TraumaA4FM/AENCT05674734
4FM Acceptance Training as the New Form of cPTSD-focused Treatment Based on Existential Analysis
A study testing 4FM Acceptance Training in people with Trauma, run by Institute of Psychiatry and Neurology, Warsaw.
Trial summary
Research project entitled "The experience of relational trauma as an important etiological factor of neurotic and/or personality disorders. The 4FM Acceptance training as a new form of therapy for these disorders" assumes the following goals: 1. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Trauma
- What is being tested?
- 4FM Acceptance Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Signed informed consent provide.
- Stable mental state allowing for reliable completion of the questionnaires.
- Native Polish language.
- Meeting the cPTSD diagnosis based on ITQ - International Trauma Questionnaire), self-report questionnaire, Cloitre et al. (2021), Polish version validated within the project.
Who cannot join
- No consent to participate in the research.
- Coexisting addiction to alcohol or psychoactive substances, documented intellectual disability, dementia or organic changes of the central nervous system.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Relational Trauma as an Etiological Factor of Neurotic and/or Personality Disorders Training Acceptance 4FM as a New Form of Therapy for These Disorders
Research project entitled "The experience of relational trauma as an important etiological factor of neurotic and/or personality disorders. The 4FM Acceptance training as a new form of therapy for these disorders" assumes the following goals:
- validation of the Polish version of the International Trauma Questionnaire (ITQ);
- assessment of prevalence of relational trauma among adult psychiatric patients hospitalized at the Institute of Psychiatry and Neurology;
- development a new therapeutic intervention - 4FM Acceptance training - based on the methodology of the Existential Analysis;
- assessment of the impact of the 4FM Acceptance training among patients with cPTSD.
The original therapeutic intervention - 4FM Acceptance training - will be developed based on the methodological assumptions of the 4 Fundamental Motivations (4FM) in the Existential Analysis methodology, developed by Alfried Längle, student of Viktor Frankl, a representative of the Existential Psychology, together with other important representatives, i.e. Rollo May, Irvin Yalom and in Poland prof. Antoni Kępiński.
Read the detailed description
Relational trauma, related to early childhood traumatic experiences in relationships with caregivers, usually parents, significantly affects the overall functioning of a person in adulthood. It may also contribute to the occurrence of neurotic disorders and/or personality disorders. The ICD-11 classification introduces a new diagnosis related to the experience of relational trauma, i.e., "complex post-traumatic stress disorder - complex PTSD" (6B41, complex Post Traumatic Stress Disorder, cPTSD). It is a separate nosological unit from PTSD (6B40) (ICD-11, 2022).
Relational trauma therapy should differ from that recommended in PTSD, as it often happens that the "burden of the past" affects the present. Existential psychotherapy may be an effective form of treatment. The Existential Analysis, Alfried Längle's theory of motivation, can be used to treat people who have experienced relational trauma and meet the criteria of cPTSD diagnosis. The project will analyze the impact of a new group therapeutic intervention - 4FM Acceptance Training - on improving existential fulfilment, increasing basic hope, and reducing symptoms of anxiety and depression. 4FM Acceptance Training is the intervention including self-regulatory strategies and trauma-focused interventions.
The obtained results will allow for the assessment of: dissemination of relational trauma, alexithymia, dissociation, somatoform dissociation in the context of the attachment style among people with mental disorders. Thus, they will contribute to the verification of the hypothesis of relational trauma as an important etiological factor of personality disorders and / or neurotic disorders; the usefulness of the 4FM Acceptance group training in the therapy of people with relational trauma and cPTSD.
- Conditions
- Trauma
- Being tested
- 4FM Acceptance Training
- Keywords
- cPTSD, complex trauma treatment, 4 Fundamental Motivations, Existential Analysis
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4FM Acceptance TrainingBehavioural
4FM Acceptance Training, therapeutic intervention in the form of an additional to TAU module - 12 (1,5 hour) group meetings in the form of 4FM Acceptance Training at Day Care Units at IPIN Mental Health Centre for Mokotów and IPiN (1 meeting weekly).
| Study group | Role | What they receive |
|---|---|---|
| 4FM/AT | Experimental | 4FM Acceptance Training, therapeutic intervention in the form of an additional to TAU (Treatment-As-Usual) module - 12 (1,5 hour) group meetings in the form of 4FM Acceptance Training at Day Care Units at Institute of Psychiatry and Neurology (IPiN) Mental Health Centre for Mokotów and IPiN. Receives: Behavioral: 4FM Acceptance Training |
| 4FM/TAU | No intervention | Treatment As Usual - 12 group therapy meetings at Day Care Units at IPIN and IPIN Mental Health Centre for Mokotów. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The International Trauma Questionnaire (ITQ; Cloitre et al., 2018, Polish version (PL) validated within this study as the separate task)
20-item self-report scale to assess the diagnostic criteria for PTSD and CPTSD according to ICD-11 (WHO, 2018), cPTSD is diagnosed if the criteria for PTSD are met - at least 2 scores of one of two symptoms from the symptom clusters - AND criteria for Disturbances in Self-Organization are met - at least 2 scores of one of two symptoms from the symptom clusters
Measured: Through study completion, up to 2 years, before start of the intervention
Trauma Experiences Checklist (TEC, Nijenhuis et al., 2002, PL: Pietkiewicz, Tomalski, 2016).
29-item self-report questionnaire that measures 29 types of potential trauma, including criterion A events of PTSD, to assess the correlations among a wide range of reported traumatic experiences, including emotional neglect, emotional abuse, somatoform, as well as psychological, manifestations of dissociation according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (APA, 1994), possible trauma area severity scores range from 0 to 12 for emotional neglect, emotional abuse, physical abuse, sexual harassment, and sexual abuse, and from 0 to 24 for bodily threat
Measured: Through study completion, up to 2 years, before start of the intervention
Toronto Alexithymia Scale (TAS-20, Taylor et al.,1994, PL: Ścigała et al., 2020)
20-item self-report scale that measures alexithymia, difficulty in identifying and describing emotions, a score below 51 indicates no alexithymia, a score equal to or greater than 61 indicates the presence of alexithymia, scores between 52 and 60 indicate the presence of alexithymia
Measured: Through study completion, up to 2 years, before start of the intervention
Dissociative Experiences Scale, (DES-R PL, Dalenberg, Carlson, 2010, PL: Pietkiewicz et al., (2016)
28-item self-report scale that measures frequency of dissociation, the total score ranges from 0 to 196 in DES-R PL, the cutoff for dissociative disorders is over 71 points
Measured: Through study completion, up to 2 years, before start of the intervention
Somatoform Dissociation Questionnaire (SDQ-20 PL, Nijenhuis et al., (1996), PL: Pietkiewicz et al., 2018)
20-item self-report scale that evaluates the severity of somatoform dissociation, the total score ranges from 20 to 100, the cut-off point to reach the maximum sensitivity and specificity of the tool for dissociative (conversion) disorders is 29.5
Measured: Through study completion, up to 2 years, before start of the intervention
Attachment Style Questionnaire (ASQ, Feeney,1994, PL: Żechowski et al., 2014)
40-item self-report scale that measures the attachment style based on four-dimensions model by Bartholomew and Horowitz, attachment dimensions: secure, fearful, preoccupied and dismissing, on each dimension separately, respondents give answers on a 5-point scale, ranging from 1 (strongly disagree) to 5 (strongly agree)
Measured: Through study completion, up to 2 years, before start of the intervention
Brief Psychiatric Rating Scale (BPRS, Overall, Gorham, 1962)
The BPRS assesses the level of 18 symptoms by clinicians or researchers to measure psychiatric symptoms such as anxiety, depression, and psychoses, the rater enters a number for each symptom construct that ranges from 1 (not present) to 7 (extremely severe)
Measured: Before treatment, 1st week of intervention (first session)
The Existence Scale (ES, Längle et al., 2003, PL researchers of the Medical University of Warsaw II Psychiatric Clinic under the direction of Kokoszka and Längle)
46-item self-report questionnaire to assess existential fulfillment, the possible score ranges from 46 to 276 points, a high score corresponds to a high degree of existential fulfillment
Measured: Before treatment, 1st week of intervention (first session)
Penn State Worry Questionnaire (PSQW, Meyer et al., 1990, PL Janowski, 2007)
16-item self-report questionnaire to measure intensity of worry and anxiety, the possible score rages from 16 to 80, higher score corresponds to a higher intensity of worry and anxiety
Measured: Before treatment, 1st week of intervention (first session)
Center for Epidemiologic Studies Depression Scale-Revised (CESD-R, Eaton et al., 2004, PL: Koziara, 2016)
20-item self-report scale to measure symptoms of depression in nine different groups as defined by the APA Diagnostic and Statistical Manual, fifth edition, a higher score means a higher probability of meeting the criteria for depression
Measured: Before treatment, 1st week of intervention (first session)
Basic Hope Questionnaire (BHI-12, Trzebiński and Zięba, 2003)
16-item self-report questionnaire to measure basic hope understood, according to Erikson's theory, as an individual's conviction about the order and sense of the world and its favor for people, the possible score rages from 12 to 60, higher score corresponds to a higher basic hope
Measured: Before treatment, 1st week of intervention (first session)
Secondary outcomes (5)
Brief Psychiatric Rating Scale (BPRS, Overall, Gorham, 1962)
The BPRS assesses the level of 18 symptoms by clinicians or researchers to measure psychiatric symptoms such as anxiety, depression, and psychoses, the rater enters a number for each symptom construct that ranges from 1 (not present) to 7 (extremely severe)
Measured: After treatment, 12th week of intervention (last session), report - through study completion, an average of 2,5 years
The Existence Scale (ES, Längle et al., 2003, PL researchers of the Medical University of Warsaw II Psychiatric Clinic under the direction of Kokoszka and Längle)
46-item self-report questionnaire to assess existential fulfillment, the possible score ranges from 46 to 276 points, a high score corresponds to a high degree of existential fulfillment
Measured: After treatment, 12th week of intervention (last session), report - through study completion, an average of 2,5 years
Penn State Worry Questionnaire (PSQW, Meyer et al., 1990, PL Janowski, 2007)
16-item self-report questionnaire to measure intensity of worry and anxiety, the possible score rages from 16 to 80, higher score corresponds to a higher intensity of worry and anxiety
Measured: After treatment, 12th week of intervention (last session), report - through study completion, an average of 2,5 years
Center for Epidemiologic Studies Depression Scale-Revised (CESD-R, Eaton et al., 2004, PL: Koziara, 2016)
20-item self-report scale to measure symptoms of depression in nine different groups as defined by the APA Diagnostic and Statistical Manual, fifth edition, a higher score means a higher probability of meeting the criteria for depression
Measured: After treatment, 12th week of intervention (last session), report - through study completion, an average of 2,5 years
Basic Hope Questionnaire (BHI-12, Trzebiński and Zięba, 2003)
16-item self-report questionnaire to measure basic hope understood, according to Erikson's theory, as an individual's conviction about the order and sense of the world and its favor for people, the possible score rages from 12 to 60, higher score corresponds to a higher basic hope
Measured: After treatment, 12th week of intervention (last session), report - through study completion, an average of 2,5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start1 Apr 2023 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Psychiatry and Neurology, Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dorota Draczyńska, Principal investigator, Institute of Psychiatry and NeurologyMarta Anczewska, prof., Study director, Institute of Psychiatry and NeurologyAgnieszka Nowakowska, PhD, Study chair, Nowowiejski Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05674734
- Sponsor's protocol ID
- A4FM/AE
- Acronym
- A4FM/AE
- Status last verified
- Mar 2023
- First submitted
- 16 Dec 2022
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relational Trauma as an Etiological Factor of Neurotic and/or Personality Disorders Training Acceptance 4FM as a New Form of Therapy for These Disorders
- ClinicalTrials.gov ID
- NCT05674734
- Acronym / sponsor ID
- A4FM/AE / A4FM/AE
- Conditions
- Trauma
- Keywords
- cPTSD, complex trauma treatment, 4 Fundamental Motivations, Existential Analysis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Institute of Psychiatry and Neurology, WarsawUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Jan 2023 (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.
Research project entitled "The experience of relational trauma as an important etiological factor of neurotic and/or personality disorders. The 4FM Acceptance training as a new form of therapy for these disorders" assumes the following goals:
- validation of the Polish version of the International Trauma Questionnaire (ITQ);
- assessment of prevalence of relational trauma among adult psychiatric patients hospitalized at the Institute of Psychiatry and Neurology;
- development a new therapeutic intervention - 4FM Acceptance training - based on the methodology of the Existential Analysis;
- assessment of the impact of the 4FM Acceptance training among patients with cPTSD.
The original therapeutic intervention - 4FM Acceptance training - will be developed based on the methodological assumptions of the 4 Fundamental Motivations (4FM) in the Existential Analysis methodology, developed by Alfried Längle, student of Viktor Frankl, a representative of the Existential Psychology, together with other important representatives, i.e. Rollo May, Irvin Yalom and in Poland prof. Antoni Kępiński.
Detailed description
Relational trauma, related to early childhood traumatic experiences in relationships with caregivers, usually parents, significantly affects the overall functioning of a person in adulthood. It may also contribute to the occurrence of neurotic disorders and/or personality disorders. The ICD-11 classification introduces a new diagnosis related to the experience of relational trauma, i.e., "complex post-traumatic stress disorder - complex PTSD" (6B41, complex Post Traumatic Stress Disorder, cPTSD). It is a separate nosological unit from PTSD (6B40) (ICD-11, 2022).
Relational trauma therapy should differ from that recommended in PTSD, as it often happens that the "burden of the past" affects the present. Existential psychotherapy may be an effective form of treatment. The Existential Analysis, Alfried Längle's theory of motivation, can be used to treat people who have experienced relational trauma and meet the criteria of cPTSD diagnosis. The project will analyze the impact of a new group therapeutic intervention - 4FM Acceptance Training - on improving existential fulfilment, increasing basic hope, and reducing symptoms of anxiety and depression. 4FM Acceptance Training is the intervention including self-regulatory strategies and trauma-focused interventions.
The obtained results will allow for the assessment of: dissemination of relational trauma, alexithymia, dissociation, somatoform dissociation in the context of the attachment style among people with mental disorders. Thus, they will contribute to the verification of the hypothesis of relational trauma as an important etiological factor of personality disorders and / or neurotic disorders; the usefulness of the 4FM Acceptance group training in the therapy of people with relational trauma and cPTSD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4FM/AT | Experimental | Behavioral: 4FM Acceptance Training4FM Acceptance Training, therapeutic intervention in the form of an additional to TAU (Treatment-As-Usual) module - 12 (1,5 hour) group meetings in the form of 4FM Acceptance Training at Day Care Units at Institute of Psychiatry and Neurology (IPiN) Mental Health Centre for Mokotów and IPiN. |
| 4FM/TAU | No intervention | –Treatment As Usual - 12 group therapy meetings at Day Care Units at IPIN and IPIN Mental Health Centre for Mokotów. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Signed informed consent provide.
- Stable mental state allowing for reliable completion of the questionnaires.
- Native Polish language.
- Meeting the cPTSD diagnosis based on ITQ - International Trauma Questionnaire), self-report questionnaire, Cloitre et al. (2021), Polish version validated within the project.
Key exclusion criteria (2 listed)
- No consent to participate in the research.
- Coexisting addiction to alcohol or psychoactive substances, documented intellectual disability, dementia or organic changes of the central nervous system.
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 |
|---|---|---|
| 4FM Acceptance Training4FM Acceptance Training, therapeutic intervention in the form of an additional to TAU module - 12 (1,5 hour) group meetings in the form of 4FM Acceptance Training at Day Care Units at IPIN Mental Health Centre for Mokotów and IPiN (1 meeting weekly). | Behavioural | 4FM/AT |
Primary outcome
The International Trauma Questionnaire (ITQ; Cloitre et al., 2018, Polish version (PL) validated within this study as the separate task)
Time frame: Through study completion, up to 2 years, before start of the intervention
20-item self-report scale to assess the diagnostic criteria for PTSD and CPTSD according to ICD-11 (WHO, 2018), cPTSD is diagnosed if the criteria for PTSD are met - at least 2 scores of one of two symptoms from the symptom clusters - AND criteria for Disturbances in Self-Organization are met - at least 2 scores of one of two symptoms from the symptom clusters
Trauma Experiences Checklist (TEC, Nijenhuis et al., 2002, PL: Pietkiewicz, Tomalski, 2016).
Time frame: Through study completion, up to 2 years, before start of the intervention
29-item self-report questionnaire that measures 29 types of potential trauma, including criterion A events of PTSD, to assess the correlations among a wide range of reported traumatic experiences, including emotional neglect, emotional abuse, somatoform, as well as psychological, manifestations of dissociation according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (APA, 1994), possible trauma area severity scores range from 0 to 12 for emotional neglect, emotional abuse, physical abuse, sexual harassment, and sexual abuse, and from 0 to 24 for bodily threat
Toronto Alexithymia Scale (TAS-20, Taylor et al.,1994, PL: Ścigała et al., 2020)
Time frame: Through study completion, up to 2 years, before start of the intervention
20-item self-report scale that measures alexithymia, difficulty in identifying and describing emotions, a score below 51 indicates no alexithymia, a score equal to or greater than 61 indicates the presence of alexithymia, scores between 52 and 60 indicate the presence of alexithymia
Dissociative Experiences Scale, (DES-R PL, Dalenberg, Carlson, 2010, PL: Pietkiewicz et al., (2016)
Time frame: Through study completion, up to 2 years, before start of the intervention
28-item self-report scale that measures frequency of dissociation, the total score ranges from 0 to 196 in DES-R PL, the cutoff for dissociative disorders is over 71 points
Somatoform Dissociation Questionnaire (SDQ-20 PL, Nijenhuis et al., (1996), PL: Pietkiewicz et al., 2018)
Time frame: Through study completion, up to 2 years, before start of the intervention
20-item self-report scale that evaluates the severity of somatoform dissociation, the total score ranges from 20 to 100, the cut-off point to reach the maximum sensitivity and specificity of the tool for dissociative (conversion) disorders is 29.5
Attachment Style Questionnaire (ASQ, Feeney,1994, PL: Żechowski et al., 2014)
Time frame: Through study completion, up to 2 years, before start of the intervention
40-item self-report scale that measures the attachment style based on four-dimensions model by Bartholomew and Horowitz, attachment dimensions: secure, fearful, preoccupied and dismissing, on each dimension separately, respondents give answers on a 5-point scale, ranging from 1 (strongly disagree) to 5 (strongly agree)
Brief Psychiatric Rating Scale (BPRS, Overall, Gorham, 1962)
Time frame: Before treatment, 1st week of intervention (first session)
The BPRS assesses the level of 18 symptoms by clinicians or researchers to measure psychiatric symptoms such as anxiety, depression, and psychoses, the rater enters a number for each symptom construct that ranges from 1 (not present) to 7 (extremely severe)
The Existence Scale (ES, Längle et al., 2003, PL researchers of the Medical University of Warsaw II Psychiatric Clinic under the direction of Kokoszka and Längle)
Time frame: Before treatment, 1st week of intervention (first session)
46-item self-report questionnaire to assess existential fulfillment, the possible score ranges from 46 to 276 points, a high score corresponds to a high degree of existential fulfillment
Penn State Worry Questionnaire (PSQW, Meyer et al., 1990, PL Janowski, 2007)
Time frame: Before treatment, 1st week of intervention (first session)
16-item self-report questionnaire to measure intensity of worry and anxiety, the possible score rages from 16 to 80, higher score corresponds to a higher intensity of worry and anxiety
Center for Epidemiologic Studies Depression Scale-Revised (CESD-R, Eaton et al., 2004, PL: Koziara, 2016)
Time frame: Before treatment, 1st week of intervention (first session)
20-item self-report scale to measure symptoms of depression in nine different groups as defined by the APA Diagnostic and Statistical Manual, fifth edition, a higher score means a higher probability of meeting the criteria for depression
Basic Hope Questionnaire (BHI-12, Trzebiński and Zięba, 2003)
Time frame: Before treatment, 1st week of intervention (first session)
16-item self-report questionnaire to measure basic hope understood, according to Erikson's theory, as an individual's conviction about the order and sense of the world and its favor for people, the possible score rages from 12 to 60, higher score corresponds to a higher basic hope
5 secondary outcomes
Brief Psychiatric Rating Scale (BPRS, Overall, Gorham, 1962)
Time frame: After treatment, 12th week of intervention (last session), report - through study completion, an average of 2,5 years
The Existence Scale (ES, Längle et al., 2003, PL researchers of the Medical University of Warsaw II Psychiatric Clinic under the direction of Kokoszka and Längle)
Time frame: After treatment, 12th week of intervention (last session), report - through study completion, an average of 2,5 years
Penn State Worry Questionnaire (PSQW, Meyer et al., 1990, PL Janowski, 2007)
Time frame: After treatment, 12th week of intervention (last session), report - through study completion, an average of 2,5 years
Center for Epidemiologic Studies Depression Scale-Revised (CESD-R, Eaton et al., 2004, PL: Koziara, 2016)
Time frame: After treatment, 12th week of intervention (last session), report - through study completion, an average of 2,5 years
Basic Hope Questionnaire (BHI-12, Trzebiński and Zięba, 2003)
Time frame: After treatment, 12th week of intervention (last session), report - through study completion, an average of 2,5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
Related trials for Trauma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
Safety Study of Microlyte DualGuard
Wound Closure, Wound Care
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
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.
Dorota Draczyńska principal investigator
Institute of Psychiatry and Neurology
Marta Anczewska, prof. study director
Institute of Psychiatry and Neurology
Agnieszka Nowakowska, PhD study chair
Nowowiejski Hospital
Questions about this trial
What is this clinical trial studying?
A study testing 4FM Acceptance Training in people with Trauma, run by Institute of Psychiatry and Neurology, Warsaw.
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 4 inclusion and 2 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: opening soon, as of the sponsor's last update on 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dorota Draczynska (22 45 82 242 ext. +48, ddraczynska@ipin.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The International Trauma Questionnaire (ITQ; Cloitre et al., 2018, Polish version (PL) validated within this study as the separate task) (time frame: Through study completion, up to 2 years, before start of the intervention). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2023.