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Not yet recruiting NCT05674734

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

No phase Interventional Trauma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 4FM Acceptance Training.
Who it may be relevant to
Registry conditions: Trauma. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Interventions

  • Behavioral 4FM Acceptance Training
    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 measures

  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • Brief Psychiatric Rating Scale (BPRS, Overall, Gorham, 1962) [Time frame: 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) [Time frame: Before treatment, 1st week of intervention (first session)]
  • Penn State Worry Questionnaire (PSQW, Meyer et al., 1990, PL Janowski, 2007) [Time frame: Before treatment, 1st week of intervention (first session)]
  • 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)]
Secondary outcome measures (5)
  • 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]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05674734 · A4FM/AE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗