Prolonged Grief Disorder
Conditions
Keywords
prolonged grief disorder, psilocybin, psychedlic-assisted treatment, psilocybin-assisted therapy, grief, grief disorder
Brief summary
The primary purpose of this study is to explore the feasibility of conducting a clinical trial on the effects of psilocybin for individuals with prolonged grief disorder (PGD).
Detailed description
The study aims to investigate whether a single dose of 25 mg psilocybin can reduce the symptoms of grief and trauma associated with Prolonged Grief Disorder (PGD). It is hypothesized that psilocybin will significantly reduce the symptoms of PGD, and that the treatment will facilitate subjective mystical, spiritual, or insightful experiences, which in turn may contribute to the alleviation of grief and trauma symptoms. Neuroimaging will be used to help researchers better understand the relationship between grief and brain functions, comparing pre- and post-dose scans. Participants will undergo two MRI (magnetic resonance imaging) where they are asked to look at images (this is called a functional MRI or fMRI).
Interventions
DRUGPsilocybin 25 mg
25 mg psilocybin administered to each participant in single arm, open-label trial
DIAGNOSTIC_TESTFunctional Magnetic Resonance Imaging (fMRI)
There are two "fMRIs" (functional magnetic resonance imaging) that take place 1-14 days before and 1-14 days after psilocybin administration.
Sponsors
University of Virginia
Tiny Blue Dot Foundation
Texas Tech University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All eligible participants will receive 25 mg of psilocybin.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Ages 18 years old up to and including 65 years of age * Negative UDS results for illicit drugs at screening and prior to each drug administration session * Consent to all study procedures * Have an existing diagnosis of Prolonged Grief Disorder. May also be determined to have Complicated Grief Disorder without official diagnosis as determined by PI or designate based on DSM V criteria * Score of greater than 25 on the Inventory of Complicated Grief * Agree to abstain from any psychoactive drugs on the day prior to and the day of the drug administration session * People of childbearing potential that are sexually active must agree to continue or initiate practice of a highly effective means of birth control, alone or in combination with another, throughout the study. Highly effective options are: implants, intrauterine devices (IUD), and sterilization. Exclusive use of condoms is not effective. * Be judged by study team clinicians to be at low risk for suicidality as determined by MINI, Columbia Suicide Severity Scale, and the Patient Health Questionnaire-9. * Concurrent psychotherapy or pharmacotherapy with SSRIs, SNRIs, and/or bupropion (\< 300 mg bupropion) is allowed if the type and frequency of the therapy has been stable for at least two months prior to screening and is expected to remain stable during participation in the study * Be otherwise medically stable as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), urine beta-HCG, and urine toxicology screen * Participant must agree to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) that they consume on a usual morning, before arriving at the research unit on the mornings of drug session days. If the participant does not routinely consume caffeinated beverages, they must agree not to do so on session days * Agree not to take any PRN medications on the mornings of drug sessions * Agree not to take sildenafil (Viagra®), tadalafil, or similar medications within 72 hours of each drug administration * Agree that for one week before each drug session, participant will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except when approved by the study investigators. Exceptions will be evaluated by the study investigators and will include acetaminophen, non-steroidal anti-inflammatory drugs, and common doses of vitamins and minerals * Willingness and ability to remain within the observation room for the duration of the study visits up to 10 hours * Willingness and ability to follow study protocol as directed by research staff * Willing and able to attend all sessions in the study and complete follow up assessments * Fluent in English * Ability to provide one photo of a deceased loved one and one photo of a living loved one, as required for the grief elicitation task.
Exclusion criteria
General medical
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Rate | Through end of enrollment period | Number of participants enrolled divided by number screened over the recruitment period. |
| Dropout Rate | Baseline to 6-month Follow-up | Proportion of enrolled participants who withdraw or are lost to follow-up prior to completing the 6-month assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Prolonged Grief Disorder Symptoms (ICG) | Baseline (Visit 0 - Screening) to 6-month Follow-up | Change in the Inventory of Complicated Grief (ICG) is a 19-item scale assessing prolonged grief symptoms. Scores range from 0 to 76, with higher scores indicating greater symptom severity. |
| Change in PTSD Symptoms (DTS) | Baseline (Visit 0 Screening) to 6-month Follow-up | Change in Davidson Trauma Scale (DTS) total score; range 0-136; higher scores indicate more severe PTSD symptoms. |
| Mystical Experience (MEQ) | Baseline (Visit 3 - Treatment Visit) to 6-month Follow-up | Change in Mystical Experiences Questionnaire (MEQ-30) mean score; range 0-5; higher scores indicate greater mystical-type experience. |
| Altered States of Consciousness (5-D ASC) | Baseline (Visit 3 - Treatment Visit) to 6-month Follow-up | Change in 5-Dimensions of Altered States of Consciousness score; range 0-100%; higher percentages indicate greater altered-state intensity. |
| Awe Experience (AWE-S) | Baseline (Visit 3 - Treatment Visit) to 6-month Follow-up | Change in Awe Experience Scale mean score; range 1-7; higher scores indicate greater awe. |
| Challenging Experiences (CEQ) | Baseline (Visit 3 - Treatment Visit) to 6-month Follow-up | Change in Challenging Experiences Questionnaire mean score; range 0-5; higher scores indicate more intense challenging experiences. |
| Psychological Flexibility (AAQ-II) | Baseline (Visit 2 - Preparation for Treatment) to 6-month Follow-up | Change in Acceptance and Action Questionnaire-II total score; range 7-49; higher scores indicate greater psychological inflexibility. |
| Closeness to Others (IOS) | Baseline (Visit 0 - Screening) to 6-month Follow-up | Change in Inclusion of Others in the Self single-item score; range 1-7; higher scores indicate greater perceived interpersonal closeness. |
| Meaning in Life (MIL) | Baseline (Visit 2 - Preparation for Treatment) to 6-month Follow-up | Change in Meaning in Life Questionnaire Presence and Search subscales; each subscale range 5-35; higher scores indicate greater presence of meaning (Presence) or search for meaning (Search). |
| Psychological Insight (PIQ) | Baseline (Visit 3 - Treatment Visit) to 6-month Follow-up | Change in Psychological Insight Questionnaire mean score; range 0-5; higher scores indicate greater psychological insight. |
| Personality Traits (NEO-FFI) | Baseline (Visit 2 - Preparation for Treatment) to 6-month Follow-up | Change in the NEO Five-Factor Inventory (NEO-FFI) is a 60-item measure assessing five personality domains: Neuroticism, Extraversion, Openness, Agreeableness, and Conscientiousness. Each domain score ranges from 0-48, with higher scores indicating greater expression of the corresponding personality trait. |
Countries
United States
Contacts
CONTACTFatma Wise, PhD
CONTACTMadison Focht
PRINCIPAL_INVESTIGATORJennifer K Penberthy, PhD
University of Virginia
Outcome results
None listed