The Effect of the Apollo Neuro Device on Anxiety Among Participants who Underwent Ketamine Assisted Therapy: Non-randomized, Observational Cohort Study (Preprint)

Background: Positive feedback from a mental health treatment program that uses treatment adjuncts inspired researchers to assess the potential role of the Apollo Neuro device in mental health outcomes.

Objective: To assess the impact of the Apollo Neuro device on anxiety levels in a ketamine-assisted therapy treatment program, comparing those using the device with those not using the device.

Methods: This is a quantitative study where the primary outcome measure was the change in Generalized Anxiety Disorder 7-item (GAD-7) scores, calculated as the difference between pre-GAD-7 and post-GAD-7 scores between patients with and without the Apollo Neuro device. Data cleaning was performed to handle missing values and non-numeric entries. Propensity score matching was used to match participants from the "Apollo" and "Control" groups based on demographic and baseline GAD-7 scores. An independent sample t-test was conducted to compare the mean change in GAD-7 scores between the two groups.

Results: Shapiro test did not suggest non-normality of GAD-7 change over the duration of the treatment program. Without pre-balancing of age/sex/pre-gad-7, an independent Welch Two Sample t-test was conducted to compare the mean change in GAD-7 scores CONCLUSIONS Despite limitations of randomization and diversified participant groups, GAD-7 score analysis revealed median reduction in anxiety symptoms both with and without the Apollo Neuro device.