- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06824532
Veteran's Perceptions of Ketamine-Assisted Psychotherapy for Depression and End-of-Life (KAP)
February 11, 2025 updated by: Caitlin Holley, Albany Research Institute, Inc.
Veteran's Perceptions of Ketamine-Assisted Psychotherapy (KAP) for Depression and End-of-Life
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 aged 65+ who are enrolled for care at the VA understand ketamine assisted psychotherapy for depression and for end-of-life distress?
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 ketamine assisted psychotherapy.
Study Overview
Status
Recruiting
Conditions
Detailed Description
Veterans will be informed of the study by their VA providers (Behavioral Health Clinic, Primary Care, etc).
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: Patient Health Questionnaire 9, Ten Item Personality Inventory, and the Death Anxiety Questionnaire.
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 depression is offered an opportunity to engage in ketamine assisted psychotherapy (KAP).
The veteran then receives a cancer diagnosis and is again offered a chance to consider KAP.
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 around KAP.
Study Type
Observational
Enrollment (Estimated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Caitlin Holley, Ph.D.
- Phone Number: 518-626-5365
- Email: caitlin.holley@va.gov
Study Contact Backup
- Name: Stacey Farmer, Ph.D.
- Phone Number: 518-798-6066
- Email: stacey.farmer@va.gov
Study Locations
-
-
New York
-
Albany, New York, United States, 12208
- Recruiting
- Stratton VA Medical Center
-
Contact:
- Caitlin Holley, Ph.D.
- Phone Number: 518-626-5365
- Email: caitlin.holley@va.gov
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
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.
Description
Inclusion Criteria:
- Veterans enrolled in VA care.
- Age 65 or older.
- Fluent in written and spoken English.
Exclusion Criteria:
- Cognitively impaired to the extent that patient cannot comprehend the survey.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Health Questionnaire 9
Time Frame: 2 weeks
|
Screening tool for depressive symptoms.
Scores range from 0-27 with lower scores indicating better outcomes
|
2 weeks
|
|
Ten Item Personality Inventory
Time Frame: 2 weeks
|
A 10-item measure of the Big Five dimensions is offered for situations when very short measures are needed, personality is not the primary topic of interest.
It assesses the big-five traits-Emotional Stability, Extraversion, Openness, Agreeableness, and Conscientiousness-using two items for each scale.
Scores range from 1-70.
|
2 weeks
|
|
Death Anxiety Questionnaire
Time Frame: 2 weeks
|
The 15-item self report scale is a reliable and valid measure of individual differences in and perceptions of death anxiety.
Scores range from 0-30 with higher scores indicate a higher level of anxiety.
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Caitlin Holley, Ph.D., Albany Research Institute, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 8, 2024
Primary Completion (Estimated)
March 1, 2025
Study Completion (Estimated)
April 1, 2025
Study Registration Dates
First Submitted
February 6, 2025
First Submitted That Met QC Criteria
February 11, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 11, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AlbanyRI
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.