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

NCT05674734 | Not Yet Recruiting

• 1 other identifier: A4FM/AE
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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

Conditions

Trauma

Keywords

cPTSD; complex trauma treatment; 4 Fundamental Motivations; Existential Analysis

Outcome Measures

Primary Outcomes (11)

• 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

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

• 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

  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)

  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

  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)

  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

  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)

  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

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

• 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)

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

• 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)

  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)

  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

  Before treatment, 1st week of intervention (first session)

• 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

  Before treatment, 1st week of intervention (first session)

• 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

  Before treatment, 1st week of intervention (first session)

• 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

  Before treatment, 1st week of intervention (first session)

Secondary Outcomes (5)

• Brief Psychiatric Rating Scale (BPRS, Overall, Gorham, 1962)

  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)

  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)

  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)

  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)

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

Other Outcomes (2)

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

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

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

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

Study Arms (2)

4FM/AT

EXPERIMENTAL

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.

Behavioral: 4FM Acceptance Training

4FM/TAU

NO INTERVENTION

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

Interventions

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).

4FM/AT

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Psychiatry and Neurology, Warsaw: lead

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Dorota Draczyńska

  Institute of Psychiatry and Neurology

  PRINCIPAL INVESTIGATOR

• Marta Anczewska, prof.

  Institute of Psychiatry and Neurology

  STUDY DIRECTOR

• Agnieszka Nowakowska, PhD

  Nowowiejski Hospital

  STUDY CHAIR

Central Study Contacts

Dorota Draczynska

CONTACT

22 45 82 242; ddraczynska@ipin.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2022
• First Posted: January 6, 2023
• Study Start: April 1, 2023
• Primary Completion: June 30, 2023
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 6, 2023

Record last verified: 2023-03