Treatment, Emotion, and Neuromodulation of Depression (TREND) Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Depression
- Sponsor
- Erika Forbes
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- depression severity
- Status
- Completed
- Last Updated
- 4 months ago
Overview
Brief Summary
The investigators will administer theta burst stimulation (TBS) in efforts to observe a decrease in severity of reported depression symptoms. A subset of participants will receive positive affect training during this intervention.
Detailed Description
The study has a longitudinal design in which participants complete a baseline assessment, 20 or 30 theta burst stimulation (TBS) sessions, a post-TBS assessment, and a follow-up assessment 4 months later. Ideally, TBS sessions will be delivered two or three times a day, 5 days/week, for 2 weeks. This procedural design of a shorter treatment duration is based on findings of pattern of improvement and newly developed SAINT protocol. A subset of participants will receive training in enhancing positive affect, with 10 training sessions occurring between pairs of TBS sessions. In this study, "response" to intervention will be defined as a greater than 50% decrease in severity of depression symptoms reported by participants.
Investigators
Erika Forbes
Professor
University of Pittsburgh
Eligibility Criteria
Inclusion Criteria
- •Current Diagnostic and Statistical Manual (DSM-5) Depressive Disorder
Exclusion Criteria
- •Bipolar disorder (lifetime)
- •Obsessive-compulsive disorder (lifetime)
- •History of psychosis
- •Daily use of nicotine
- •Past-month use of cocaine, amphetamines, Methyl enedioxy methamphetamine (MDMA), Phencyclidine (PCP), Ketamine, or gamma-hydroxybutyrate (GHB)
- •Past 6 month substance use disorder
- •Binge drinking (using NIAAA criteria) within the past week, alcohol use in the past 12 hours
- •Neurological disorders: Epilepsy, Parkinson's Disease, brain tumor, brain injury, stroke
- •History of head trauma with a loss of consciousness (e.g., concussion)
- •History of seizures
Outcomes
Primary Outcomes
depression severity
Time Frame: up to 1 year
Score on the Montgomery-Asberg Depression Rating Scale (MADRS), administered by a study team member