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4FM Acceptance Training as the New Form of cPTSD-focused Treatment Based on Existential Analysis (A4FM/AE)

Primary Purpose

Trauma

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
4FM Acceptance Training
Sponsored by
Institute of Psychiatry and Neurology, Warsaw
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trauma focused on measuring cPTSD, complex trauma treatment, 4 Fundamental Motivations, Existential Analysis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    4FM/AT

    4FM/TAU

    Arm Description

    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.

    Treatment As Usual - 12 group therapy meetings at Day Care Units at IPIN and IPIN Mental Health Centre for Mokotów.

    Outcomes

    Primary Outcome Measures

    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
    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
    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
    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
    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
    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)
    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)
    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
    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
    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
    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

    Secondary Outcome Measures

    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)
    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
    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
    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
    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

    Full Information

    First Posted
    December 16, 2022
    Last Updated
    March 3, 2023
    Sponsor
    Institute of Psychiatry and Neurology, Warsaw
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05674734
    Brief Title
    4FM Acceptance Training as the New Form of cPTSD-focused Treatment Based on Existential Analysis
    Acronym
    A4FM/AE
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 1, 2023 (Anticipated)
    Primary Completion Date
    June 30, 2023 (Anticipated)
    Study Completion Date
    December 31, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Institute of Psychiatry and Neurology, Warsaw

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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: 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Trauma
    Keywords
    cPTSD, complex trauma treatment, 4 Fundamental Motivations, Existential Analysis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    4FM/AT
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    4FM/TAU
    Arm Type
    No Intervention
    Arm Description
    Treatment As Usual - 12 group therapy meetings at Day Care Units at IPIN and IPIN Mental Health Centre for Mokotów.
    Intervention Type
    Behavioral
    Intervention Name(s)
    4FM Acceptance Training
    Intervention Description
    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).
    Primary Outcome Measure Information:
    Title
    The International Trauma Questionnaire (ITQ; Cloitre et al., 2018, Polish version (PL) validated within this study as the separate task)
    Description
    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
    Time Frame
    Through study completion, up to 2 years, before start of the intervention
    Title
    Trauma Experiences Checklist (TEC, Nijenhuis et al., 2002, PL: Pietkiewicz, Tomalski, 2016).
    Description
    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
    Time Frame
    Through study completion, up to 2 years, before start of the intervention
    Title
    Toronto Alexithymia Scale (TAS-20, Taylor et al.,1994, PL: Ścigała et al., 2020)
    Description
    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
    Time Frame
    Through study completion, up to 2 years, before start of the intervention
    Title
    Dissociative Experiences Scale, (DES-R PL, Dalenberg, Carlson, 2010, PL: Pietkiewicz et al., (2016)
    Description
    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
    Time Frame
    Through study completion, up to 2 years, before start of the intervention
    Title
    Somatoform Dissociation Questionnaire (SDQ-20 PL, Nijenhuis et al., (1996), PL: Pietkiewicz et al., 2018)
    Description
    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
    Time Frame
    Through study completion, up to 2 years, before start of the intervention
    Title
    Attachment Style Questionnaire (ASQ, Feeney,1994, PL: Żechowski et al., 2014)
    Description
    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)
    Time Frame
    Through study completion, up to 2 years, before start of the intervention
    Title
    Brief Psychiatric Rating Scale (BPRS, Overall, Gorham, 1962)
    Description
    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)
    Time Frame
    Before treatment, 1st week of intervention (first session)
    Title
    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)
    Description
    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
    Time Frame
    Before treatment, 1st week of intervention (first session)
    Title
    Penn State Worry Questionnaire (PSQW, Meyer et al., 1990, PL Janowski, 2007)
    Description
    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
    Time Frame
    Before treatment, 1st week of intervention (first session)
    Title
    Center for Epidemiologic Studies Depression Scale-Revised (CESD-R, Eaton et al., 2004, PL: Koziara, 2016)
    Description
    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
    Time Frame
    Before treatment, 1st week of intervention (first session)
    Title
    Basic Hope Questionnaire (BHI-12, Trzebiński and Zięba, 2003)
    Description
    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
    Time Frame
    Before treatment, 1st week of intervention (first session)
    Secondary Outcome Measure Information:
    Title
    Brief Psychiatric Rating Scale (BPRS, Overall, Gorham, 1962)
    Description
    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)
    Time Frame
    After treatment, 12th week of intervention (last session), report - through study completion, an average of 2,5 years
    Title
    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)
    Description
    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
    Time Frame
    After treatment, 12th week of intervention (last session), report - through study completion, an average of 2,5 years
    Title
    Penn State Worry Questionnaire (PSQW, Meyer et al., 1990, PL Janowski, 2007)
    Description
    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
    Time Frame
    After treatment, 12th week of intervention (last session), report - through study completion, an average of 2,5 years
    Title
    Center for Epidemiologic Studies Depression Scale-Revised (CESD-R, Eaton et al., 2004, PL: Koziara, 2016)
    Description
    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
    Time Frame
    After treatment, 12th week of intervention (last session), report - through study completion, an average of 2,5 years
    Title
    Basic Hope Questionnaire (BHI-12, Trzebiński and Zięba, 2003)
    Description
    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
    Time Frame
    After treatment, 12th week of intervention (last session), report - through study completion, an average of 2,5 years
    Other Pre-specified Outcome Measures:
    Title
    Clinical Global Impression - Improvement scale (CGI-I), patient
    Description
    7-point self report rating scale to rate symptom severity, treatment response and the efficacy of treatment from patient's perspective
    Time Frame
    After treatment, 12th week of intervention (last session), report - through study completion, an average of 2,5 years
    Title
    Clinical Global Impression - Improvement scale (CGI-I), psychotherapist
    Description
    7-point self report rating scale to rate symptom severity, treatment response and the efficacy of treatment from psychotherapist's perspective
    Time Frame
    After treatment, 12th week of intervention (last session), report - through study completion, an average of 2,5 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dorota Draczynska
    Phone
    22 45 82 242
    Ext
    +48
    Email
    ddraczynska@ipin.edu.pl
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dorota Draczyńska
    Organizational Affiliation
    Institute of Psychiatry and Neurology
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Marta Anczewska, prof.
    Organizational Affiliation
    Institute of Psychiatry and Neurology
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Agnieszka Nowakowska, PhD
    Organizational Affiliation
    Nowowiejski Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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    4FM Acceptance Training as the New Form of cPTSD-focused Treatment Based on Existential Analysis

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