnaire and the Psychopathology questionnaire in the indicator of global severity, paranoid ideation, and psychoticism.
- Any problem of addiction to alcohol or other substances at the time of the evaluation, etc. that may interfere with adherence to treatment and group dynamics.
- Being currently in treatment to treat the traumatic experience.
- Present severe dissociative symptoms, beyond those typical of the PTSD diagnosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRAUMA CENTERED EMDR-BASED TREATMENT and TRAUMA-FOCUSED CBT-BASED TREATMENTPsychological evidence-based intervention for the reduction of the impact of childhood sexual abuse. | Behavioural | TRAUMA CENTERED EMDR-BASED TREATMENT, TRAUMA-FOCUSED CBT-BASED TREATMENT |
Primary outcome
Decrease in the scores of the Post-Traumatic Stress Disorder Symptom Severity Scale according to the DSM-5 (EGS-R)
Time frame: 4.5 months, after receiving both interventions.
The Revised Symptom Severity Scale for Post-Traumatic Stress Disorder (PTSD) consists of 21 items, based on the DSM-5 diagnostic criteria, and is used to assess the severity of the symptoms of this clinical picture. It is a structured assessment instrument, with responses measured with a Likert-type scale from 0 to 3 according to the frequency and intensity of the symptoms. This scale has a nuclear part (EGS-R) and a complementary part. The core part consists of 21 central items (range: 0-63 points) in correspondence with the diagnostic criteria of the DSM-5 (APA, 2013): 5 refer to intrusion (range: 0-15), 3 to avoidance behavioral / cognitive (range: 0-9), 7 to cognitive disturbances and negative mood (AC / EAN) (range: 0-21) and 6 to hyperarousal (range: 0-18), as well as 4 additional ones referred to dissociation (range: 0-12). It is expected that in all these subscales they will be significantly reduced (P <0.05) scores by patients after the treatments.
Decrease in the scores of the clinical symptoms measured using the Symptom Checklist-90-Revised (SCL-R)
Time frame: 4.5 months, after receiving both interventions.
The SCL-90-R is a self-administered questionnaire that presents 90 elements that describe symptoms and requires the individual to indicate through a Likert-type scale graduated between 0 (not at all) and 4 (a lot or extremely) to what extent they have annoying feeling for each of the symptoms described. The questionnaire allows obtaining three global indices and 10 symptomatic dimensions: 1) Global Severity Index, 2) Total Positive Symptoms, 3) Positive Discomfort Index, 4) Somatization, 5) Obsession-compulsion, 6) Interpersonal sensitivity, 7) Depression, 8) Anxiety, 9) Hostility, 10) Phobic anxiety, 11) Paranoid ideation, 12) Psychoticism, 13) Additional scale (ADI). It collects seven symptoms that have a relevant factorial weight on different scales. A clinically significant reduction (P <0.05) is expected in the Global Severity index, in the Total of positive symptoms, in the positive index of discomfort, in depression and anxiety.
Decrease in the scores on the Dissociative Symptom Scale.
Time frame: 4.5 months, after receiving both interventions.
It is a 28-item self-administered scale, developed by Bernstein and Putnam (1986), designed to measure dissociative symptomatology. Items are scored, according to the frequency of each dissociative experience, in a range of 0 to 100, where 0 represents "never" and 100 "always." The center points represent 50% of the time. The global score is the sum of the score assigned to each item, divided by 28. The higher the global score, the more severe the dissociative symptoms, therefore improvement is indicated by a decrease in the DES score. A clinically significant reduction (P <0.05) in the total score of this scale is expected after the treatments.
3 secondary outcomes
Increase in the scores of the Satisfaction with Life Scale (SWLS)
Time frame: 4.5 months, after receiving both interventions.
Increase in the scores of the Rosenberg Self-Esteem Scale
Time frame: 4.5 months, after receiving both interventions.
Increase in the scores of the Emotional Regulation Difficulties Scale (DERS)
Time frame: 4.5 months, after receiving both interventions.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2021.
- Background: PubMed 24338345Bisson JI, Roberts NP, Andrew M, Cooper R, Lewis C. Psychological therapies for chronic post-traumatic stress disorder (PTSD) in adults. Cochrane Database Syst Rev. 2013 Dec 13;2013(12):CD003388. doi: 10.1002/14651858.CD003388.pub4.
- Background: PubMed 22456587Canton-Cortes D, Canton J, Cortes MR. The interactive effect of blame attribution with characteristics of child sexual abuse on posttraumatic stress disorder. J Nerv Ment Dis. 2012 Apr;200(4):329-35. doi: 10.1097/NMD.0b013e31824cc078.
- Background: PubMed 22749612Cohen JA, Mannarino AP, Kliethermes M, Murray LA. Trauma-focused CBT for youth with complex trauma. Child Abuse Negl. 2012 Jun;36(6):528-41. doi: 10.1016/j.chiabu.2012.03.007. Epub 2012 Jun 30.
- Background: PubMed 11393607Davidson PR, Parker KC. Eye movement desensitization and reprocessing (EMDR): a meta-analysis. J Consult Clin Psychol. 2001 Apr;69(2):305-16. doi: 10.1037//0022-006x.69.2.305.
- Background: PubMed 32128048De Jongh A, Groenland GN, Sanches S, Bongaerts H, Voorendonk EM, Van Minnen A. The impact of brief intensive trauma-focused treatment for PTSD on symptoms of borderline personality disorder. Eur J Psychotraumatol. 2020 Feb 14;11(1):1721142. doi: 10.1080/20008198.2020.1721142. eCollection 2020.
- Background: PubMed 26701151Deblinger E, Pollio E, Dorsey S. Applying Trauma-Focused Cognitive-Behavioral Therapy in Group Format. Child Maltreat. 2016 Feb;21(1):59-73. doi: 10.1177/1077559515620668. Epub 2015 Dec 23.
- Background: PubMed 20830695Deblinger E, Mannarino AP, Cohen JA, Runyon MK, Steer RA. Trauma-focused cognitive behavioral therapy for children: impact of the trauma narrative and treatment length. Depress Anxiety. 2011 Jan;28(1):67-75. doi: 10.1002/da.20744. Epub 2010 Sep 9.
- Background: PubMed 31663396Karadag M, Gokcen C, Sarp AS. EMDR therapy in children and adolescents who have post-traumatic stress disorder: a six-week follow-up study. Int J Psychiatry Clin Pract. 2020 Mar;24(1):77-82. doi: 10.1080/13651501.2019.1682171. Epub 2019 Oct 30.
- Background: PubMed 23266601Lee CW, Cuijpers P. A meta-analysis of the contribution of eye movements in processing emotional memories. J Behav Ther Exp Psychiatry. 2013 Jun;44(2):231-9. doi: 10.1016/j.jbtep.2012.11.001. Epub 2012 Nov 20.
- Background: PubMed 29487548Ostacoli L, Carletto S, Cavallo M, Baldomir-Gago P, Di Lorenzo G, Fernandez I, Hase M, Justo-Alonso A, Lehnung M, Migliaretti G, Oliva F, Pagani M, Recarey-Eiris S, Torta R, Tumani V, Gonzalez-Vazquez AI, Hofmann A. Comparison of Eye Movement Desensitization Reprocessing and Cognitive Behavioral Therapy as Adjunctive Treatments for Recurrent Depression: The European Depression EMDR Network (EDEN) Randomized Controlled Trial. Front Psychol. 2018 Feb 13;9:74. doi: 10.3389/fpsyg.2018.00074. eCollection 2018.
- Background: PubMed 28868042Horst F, Den Oudsten B, Zijlstra W, de Jongh A, Lobbestael J, De Vries J. Cognitive Behavioral Therapy vs. Eye Movement Desensitization and Reprocessing for Treating Panic Disorder: A Randomized Controlled Trial. Front Psychol. 2017 Aug 18;8:1409. doi: 10.3389/fpsyg.2017.01409. eCollection 2017.
- Results publication: PubMed 3783140Bernstein EM, Putnam FW. Development, reliability, and validity of a dissociation scale. J Nerv Ment Dis. 1986 Dec;174(12):727-35. doi: 10.1097/00005053-198612000-00004.
- Individual participant dataSharing planned: Yes. The information will be available in a private server or in a server of the journal(s) that we will publish the articles that will be the result of this study. The protocol of the study is currently in progress to be published, in this article will be included such study protocol, the informed consent is already shared in the register of clinical trials.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Milagros Molero Zafra, MD study chair
Universidad Internacional de Valencia
Alejandro Domínguez Rodríguez, PhD study chair
Universidad Internacional de Valencia
Marian Pérez Marín, PhD study chair
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRAUMA CENTERED EMDR-BASED TREATMENT and TRAUMA-FOCUSED CBT-BASED TREATMENT in people with Posttraumatic Stress Disorder and Somatization, run by Universidad Internacional de Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact María Teresa Mitjans Lafont, PhD (+34600325732, mariateresa.mitjans@campusviu.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in the scores of the Post-Traumatic Stress Disorder Symptom Severity Scale according to the DSM-5 (EGS-R) (time frame: 4.5 months, after receiving both interventions.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04813224, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2021.