Psilocybin for Chronic Pelvic Pain (CPP) in Women: A Pilot Feasibility Study

Proportion of eligible participants who complete the study from baseline to 1 month post psilocybin dose

Acceptability will use qualitative data collection to provide information on the benefits and challenges of the intervention using a semi-structured interview.

Adverse events will be collected using a 12- item adverse events checklist covering all major organ systems will be included to probe for adverse events. The nature of each AE, its severity (mild, moderate, or severe), its likely relationship to study treatment (definite, probable, possible, not related, or unknown), its duration and any necessary treatment modifications or adjustments will be recorded. In addition to recording of AEs,, and labs to assess basic metabolic function (including liver function tests), a complete blood count

Provides a rating on pain's impact on physical, emotional, and social functioning, enjoyment, and quality of life.

Provides a rating to assess symptoms associated with central sensitization (CS) and related conditions. The inventory is divided in two parts: Part A consists of 25 symptoms rated on a Likert scale from 0 (never) to 3 (often), with a total score ranging from 0 to 100, where scores 40 and higher are considered clinically relevant and indicative of a higher degree of CS. Part B screens for prior diagnoses of conditions related to CS, including seven chronic overlapping pain conditions (COPCs) such as irritable bowel syndrome, fibromyalgia, and migraine, as well as three CS-related disorders like anxiety, depression, and neck injury.

Provides a rating to assess phenomenology and intensity of mystical experiences, often in the context of altered states of consciousness, such as those induced by psychedelics.

Provides a rating to assess difficult or challenging psychological experiences, often in the context of altered states induced by psychedelics. It evaluates seven domains of challenging experiences: fear, grief, physical distress, insanity, isolation, death, and paranoia.

Provides a rating to assess positive and negative emotion.

Provides a rating to assess a participant reactions to any physical touch between therapist and participant that occurs during the psychedelic sessions.

Provides a rating to assess the presence and severity of post-traumatic stress disorder (PTSD) symptoms based on DSM-5 criteria. It consists of 20 items corresponding to the four symptom clusters: re-experiencing, avoidance, negative alterations in cognition and mood, and hyper-arousal. Total score range of 0 to 80, with higher scores indicating greater symptom severity.

Provides a rating to assess female sexual health: desire, arousal, lubrication, orgasm, satisfaction, and pain, with each domain scored on a scale contributing to a total score indicated of a woman's sexual function.

A simple expectancy visual analogue scale to provide a rating of treatment expectancy that will be used to assess the mediating effects of expectancy on treatment outcomes. How much do you think this treatment will reduce your pelvic pain? none to minimal reduction (0-4 mm), mild reduction (5-44 mm), moderate reduction (45-74 mm), substantial to complete reduction (75-100 mm).

Provides a rating of depression severity. The score range is 0-63, a higher score reflects more severe depression.

Provides a rating of anxiety severity. The score range is 0-63, a higher score reflects more severe anxiety

Provides a rating of self-compassion, or responding to one's own failure, suffering or inadequacies with kindness and compassion and recognizing one's own flaws and suffering as part of common human experience

Provides a rating of hedonic pleasure capacity in social interactions (sample item: "I would enjoy being with my family or close friends"). Each question is anchored to a time frame of the "past few days" and rated on a 1 (Strongly disagree) - 4 (Strongly agree) scale.

Provides a rating of psychological flexibility: openness to experience (5 items), behavioral awareness (5 items), and valued action (5 items).

A clinician or self-administered tool designed to assess suicidal ideation and behavior. It evaluates the severity and intensity of suicidal thoughts, including wish to die, active suicidal ideation with or without a plan, and preparatory acts. It also captures suicidal behavior such as attempts, interrupted or aborted attempts, and non-suicidal self-injury.