About the Study

This study investigates the experiences of individuals who have identified as recovered or recovering from mental illness using a ketogenic diet. The research will also gather observations from family members about the recovery process when available. The goal is to understand how ketogenic diets contribute to mental health recovery through a qualitative retrospective analysis.

Study Title

Recovery from Mental Illness with Ketogenic Diets: A Qualitative Retrospective Analysis

Eligibility Criteria

Adults (18 years and older) or adolescents (ages 14-17) with signed parental consent.

Must be using or have used a ketogenic diet as part of treatment for mental illness.

Must have prior baseline and follow-up scores showing at least a 50% improvement on mood assessment (such as PHQ-9, GAD-7, DASS, PCL-5, or other validated instruments relevant to prior or existing diagnosis).

Stable in the use of the ketogenic diet and not currently receiving regular consultation from a dietary professional.

Self-reported confirmation of ketone levels at some point during the ketogenic diet treatment (through blood, breath, or urine).

Currently, self-identify as recovered or in the process of recovering from a mental illness categorized under DSM-V.

Must be physically present in the United States at the time of participation.

Study Details

Submission of previous mood assessment scores for eligibility verification.

Participation involves semi-structured interviews conducted via Zoom. Interviews will be video-recorded and auto-transcribed with consent.

Participants may consent to include family members who can provide additional insights into their recovery process. Individuals without participating family members can still participate.

Data Privacy and Confidentiality

All data collected will be handled with strict confidentiality and stored securely in compliance with HIPAA regulations.

Participation Benefits and Risks

While there may be no direct benefits, your participation will contribute to a better understanding of the role of ketogenic diets in mental health recovery. This information can inform future research and potentially guide the development of new treatment strategies.

Potential risks include the possibility that talking about past experiences with illness and topics related to the recovery process can be upsetting to participants.

IRB Approval

IRB Number: Expedited Review Approved: IRB #2596

This study’s human subjects’ protection protocols, as stated in the materials submitted, received research ethics review approval on 06/05/2024 in accordance with the requirements of the US Code of Federal Regulations for the Protection of Human Subjects (45CFR46 & 45CFR46.110) and were expedited by (7) Research on individual or group characteristics or behavior.

Approving Body: HML IRB is authorized by the U.S. Department of Health and Human Services, Office of Human Research Protections (IRB #00001211, IORG #0000850), and has DHHS Federal-Wide Assurance approval (FWA #00001102).

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