Trial · NCT07563296
KALM-B: Ketamine-assisted Psychotherapy (KAP) to Lessen Morbidity After Burn Injury
NCT07563296, Phase 2, Recruiting, Irma Fleming
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. KALM-B: Ketamine-assisted Psychotherapy (KAP) to Lessen Morbidity After Burn Injury. Trials, record NCT07563296. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07563296
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- KALM-B: Ketamine-assisted Psychotherapy (KAP) to Lessen Morbidity After Burn Injury
- NCT number
- NCT07563296
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 12 participants, estimated
- Lead sponsor
- Irma Fleming
- Conditions
- PTSD and Trauma-related Symptoms
- Interventions
- Preparatory Session, Ketamine-assisted Psychotherapy Session #1, Ketamine-assisted Psychotherapy Session #2, Integration Session
- First posted
- 2026-05-04
- Last updated
- 2026-08-27
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety and Tolerability defined by the number of participants with treatment-related adverse events | From baseline through 6 months post-treatment follow-up (assessments at 1, 3, and 6 months) | Assess the safety and tolerability of KAP in the burn population. Safety and Tolerability will be measure by the frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type, severity (as defined by the NIH CTCAE, version 5.0), seriousness, duration, and relationship to study treatment. |
| Secondary | Feasibility - Recruitment rate | From study opening to completion of recruitment, up to 24 months | The proportion of eligible participants who provided informed consent |
| Secondary | Feasibility - Treatment Completion Rate | From enrollment through completion of all scheduled KAP sessions, assessed up to 12 weeks | Proportion of participants who complete all scheduled KAP sessions. |
| Secondary | Feasibility - Follow-up Completion Rate | From baseline through 6 months post-treatment follow-up (assessments at 1, 3, and 6 months) | Proportion of participants who complete follow-up assessments at 1, 3, and 6 months. |
| Secondary | Timeliness of Intervention Delivery | Baseline (from injury to initiation of treatment; up to 12 months) | Time from injury to initiation of the KAP intervention, defined as the number of days between the date of injury and the date of first KAP session. |
| Secondary | Opioid Use | From baseline through 6 months post-treatment follow-up (assessments at 1, 3, and 6 months) | Total opioid use (MME) at discharge and up to 6 months post-KAP. |
| Secondary | Acute Stress Symptoms based on National Stressful Events Survey Acute Stress Disorder Short Scale (NSESSS) | From baseline through 6 months post-treatment follow-up (assessments at 1, 3, and 6 months) | Change in acute stress symptoms from baseline to post-treatment follow-up, measured using the National Stressful Events Survey Acute Stress Disorder Short Scale (NSESSS). Scoring and Interpretation: Each item is rated on a 5-point scale (0=Not at all; 1=A little bit; 2=Moderately; 3=Quite a bit, and 4=Extremely). The total score can range from 0 to 28, with higher scores indicating greater severity of acute stress disorder. The raw scores on the 7 items should be summed to obtain a total raw score. In addition, the clinician is asked to calculate and use the average total score. The average total score reduces the overall score to a 5-point scale, which allows the clinician to think of the severity of the individual's acute stress disorder in terms of none (0), mild (1), moderate (2), severe (3), or extreme (4). |
| Secondary | Incidence of PTSD based on PTSD Checklist for DSM-5 (PCL-5) | From baseline through 6 months post-treatment follow-up (assessments at 1, 3, and 6 months) | Incidence of progression from acute stress to PTSD at follow-up, based on DSM-5 criteria and assessed using the PTSD Checklist for DSM-5 (PCL-5). The PCL-5 can be scored to provide a provisional PTSD diagnosis. Scoring and Interpretation: The PCL-5 is a 20-item self-report questionnaire assessing DSM-5 PTSD symptoms, scored from 0-80 by summing items rated 0 ("Not at all") to 4 ("Extremely"). A total score of 31-33 or higher typically indicates a probable PTSD diagnosis, though 32 is often used. A 5-point change represents a clinically significant change. |
| Secondary | Anxiety Symptoms based on the Generalized Anxiety Disorder 7-item scale | From baseline through 6 months post-treatment follow-up (assessments at 1, 3, and 6 months) | Change in anxiety symptoms from baseline to follow-up, measured using the Generalized Anxiety Disorder 7-item scale (GAD-7). Scoring and Interpretation: The GAD-7 (Generalized Anxiety Disorder-7) is a 7-item, self-report scale used to measure anxiety severity, with a total score range of 0-21. Scores are calculated by summing the ratings (0-3) for seven questions, with cut-offs of 5, 10, and 15 representing: 0-4: Minimal or no anxiety 5-9: Mild anxiety (monitor; consider lifestyle changes) 10-14: Moderate anxiety (clinically significant; consider counseling/medication) 15-21: Severe anxiety (refer to a mental health professional) Cut-off for Diagnosis: A score of 10 or higher is generally used to identify potential Generalized Anxiety Disorder. |
| Secondary | Depressive Symptoms based on Patient Health Questionnaire-9 Screening tool | From baseline through 6 months post-treatment follow-up (assessments at 1, 3, and 6 months) | Change in depressive symptoms from baseline to follow-up, measured using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is scored by summing 9 items (0-3 each) to a total of 0-27, with higher scores indicating severe depression. Interpretation of Total Score: 0-4: Minimal or None 5-9: Mild depression (suggests monitoring) 10-14: Moderate depression (suggests treatment) 15-19: Moderately severe depression (often requires active treatment) 20-27: Severe depression (usually requires immediate intervention) |
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.
Papers12
The papers the trial lists on ClinicalTrials.gov.
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/NCT07563296
GET https://conductscience.org/api/trials/v1/NCT07563296/registered