An interventional study of Behavioral: Cognitive Processing Therapy (individual) and Magnetoencephalography (MEG) in Trauma, Psychological and Traumatic Stress Disorder, sponsored by Universidad Complutense de Madrid. Not yet recruiting at 2 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Universidad Complutense de Madrid · Not applicable, Interventional, and Treatment
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.
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).
144 studies on the registry are indexed under Psychological Trauma; 41 are open to participants now.
This study's planned enrollment of 10 is below the median of 80 across 109 interventional studies indexed under Psychological Trauma.
Browse Psychological Trauma studies →Universidad Complutense de Madrid is the lead sponsor of 206 studies on the registry; 64 are open to participants now.
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Participants receive 12 weekly individual sessions of CPT and undergo MEG and clinical assessment before and after treatment.
Behavioral: Behavioral: Cognitive Processing Therapy (individual) · Diagnostic Test: Magnetoencephalography (MEG)
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
Feasibility of integrating MEG into CPT
Proportion of enrolled participants who complete the 12 sessions and both MEG recordings
Time frame: 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
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.
Time frame: 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
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.
Time frame: Baseline and end of treatment (week 12)
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).
Time frame: Baseline, at the beginning of each session, and end of treatment (week 12)
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).
Time frame: Baseline and end of treatment (week 12)
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).
Time frame: Baseline and end of treatment (week 12)
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).
Time frame: Baseline and end of treatment (week 12)
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).
Time frame: Baseline and end of treatment (week 12)
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.
Time frame: Baseline and end of treatment (week 12)
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.
Time frame: Baseline and end of treatment (week 12)
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).
Time frame: Immediately after the intervention (week 12)
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).
Time frame: Baseline to post-treatment (about 12 weeks)
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).
Time frame: Baseline, at the beginning of each session, and end of treatment (week 12)
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