BACKGROUND: The Apollo wearable device (wrist or ankle) is an investigational device which provides touch therapy with silent vibrations that may help individuals reduce the symptoms of stress such as difficulty breathing, sleeping or focusing on tasks. Positive feedback from a mental health treatment program that uses ketamine-assisted therapy as a treatment adjunct inspired researchers to assess the impact of the Apollo Neuro device on anxiety levels, comparing those using the device with those not using the device.
METHODS: RTT-KAT is 12-weeks in length, with 30 min of curriculum, and 1.5 h of virtual CoP integration sessions each week. Patients receive group ketamine treatment at weeks 4,6,8 of the 12-week program. Intramuscular, gluteal, or deltoid injections of ketamine in the weight-based range of 0.5-1.5 mg/kg were used for each treatment. Doses ranged from 45 to 145 mg per session. 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 ANALYSIS: 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: Sixteen Apollo participants and 18 Control group participants were included in final analysis. 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 between the two groups. There was no significant difference (p = 0.572).
DISCUSSION: 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. However, with propensity-score balancing of baseline factors, there was no significant difference between the Apollo and Control groups (p = 0.63).
