NCT05436379

Treatment, Emotion, and Neuromodulation of Depression (TREND) Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Erika Forbes · Academic / Other
• Sex: All
• Age: 18 Years – 26 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Depression

Interventions

Type	Name	Description
DEVICE	Theta Burst Stimulation	TBS, a next-gen form of transcranial magnetic stimulation (TMS), requires shorter duration and frequency of stimulation and provides comparable clinical efficacy to traditional repetitive TMS for depression. Thus it is an appropriate technique for use with young adults with depression. TBS can be delivered safely and effectively on an accelerated schedule with two sessions/day. Based on an earlier (ongoing) study of TBS to dorsomedial prefrontal cortex, investigators will administer TBS to dmPFC over 2 weeks in young adults with depression. Addressing the behavioral aspects of anhedonia and reward processing, a subset of participants will also receive positive affect training. Magnetic resonance imaging will guide the personalized location of TBS and will be used to examine change in frontostriatal circuitry with TBS. This study has the potential to influence development of new treatments for depression and anhedonia, with possible mechanisms in frontostriatal brain function.

Timeline

• Start date: 2022-06-17
• Primary completion: 2025-11-30
• Completion: 2025-11-30
• First posted: 2022-06-29
• Last updated: 2025-12-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study