Treatment, Emotion, and Neuromodulation of Depression (TREND) Study
Purpose
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.
Condition
- Depression
Eligibility
- Eligible Ages
- Between 18 Years and 26 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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 - MRI contraindications: body shape/size too large to fit in scanner, claustrophobia, and ferromagnetic metal in the body - Pregnancy - Current use of Clozapine, Bupropion, or prescription stimulants - Current use of benzodiazepines or mood stabilizers - Body shape/size too large to fit in MRI scanner - Claustrophobia - Metal in the head or ferromagnetic metal in the rest of the body - Implanted medical devices - High-risk suicidality
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- The proposed study will use theta burst stimulation (TBS) in an open-label, non-randomized open study for young adults with depression. The study will include measurement of brain function before and after TBS to investigate treatment mechanisms. A subset of participants will also complete a training to enhance positive emotions.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Other TBS |
In this open-label trial, all participants will undergo 2 continuous TBS (cTBS) sessions per visit over 10 days (weekdays, over 2 weeks; total = 20 TBS sessions in 10 visits). The total time of each pair of sessions (including pause between sessions) will be approximately 1 hour, with each session lasting approximately 100 seconds. There is only 1 group and 1 arm of the study. All participants will receive the treatment. |
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Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Erika Forbes
Detailed Description
The study has a longitudinal design in which participants complete a baseline assessment, 20 theta burst stimulation (TBS) sessions, a post-TBS assessment, and a follow-up assessment 4 months later. Ideally, TBS sessions will be delivered twice/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.