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

NCT ID: NCT05674734

Last Updated: 2023-03-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2026-12-31

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.

Conditions

Trauma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

4FM/AT

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.

Group Type: EXPERIMENTAL

4FM Acceptance Training

Intervention Type: BEHAVIORAL

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).

4FM/TAU

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Psychiatry and Neurology, Warsaw

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dorota Draczyńska

Role: PRINCIPAL_INVESTIGATOR

Institute of Psychiatry and Neurology

Marta Anczewska, prof.

Role: STUDY_DIRECTOR

Institute of Psychiatry and Neurology

Agnieszka Nowakowska, PhD

Role: STUDY_CHAIR

Nowowiejski Hospital

Central Contacts

Dorota Draczynska

Role: CONTACT

ddraczynska@ipin.edu.pl

22 45 82 242 ext. +48

Other Identifiers

A4FM/AE

Identifier Type: -

Identifier Source: org_study_id