Finding studies
Finding studies
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Flavio Frohlich, PhD
CONTACT
Haileigh Taylor, BA
CONTACT
Lead
University of North Carolina, Chapel Hill
With
The purpose of this study is to primarily assess the feasibility and secondarily assess the efficacy of a single session intervention (SSI) that combines non-invasive brain stimulation and psychotherapy for Major Depressive Disorder (MDD). Investigators will recruit 30 people with MDD, with at least mild to moderate symptoms, who are resistant to typical interventions for Major Depressive Disorder. In this trial, participants will receive 3 interventions in a single session: psychotherapy, Intermittent Theta Burst Stimulation (iTBS), and participants will be randomized to receive either active or placebo Transcranial Alternating Current Stimulation (tACS). Additionally, Clinical assessments of depression symptoms are performed at Screening (for eligibility), Baseline (at start of day, prior to any intervention), Follow up 1 (FUP1); 2 weeks after SSI) and Follow up 2 (FUP2; 3 months after SSI). Additional assessments of anxiety symptoms, emotion regulation, clinical improvement and quality of life are included. Primary Objective: * Establish the safety, feasibility, and tolerability of the SSI Second Objective: * Establish the efficacy of the SSI for the treatment of depression symptoms by determining symptom reduction 2 weeks after completion of SSI. * Determine whether the combined effect of psychotherapy, TMS and tACS for treating depression reduces symptoms above and beyond TMS and therapy alone at FUP1. * Determine the longevity of intervention effectiveness (if effective) via follow up (FUP) timepoints for both groups and between groups by comparing scores at FUP1 to scores at FUP2
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
