TOR-C 1 for Anxiety

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Massachusetts General Hospital, Boston, MA
Anxiety+5 More
TOR-C 1 - Behavioral
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

The investigator aims to conduct a pilot randomized controlled trial to test the feasibility of two symptom management programs for college-age individuals with recent concussions and anxiety, TOR-C 1 and TOR-C 2. The investigator will assess the feasibility of recruitment procedures (screening, eligibility, and enrollment) and data collection as well as the feasibility, credibility, and acceptability of the programs (adherence, retention, fidelity, and satisfaction), following prespecified benchmarks. Both programs will be delivered virtually (Zoom).

Eligible Conditions

  • Anxiety
  • Mild Traumatic Brain Injury (MTBI)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

10 Primary · 9 Secondary · Reporting Duration: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)

Baseline (0 Weeks)
Credibility and Expectancy Questionnaire
Feasibility of assessments at Baseline
Feasibility of recruitment
Week 12
Behavioral Response To Illness (BRIQ)
Cognitive And Affective Mindfulness Scale-Revised (CAMS-R)
Fear Avoidance Behavior After Traumatic Brain Injury (FAB-TBI)
Generalized Anxiety Disorder (GAD-7)
Hospital Anxiety And Depression Scale (HADS)
Numerical Rating Scale
Pain Catastophizing Scale (PCS)
Post-Concussion Symptom Scale
Who Disability Assessment Schedule 2.0 (WHODAS)
Collected during intervention
Adherence to homework
Adverse Events
Therapist adherence
Follow-up (12 Weeks)
Feasibility of assessments at Follow-up
Post-Test (4 Weeks)
Acceptability of treatment
Client Satisfaction Score
Feasibility of assessments at Post-Test

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

TOR-C 2
1 of 2
TOR-C 1
1 of 2
Active Control
Experimental Treatment

50 Total Participants · 2 Treatment Groups

Primary Treatment: TOR-C 1 · No Placebo Group · N/A

TOR-C 1
Behavioral
Experimental Group · 1 Intervention: TOR-C 1 · Intervention Types: Behavioral
TOR-C 2
Behavioral
ActiveComparator Group · 1 Intervention: TOR-C 2 · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline (0 weeks), post-test (4 weeks), follow-up (12 weeks)
Closest Location: Massachusetts General Hospital · Boston, MA
Photo of Massachusetts General Hospital 1Photo of Massachusetts General Hospital 2Photo of Massachusetts General Hospital 3
1993First Recorded Clinical Trial
15 TrialsResearching Anxiety
2430 CompletedClinical Trials

Who is running the clinical trial?

National Center for Complementary and Integrative Health (NCCIH)NIH
762 Previous Clinical Trials
640,656 Total Patients Enrolled
17 Trials studying Anxiety
4,171 Patients Enrolled for Anxiety
Massachusetts General HospitalLead Sponsor
2,660 Previous Clinical Trials
30,828,747 Total Patients Enrolled
23 Trials studying Anxiety
2,445 Patients Enrolled for Anxiety
Jonathan Greenberg, PhDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
52 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are male or female, ages 18-24

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.