Clinical trial NCT05674734: 4FM Acceptance Training as the New Form of cPTSD-focused Treatment Based on Existential Analysis
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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Trauma
Keywords: cPTSD
complex trauma treatment
4 Fundamental Motivations
Existential Analysis
Lead sponsor: Institute of Psychiatry and Neurology, Warsaw
Sponsor class: OTHER
First posted: 2023-01-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

1. validation of the Polish version of the International Trauma Questionnaire (ITQ);
2. assessment of prevalence of relational trauma among adult psychiatric patients hospitalized at the Institute of Psychiatry and Neurology;
3. development a new therapeutic intervention - 4FM Acceptance training - based on the methodology of the Existential Analysis;
4. 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.

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent provide.
2. Stable mental state allowing for reliable completion of the questionnaires.
3. Native Polish language.
4. 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:

1. No consent to participate in the research.
2. Coexisting addiction to alcohol or psychoactive substances, documented intellectual disability, dementia or organic changes of the central nervous system.

Primary outcomes:
measure: The International Trauma Questionnaire (ITQ; Cloitre et al., 2018, Polish version (PL) validated within this study as the separate task)
timeFrame: Through study completion, up to 2 years, before start of the intervention
measure: Trauma Experiences Checklist (TEC, Nijenhuis et al., 2002, PL: Pietkiewicz, Tomalski, 2016).
timeFrame: Through study completion, up to 2 years, before start of the intervention
measure: Toronto Alexithymia Scale (TAS-20, Taylor et al.,1994, PL: Ścigała et al., 2020)
timeFrame: Through study completion, up to 2 years, before start of the intervention
measure: Dissociative Experiences Scale, (DES-R PL, Dalenberg, Carlson, 2010, PL: Pietkiewicz et al., (2016)
timeFrame: Through study completion, up to 2 years, before start of the intervention
measure: Somatoform Dissociation Questionnaire (SDQ-20 PL, Nijenhuis et al., (1996), PL: Pietkiewicz et al., 2018)
timeFrame: Through study completion, up to 2 years, before start of the intervention
measure: Attachment Style Questionnaire (ASQ, Feeney,1994, PL: Żechowski et al., 2014)
timeFrame: Through study completion, up to 2 years, before start of the intervention
measure: Brief Psychiatric Rating Scale (BPRS, Overall, Gorham, 1962)
timeFrame: Before treatment, 1st week of intervention (first session)
measure: 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)
timeFrame: Before treatment, 1st week of intervention (first session)
measure: Penn State Worry Questionnaire (PSQW, Meyer et al., 1990, PL Janowski, 2007)
timeFrame: Before treatment, 1st week of intervention (first session)
measure: Center for Epidemiologic Studies Depression Scale-Revised (CESD-R, Eaton et al., 2004, PL: Koziara, 2016)
timeFrame: Before treatment, 1st week of intervention (first session)
measure: Basic Hope Questionnaire (BHI-12, Trzebiński and Zięba, 2003)
timeFrame: Before treatment, 1st week of intervention (first session)
Secondary outcomes:
measure: Brief Psychiatric Rating Scale (BPRS, Overall, Gorham, 1962)
timeFrame: After treatment, 12th week of intervention (last session), report - through study completion, an average of 2,5 years
measure: 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)
timeFrame: After treatment, 12th week of intervention (last session), report - through study completion, an average of 2,5 years
measure: Penn State Worry Questionnaire (PSQW, Meyer et al., 1990, PL Janowski, 2007)
timeFrame: After treatment, 12th week of intervention (last session), report - through study completion, an average of 2,5 years
measure: Center for Epidemiologic Studies Depression Scale-Revised (CESD-R, Eaton et al., 2004, PL: Koziara, 2016)
timeFrame: After treatment, 12th week of intervention (last session), report - through study completion, an average of 2,5 years
measure: Basic Hope Questionnaire (BHI-12, Trzebiński and Zięba, 2003)
timeFrame: After treatment, 12th week of intervention (last session), report - through study completion, an average of 2,5 years
Other outcomes:
measure: Clinical Global Impression - Improvement scale (CGI-I), patient
timeFrame: After treatment, 12th week of intervention (last session), report - through study completion, an average of 2,5 years
measure: Clinical Global Impression - Improvement scale (CGI-I), psychotherapist
timeFrame: After treatment, 12th week of intervention (last session), report - through study completion, an average of 2,5 years
Locations:
Study officials:
affiliation: Institute of Psychiatry and Neurology
name: Dorota Draczyńska
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Psychiatry and Neurology
name: Marta Anczewska, prof.
role: STUDY_DIRECTOR
affiliation: Nowowiejski Hospital
name: Agnieszka Nowakowska, PhD
role: STUDY_CHAIR
References: