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

December 26, 2025 updated by: Erika Forbes
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • The University of Pittsburgh, Department of Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 26 years (Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: TBS

In this open-label trial, all participants will undergo 2 or 3 continuous TBS (cTBS) sessions per visit over 10 days (weekdays, over 2 weeks; total = 20 or 30 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
depression severity
Time Frame: up to 1 year
Score on the Montgomery-Asberg Depression Rating Scale (MADRS), administered by a study team member
up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erika Forbes

Investigators

  • Principal Investigator: Erika E Forbes, Ph.D, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2022

Primary Completion (Actual)

November 30, 2025

Study Completion (Actual)

November 30, 2025

Study Registration Dates

First Submitted

February 4, 2022

First Submitted That Met QC Criteria

June 24, 2022

First Posted (Actual)

June 29, 2022

Study Record Updates

Last Update Posted (Actual)

December 30, 2025

Last Update Submitted That Met QC Criteria

December 26, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY21060041

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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