Brief Summary

Mental illness rarely occurs as a single, easily categorized condition. Instead, multiple disorders often co-occur. This complicates the treatment plan for many Veterans, especially those suffering the most severe dysfunction. This also means that clinical research aimed at one specific disorder may not be optimized to treat the realworld presentation of neuropsychiatric illness. The investigators propose in this study to develop a novel, non-invasive brain stimulation treatment that would promote rehabilitation for Veterans suffering a wide range of emotional difficulties. More specifically, the investigators propose to up-regulate the brain circuitry that supports flexible problem solving and contending with daily demands. Rather than focusing on reducing the symptoms of a specific disorder to reduce the intrusion into daily life, the investigators propose to augment those brain circuits that promote adaptive cognition and thus quality of life.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_1

Timeline

Completed

Started Feb 2019

Longer than P75 for phase_1

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

4.7 years study duration

First Submitted

Initial submission to the registry

November 19, 2018

Completed

2 days until next milestone

First Posted

Study publicly available on registry

November 21, 2018

Completed

2 months until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed

4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2023

Completed

Last Updated

November 9, 2023

Status Verified

November 1, 2023

Enrollment Period

4.6 years

First QC Date

November 19, 2018

Last Update Submit

November 8, 2023

Conditions

Mental Health Depression rTMS Anxiety PTSD Psychosocial Impairment

Keywords

Depression

Outcome Measures

Primary Outcomes (3)

Inventory of Psychosocial Functioning (IPF)
The IPF is an 80-item self-report measure used to assess functional impairment across multiple psychosocial domains of functioning. It was iteratively developed in 697 male and female Veteran stakeholders to identify relevant domains of functional impairment common in PTSD and related psychiatric dysfunction. Total score range=0-480. Increased scores pre- to 4 weeks post-treatment would indicate improved function.
4 weeks post-treatment
World Health Organization Quality of Life - Brief Form (WHOQOL-BF)
The WHOQOL-BREF is a 26-item self-assessment form. Questions are rated on a 5 point scale (from 1-5) Likert scale. Reflects four domains: physical, psychological, social and environment.
4 weeks post-treatment
Illness Intrusiveness Rating Scale (IIRS)
The IIRS is a self-report measure of the extent of psychosocial impairment secondary to illness. Total score range=13-91. Decreased scores pre- to 4 weeks post-treatment would indicate improved function.
4 weeks post-treatment

Secondary Outcomes (4)

Neurocognitive performance
4 weeks post-treatment
Inventory of Depression and Anxious Symptoms (IDAS-II)
4 weeks post-treatment
Hamilton Scale for Depression (HAM-D)
4 weeks post-treatment
Mood and Anxiety Symptom Questionnaire (MASQ)
4 weeks post-treatment

Study Arms (10)

Dose 1

EXPERIMENTAL

All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 1 is five sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds.