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Cognitive Behavioral Therapy

Waitlist Control for Traumatic Brain Injury

N/A
Waitlist Available
Led By Lauren B Fisher, PHD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study Summary

This trial is testing a cognitive behavioral treatment for major depressive disorder adapted for individuals with moderate to severe traumatic brain injury. The aim is to see if it is acceptable and tolerable, and if it works.

Eligible Conditions
  • Depression
  • Traumatic Brain Injury

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acceptability - satisfaction with treatment
Feasibility - drop out rates
Feasibility - randomization, recruitment rates
+1 more
Secondary outcome measures
Efficacy - Treatment Response [Inventory of Depressive Symptomatology - Clinician Rated (IDS-C)] (Exploratory Aim)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Waitlist ControlExperimental Treatment1 Intervention
Participants who are randomized to be put on a waitlist after screening. After 12 weeks of being on the waitlist, participants will be offered the Cognitive Behavioral Therapy for individuals with TBI
Group II: Active GroupActive Control1 Intervention
Participants who are randomized to begin the Cognitive Behavioral Therapy for individuals with TBI immediately after screening. This treatment is a version of Cognitive Behavioral Therapy (CBT) adapted specifically for patients who have experienced a moderate to severe Traumatic Brain Injury (TBI).

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,933 Previous Clinical Trials
13,198,439 Total Patients Enrolled
Spaulding Rehabilitation HospitalOTHER
135 Previous Clinical Trials
10,993 Total Patients Enrolled
Lauren B Fisher, PHDPrincipal InvestigatorMassachusetts General Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
JMIR Formative ResearchJournal
Transitioning from In-person to Remote Clinical Research on Depression and Traumatic Brain Injury During the COVID-19 Pandemic: Study Modifications and Preliminary Feasibility from a Randomized Controlled Pilot Study
Fisher, Lauren B, Sylvie Tuchman, Andrew J Curreri, Maggie Markgraf, Maren B Nyer, Paolo Cassano, Grant L Iverson, Maurizio Fava, Ross D Zafonte, and Paola Pedrelli. 2021. “Transitioning from In-person to Remote Clinical Research on Depression and Traumatic Brain Injury During the COVID-19 Pandemic: Study Modifications and Preliminary Feasibility from a Randomized Controlled Pilot Study”. JMIR Formative Research. JMIR Publications Inc.. doi:10.2196/28734.
clinicaltrials.govStudy
Adapted Cognitive Behavioral Treatment for Depression in Patients With Moderate to Severe Traumatic Brain Injury
Lauren Fisher 2017. "Adapted Cognitive Behavioral Treatment for Depression in Patients With Moderate to Severe Traumatic Brain Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03307070.
~8 spots leftby Apr 2025
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