Effectiveness of Frequency-Specific Microcurrent (FSM) Therapy and Relaxation in Adults with Distress: A Pilot Randomized Controlled Trial.

Background: Somatic symptoms of stress are a major concern among the general population, given their severity and overall burden. Objectives: This pilot randomized controlled study (RCT) aimed to assess the effectiveness of frequency-specific microcurrent (FSM) therapy alone (experimental group 1 [EG1]) and combined with a relaxation intervention (experimental group 2 [EG2]), compared to a relaxation intervention alone (active control group [ACG]) and combined with placebo (passive control group [PCG]), to determine the need for a future definitive RCT. Methods: Participants with clinically significant levels of stress were recruited and assessed at three moments (i.e., baseline assessment [T0], at the end of six sessions [T1], and at the end of 12 sessions [T2]) on somatic symptoms and satisfaction with life (primary outcomes), perceived stress, emotional distress, emotional states, and emotion regulation (secondary outcomes). A total of 85 participants completed T0, of whom 58 were randomized into four groups. Results: Using linear mixed models, differences between groups revealed that the participants receiving FSM therapy reported fewer somatic symptoms and negative emotions than those who received relaxation, at T1. Within-group analysis showed that somatic symptoms and satisfaction with life significantly improved after six or twelve sessions of FSM therapy as well as after relaxation. There were also significant improvements in perceived stress, emotional distress, emotion regulation, and emotional states (negative emotions, self-efficacy, and serenity), after six and/or 12 sessions of FSM therapy or relaxation. Conclusions: The results suggest that FSM may be a promising treatment for addressing somatic complaints and negative emotional states, supporting the implementation of a definitive RCT.