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Magnetoencephalographic Correlates of Clinical Change After Cognitive Processing Therapy in Adults With PTSD (REC-HEALING-TR)

3. November 2026 aktualisiert von: Carmen Valiente Ots, Universidad Complutense de Madrid

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.

Studienübersicht

Detaillierte Beschreibung

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).

Studientyp

Interventionell

Einschreibung (Geschätzt)

10

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

  • Name: Javier Galgo Bendito, PhD student
  • Telefonnummer: +34608011034
  • E-Mail: jgalgo@ucm.es

Studienorte

    • Madrid
      • Pozuelo de Alarcón, Madrid, Spanien, 28223
        • Centro de Neurociencia Cognitiva y Computacional (C3N) ; Clínica Universitaria de Psicología (CUP-UCM)
        • Kontakt:
          • Carmen Valiente Ots, PhD
          • Telefonnummer: +34913943135
          • E-Mail: mcvalien@ucm.es
      • Pozuelo de Alarcón, Madrid, Spanien, 28223
        • Clínica Universitaria de Psicología de la UCM
        • Kontakt:
          • Carmen Valiente Ots, PhD
          • Telefonnummer: +34913943135
          • E-Mail: mcvalien@ucm.es
        • Kontakt:
          • Javier Galgo Bendito, PhD Student
          • Telefonnummer: +34 608011034
          • E-Mail: jgalgo@ucm.es

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Feasibility of integrating MEG into CPT
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in PTSD/CPTSD symptoms (I) at 12 weeks
Zeitfenster: Baseline, at the beginning of each session, and end of treatment (week 12)

PTSD Checklist for DSM-5 (PCL-5; Weathers et al., 2013).

  • 20 items rated from 0 (not at all) to 4 (extremely). Total score ranges from 0 to 80.
  • Higher scores indicate a worse outcome (more severe symptoms).
Baseline, at the beginning of each session, and end of treatment (week 12)
Change in PTSD/CPTSD symptoms (II) at 12 weeks
Zeitfenster: Baseline and end of treatment (week 12)

International Trauma Questionnaire (ITQ; Cloitre et al., 2018).

  • 12 symptom items (6 PTSD, 6 Disturbances in Self-Organization) rated from 0 (not at all) to 4 (extremely). Symptom total score ranges from 0 to 48 (each of the two sets of items from 0 to 24).
  • Higher scores indicate a worse outcome (more severe symptoms).
Baseline and end of treatment (week 12)
Change from psychopathological symptoms at 12 weeks
Zeitfenster: 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).

  • 45 items rated from 0 (not at all) to 4 (a lot). It covers a total of 9 different symptomatic areas (e.g. depression, anxiety, interpersonal sensibility) and gives an overall severity score. Total score ranges from [0 to 180].
  • Higher scores indicate a worse outcome (more severe symptoms).
Baseline and end of treatment (week 12)
Change from Well-being at 12 weeks
Zeitfenster: Baseline and end of treatment (week 12)

Ryff's Scales of Psychological Well-Being (Ryff & Keyes, 1995).

  • 29 items rated from 1 (strongly disagree) to 6 (strongly agree). The SPWB evaluates 6 dimensions of psychological well-being: Self-acceptance, Positive relationships, Autonomy, Environmental mastery, Life purpose, and Personal growth. Scores ranges differ from scale to scale:
  • Self-acceptance [4-24]
  • Positive relationships [5-30]
  • Autonomy [6-36]
  • Environmental mastery [5-30]
  • Life purpose [4-24]
  • Personal growth [5-30]
  • Higher scores indicate a better outcome (more psychological wellbeing).
Baseline and end of treatment (week 12)
Change from Satisfaction with life at 12 weeks
Zeitfenster: Baseline and end of treatment (week 12)

Satisfaction with Life Scale (SWLS; Diener et al., 1985).

  • 5 items rated from 1 (strongly disagree) to 7 (strongly agree). Total score ranges from 5 to 35.
  • Higher scores indicate a better outcome (more satisfaction with life).
Baseline and end of treatment (week 12)
Change from Emotion Regulation at 12 weeks
Zeitfenster: Baseline and end of treatment (week 12)

Cognitive Emotion Regulation Questionnaire-short (CERQ-short; Garnefski & Kraaij, 2007).

  • 18 items rated from 1 (almost never) to 5 (almost always). The CERQ-short evaluates 9 dimensions (composed by 2 items each): Self-blame, Acceptance, Rumination, Positive refocusing, Refocus on planning, Positive reappraisal, Putting into perspectiva, Catastrophizing, and Other-blame. Each dimension ranges from 5 to 10. Also, two big dimensions are calculated depending on the type of strategy:
  • Sum of the adaptive subscales (acceptance, positive refocusing, refocus on planning, positive reappraisal, putting into perspective; 10 items) ranges from 10 to 50. Higher scores indicate a better outcome.
  • Sum of the maladaptive subscales (self-blame, rumination, catastrophizing, other-blame; 8 items) ranges from 8 to 40. Higher scores indicate a worse outcome.
Baseline and end of treatment (week 12)
Change from Self-care at 12 weeks
Zeitfenster: Baseline and end of treatment (week 12)

Self-Care Scale (Spanish instrument; "Escala de autocuidado", Gonzalez et al., 2017),

  • 31 items rated from 1 (completely disagre) to 7 (completely agree). The scale evaluates dimensions: Self-destructive behaviors, Non-tolerance towards positive affect, Issues accepting help, Resentment due to non-reciprocity, No positive activities, and None attendace towards personal needs.
  • Higher scores indicate worse self-care.
Baseline and end of treatment (week 12)
Client Satisfaction Questionnaire
Zeitfenster: 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
Zeitfenster: 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)
Change from depression at 12 weeks
Zeitfenster: Baseline, at the beginning of each session, and end of treatment (week 12)

Patient Health Questionnaire-9 (PHQ-9; Kroenke et al., 2001).

  • 9 items rated from 0 (not at all) to 3 (nearly every day). Total score ranges from 0 to 27.
  • Higher scores indicate a worse outcome (more severe symptoms).
Baseline, at the beginning of each session, and end of treatment (week 12)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

15. Januar 2027

Primärer Abschluss (Geschätzt)

15. Januar 2028

Studienabschluss (Geschätzt)

15. Juli 2028

Studienanmeldedaten

Zuerst eingereicht

28. Oktober 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

3. November 2026

Zuerst gepostet (Tatsächlich)

4. November 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

4. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

3. November 2026

Zuletzt verifiziert

1. Oktober 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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