Vivian W.L. Tsang , Brendan Tao , Raimey Olthuis , Pearl Allard , Saundarai Bhanot , Sandra Wong , Pamela Kryskow
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引用次数: 0
Abstract
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).
期刊介绍:
Founded in 1961 to report on the latest work in psychiatry and cognate disciplines, the Journal of Psychiatric Research is dedicated to innovative and timely studies of four important areas of research:
(1) clinical studies of all disciplines relating to psychiatric illness, as well as normal human behaviour, including biochemical, physiological, genetic, environmental, social, psychological and epidemiological factors;
(2) basic studies pertaining to psychiatry in such fields as neuropsychopharmacology, neuroendocrinology, electrophysiology, genetics, experimental psychology and epidemiology;
(3) the growing application of clinical laboratory techniques in psychiatry, including imagery and spectroscopy of the brain, molecular biology and computer sciences;