- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07917377
Magnetoencephalographic Correlates of Clinical Change After Cognitive Processing Therapy in Adults With PTSD (REC-HEALING-TR)
REC-Healing Trauma: Clinical and Neurophysiological Mechanisms of Change in Cognitive Processing Therapy for Posttraumatic Stress Disorder. A Single-Arm Proof-of-Concept Pilot Study Using Magnetoencephalography
Cognitive Processing Therapy (CPT) is a first-line, evidence-based trauma-focused treatment for posttraumatic stress disorder (PTSD), but the clinical and neurophysiological mechanisms underlying therapeutic response remain poorly understood. This single-arm proof-of-concept pilot study will recruit 10 adults with active posttraumatic symptoms who will receive a 12-session 60 minutes individual CPT protocol. Before and after treatment, participants will undergo a clinical assessment and a magnetoencephalography (MEG) recording at the Center for Computational Cognitive Neuroscience (C3N-UCM). The study will test the feasibility of integrating MEG into a therapeutic process and explore whether changes in brain dynamics, particularly connectivity of cognitive-control and autobiographical-memory networks, are associated with clinical improvement.
Przegląd badań
Status
Szczegółowy opis
Background: PTSD affects around 3.9% of the world population and is associated with impaired emotion regulation, interpersonal functioning and quality of life. CPT is recommended by major guidelines as a first-line treatment for PTSD (APA 2017, NICE 2018, WHO 2024, VA/DoD 2023). Its authors propose a neurobiological hypothesis in which PTSD involves amygdala hyperactivity and reduced frontal cortex activation, and in which the use of language during therapy would increase prefrontal activity while, simultaneously, reducing amygdala activity. To our knowledge, no study has examined the neurophysiological correlates of clinical improvement after CPT, whereas preliminary small studies exist for EMDR.
Design: Single-arm, quasi-experimental proof-of-concept pilot with pre- and post-treatment assessments.
Participants: Adults (≥ 18 years) with active PTSD symptoms who have been exposed to at least one traumatic event, attended at the University Psychology Clinic of the Universidad Complutense de Madrid (CUP-UCM) or referred to it by other social and health services. Target N = 10.
Intervention: A Spanish-adapted CPT protocol of 12 weekly individual 60-minute sessions in two phases: (1) worksheets and weekly assignments based on cognitive therapy, with psychoeducation, cognitive restructuring and Socratic dialogue; (2) continued work on five themes commonly affected by trauma: safety, trust, power/control, esteem and intimacy.
Assessment: Pre- and post-treatment (1) clinical assessment with a battery of psychometric instruments validated in Spanish; and (2) MEG recording at the Centro de Neurociencia Cognitiva y Computacional (C3N-UCM). Neurophysiological changes will then be correlated with clinical changes.
Context: The team has previous successful experience recruiting, delivering and assessing trauma-focused therapy in PTSD populations (Spanish Ministry of Science, Innovation and Universities grant PID2020-115003RB-I00).
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Almudena Trucharte Martínez, Post-doc
- Numer telefonu: +34 680 19 61 23
- E-mail: a.trucharte@sheffield.ac.uk
Kopia zapasowa kontaktu do badania
- Nazwa: Javier Galgo Bendito, PhD student
- Numer telefonu: +34608011034
- E-mail: jgalgo@ucm.es
Lokalizacje studiów
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Madrid
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Pozuelo de Alarcón, Madrid, Hiszpania, 28223
- Centro de Neurociencia Cognitiva y Computacional (C3N) ; Clínica Universitaria de Psicología (CUP-UCM)
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Kontakt:
- Carmen Valiente Ots, PhD
- Numer telefonu: +34913943135
- E-mail: mcvalien@ucm.es
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Pozuelo de Alarcón, Madrid, Hiszpania, 28223
- Clínica Universitaria de Psicología de la UCM
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Kontakt:
- Carmen Valiente Ots, PhD
- Numer telefonu: +34913943135
- E-mail: mcvalien@ucm.es
-
Kontakt:
- Javier Galgo Bendito, PhD Student
- Numer telefonu: +34 608011034
- E-mail: jgalgo@ucm.es
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Age ≥ 18 years.
- Exposure to at least one traumatic event.
- Active posttraumatic symptoms derived from that event (PCL-5 score above cut-off >= 30).
Exclusion Criteria
- Active suicidal ideation at assessment (PHQ-9 item 9 and clinical judgment).
- Substance dependence.
- Severe cognitive impairment.
- Concurrent trauma-focused individual or group psychotherapy (e.g., Prolonged Exposure, EMDR, CPT).
- Contraindications for MEG: Metallic implants or active devices; claustrophobia.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Individual CPT with pre/post MEG
Participants receive 12 weekly individual sessions of CPT and undergo MEG and clinical assessment before and after treatment. |
12 weekly 60-minute sessions; Spanish-adapted protocol based on Resick, Monson & Chard (2017); psychoeducation, cognitive restructuring, Socratic dialogue, weekly assignments; five themes: safety, trust, power/control, esteem and intimacy. Recording at C3N-UCM before and after the intervention |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Feasibility of integrating MEG into CPT
Ramy czasowe: Baseline and end of treatment (week 12)
|
Proportion of enrolled participants who complete the 12 sessions and both MEG recordings |
Baseline and end of treatment (week 12)
|
|
Change in MEG Source-Space Functional Connectivity of Cognitive-Control and Autobiographical-Memory Networks During a Trauma Memory Cue Task at 12 weeks
Ramy czasowe: Baseline and end of treatment (week 12)
|
Magnetoencephalography (MEG) will be recorded while participants perform a trauma memory cue task, adapted for MEG from the script-driven procedure used in the STAR mechanism study (Lanius et al., 2003; Whalley et al., 2013). Participants view personalised cues related to their trauma memory, contrasted with comparison cues. Functional connectivity (phase synchronisation between source-reconstructed regions of the cognitive-control and autobiographical-memory networks) will be estimated across canonical frequency bands. As this is the first MEG adaptation of the paradigm, the connectivity metric and bands are exploratory, with correction for multiple comparisons. The outcome is the change from baseline to week 12 in connectivity for the trauma versus comparison contrast. |
Baseline and end of treatment (week 12)
|
|
Change in MEG Resting-State Source-Space Functional Connectivity of Cognitive-Control and Autobiographical-Memory Networks (Eyes-Open and Eyes-Closed) at 12 weeks
Ramy czasowe: Baseline and end of treatment (week 12)
|
MEG will be recorded during eyes-open and eyes-closed resting-state conditions. Functional connectivity (phase synchronisation between source-reconstructed regions of the cognitive-control and autobiographical-memory networks) will be estimated across canonical frequency bands, separately for each condition. The connectivity metric and bands are exploratory, with correction for multiple comparisons. The outcome is the change from baseline to week 12. |
Baseline and end of treatment (week 12)
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in PTSD/CPTSD symptoms (I) at 12 weeks
Ramy czasowe: Baseline, at the beginning of each session, and end of treatment (week 12)
|
PTSD Checklist for DSM-5 (PCL-5; Weathers et al., 2013).
|
Baseline, at the beginning of each session, and end of treatment (week 12)
|
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Change in PTSD/CPTSD symptoms (II) at 12 weeks
Ramy czasowe: Baseline and end of treatment (week 12)
|
International Trauma Questionnaire (ITQ; Cloitre et al., 2018).
|
Baseline and end of treatment (week 12)
|
|
Change from psychopathological symptoms at 12 weeks
Ramy czasowe: Baseline and end of treatment (week 12)
|
Symptom Assessment-45 Questionnaire (SA-45; Davison et al., 1997), a brief version of the Symptom Checklist-90-Revised (SCL-90-R).
|
Baseline and end of treatment (week 12)
|
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Change from Well-being at 12 weeks
Ramy czasowe: Baseline and end of treatment (week 12)
|
Ryff's Scales of Psychological Well-Being (Ryff & Keyes, 1995).
|
Baseline and end of treatment (week 12)
|
|
Change from Satisfaction with life at 12 weeks
Ramy czasowe: Baseline and end of treatment (week 12)
|
Satisfaction with Life Scale (SWLS; Diener et al., 1985).
|
Baseline and end of treatment (week 12)
|
|
Change from Emotion Regulation at 12 weeks
Ramy czasowe: Baseline and end of treatment (week 12)
|
Cognitive Emotion Regulation Questionnaire-short (CERQ-short; Garnefski & Kraaij, 2007).
|
Baseline and end of treatment (week 12)
|
|
Change from Self-care at 12 weeks
Ramy czasowe: Baseline and end of treatment (week 12)
|
Self-Care Scale (Spanish instrument; "Escala de autocuidado", Gonzalez et al., 2017),
|
Baseline and end of treatment (week 12)
|
|
Client Satisfaction Questionnaire
Ramy czasowe: Immediately after the intervention (week 12)
|
Acceptability will be assessed after the intervention using a participant satisfaction questionnaire (CSQ-8). The questionnaire will evaluate participants' perceived usefulness, relevance, comprehensibility, and overall satisfaction with the intervention. 8 items rated from 1 to 4. Total score ranges from 8 to 32. Higher scores indicate greater satisfaction and acceptability (better outcome). |
Immediately after the intervention (week 12)
|
|
Change in neurophysiological measures at 12 weeks
Ramy czasowe: Baseline to post-treatment (about 12 weeks)
|
Experimental task from the STAR trial, adapted to MEG. This task is designed to activate trauma-related autobiographical memories and contrast them with neutral memories. This paradigm probes how traumatic experiences are represented and contextualized in the brain. It has been adapted from previously validated script-driven trauma memory procedures used in neuroimaging studies of PTSD, which have consistently demonstrated sensitivity to trauma recall and associated neural responses (e.g., Lanius et al., 2003: Whalley et al., 2013). |
Baseline to post-treatment (about 12 weeks)
|
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Change from depression at 12 weeks
Ramy czasowe: Baseline, at the beginning of each session, and end of treatment (week 12)
|
Patient Health Questionnaire-9 (PHQ-9; Kroenke et al., 2001).
|
Baseline, at the beginning of each session, and end of treatment (week 12)
|
Współpracownicy i badacze
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- REC-HT-2026
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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