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

ConditionTrauma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorInstitute of Psychiatry and Neurology, Warsaw

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • 4FM Acceptance Training

    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).

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: 4FM/ATExperimental treatment 1 intervention
Group B: 4FM/TAUNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Through study completion, up to 2 years, before start of the intervention
2

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

Time frame
Through study completion, up to 2 years, before start of the intervention
3

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

Time frame
Through study completion, up to 2 years, before start of the intervention
4

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

Time frame
Through study completion, up to 2 years, before start of the intervention

Secondary outcomes

1

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)

Time frame
After treatment, 12th week of intervention (last session), report - through study completion, an average of 2,5 years
2

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

Time frame
After treatment, 12th week of intervention (last session), report - through study completion, an average of 2,5 years
3

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

Time frame
After treatment, 12th week of intervention (last session), report - through study completion, an average of 2,5 years
4

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

Time frame
After treatment, 12th week of intervention (last session), report - through study completion, an average of 2,5 years

Other outcomes

1

Clinical Global Impression - Improvement scale (CGI-I), patient

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
2

Clinical Global Impression - Improvement scale (CGI-I), psychotherapist

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

Locations

This trial has no locations.

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