The present study was approved by the Croce e Carle hospital ethics committee, Cuneo, Italy, and registered at the Australian New Zealand Clinical Trials Register. The study was conducted according to the principles of the Declaration of Helsinki.
Twenty-four outpatients (20 females and four males, mean age 46.7 ± 8.9 years) diagnosed with GAD-MD using current Diagnostic and Statistical Manual of Mental Disorders Fourth Revision criteria and the Symptom Checklist-90-Revised (SCL-90R)35 (link),36 (link) participated in the study. The patients were being treated at the Psychiatric Hospital of Cuneo, Italy. All patients were dissatisfied with the results of their ongoing medical treatment of serotonin and noradrenaline reuptake inhibitors or selective serotonin reuptake inhibitors at a standard dose and duration of treatment. All participants were maintained on their current pharmacological treatment. At baseline (T0), the average 21-item Hamilton Depression (HAM-D)37 (link) rating scale score was 15.5 ± 4.6, corresponding to a “mild” level of severity. The SCL-90R and HAM-D were administered prior to and after a standard cycle of REAC treatments (one Neuro Postural Optimization32 (link) followed by 18 Neuro Psycho Physical Optimization32 (link) sessions). Nine SCL-90R clusters were examined, ie, somatization, obsession-compulsion, interpersonal sensitivity, depression, anxiety, anger-hostility, phobic anxiety, paranoid ideation, and psychotic behavior. The SCL-90R was specifically used due to its greater sensitivity to critical clinical aspects of anxiety (ie, interpersonal sensitivity and phobic anxiety) than the classic Hamilton Anxiety Scale (HAM-A).38 (link) In addition, the overlap between HAM-D and HAM-A is well known.
REAC25 ,26 was applied using a medical device based on an innovative biostimulation technology. REAC typically runs within a frequency range of 2.4, 5.8, or 10.5 gHz. For the current study, a frequency of 10.5 gHz, with a specific absorption rate of 7 μW/kg, was used. The REAC pulse protocol was seven radiofrequency bursts of 500 msec each, applied by touching the metallic tip of the REAC probe (Convogliatore di Radianza Modulante, Asmed, Italy) to the ear pavilion using Neuro Postural Optimization and Neuro Psycho Physical Optimization protocols which have been described in detail elsewhere.31 –34 (link) The time interval from the initial clinical assessment until the last Neuro Psycho Physical Optimization session was approximately one month. Data were analyzed with t-tests, Wilcoxon signed-rank tests and Sign-tests. Statistical significance was set at P < 0.05.