Clinical trial NCT06824532: Veteran's Perceptions of Ketamine-Assisted Psychotherapy for Depression and End-of-Life
Official title: Veteran's Perceptions of Ketamine-Assisted Psychotherapy (KAP) for Depression and End-of-Life
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Depression
Lead sponsor: Albany Research Institute, Inc.
Sponsor class: OTHER
First posted: 2025-02-13
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient Health Questionnaire 9
timeFrame: 2 weeks
measure: Ten Item Personality Inventory
timeFrame: 2 weeks
measure: Death Anxiety Questionnaire
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Albany
country: United States
facility: Stratton VA Medical Center
state: New York
Study officials:
affiliation: Albany Research Institute, Inc.
name: Caitlin Holley, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: