- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07360990
Effectiveness of a Brief Psychological Intervention (P-CRP) for Complex Trauma and Loss (P-CRP)
February 23, 2026 updated by: Zahide Betül Baydar
First Pilot RCT of Episodic-Buffer-Oriented P-CRP for Adults Complex Loss and Trauma
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
43
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Istanbul
-
Istanbul, Istanbul, Turkey (Türkiye), 34876
- Zahide Betül Baydar
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Individuals were excluded if they had:
- An Adverse Childhood Experiences (ACE) score greater than 7.
- A history of psychotic disorder or bipolar disorder.
- Current suicide risk.
- Substance use disorder.
- Prior therapeutic contact with the researcher.
- A target traumatic event that had occurred more than one year earlier.
- Not meeting clinical DSM-5 criteria for PTSD during the clinician-administered semi-structured interview, regardless of initial self-report scores.
- Current participation in any other form of psychotherapy or psychiatric intervention.
Individuals were included if they had:
- Meeting DSM-5 criteria for PTSD symptoms (verified by IES-R scores and clinician-led semi-structured interview).
- Having experienced a target traumatic event or loss within the past 12 months.
- Willingness to provide informed consent and participate in all intervention sessions.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Psychological-cognitive reprocessing procedure (P-CRP).
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.
|
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.
|
|
Active Comparator: Expressive Narrative and Symbolic Drawing (ENSD)
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.
|
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.
|
|
No Intervention: Waitlist Group
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Impact of Event Scale -Revised (IES-R)
Time Frame: Baseline (Week 0), Post-intervention (Week 6), and Follow-up (Week 10) .
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
State-Trait Anxiety Inventory (STAI).
Time Frame: Baseline (Week 0), Post-intervention (Week 6), and Follow-up (Week 10)
|
At the beginning of the scale, four demographic questions are included (name, gender, age, and occupation).
The instrument uses a four-point Likert-type response format.
The State Anxiety subscale consists of 20 items rated on a scale from (1) Not at all to (4) Very much so.
The Trait Anxiety subscale also contains 20 items, with response options ranging from (1) Almost never to (4) Almost always.
Cronbach's alpha coefficients reported in the Turkish adaptation were α = .72
for the State Anxiety subscale, α = .67
for the Trait Anxiety subscale, and α = .70
for the total scale; overall reliability values for the instrument have been reported to fall between α = .60
and α = .80.
|
Baseline (Week 0), Post-intervention (Week 6), and Follow-up (Week 10)
|
|
The Body Sensations Questionnaire (BSQ).
Time Frame: Baseline (Week 0), Post-intervention (Week 6), and Follow-up (Week 10)
|
It is a 17-item self-report measure assessing fear of bodily sensations associated with arousal and panic.
Cronbach's alpha for the scale is reported as .92; in the current study, internal consistency was α = .93.
|
Baseline (Week 0), Post-intervention (Week 6), and Follow-up (Week 10)
|
|
The Positive and Negative Affect Schedule (PANAS)
Time Frame: Baseline (Week 0), Post-intervention (Week 6), and Follow-up (Week 10)
|
Scale is a 20-item scale consisting of 10 positive and 10 negative affect items.
In the present study, Cronbach's alpha coefficients were α = .86
for Positive Affect and α = .82
for Negative Affect.
|
Baseline (Week 0), Post-intervention (Week 6), and Follow-up (Week 10)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Zahide B. Baydar, Clinical Psychologist (Msc.), Istanbul Rumeli University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- Hertzog MA. Considerations in determining sample size for pilot studies. Res Nurs Health. 2008 Apr;31(2):180-91. doi: 10.1002/nur.20247.
- 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
- Foa EB, Kozak MJ. Emotional processing of fear: exposure to corrective information. Psychol Bull. 1986 Jan;99(1):20-35. No abstract available.
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
- Edwards, B. (1989). Drawing on the right side of the brain. New York: Jeremy P. Tarcher/Putnam.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Baddeley, A. and Hitch, G. J. (1974). Working memory. Psychology of Learning and Motivation, 47-89.
- Yıldız, D. (2014). Geçerlik ve güvenirlik çalışmaları. In A. Öztürk (Ed.), Psikolojik Değerlendirme Araçları (pp. 240-260). Nobel Yayıncılık.
- Ulukal, M., Demir, F., & Yalçın, M. (2013). Çocukluk Çağı Olumsuz Yaşantılar Ölçeği'nin Türkçe uyarlaması. [Bildiri/rapor].
- Spielberger, C. D., Gorsuch, R. L.,& Lushene, R. E.(1970). Manual for the State-Trait Anxiety Inventory. Consulting Psychologists Press.
- Kart, A., & Türkçapar, H. (2014). Beden Duyumları Ölçeği Türkçe formunun geçerlilik ve güvenilirlik çalışması. Klinik Psikiyatri Dergisi, 17(suppl 1), 28-37.
- 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.
- Gençöz, T. (2000).Pozitif ve Negatif Duygu Ölçeği: Geçerlik ve güvenirlik çalışması. Türk Psikoloji Dergisi, 15(46), 19-26.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 5, 2025
Primary Completion (Actual)
June 11, 2025
Study Completion (Actual)
July 11, 2025
Study Registration Dates
First Submitted
January 1, 2026
First Submitted That Met QC Criteria
January 14, 2026
First Posted (Actual)
January 22, 2026
Study Record Updates
Last Update Posted (Actual)
February 25, 2026
Last Update Submitted That Met QC Criteria
February 23, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-53938333-050-50007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Trauma and Stress Related Disorders
-
St. Joseph's Healthcare HamiltonNot yet recruitingChildbirth-Related Posttraumatic Stress Disorder | Childbirth-related TraumaCanada
-
Irma FlemingUniversity of UtahNot yet recruitingPTSD and Trauma-related SymptomsUnited States
-
Laureate Institute for Brain Research, Inc.Recruiting
-
Health Sciences North Research InstituteNorth Shore Tribal CouncilCompletedSubstance Use Disorders | Post-Traumatic Stress Disorder | Intergenerational TraumaCanada
-
Vestre Viken Hospital TrustNot yet recruitingStress Disorders, Traumatic | Psychological Trauma | Sexual Trauma | Stress Disorders, Post-Traumatic; Mental DisordersNorway
-
Emory UniversityNational Institute of Mental Health (NIMH)Not yet recruiting
-
Kuopio University HospitalUniversity of Eastern FinlandNot yet recruitingStress Disorders, Post-TraumaticFinland
-
Anthony VescoNorthwestern University Feinberg School of Medicine; Substance Abuse and Mental...Not yet recruitingPosttraumatic Stress Disorders | Trauma | Posttraumatic Stress Symptoms | Chronic Medical Conditions | Chronic Medical Illness | Trauma Exposure | Chronic Medical Condition | Posttraumatic Stress | Posttraumatic Stress Disorder PTSD | Mental Health Functioning | Trauma and Stressor Related DisorderUnited States
-
Medical University of South CarolinaNational Institute of Mental Health (NIMH)Not yet recruitingTrauma Exposure | Posttraumatic Stress Disorder (PTSD)United States
-
The University of Texas Health Science Center,...Baylor College of Medicine; University of South Florida; University of Houston; Texas Child Mental Health Care ConsortiumNot yet recruitingTrauma | Posttraumatic Stress DisorderUnited States
Clinical Trials on Psychological-cognitive reprocessing procedure (P-CRP).
-
Children's Oncology GroupActive, not recruitingCentral Nervous System CarcinomaUnited States, Puerto Rico