Magnetoencephalographic Correlates of Clinical Change After Cognitive Processing Therapy in Adults With PTSD
NCT07917377, Not applicable, Not yet recruiting, Universidad Complutense de Madrid
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Magnetoencephalographic Correlates of Clinical Change After Cognitive Processing Therapy in Adults With PTSD | ClinicalTrials.gov |
| NCT number | NCT07917377 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 10 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Universidad Complutense de Madrid | ClinicalTrials.gov |
| Conditions | Trauma, Psychological, Traumatic Stress Disorder | ClinicalTrials.gov |
| Interventions | Behavioral: Cognitive Processing Therapy (individual), Magnetoencephalography (MEG) | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Feasibility of integrating MEG into CPT | Baseline and end of treatment (week 12) | Proportion of enrolled participants who complete the 12 sessions and both MEG recordings | ClinicalTrials.gov |
| Primary | Change in MEG Source-Space Functional Connectivity of Cognitive-Control and Autobiographical-Memory Networks During a Trauma Memory Cue Task at 12 weeks | 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. | ClinicalTrials.gov |
| Primary | Change in MEG Resting-State Source-Space Functional Connectivity of Cognitive-Control and Autobiographical-Memory Networks (Eyes-Open and Eyes-Closed) at 12 weeks | 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. | ClinicalTrials.gov |
| Secondary | Change in PTSD/CPTSD symptoms (I) at 12 weeks | 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). | ClinicalTrials.gov |
| Secondary | Change in PTSD/CPTSD symptoms (II) at 12 weeks | 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). | ClinicalTrials.gov |
| Secondary | Change from psychopathological symptoms at 12 weeks | 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). | ClinicalTrials.gov |
| Secondary | Change from Well-being at 12 weeks | 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). | ClinicalTrials.gov |
| Secondary | Change from Satisfaction with life at 12 weeks | 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). | ClinicalTrials.gov |
| Secondary | Change from Emotion Regulation at 12 weeks | 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. | ClinicalTrials.gov |
| Secondary | Change from Self-care at 12 weeks | 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. | ClinicalTrials.gov |
| Secondary | Client Satisfaction Questionnaire | 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). | ClinicalTrials.gov |
| Secondary | Change in neurophysiological measures at 12 weeks | 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). | ClinicalTrials.gov |
| Secondary | Change from depression at 12 weeks | 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). | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
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Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
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Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
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Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
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Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
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Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
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Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)