이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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

2026년 11월 3일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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).

연구 유형

중재적

등록 (추정된)

10

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

  • 이름: Javier Galgo Bendito, PhD student
  • 전화번호: +34608011034
  • 이메일: jgalgo@ucm.es

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Feasibility of integrating MEG into CPT
기간: 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
기간: 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
기간: 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)

2차 결과 측정

결과 측정
측정값 설명
기간
Change in PTSD/CPTSD symptoms (I) at 12 weeks
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

협력자

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2027년 1월 15일

기본 완료 (추정된)

2028년 1월 15일

연구 완료 (추정된)

2028년 7월 15일

연구 등록 날짜

최초 제출

2026년 10월 28일

QC 기준을 충족하는 최초 제출

2026년 11월 3일

처음 게시됨 (실제)

2026년 11월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 4일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 3일

마지막으로 확인됨

2026년 10월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • REC-HT-2026

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .