NCT07360990

Brief Summary

The purpose of this retrospective study was to evaluate the effectiveness of a new psychotherapy technique called Psychological Cognitive Reprocessing Procedure (P-CRP) in treating trauma symptoms. The P-CRP intervention was developed and manualized by the principal investigator (Z.B.Baydar). Participants were randomly assigned to either the P-CRP intervention group, an active control group, or a waitlist condition. The study aimed to determine if this new method, which focused on episodic buffer processing, significantly reduced trauma-related psychological distress compared to standard approaches. Data collected during the intervention phase were analyzed to assess the efficacy of the P-CRP technique.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 1, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 22, 2026

Completed
Last Updated

February 25, 2026

Status Verified

January 1, 2026

Enrollment Period

3 months

First QC Date

January 1, 2026

Last Update Submit

February 23, 2026

Conditions

Keywords

Early pilot randomized control trialComplex loss and traumaEpisodic bufferP-CRPBrief intervention

Outcome Measures

Primary Outcomes (1)

  • The Impact of Event Scale -Revised (IES-R)

    The IES-R is a 22-item self-report scale designed to assess the psychological impact of traumatic experiences across three subdimensions: intrusion, avoidance, and hyperarousal. Items are rated on a 5-point Likert scale (0 = not at all to 4 = extremely) based on symptom frequency over the past seven days. Total scores range from 0 to 88, where higher scores indicate greater severity of post-traumatic stress symptoms. According to the literature, scores of 33 and above suggest a probable PTSD diagnosis. The Turkish adaptation was used, which demonstrated high validity and reliability.

    Baseline (Week 0), Post-intervention (Week 6), and Follow-up (Week 10) .

Secondary Outcomes (3)

  • State-Trait Anxiety Inventory (STAI).

    Baseline (Week 0), Post-intervention (Week 6), and Follow-up (Week 10)

  • The Body Sensations Questionnaire (BSQ).

    Baseline (Week 0), Post-intervention (Week 6), and Follow-up (Week 10)

  • The Positive and Negative Affect Schedule (PANAS)

    Baseline (Week 0), Post-intervention (Week 6), and Follow-up (Week 10)

Study Arms (3)

Psychological-cognitive reprocessing procedure (P-CRP).

EXPERIMENTAL

The P-CRP was the experimental group receiving four session the intervention. The Psychological-Cognitive Reprocessing Procedure (P-CRP) is a brief and a neuro-psychological intervention based on the episodic buffer model. This process facilitates the separation of cognitions from automatic processing and pulls traumatic fragments into the episodic buffer through simultaneous neuronal firing. This integration helps resolve the semantic fragmentation caused by trauma, allowing for cognitive reintegration and meaning making.

Behavioral: Psychological-cognitive reprocessing procedure (P-CRP).

Expressive Narrative and Symbolic Drawing (ENSD)

ACTIVE COMPARATOR

Control participants received four session a narrative-based expressive and symbolic drawing protocol. The intervention delivered to the control group can be characterized as an active, experiential, projective, and sensory-supported approach.

Behavioral: Expressive Narrative and Symbolic Drawing (ENSD)

Waitlist Group

NO INTERVENTION

Participants in this group did not receive any active psychological intervention during the study period. They completed the pre-test and follow-up assessments at the same time intervals as the intervention groups. Following the completion of the follow-up phase, participants in the wait-list group were offered a psychological intervention protocol based on the study's findings to ensure ethical treatment standards.

Interventions

Unlike traditional approaches, the traumatic imagery is not directly targeted in the first session. The intervention begins with the silent repetition of a word or phrase representing the core negative belief associated with the traumatic experience. . During each 1-minute set, bilateral stimulation (synchronized tapping on the shoulders only) is applied, allowing the client to process the traumatic material through spontaneously emerging associations selected by the mind itself. Rather than relying on external direction, the protocol activates internal self-regulation capacities. In this respect, it aims to promote semantic and symbolic reorganization, differing from classical cognitive restructuring or desensitization-based methods. The decision about which aspect of the experience will be processed or desensitized is determined by the client's own mental flow, thereby reinforcing a sense of trust in the mind's capacity despite the traumatic history.

Psychological-cognitive reprocessing procedure (P-CRP).

Following initial anamnesis and psychoeducation, clients recounted their trauma and drew a self-selected symbol of the event using their non-dominant hand. Each session involved discussing the memory and updating this symbol to facilitate indirect processing through creative expression.

Expressive Narrative and Symbolic Drawing (ENSD)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Individuals were excluded if they had: 1. An Adverse Childhood Experiences (ACE) score greater than 7. 2. A history of psychotic disorder or bipolar disorder. 3. Current suicide risk. 4. Substance use disorder. 5. Prior therapeutic contact with the researcher. 6. A target traumatic event that had occurred more than one year earlier. 7. Not meeting clinical DSM-5 criteria for PTSD during the clinician-administered semi-structured interview, regardless of initial self-report scores. 8. Current participation in any other form of psychotherapy or psychiatric intervention. Individuals were included if they had: 1. Meeting DSM-5 criteria for PTSD symptoms (verified by IES-R scores and clinician-led semi-structured interview). 2. Having experienced a target traumatic event or loss within the past 12 months. 3. Willingness to provide informed consent and participate in all intervention sessions.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Zahide Betül Baydar

Istanbul, Istanbul, 34876, Turkey (Türkiye)

Location

Related Publications (31)

  • Whitall, J., Waller, S. M., Silver, K. H. C., & Macko, R. F. (2000). Repetitive bilateral arm training with rhythmic auditory cueing improves motor function in chronic hemiparetic stroke. Stroke, 31(10), 2390-2395. Whitall, J., Waller, S. M., Sorkin, J. D., Forrester, L. W., Macko, R. F., Hanley, D. F., & Goldberg, A. P. (2011). Bilateral and unilateral arm training improve motor function through differing neuroplastic mechanisms: A single-blinded randomized controlled trial. Neurorehabilitation and Neural Repair, 25(2), 118-129. Zainal, N., Newman, M., & Hong, R. (2019). Cross-cultural and gender invariance of transdiagnostic processes in the united states and singapore. Assessment, 28(2), 485-502.

    BACKGROUND
  • Van der Kolk, B. A. (2018). Beden kayıt tutar: Travmanın iyileşmesinde beyin, zihin ve beden (N. Cihanşümül Maral, Çev.). Nobel Yaşam. (Orijinal eser 2014'te yayımlandı) Webb, C. A., Derubeis, R. J., & Barber, J. P. (2010). Therapist adherence/competence and treatment outcome: A meta-analytic review. Journal of consulting and clinical psychology, 78(2), 200-211. Weiss, D. S., & Marmar, C. R. (1997). The Impact of Event Scale-Revised. In J. P. Wilson & T. M. Keane (Eds.), Assessing psychological trauma and PTSD (pp. 399-411). Guilford Press.

    BACKGROUND
  • Pagani, M., Di Lorenzo, G., Verardo, A. R., Nicolais, G., Monaco, L., Lauretti, G., Russo, R., Niolu, C., & Siracusano, A. (2012). Neurobiological correlates of EMDR monitoring-An EEG study. PLoS ONE, 7(9), e45753. Pagani, M., Amann, B. L., Landin-Romero, R., & Carletto, S. (2017). Eye Movement Desensitization and Reprocessing and slow wave sleep: A putative mechanism of action. Frontiers in Psychology, 8, 1935. Park, C. L. (2022). Meaning making following trauma. Frontiers in Psychology, 13:844891 Picó-Pérez, M., Fullana, M. À., Albajes-Eizagirre, A., Vega, D., Marco-Pallarés, J., Vilar, A., … & Soriano-Mas, C. (2022). Neural predictors of cognitive-behavior therapy outcome in anxiety-related disorders: a meta-analysis of task-based fmri studies. Psychological Medicine, 53(8), 3387-3395. Rank, O. (2001/2024). Doğum travması (S. Yücesoy, Çev.). Metis Yayınları. (Orijinal eser 1924'te yayımlandı.) Resick, P. A., Wachen, J. S., Mintz, J., Young-McCaughan, S., Roache, J. D., Borah, A. M., … & Peterson, A. L. (2015). A randomized clinical trial of group cognitive processing therapy compared with group present-centered therapy for ptsd among active duty military personnel.Journal of Consulting and Clinical Psychology, 83(6), 1058-1068. Shapiro, F. (2001). Eye movement desensitization and repro-cessing: Basic principles, protocols and procedures (2nd ed.).New York: Guilford Shapiro, F. (2021). Eye movement desensitization and reprocessing (EMDR) therapy: Basic principles, protocols, and procedures (3rd ed.). Guilford Press. Shiffrin, R. and Atkinson, R. (1969). Storage and retrieval processes in long-term memory.. Psychological Review, 76(2), 179-193. Schore, A. (2021). The interpersonal neurobiology of intersubjectivity. Frontiers in Psychology, 12. Silfwerbrand, L., Ogata, Y., Yoshimura, N., Koike, Y., & Gingnell, M. (2022). An fMRI-study of leading and following using rhythmic tapping. Social Neuroscience, 17(6), 558-567. Spielberger, C. D., Gorsuch, R. L.,& Lu

    BACKGROUND
  • Jung, C. G. (1968). The collected works of C. G. Jung: Vol. 9, Part 1. The archetypes and the collective unconscious (R. F. C. Hull, Trans.). Princeton University Press.Kazdin, A. E. (2019). Research design in clinical psychology (5th ed.). Pearson Lakoff, G. and Johnson, M. H. (2003). Metaphors we live by.. LeDoux, J. E. (1996). The emotional brain: The mysterious underpinnings of emotional life. Simon & Schuster. Lind, J. and Zumbo, B. D. (1993). The continuity principle in psychological research: an introduction to robust statistics.. Canadian Psychology / Psychologie Canadienne, 34(4), 407-414. Malmberg, K. J., Raaijmakers, J. G. W., & Shiffrin, R. M. (2019). 50 years of research sparked by atkinson and shiffrin (1968). Memory & Cognition, 47(4), 561-574. McEvoy, P., Nathan, P., & Norton, P. (2009). Efficacy of transdiagnostic treatments: a review of published outcome studies and future research directions. Journal of Cognitive Psychotherapy, 23(1), 20-33. Nechvatal, J. M. and Lyons, D. M. (2013). Coping changes the brain. Frontiers in Behavioral Neuroscience, 7.

    BACKGROUND
  • Husabø, E., Haugland, B. S. M., McLeod, B. D., Baste, V., Haaland, V. Ø., Bjaastad, J. F., … & Wergeland, G. J. (2021). Treatment fidelity in brief versus standard-length school-based interventions for youth with anxiety. School Mental Health, 14(1), 49-62.

    BACKGROUND
  • Foa, E. B., Huppert, J. D., & Cahill, S. P. (2006). Emotional processing theory: An update. In B. O. Rothbaum (Ed.), Pathological anxiety: Emotional processing in etiology and treatment (pp. 3 -24). Guilford Press. Gaden, T. S., Gold, C., Aßmus, J., Kvestad, I., Stordal, A. S., Bieleninik, Ł., … & Ghetti, C. (2023). Treatment fidelity in a pragmatic clinical trial of music therapy for premature infants and their parents: the longstep study. Trials, 24(1). Gazzaniga, M. S. (2000). Cerebral specialization and interhemispheric communication: Does the corpus callosum enable the human condition? Brain, 123(7), 1293-1326. Hertzog, M. (2008). Considerations in determining sample size for pilot studies. Research in Nursing & Health, 31(2), 180-191. Hinton, D. E., & Good, B. J. (2016). *Culture and PTSD: Trauma in global and historical perspective*. University of Pennsylvania Press.

    BACKGROUND
  • Foa EB, Kozak MJ. Emotional processing of fear: exposure to corrective information. Psychol Bull. 1986 Jan;99(1):20-35. No abstract available.

    PMID: 2871574BACKGROUND
  • Ehlers A, Clark DM. A cognitive model of posttraumatic stress disorder. Behav Res Ther. 2000 Apr;38(4):319-45. doi: 10.1016/s0005-7967(99)00123-0.

    PMID: 10761279BACKGROUND
  • Edwards, B. (1989). Drawing on the right side of the brain. New York: Jeremy P. Tarcher/Putnam.

    BACKGROUND
  • De Guio, F., St-Onge, E., Perlbarg, V., Urbain, C., Benali, H., & Cohen, L. (2012). An fMRI study comparing rhythmic finger tapping and complex movement sequences. Frontiers in Human Neuroscience, 6, 318.

    BACKGROUND
  • Cowan N, Elliott EM, Scott Saults J, Morey CC, Mattox S, Hismjatullina A, Conway AR. On the capacity of attention: its estimation and its role in working memory and cognitive aptitudes. Cogn Psychol. 2005 Aug;51(1):42-100. doi: 10.1016/j.cogpsych.2004.12.001. Epub 2005 Mar 2.

    PMID: 16039935BACKGROUND
  • Brown, R. E. (2007). The life and work of Donald Olding Hebb, Canada's greatest psychologist. Proceedings of the Nova Scotian Institute of Science, 44(1), 1-25.

    BACKGROUND
  • Brewin CR. Episodic memory, perceptual memory, and their interaction: foundations for a theory of posttraumatic stress disorder. Psychol Bull. 2014 Jan;140(1):69-97. doi: 10.1037/a0033722. Epub 2013 Aug 5.

    PMID: 23914721BACKGROUND
  • Bryant RA, Erlinger M, Felmingham K, Klimova A, Williams LM, Malhi G, Forbes D, Korgaonkar MS. Reappraisal-related neural predictors of treatment response to cognitive behavior therapy for post-traumatic stress disorder. Psychol Med. 2021 Oct;51(14):2454-2464. doi: 10.1017/S0033291720001129. Epub 2020 May 5.

    PMID: 32366351BACKGROUND
  • Bonanno GA. Loss, trauma, and human resilience: have we underestimated the human capacity to thrive after extremely aversive events? Am Psychol. 2004 Jan;59(1):20-8. doi: 10.1037/0003-066X.59.1.20.

    PMID: 14736317BACKGROUND
  • Baddeley A. The episodic buffer: a new component of working memory? Trends Cogn Sci. 2000 Nov 1;4(11):417-423. doi: 10.1016/s1364-6613(00)01538-2.

    PMID: 11058819BACKGROUND
  • Baddeley, A. and Hitch, G. J. (1974). Working memory. Psychology of Learning and Motivation, 47-89.

    BACKGROUND
  • Yıldız, D. (2014). Geçerlik ve güvenirlik çalışmaları. In A. Öztürk (Ed.), Psikolojik Değerlendirme Araçları (pp. 240-260). Nobel Yayıncılık.

    BACKGROUND
  • Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.

    PMID: 3397865BACKGROUND
  • Ulukal, M., Demir, F., & Yalçın, M. (2013). Çocukluk Çağı Olumsuz Yaşantılar Ölçeği'nin Türkçe uyarlaması. [Bildiri/rapor].

    BACKGROUND
  • Spielberger, C. D., Gorsuch, R. L.,& Lushene, R. E.(1970). Manual for the State-Trait Anxiety Inventory. Consulting Psychologists Press.

    BACKGROUND
  • Kart, A., & Türkçapar, H. (2014). Beden Duyumları Ölçeği Türkçe formunun geçerlilik ve güvenilirlik çalışması. Klinik Psikiyatri Dergisi, 17(suppl 1), 28-37.

    BACKGROUND
  • Julious, S. A. (2005). Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical Statistics, 4(4), 287-291. https://doi.org/10.1002/pst.185

    BACKGROUND
  • Horowitz M, Wilner N, Alvarez W. Impact of Event Scale: a measure of subjective stress. Psychosom Med. 1979 May;41(3):209-18. doi: 10.1097/00006842-197905000-00004.

    PMID: 472086BACKGROUND
  • Hertzog MA. Considerations in determining sample size for pilot studies. Res Nurs Health. 2008 Apr;31(2):180-91. doi: 10.1002/nur.20247.

    PMID: 18183564BACKGROUND
  • Gündüz, A., Yaşar, A. B., Gündoğmuş, İ., Savran, C., & Konuk, E. (2018). Çocukluk Çağı Olumsuz Yaşantılar Ölçeği Türkçe Formunun geçerlilik ve güvenilirlik çalışması. Anadolu Psikiyatri Dergisi, 19(Özel sayı 1), 68-75.

    BACKGROUND
  • Gençöz, T. (2000).Pozitif ve Negatif Duygu Ölçeği: Geçerlik ve güvenirlik çalışması. Türk Psikoloji Dergisi, 15(46), 19-26.

    BACKGROUND
  • Felitti VJ, Anda RF, Nordenberg D, Williamson DF, Spitz AM, Edwards V, Koss MP, Marks JS. Relationship of childhood abuse and household dysfunction to many of the leading causes of death in adults. The Adverse Childhood Experiences (ACE) Study. Am J Prev Med. 1998 May;14(4):245-58. doi: 10.1016/s0749-3797(98)00017-8.

    PMID: 9635069BACKGROUND
  • Çorapçıoğlu, A., Yargıç, İ., Geyran, P., & Kocabaşoğlu, N. (2006). Olayların Etkisi Ölçeği'nin (IES-R) Türkçe sürümünün geçerlilik ve güvenilirliği. Yeni Symposium, 44(1), 14-22.

    BACKGROUND
  • Creamer M, Bell R, Failla S. Psychometric properties of the Impact of Event Scale - Revised. Behav Res Ther. 2003 Dec;41(12):1489-96. doi: 10.1016/j.brat.2003.07.010.

    PMID: 14705607BACKGROUND
  • Beck JG, Grant DM, Read JP, Clapp JD, Coffey SF, Miller LM, Palyo SA. The impact of event scale-revised: psychometric properties in a sample of motor vehicle accident survivors. J Anxiety Disord. 2008;22(2):187-98. doi: 10.1016/j.janxdis.2007.02.007. Epub 2007 Feb 24.

    PMID: 17369016BACKGROUND

MeSH Terms

Conditions

Trauma and Stressor Related DisordersProlonged Grief DisorderStress Disorders, Post-TraumaticWounds and Injuries

Condition Hierarchy (Ancestors)

Mental DisordersStress Disorders, Traumatic

Study Officials

  • Zahide B. Baydar, Clinical Psychologist (Msc.)

    Istanbul Rumeli University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study is a three-arm pilot randomized controlled trial consisting of an intervention group, a control group, and a waiting-list group.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Psychologist

Study Record Dates

First Submitted

January 1, 2026

First Posted

January 22, 2026

Study Start

March 5, 2025

Primary Completion

June 11, 2025

Study Completion

July 11, 2025

Last Updated

February 25, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

The datasets generated and analyzed during the current study are not publicly available due to participant confidentiality and ethical restrictions established in the informed consent agreement. However, de-identified data may be made available from the corresponding author (\[Z.B.B\]) upon reasonable request for scientific purposes.

Locations