Trial · NCT07904000
Written Exposure Therapy Plus Adjunctive Methylphenidate Treatment for Veterans With PTSD
NCT07904000, Phase 2, Not yet recruiting, VA Office of Research and Development
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Written Exposure Therapy Plus Adjunctive Methylphenidate Treatment for Veterans With PTSD. Trials, record NCT07904000. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07904000
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Written Exposure Therapy Plus Adjunctive Methylphenidate Treatment for Veterans With PTSD
- NCT number
- NCT07904000
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 138 participants, estimated
- Lead sponsor
- VA Office of Research and Development
- Conditions
- PTSD - Post Traumatic Stress Disorder
- Interventions
- Written Exposure Therapy (WET), methylphenidate (MPH), placebo (PBO)
- First posted
- 2026-10-29
- Last updated
- 2026-10-29
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) | Change from pre-treatment to 4-weeks post-treatment | Post-traumatic stress disorder (PTSD) symptom severity will be measured via the diagnostic interview, the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), where the CAPS-5 score range = 0 - 80. Higher scores = more severe PTSD symptoms. |
| Secondary | Adverse Event Checklist (AE Checklist) | The Modified-FIBSER is collected at every WET session (sessions 1-5), over a timeframe of up to 10 weeks | The Adverse Event Checklist (AE Checklist) is a list of standard complaints that includes frequent side effects of methylphenidate. The AE Checklist will be used to guide evaluation of adverse events and to help determine AE occurrence, AE-related medication dose adjustments, AE-related medication discontinuation, or AE-related study withdrawal. Greater number of items endorsed = greater occurrence of adverse events. |
| Secondary | Modified Frequency, Intensity, and Burden of Side Effects Rating (FIBSER) Scale | The Modified-FIBSER is collected at every WET session (sessions 1-5), over a timeframe of up to 10 weeks | Self-rated severity of within session side effects as measured by a Modified Frequency, Intensity, and Burden of Side Effects Rating (FIBSER) Scale . The FIBSER scale is a self-report measure providing 3 global ratings of frequency, intensity, and burden to assess side effects of pharmacotherapy. The scale was modified to measure perceived within-session medication side-effects and the degree to which they interfere with Written Exposure Therapy session goals. The M-FIBSER will be used to guide evaluation of side effects and to help determine study medication tolerability. The M-FIBSER score has three items ranging 0 - 6. Higher scores = more severe frequent/severe/or burdensome side effects. |
| Secondary | Fear Extinction learning | Change from pre-treatment to 4-weeks post-treatment | Fear potentiated startle is a behavioral indicator of conditioned fear responses, collected during extinction, measured using eyeblink electromyogram (EMG) response. Extinction learning (change in response to conditioned fear cue) as measured by EMG during extinction training session is the secondary outcome measure. EMG responses are measured as arbitrary digital units 0-4095 AU (0.5 mV input unit=2500 mV output unit). |
| Other | Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) | Change from pre-treatment to 20-weeks post-treatment | Post-traumatic stress disorder (PTSD) symptom severity will be measured via the diagnostic interview, the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), where the CAPS-5 score range = 0 - 80. Higher scores = more severe PTSD symptoms. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07904000
GET https://conductscience.org/api/trials/v1/NCT07904000/registered