Client Informed Consent to Treatment

Background

Mindbloom, Inc. is a technology solution and platform that assists affiliated psychiatric medical practices, which are independently owned and operated, to provide important mental health services to clients and potential clients, like you. The affiliated medical practices and the states in which they operate are named on the Mindbloom website. The affiliated medical practice that operates in your state is the practice that will be providing services to you (hereinafter referred to as “Practice”).

The Practice provides psychiatric treatment services using telehealth and potentially in-person services. As part of these psychiatric treatment services, you may be prescribed a medicine named ketamine, which has been shown to have positive effects for the treatment of anxiety, depression and other indications. Your clinician may prescribe ketamine in the form of tablets or liquid that are compounded by pharmacies under Section 503A of the federal Food, Drug, and Cosmetic Act (FDCA), and therefore do not require FDA approval; as such, the FDA has not determined that the compounded ketamine prescribed is safe and effective for mental health conditions. Other drugs containing ketamine have been approved by the FDA for use in anesthesia and analgesia; however, the FDA has not evaluated the safety and efficacy of ketamine for the treatment of depression, anxiety, and other mental health conditions. Ketamine is a Schedule III medication that is not clinically appropriate for all people, and has risks (discussed in more detail below) that must be considered when determining whether this treatment is right for you.

How it Works

Ketamine is an NMDA receptor antagonist working through the glutamate neurotransmitter system, and at low doses, it is believed to exert its antidepressant effects through the enhancement of neuroplasticity, or the ability of brain cells to form new connections with one another. The glutamate pathway is different from that used by other psychiatric drugs (e.g., SSRIs, SNRIS, lamotrigine, antipsychotics, benzodiazepines), which is part of what makes ketamine’s antidepressant effects novel and unlike other known forms of treatment. However, the medical community's understanding of ketamine’s mode of action is incomplete, and we may find other mechanisms that contribute to its antidepressant effects in the future.

Ketamine is classified as a dissociative anesthetic that produces a sense of disconnection from one’s ordinary reality and usual self. At the dosage level administered to you, you will likely experience mild anesthetic, anxiolytic, antidepressant and, potentially, psychedelic effects. Relaxation from ordinary concerns and usual states of mind, while maintaining conscious awareness of the flow of mind under the influence of ketamine is characteristic. This can lead to a disruption of negative feelings and obsessional preoccupations. The dissociative effects of ketamine are short-lived, and most people return to their ordinary level of awareness and state of mind within 45-60 minutes following administration.

Potential Benefits

Ketamine has been shown to alleviate symptoms across a variety of mental health issues. For people who have responded to ketamine in clinical studies, the initial antidepressant and anxiolytic effects are often detectable within hours of administration, with peak antidepressant and anxiolytic effects typically occurring approximately 24-48 hours after administration. The duration of ketamine’s antidepressant and anxiolytic effect varies from person to person and can range from a few days to two weeks or longer following a single treatment.

While the benefits of ketamine have been demonstrated across modalities (e.g., sublingual, intravenous, intramuscular, subcutaneous, oral), clinical studies have most often focused on intravenous (IV) administration. Studies have shown that a series of IV treatments over 2-3 weeks can extend the antidepressant and anxiolytic effects of ketamine to anywhere from weeks to months after the final treatment. Prior to your initial treatment, you and the Practice’s clinician will determine the initial treatment regimen that has the greatest likelihood of achieving your treatment goals.

Eligibility

Before participating in ketamine treatment, the Practice will carefully review your intake information (including medical history and assessment responses) and will require a physical and/or psychiatric consult, telehealth or in person, to confirm your diagnosis and eligibility for treatment. Clients must be at least 18 years old and cannot meet the exclusion criteria below:

Ketamine allergy
Ketamine use disorder, mild, moderate, or severe; active or in remission
Active psychotic symptoms, manic symptoms, or a history of a primary psychotic disorder (e.g., schizophrenia, schizoaffective disorder)
Active suicidal ideation with method, intent, or plan
Suicide attempt within the past year
Untreated high blood pressure
Congestive heart failure or other serious heart problems
Severe breathing problems (e.g., COPD)
Unstable thyroid disease
Elevated intraocular pressure (e.g., glaucoma)
Elevated intracranial pressure
Other serious medical illness not listed above
Pregnant, nursing, or currently trying to become pregnant

While clinical studies have demonstrated the effectiveness of ketamine for treating the conditions below, they may indicate you are not a good fit for our treatment model. The clinician will determine eligibility on a case-by-case basis, and confirmation of regular, ongoing therapeutic support outside of Mindbloom may be necessary to move forward.

Active substance use disorder
History of severe trauma
Acute suicidality

Please notify your provider immediately and discontinue treatment if there are any changes to your physical or mental health that impact your eligibility for treatment.

Client Requirements for Treatment

You are obligated to strictly comply with the guidelines below for all ketamine treatments.
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Identify a Peer Treatment Monitor (partner, family member, close friend, roommate, or other trusted adult) that will be present for your treatments
Avoid stimulants on the day of treatment to avoid mild agitation and/or blood pressure elevation (these may be resumed following your ketamine session)
Avoid benzodiazepines on the day of treatment if this doesn’t pose any risks to your health/safety, since these medications may diminish your response to ketamine
Avoid alcohol, cannabis, or a hangover on the day of treatment to promote your safety and the likelihood of a strong clinical response
Continue to take antihypertensive medication as prescribed

Refrain from consuming food for 3 hours prior to treatment to mitigate the risk of nausea (your clinician may prescribe anti-nausea medication, if appropriate)
Refrain from consuming liquids for 1 hour prior to treatment to avoid bathroom breaks that may disrupt your treatment
Do not proceed with treatment if your blood pressure is above 150/100 or your heart rate is above 100 beats per minute (prior to treatment, we'll send you a Bloombox that contains a digital blood pressure monitor)
Set aside at least 2 hours for your treatment and avoid moving around until you return to your baseline physical and mental states (ask your Peer Treatment Monitor to assist you if you need to get up for any reason, e.g., to use the restroom)
Do not operate a vehicle (e.g., car, motorcycle, bicycle) or heavy machinery following treatment until you’ve had a full night of sleep

Additionally, you may not receive ketamine treatment from a Mindbloom clinician at the same time as you receive ketamine treatment from another provider. If you are receiving ketamine treatment from another provider, you must disclose it to your Mindbloom clinician during your initial consultation. If you wish to receive ketamine treatment from another provider during the course of your Mindbloom program, you must inform your Mindbloom clinician before doing so. Receiving ketamine treatment from another provider during the course of your Mindbloom program may result in the discontinuation of your Mindbloom treatment.

Ketamine Treatment

During your initial video consultation, your clinician will conduct a psychiatric evaluation, determine whether you have a diagnosis that qualifies you for treatment using this medication, and confirm that you do not meet any of the exclusion criteria listed above. If your clinician determines that you are eligible for treatment, they will review this Informed Consent with you and provide an opportunity for you to ask any questions.

Your clinician may prescribe sublingual ketamine tablets. The tablets are administered by placing them under your tongue or in between your cheek and gums for 7 minutes without swallowing, and then any saliva that has accumulated is spit out. Clinicians advise against swallowing the ketamine because ketamine ingested orally may have a longer onset time, increase the adverse effects listed below, and/or extend the time required for you to return to your baseline physical and mental states. Your clinician may also prescribe compounded liquid ketamine, which may be combined with vitamins B6 and B12, and is administered through subcutaneous injection. If so, you will receive specific guidance and instructions on the preparation and administration of the medicine through subcutaneous injection. Do not proceed with treatment if you are unsure how to properly administer the medicine.

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The effects of the ketamine can typically be observed about 5-10 minutes after administration, and the peak experience lasts approximately 30-45 minutes thereafter. About an hour after taking the medication, effects of ketamine will begin to diminish. The side effects of ketamine, such as dissociation, dizziness, headache, anxiety, or nausea, may persist for several hours following treatment.

Side Effects & Risks Associated with Ketamine Treatment

Ketamine may cause serious side effects, including but not limited to risks of: sedation; dissociation; psychiatric events or worsening of psychiatric disorders, including problems in people with schizophrenia, severe personality disorders, or other serious mental disorders; dependence, abuse and misuse; anxiety; increases in blood pressure or heart rate; respiratory depression (breathing becomes slower and shallower and the lungs fail to exchange carbon dioxide and oxygen efficiently); lower urinary tract and bladder symptoms, including frequency of urination, urinary incontinence, pain urinating, passing blood in the urine, or reduced bladder size; altered sense of time; dry mouth; elevated intraocular or intracranial pressure; loss of appetite; confusion; nausea/vomiting; blurred vision; and slurred speech. When these occur, they tend to resolve spontaneously as the acute effects of the ketamine wear off.

While ketamine has been reported to produce adverse outcomes including but not limited to those outlined below, lasting adverse side-effects are rare when medical protocols are carefully followed. By signing this informed consent document, you agree to adhere to Mindbloom’s treatment guidelines, which are designed to minimize the risk of the side effects listed above and adverse outcomes, and to maximize its potential benefits. You agree to take ketamine only as directed by your clinician.

Ketamine has been found to cause moderate psychological dependency in some users.

In rare cases, frequent, heavy users have reported increased frequency of urination, urinary incontinence, pain urinating, passing blood in the urine, or reduced bladder size
The dissociative effects of ketamine may increase vulnerability and the risk of accidents
People with a personal history of schizophrenia, schizoaffective disorder, other primary psychotic illnesses or severe personality disorder are not eligible for ketamine therapy, due to the risk for ketamine to exacerbate psychotic symptoms in susceptible individuals
Worsening symptoms of depression, anxiety or suicidal ideations may occur. If you experience worsening symptoms, notify your treatment team. If you are experiencing suicidal thoughts and feel unsafe, contact the National Suicide Prevention Hotline by dialing 988, call 911, or go to the nearest emergency room.

Guides

As part of your program you may work with a Guide who is affiliated with Mindbloom. Your Guide can help you navigate your program, set intentions, and develop your integration plan. Guides are trained in life coaching, best practices for working with psychedelic medicine, and how to best collaborate with your clinician to support your treatment.

While your Guide may be able to support you in changing unwanted thoughts or behaviors and achieve the goals you set for your program, Guides are not licensed therapists, so they are not licensed to treat anxiety, depression, or other diagnoses. That’s the role of your clinician or other licensed mental healthcare provider you may work with outside of this treatment.

Guides aim to reply to client messages within 48 hours (or much sooner), but they do not provide 24/7 support.

Consent to Telehealth

Telehealth involves the use of electronic communications to enable healthcare providers at different locations to share individual client medical information for the purpose of improving client care. Telehealth services offered through the Mindbloom platform by Practice’s clinicians may include consultations by video or by phone, chart review, remote prescribing, appointment scheduling, health information sharing, and non-clinical services, such as client education. The information you provide may be used for diagnosis, therapy, follow-up and/or client education, and may be provided through any combination of the following: (1) health records and test results; (2) images and asynchronous communications; (3) live two-way audio and video; (4) interactive audio with asynchronous communications; and (5) output data from medical devices and sound and video files.

The electronic communication systems we use will incorporate network and software security protocols to protect the confidentiality of client identification and imaging data and will include measures to safeguard the data and to ensure its integrity against intentional or unintentional corruption. It is possible, though unlikely, that your information or data may be lost due to technical failures. You agree to hold Mindbloom and Practice harmless against any information or data that is lost due to technical failures.

The Practice’s clinicians are an addition to, and not a replacement for, your primary care physician and/or primary mental health provider. Responsibility for your overall medical care should remain with your local primary care doctor, if you have one, and we strongly encourage you to locate one if you do not.

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Expected benefits of telehealth:

Improved access to care
More efficient care evaluation and management

Possible risks of telehealth:

Delays in evaluation and treatment could occur due to deficiencies or failures of the equipment and technologies
In rare events, a provider may determine that the transmitted information is of inadequate quality, thus necessitating a rescheduled telehealth consult or a visit with your local primary care doctor
In very rare events, security protocols could fail, causing a breach of privacy of personal medical information
In rare events, a lack of access to complete medical records may result in inaccurate and/or incomplete medical advice.
The FDA has advised that at-home administration of compounded ketamine may present additional risks because a health care provider is not available onsite to monitor for adverse outcomes resulting from sedation and dissociation.

Your clinician or guide may use software including artificial intelligence tools for recording and/or transcribing your consultation for the purposes of creating visit notes and supporting quality assurance. If you do not consent to recording your consultation for these purposes, you may request that your clinician or guide disable it.

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Alternative Treatments

Before deciding to proceed with ketamine treatment, you should consider the benefits and risks of available mood and anxiety disorder treatment options, such as other antidepressant and anti-anxiety medications, mood stabilizers, or psychotherapy. You should also consider alternatives to telehealth consultation, such as in-person services, before choosing to participate in a telehealth consultation. You can discuss these alternative treatments with your Practice clinician or with your local primary care doctor.

Confidentiality

Your privacy is a priority and all treatment records will be kept confidential. They will be maintained with the same precautions as ordinary medical records. If you would like to provide other individuals or organizations with access to your records, contact us for a release form. You also understand that your personal information may be used and shared according to the Medical Groups’ Privacy Practices and Mindbloom, Inc.’s Privacy Policy.

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By electronically signing this document, I confirm that:

I have fully read and understand this agreement. I understand the potential benefits, risks, and alternative treatment options, and I freely give my consent to participate in ketamine treatment and receive services via telehealth from Practice providers affiliated with Mindbloom.
I will abide by all of Mindbloom’s guidelines and requirements outlined in this document and/or those that have been communicated by my clinician, as well as the directions in any prescription I receive. I understand that my failure to follow all guidelines, requirements, and directions may result in the discontinuation of my treatment.
I meet the eligibility criteria and do not meet the exclusion criteria listed in the “Eligibility” section above. If there are any changes to my physical or mental health that impact my eligibility for treatment, I will notify my providers immediately and discontinue treatment, if necessary.
I will be physically located in my state of residence, as identified in my new client registration, during my telehealth consultation. I will notify my Practice Clinician and Mindbloom immediately and no later than at the beginning of your telehealth consultation if I am located in a different state.
I understand that Practice providers are not able to connect me directly to any emergency services. If I am in a life-threatening situation, I will call the National Suicide Prevention Line at 988 or +1-800-273-8255, call 911, or go to the nearest emergency room.
I understand it is up to the Practice clinician to determine whether or not my specific clinical needs are appropriate for a telehealth encounter. The Practice’s clinician may deny care for potential misuse of the telehealth services or for any other reason if, in the professional judgment of the provider, the telehealth encounter is not medically or ethically appropriate.
I understand that my healthcare information may be shared with other individuals for the purposes of treatment, scheduling, billing, and other healthcare operations as set forth in the Medical Groups’ Privacy Practices and Mindbloom, Inc.’s Privacy Policy.
I understand that I have the right to object to the videotaping or other recording of a telemedicine visit, and I also agree not to record a telemedicine visit without my provider’s permission.
I give Mindbloom and Practice permission to access information regarding my historical medical data through their electronic health record system.
I understand that if I participate in a consultation, I have the right to request a copy of my medical records and to request that a copy of my medical records be sent to my local primary care physician or another medical provider.
I understand that I may register any complaints regarding my provider to the applicable state professional licensing board.
I understand that I may withdraw my consent from treatment and/or the use of telehealth at any time by providing notice to support@mindbloom.com. I understand that my revocation of consent may result in me no longer qualifying to receive services and that such consent will not impact the rights and actions of Mindbloom and Practice while the consent was in effect.
I understand that I will have the opportunity to ask my clinician questions about this consent form at any time during my treatment. I understand that I may revoke this consent by following the process set forth in item 12 located above.

Note: we’ll send you a link to electronically sign this document prior to your first session.