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The effect of the Apollo Neuro device on anxiety among participants who underwent ketamine assisted therapy.

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

Journal of Psychiatric Research November 1, 2025 DOI: 10.1016/j.jpsychires.2025.09.032 (opens in new tab)

Study at a glance

AI-extracted from the abstract
Characteristics Observational cohort with propensity score matching Peer reviewed
Sample size 34
Population Participants in a mental health treatment program using ketamine-assisted therapy
Intervention Ketamine-assisted therapy
Dose 0.5-1.5 mg/kg intramuscular, gluteal, or deltoid injections; doses ranged from 45 to 145 mg per session
Duration 12-week program with group ketamine treatments at weeks 4, 6, and 8
Topics Anxiety Esketamine Ketamine
Keywords Anxiety reduction Apollo neuro device Gad-7 Ketamine-assisted therapy Wearable technology
Key findings Use of the Apollo Neuro device did not significantly reduce anxiety symptoms compared to no device in a ketamine-assisted therapy program.

Abstract

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. 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 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. 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). 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).

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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