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

Vivian W. L. Tsang, Brendan Tao, Raimey Olthuis, Pearl Allard, Saundarai Bhanot, Sandra Wong, Pamela Kryskow

DOI: 10.2196/preprints.79030 (opens in new tab)

Study at a glance

AI-extracted from the abstract
Characteristics Quantitative observational study
Population Patients in a ketamine-assisted therapy treatment program, divided into Apollo Neuro device users and non-users
Interventions Apollo Neuro device ketamine-assisted therapy
Measures Generalized Anxiety Disorder 7-item (GAD-7)
Topics Anxiety Esketamine Ketamine
Key findings The authors report that GAD-7 score analysis showed median reductions in anxiety symptoms both with and without the Apollo Neuro device, suggesting no clear added benefit of the device in this non-randomized comparison. They acknowledge limitations related to lack of randomization and participant diversity.

Abstract

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.

Comparable studies

Other observational and cohort studies on ketamine for anxiety, most cited first.

Study Year Design Participants
Treating bipolar depression with esketamine: Safety and effectiveness data from a naturalistic multicentric study on esketamine in bipolar versus unipolar treatment‐resistant depression Patients with treatment-resistant bipolar depression (B-TRD) and unipolar... 2023 Observational cohort n = 70
The effectiveness of ketamine on anxiety, irritability, and agitation: Implications for treating mixed features in adults with major depressive or bipolar disorder Adults with treatment-resistant major depressive disorder or bipolar disorder 2020 Retrospective analysis n = 201
At-home, sublingual ketamine telehealth is a safe and effective treatment for moderate to severe anxiety and depression: Findings from a large, prospective, open-label effectiveness trial. Outpatients receiving at-home ketamine-assisted therapy 2022 Prospective study n = 1,247
Predicting outcome with Intranasal Esketamine treatment: A machine-learning, three-month study in Treatment-Resistant Depression (ESK-LEARNING) Treatment-resistant depression patients 2023 Retrospective, multicentric, real-world study n = 149
Esketamine in treatment-resistant depression patients comorbid with substance-use disorder: A viewpoint on its safety and effectiveness in a subsample of patients from the REAL-ESK study Patients with treatment-resistant depression and a substance use disorder 2023 Observational, retrospective, multicentre study n = 26

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