KAP and Well-being

The Effect of Ketamine-Assisted Psychotherapy on Psychological Well-being: An observational cohort study

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Help investigate the potential impact of ketamine-assisted psychotherapy (KAP) on psychological well-being in a real world setting. Join our study and impact its use as a treatment option for mental health conditions.
Participants
Participants:
Recruiting to 2500
Time Commitment
Time Commitment:
About 20 minutes every 3 weeks
Study Type
Study Type:
Clinician-led, observational, cohort study
LED BY
Dr. Bhavya Rajanna
Dr. Bhavya Rajanna
Jessica Roos
Dr. Jessica Yoos
FUNDED BY
Psychedelic Data Society
Why We Are Doing This Study

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Ketamine is currently authorized for use in the USA as an anesthetic, as well as an intranasal spray for treatment resistant depression when used in conjunction with an oral antidepressant. Ketamine is also frequently used off-label in clinical settings for mental health indications and may be delivered in conjunction with psychotherapy.

Ketamine assisted psychotherapy (KAP) has shown promise for treating a range of mental health disorders including post-traumatic stress disorder (PTSD), depression, anxiety, obsessive compulsive disorder (OCD), and bipolar disorder. KAP is typically administered via sublingual or intramuscular routes to induce a dissociative state with the goal of facilitating emotional processing and promoting neuroplastic change. There is, however, variability in the manner in which KAP is implemented (i.e. no one standard KAP protocol has been established) and it is not well known how various treatment and patient-specific factors might impact KAP efficacy. High quality, large-scale research into this emerging, innovative intervention is necessary to better understand this variability and to improve the safety and efficacy of KAP for individuals with mental health conditions.

Team

Dr. Bhavya RajannaDr. Bhavya Rajanna

LinkedIn   

 

 

 

Jessica RoosDr. Jessica Yoos

LinkedIn

 

 

        

Consent

Please view the comprehensive privacy policy here.

What is the purpose of this study?

You are being invited to take part in a study which explores the impact that ketamine assisted psychotherapy (KAP) may have on psychological well-being in a real world setting. The results of this study will help improve our understanding of the effects of KAP and help guide its use as a treatment option for mental health conditions. 

Who can participate in this study? 

You will only be able to participate in this study if you:

  • Are of or above the “age of majority” in your place of residence (for example, 18 years of age in Washington State)
  • Are fluent in English
  • Are able to give adequate informed consent
  • Are not taking other psychedelics or participating in other psychedelic assisted therapies during the study period
  • Have not previously undergone ketamine assisted psychotherapy (KAP)
  • Are receiving KAP from a clinician who is enrolled in the study at the time of participant enrollment 
  • Have at least one clinically diagnosed mental health condition 
  • If you are female and of childbearing potential: you must not be pregnant, breastfeeding, or planning to become pregnant during the study period

You will need secure access to a personal mobile device (cell phone or tablet) to run the QC Pro app on.

About 2500 participants will be in this study.

What am I being asked to do?

If you choose to be in the study, once you have provided your consent you will be asked to complete an intake questionnaire using the Quantified Citizen (QC) Pro app. This includes basic demographic information (age, sex, gender), basic medical history (mental health diagnoses, current symptoms, medications, history of therapy), self-reported use of other psychoactive substances in the past, and your expectations for KAP treatment. You will then be asked to complete a set of self-administered assessments including those related to cognitive performance, mental health and adverse childhood experiences. This entire intake process will take about 30 minutes and should be completed before your first ketamine dosing session.

After each ketamine administration session, you will be asked about any effects of ketamine you experienced during the session. It is recommended that these ketamine-effects questionnaires be completed after the dosing session on the same day, or no later than by the next ketamine dosing session. You will also be asked to complete self-administered mental health questionnaires, additional side-effects questionnaires, and cognitive performance assessments every 3 weeks until 6 months after your last ketamine dosing session with your clinician. The assessments should take you about 20 minutes each time. 

As an alternative to using the QC mobile Pro app to complete questionnaires, you may be given the option to complete some questionnaires on paper or via other electronic data collection (for example, fillable PDF form, or link to complete the questionnaire(s) via the QC Platform). You may be asked to share your email address with your clinician in order for them to send certain questionnaires. Data collected on paper or via other electronic data collection means will subsequently be entered onto the QC platform by your clinician. 

This study asks for about 9 hours of your time in total over the study period. While you are enrolled in the study, you will be asked to allow the QC Pro app to send you notifications reminding you to complete the questionnaires. Once you have completed your assessment or questionnaire, the notifications will stop.

You will also have the option to allow the QC Pro app to access your Apple Health or Google Fit data. Within the QC Pro app, a pop-up will ask you if Quantified Citizen is allowed to access your Apple Health or Google Fit Data. This is not required to participate in the study. You may turn this off at any time in the “settings” function on your phone. There are no known additional risks to opting-in to this option. None of the Apple Health or Google Fit data collected will include any personally identifiable information. Data collected is limited to hours of sleep, heart rate variability, and step-count. Quantified Citizen access to the biometric data will end automatically once you complete the study or withdraw from it.

The QC Pro app is free. After you have completed the study, you may keep the app on your phone to be informed of future studies. You may also delete it. 

Will I be paid for participating?

No, you will not be paid for participating. 

Costs 

There will be no additional charge to you for your participation in this study. The QC Pro app and all study-related procedures will be provided at no additional charge to you or your insurance company.

Alternatives To Participation 

This research study is for research purposes only. The only alternative is to not participate in this study.

New Findings 

Any new important information that is discovered during the study and which may influence your willingness to continue participation in the study will be provided to you.

What are the risks of participating?

Your clinician will speak to you about the potential risks and benefits of KAP independent from this study. The purpose of this study is to observe KAP practices and effects in the real world, by asking questions about your experience and symptoms in addition to your regular care. Your decision to participate in this study will not change your clinician’s clinical practice or the care you receive in any way. 

You will not be asked to provide any personally identifying information as part of this study. No data will be stored on your phone while the study is ongoing. As soon as you complete a survey or active task, your data are securely sent to encrypted QC servers. Should there ever be a security access concern to your phone, no study data are accessible to you or any third-party. The QC Pro app is also password-protected. This adds an additional layer of security.

Some of the questions asked in this study examine topics of a personal nature (for example, mental health). You do not have to answer all the questions if you do not want to. If you do not feel comfortable with the content of the study, please do not participate. If feelings of discomfort or sensitivity arise for you during the study, remember that you may stop at any time without explanation or penalty. 

If you are having suicidal thoughts contact your clinician or call the study investigator at the telephone number listed on the first page of this form. If you feel in crisis, you can call 911 and/or a Nationwide Suicide Hotline that is answered 24 hours a day with a skilled, trained counselor. One example is the National Suicide Prevention Lifeline at 1-800-273-TALK (8255).

What are the benefits of participating?

There are no direct benefits to you being in this study. By participating in this study, you may help increase the current scientific understanding of the effects of KAP.

Will my information be kept confidential?

All information obtained during the study will be entirely anonymous on the Quantified Citizen Pro app. You will get a unique, randomly generated username and your identity will remain anonymous except to your treating clinician. Your clinician will be able to link you to your data and clinically relevant data will be available to your clinician. Please write down your username and keep it in a secure location. You will need it to login into the app should you lose your phone. If for any reason you no longer have access to your QC account, and you do not remember your username, QC will not be able to regenerate your account. 

You will never be asked to provide your real name, address, contact information, or date of birth in the QC Pro app. If you share your email address with your clinician to receive digital questionnaires, your clinician will not share your email address with anyone else. Averaged group data may be published or publicly presented, but it will not be possible to identify individual participants from this data.

The Quantified Citizen Pro app will not have access to any of your personal identifying information. Quantified Citizen will only access IP addresses from server logs for security and quality control and will delete them every 48 hours to limit indirect identifiers. Only authorized QC staff can access server logs based on their role and a need-to-know basis in order to fulfill their duties. IP addresses are not included in the data that will be analyzed in this study.

All of the data you enter into the Quantified Citizen Pro app will be encrypted and stored in perpetuity on servers located in Canada. Anonymous data will be accessible to all researchers involved with this study, as well as third party researchers who may request access to the data for secondary analysis, including the study doctor, the sponsor or persons working on behalf of the sponsor, and under certain circumstances, the United States Food and Drug Administration (FDA) and the Institutional Review Board (IRB). De-identified digital data will be kept indefinitely. 

If you would like to hear about future Quantified Citizen studies, you may provide your email address on the Quantified Citizen website (quantifiedcitizen.com). It will not be possible to link your study data with the email address you provide.

Any information collected on paper forms will be stored in compliance with the Health Insurance Portability and Accountability Act (HIPAA) and your local clinic’s privacy policies.  

As part of this research, you will be required to use the QC Pro app on your mobile phone, and you may choose to share specific data from a device that tracks information about you using Apple Health or Google Fit. While using these, information about you may be collected and shared with the researchers or people outside the study.  This data might include personal health information, location, or other data. While the Terms of Use, End User License Agreement, or Privacy Policy for your phone, other mobile apps, and/or wearable device(s) that you use may include statements limiting your rights if you are harmed as a result of your use of the app(s) or device(s), you do not release the investigator, sponsor, institution, or agents for responsibilities from mistakes in this study. You also do not waive any of your rights as a research subject.

Can I say “no”?

Your participation in this study is strictly voluntary. You may decline to enter or withdraw from the study at any time without any consequences to your clinical care. Should you choose to leave the study, you will be given the option to complete a final assessment and then be logged out of your account. No new data will be collected after you withdraw. Data that has already been collected will still be used in the study and cannot be deleted because it will already be anonymized and encrypted.

If you choose to stop the study, you will be presented with the following message: “Thank you for your participation to date. We’re sorry to see you go, but we understand and respect your choice. You are invited to complete final questionnaires, which are optional. Please note that all data you have previously entered can not be deleted because it has already been anonymized and encrypted.”

Your KAP clinician may also choose to stop their collaboration with the study team at any time. If that occurs while you are enrolled, you may continue with the study using the QC Pro app, however your clinician may not continue to input clinical data about your sessions.

The study doctor, your KAP clinician, or the sponsor can stop your participation at any time without your consent for the following reasons:

  • If it appears to be medically harmful to you;
  • If you fail to follow directions for participating in the study;
  • If it is discovered that you do not meet the study requirements;
  • If the study is canceled; or 
  • For administrative reasons.

Whom To Contact About This Study

During the study, if you experience any medical problems, suffer a research-related injury, or have questions, concerns or complaints about the study such as:

  • Whom to contact in the case of a research-related injury or illness;
  • Payment or compensation for being in the study, if any;
  • Your responsibilities as a research participant;
  • Eligibility to participate in the study;
  • The study doctor’s or study site’s decision to exclude you from participation;
  • Results of tests and/or procedures;

Please contact the study doctor at the telephone number listed on the first page of this consent document. 

An institutional review board (IRB) is an independent committee established to help protect the rights of research participants. If you have any questions about your rights as a research participant, contact:

  • By mail:

Study Subject Adviser

Advarra IRB

6100 Merriweather Dr., Suite 600

Columbia, MD 21044

Please reference the following number when contacting the Study Subject Adviser: Pro00062040.

Authorization To Use And Disclose Protected Health Information

If you decide to be in this study, the study doctor and study staff will use and share anonymous health data about you to conduct the study. Health data may include:

  • Age
  • Medical history.
  • Information from your study visits, including all test results. 

Health data may come from your study records or from existing records kept by your doctor or other health care workers. 

For this study, the study staff may share anonymous health data about you with authorized users. Authorized users may include:

  • Representatives of Psychedelic Data Society.
  • Representatives of Advarra IRB (an Institutional Review Board that reviews this study).
  • The Food and Drug Administration (FDA) and other US federal and state agencies.
  • Governmental agencies of other countries.
  • Outside individuals and companies, such as laboratories and data storage companies, that work with the researchers and sponsor and need to access your anonymous information to conduct this study, or to perform secondary analyses.
  • Other research doctors and medical centers participating in this study, if applicable. 

Your health data will be used to conduct and oversee the research, including for instance:

  • For other research activities related to the study 

Once your anonymous health data has been shared with authorized users, it may no longer be protected by federal privacy law and could possibly be used or disclosed in ways other than those listed here. 

The anonymous health data you share in the QC app for this study will be stored in perpetuity (forever). Once you have given permission to use and share anonymous health data about you for this study you cannot take it back, as the encrypted data cannot be linked back to your identity. Specifically for any data collected using a paper or fillable digital form, your permission to use and share health data about you in this format will end in 50 years unless you revoke it (take it back) sooner. You may revoke (take back) your permission to use and share health data about you on paper or fillable digital forms at any time by writing to the study doctor at the address listed on the first page of this form.  If you do this, you will not be able to stay in this study. If you withdraw early from the study, you will be given the option to complete a final assessment and then be logged out of your account on the QC app. No new data will be collected after you withdraw. Data that has already been collected will still be used in the study and given to others as described in this form; it cannot be deleted because it will already be anonymized and encrypted. You will not have access to your own historical study data during or after the study. If you decide not to give your permission in this form, you will not be able to take part in the study.

Privacy

Quantified Citizen is the creator of  the Quantified Citizen Pro app (“QC Pro”). Quantified Citizen is committed to protected personal information and complying with applicable privacy legislation.

Researchers use QC Pro to run research studies and collect study data from participants. You may choose to participate in these research studies running in QC Pro. When you participate in a study, QC Pro will transmit the information you provide, which may include personal information (“Participant Data”), to researchers. 

This Privacy Notice explains QC Pro privacy practices. By using QC Pro, you are agreeing to our Privacy Notice and terms of use. If you do not want QC Pro to use or disclose your personal information in the ways identified in this Privacy Notice, you should not use QC Pro.

Accountability

Quantified Citizen’s Privacy Officer is responsible for our privacy management program and procedures to protect Personal Information, for receiving your privacy-related questions and for providing you with information about our privacy practices. 

You can contact our Privacy Officer at:

210-128 Hastings St. W

Vancouver, BC V6B 1G8

Canada

Email: privacy@quantifiedcitizen.com

Personal Information

Personal information means information that can identify an individual or information about an identifiable individual.  

Creating a QC Pro Account

As QC Pro user, you do not have to provide personal information to create an account.  

When you join the app, you may be able to hide your identity using an email relay service. When you use this option, QC does not collect any personal information about you.

As a result, Quantified Citizen cannot identify or connect QC Pro users to their accounts or  the research they are participating in and may not be able to provide technical support for specific accounts. 

Collecting Personal Information

You will be assigned a unique Citizen ID when you join QC. Your Citizen ID is used to create your profile so that we can collect all your information for you. Your Citizen ID is not shared with anyone.

Your Citizen ID will not include personal information unless you add this yourself.

When you use the QC Pro app, Participant Data is collected and used by the researcher. The researcher will only use Participant Data in the ways described in the Informed Consent Form that participants must sign prior to joining the study. 

Some studies require participants to identify themselves. Participation in any study is voluntary. If you are not comfortable providing the personal information that the researcher is requesting, then do not participate in the study. 

If you have given permission for QC Pro to passively collect your data, for example your step count or sleep data, and provide it as part of your Participant Data, then you must understand you are giving access to your historical data collected on your app as well, if you've given permission for this.

QC Pro transmits Participant Data but does not collect or use Participant Data for its own purposes, or retain Participant Data on its systems.

QC Pro does not knowingly or intentionally collect personal information from users who are under the age of 18.

Consent

Researchers will collect, use or disclose your personal information based on your consent, which they collect using the Informed Consent Form. Please review your Informed Consent Form or contact the researcher for more information about their use of your personal information. 

Who can see your personal information

A researcher will be able to see your Participant Data.

Quantified Citizen cannot see your Participant Data.

Other research participants cannot see your Participation Data. 

Retaining personal information 

Researchers will retain your personal information as described in their Informed Consent Form. Please review your Informed Consent Form or contact the researcher for more information about their use of your Participant Data. 

Ensuring accuracy

Please contact the researcher if you are concerned about the accuracy of your Participant Data.

Our Location

Our company and the services used to provide QC Pro are located in Canada. Researchers may be located worldwide. Please contact the researcher for more information on their location and the location of your Participant Data.

Securing Personal Information

Participant Data is transmitted to researchers using QC Pro. We use industry standard security practices and take reasonable steps to protect your personal information from unauthorized access, collection, use, disclosure, copying, modification or disposal or similar risks. We train our team to follow privacy and security practices, including the principles of privacy by design.

When you use QC Pro, some data is cached in the memory of the device. Cached data is encrypted and kept on the device as long as you are logged in, even if the application is put in the background. The data is deleted from the device when you sign out of the app and does not persist. Be careful about leaving any apps with personal information open on your device, as other people can access them. 

We review and update our security policies and controls as technology changes to ensure ongoing personal information security, however please bear in mind that no Internet or email transmission is ever fully secure or error free and no security system is impenetrable. We cannot fully guarantee the confidentiality of any information that you share with us.

Individual access

If you would like to access your Participant Data, please contact the researcher directly. QC Pro cannot identify research participants, so we cannot assist with requests to access Participant Data. 

Additional information

Email is not a secure method of communication. We cannot guarantee the security of email messages you send to us.

It’s important to guard your privacy when you are online. If QC Pro contains links to other websites, this Privacy Notice does not govern those websites. Whether we have posted those links or other organizations or individuals have, you should read their privacy policies and make an informed decision about whether you want to use those websites or their services.

Changes to this Privacy Notice

Quantified Citizen may amend this QC Pro Privacy Notice from time to time. We will post the date of the most recent changes and provide previous versions upon request. If we make significant changes, we will provide a more prominent notice (including notification through QC Pro if appropriate).

Questions and Complaints

You may send your privacy-related questions, concerns or complaints to our Privacy Officer who is responsible for ensuring our compliance with this notice and with the appropriate privacy legislation.

210-128 Hastings St. W

Vancouver, BC V6B 1G8

Canada

Email: privacy@quantifiedcitizen.com

If our Privacy Officer is unable to resolve the concern, you may also write to the Information and Privacy Commissioner of British Columbia.

Updates

Check back for updates soon!

Resources

This is a free, confidential, 24/7 hotline providing free mental health and substance use support. Their platform offers various services ranging from basic wellness information, to one-on-one sessions with a counselor, to participating in a community of support

These are 24-hour, free, support lines (via text medium) for people experiencing all kinds of crises, including suicidal thoughts. 

This is a 24-hour, toll-free, confidential suicide prevention hotline available to anyone in suicidal crisis or emotional distress. For Spanish (Español), dial 1-888-628-9454.  You can also use the Lifeline Chat on the web https://suicidepreventionlifeline.org/chat

  • Substance Abuse and Mental Health Services Administration National Helpline (USA): Call 800-662-HELP (4357)

This is a free, confidential, 24/7, 365-day-a-year treatment referral and information service (in English and Spanish) for individuals and families facing mental health and/or substance use challenges.

  • Fireside Project (USA): Call or text (3pm to 3am PST) 62-FIRESIDE > 623-473-7433

This is a peer support for those in the midst of psychedelic experiences, those sitting for others, and those integrating past psychedelic experiences. You can also access support via an app: https://firesideproject.org/app

This is an online directory of experienced providers, information about integration groups/circles, and online education in the psychedelic space. 

This organization represents nurses, at all levels of training, who work with patients utilizing therapeutic psychedelic medicines. They offer a list of clinical resources for those seeking integration and harm reduction, as well as psychedelic societies/communities, and professional organizations.