AzTrials
AzTrials

Trauma, PsychologicalREC-HEALING-TRNCT07917377

Magnetoencephalographic Correlates of Clinical Change After Cognitive Processing Therapy in Adults With PTSD

A study testing Behavioral: Cognitive Processing Therapy (individual) and Magnetoencephalography (MEG) in people with Trauma, Psychological and Traumatic Stress Disorder, run by Universidad Complutense de Madrid at 2 sites in Spain.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Behavioral: Cognitive Processing Therapy (individual) and Magnetoencephalography (MEG)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
2 sitesSpain
Study dates
15 Jan 2027to 15 Jul 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years.
  • Exposure to at least one traumatic event.
  • Active posttraumatic symptoms derived from that event (PCL-5 score above cut-off >= 30).

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Almudena Trucharte Martínez, Post-doc contact

+34 680 19 61 23

a.trucharte@sheffield.ac.uk

Javier Galgo Bendito, PhD student contact

+34608011034

jgalgo@ucm.es

Spain2 sites
  • Centro de Neurociencia Cognitiva y Computacional (C3N) ; Clínica Universitaria de Psicología (CUP-UCM)

    Pozuelo de Alarcón, Madrid, 28223

    Carmen Valiente Ots, PhD, +34913943135, mcvalien@ucm.es

  • Clínica Universitaria de Psicología de la UCM

    Pozuelo de Alarcón, Madrid, 28223

    Carmen Valiente Ots, PhD, +34913943135, mcvalien@ucm.es

    Javier Galgo Bendito, PhD Student, +34 608011034, jgalgo@ucm.es

Other trials in Spain

About this study

Official title: 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.

Read the detailed description

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).

Being tested
Behavioral: Cognitive Processing Therapy (individual), Magnetoencephalography (MEG)
Keywords
trauma, Traumatic Stress Disorder, Cognitive Processing Therapy, Magnetoencephalography, Mechanisms of change, Functional connectivity, Proof of concept
Medical subject headings
Psychological Trauma, Stress Disorders, Traumatic, Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Behavioral: Cognitive Processing Therapy (individual)Behavioural

    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.

  • Magnetoencephalography (MEG)Diagnostic test

    Recording at C3N-UCM before and after the intervention

Study groups in NCT07917377
Study groupRoleWhat they receive
Individual CPT with pre/post MEGExperimentalParticipants receive 12 weekly individual sessions of CPT and undergo MEG and clinical assessment before and after treatment.
Receives: Behavioral: Behavioral: Cognitive Processing Therapy (individual); Diagnostic Test: Magnetoencephalography (MEG)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of integrating MEG into CPT

    Proportion of enrolled participants who complete the 12 sessions and both MEG recordings

    Measured: Baseline and end of treatment (week 12)

  2. Change in MEG Source-Space Functional Connectivity of Cognitive-Control and Autobiographical-Memory Networks During a Trauma Memory Cue Task at 12 weeks

    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.

    Measured: Baseline and end of treatment (week 12)

  3. Change in MEG Resting-State Source-Space Functional Connectivity of Cognitive-Control and Autobiographical-Memory Networks (Eyes-Open and Eyes-Closed) at 12 weeks

    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.

    Measured: Baseline and end of treatment (week 12)

Secondary outcomes (10)
  1. Change in PTSD/CPTSD symptoms (I) at 12 weeks

    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).

    Measured: Baseline, at the beginning of each session, and end of treatment (week 12)

  2. Change in PTSD/CPTSD symptoms (II) at 12 weeks

    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).

    Measured: Baseline and end of treatment (week 12)

  3. Change from psychopathological symptoms at 12 weeks

    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).

    Measured: Baseline and end of treatment (week 12)

  4. Change from Well-being at 12 weeks

    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).

    Measured: Baseline and end of treatment (week 12)

  5. Change from Satisfaction with life at 12 weeks

    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).

    Measured: Baseline and end of treatment (week 12)

  6. Change from Emotion Regulation at 12 weeks

    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.

    Measured: Baseline and end of treatment (week 12)

  7. Change from Self-care at 12 weeks

    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.

    Measured: Baseline and end of treatment (week 12)

  8. Client Satisfaction Questionnaire

    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).

    Measured: Immediately after the intervention (week 12)

  9. Change in neurophysiological measures at 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).

    Measured: Baseline to post-treatment (about 12 weeks)

  10. Change from depression at 12 weeks

    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).

    Measured: Baseline, at the beginning of each session, and end of treatment (week 12)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2026
  2. Study start15 Jan 2027 (estimated)
  3. Primary completion15 Jan 2028 (estimated)
  4. Study completion15 Jul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
All participants will receive the same 12 weekly CPT individual sessions. Assessments will be conducted before and after the intervention, with no concurrent comparator group.
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07917377
Sponsor's protocol ID
REC-HT-2026
Acronym
REC-HEALING-TR
Status last verified
Oct 2026
First submitted
28 Oct 2026
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Behavioral: Cognitive Processing Therapy (individual) and Magnetoencephalography (MEG) in people with Trauma, Psychological and Traumatic Stress Disorder, run by Universidad Complutense de Madrid at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Almudena Trucharte Martínez, Post-doc (+34 680 19 61 23, a.trucharte@sheffield.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of integrating MEG into CPT (time frame: Baseline and end of treatment (week 12)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in