An observational study in Post Traumatic Stress Disorder, sponsored by Albany Research Institute, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-22.
Sponsored by Albany Research Institute, Inc. · Observational
The goal of this exploratory, mixed-method design study is to gather qualitative and quantitative data obtained through interviews and questionnaires with veterans who are currently enrolled at the VA for healthcare. The main question this study aims to answer is: How do veterans diagnosed with PTSD and enrolled for care at the VA understand MDMA-assisted therapy for PTSD? Using a story-completion approach, participants will be provided with a brief story starter involving a fictitious character and scenario and asking them to complete the story. Few contextual details will be offered about the character. In responding to ambiguous cues, participants are thought to project their conscious and subconscious perceptions about the phenomenon in question onto the story, a useful method for exploring stigmatized topics. The purpose of this exercise is to ascertain the participants attitudes and perceptions regarding MDMA-Assisted Therapy.
Veterans will be informed of the study by their VA providers (Behavioral Health Clinic, PCMHI, PTSD Clinic, CDRP, Primary Care). Veterans who are interested will have their contact information passed on to the study investigators. Once screened and enrolled in the study veterans will complete a brief demographics form, and three brief symptom screening questionnaires: PTSD Checklist for DSM-5, 5-Item screener for PTSD, and Patient Health Questionnaire 9. Participants then engage in the recorded interview during which they are provided with a brief story starter, as described above. In the story, a fictitious veteran with a diagnosis of PTSD is offered an opportunity to enroll in a clinical trial and receive MDMA-Assisted therapy. Participants are asked to share what questions, concerns, hopes, and expectations may be present for the fictitious veteran in the story. Interviews will then be transcribed and the PI and the collaborators will read all transcriptions and generate recurring themes that can be reliably coded. The investigators will then code the transcripts for the presence of themes. Data analytic plans include calculating the prevalence of each theme and examining their correlates with measures of severity of symptoms as well as any demographic variables. It is hoped that this data can inform educational and other roll-out efforts within the VA system as MDMA-Assisted therapy approaches FDA approval as a treatment for PTSD.
1,147 studies on the registry are indexed under Stress Disorders, Traumatic; 108 are open to participants now.
This study's enrollment of 30 is below the median of 140 across 177 observational studies indexed under Stress Disorders, Traumatic.
Browse Stress Disorders, Traumatic studies →Albany Research Institute, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
The demographic makeup of the sample mimics the demographic makeup of the population of veterans served by VA. As such, the racial distributions will likely be primarily Caucasian, the sample is likely to be predominantly male, ranging in age from 20-100, with an average of 58 years.
Exclusion Criteria:
Patient Health Questionnaire 9
Screening tool for depressive symptoms. Scores range from 0-27 with lower scores indicating better outcomes
Time frame: 2 weeks
PTSD Checklist for DSM5
Screening tool for PTSD symptoms. Scores range from 0-80 with lower scores indicating better outcomes
Time frame: 4 weeks
5 Item Screener for PTSD
Screening tool for PTSD symptoms. Scores range from 0-4 with lower scores indicating better outcomes.
Time frame: 2 weeks
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Albany Research Institute, Inc.