ClinicalTrials.gg
RecruitingNCT06824532KAPUpdated Feb 13, 2025

Veteran's Perceptions of Ketamine-Assisted Psychotherapy for Depression and End-of-Life

An observational study in Depression, sponsored by Albany Research Institute, Inc.. Recruiting at 1 site in United States. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-13.

Sponsored by Albany Research Institute, Inc. · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 7 months ago, but the record still lists the study as recruiting.
  • Started Nov 2024; still recruiting 1 year 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
30
Ages
65 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Depression

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03

In context

Depression

8,240 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's planned enrollment of 30 is below the median of 158 across 1,111 observational studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Albany Research Institute, Inc. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Veterans enrolled in VA care.
  • Age 65 or older.
  • Fluent in written and spoken English.

Exclusion criteria

Exclusion Criteria:

  • Cognitively impaired to the extent that patient cannot comprehend the survey.
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
30 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Patient Health Questionnaire 9

    Screening tool for depressive symptoms. Scores range from 0-27 with lower scores indicating better outcomes

    Time frame: 2 weeks

  2. Ten Item Personality Inventory

    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.

    Time frame: 2 weeks

  3. Death Anxiety Questionnaire

    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.

    Time frame: 2 weeks

07

Study locations

1 of 1 sites recruiting
  • Stratton VA Medical Center
    Albany, New York 12208, United States
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Nov 2024 (actual). Primary completion is estimated for Mar 2025, 4 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 6, 2025
First posted
Feb 13, 2025
StartActual
Nov 8, 2024
Primary completionEst.
Mar 2025
CompletionEst.
Apr 2025
Last update
Feb 13, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06824532
Lead sponsor
Albany Research Institute, Inc.
Responsible party
Caitlin Holley (Psychologist, Albany Research Institute, Inc.) — Principal investigator
First posted
Feb 13, 2025
Start date
Nov 8, 2024
Primary completion
Mar 2025 (estimated)
Completion
Apr 2025 (estimated)
Last update
Feb 13, 2025

Study contacts

Caitlin Holley, Ph.D.
Contact
caitlin.holley@va.gov
518-626-5365
Stacey Farmer, Ph.D.
Contact
stacey.farmer@va.gov
518-798-6066
Caitlin Holley, Ph.D.
principal investigator · Albany Research Institute, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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