N/A N=184 Randomized Treatment

Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability

Traumatic Brain Injury

Bottom Line

View on ClinicalTrials.gov: NCT03421964 ↗

Enrolled (actual)

184

Serious AEs

0.0%

Results posted

Mar 2025

Primary outcome: Primary: Number of Subjects Completing the Two Structured Outpatient Intervention Programs Resilience and Adjustment Intervention (RAI) vs. RAI With Follow-up Booster Sessions (RAI+) on Resilience — 12; 0 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Resilience/Adjustment Counseling (Behavioral); Resilience/Adjustment Counseling with Booster Sessions (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Virginia Commonwealth University
Primary completion: May 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Subjects Completing the Two Structured Outpatient Intervention Programs Resilience and Adjustment Intervention (RAI) vs. RAI With Follow-up Booster Sessions (RAI+) on Resilience	12; 0	—
SECONDARY Mayo Portland Adaptability Inventory-4 (MPAI-4)	-3.07; -4.42	—
SECONDARY Brief Symptom Inventory-18 (BSI-18), 18-item Self-report Instrument Was Developed to Quantify Psychological Distress in the General Population	-7.6; -7.72	—
SECONDARY 13 Item Stress Test	-1.47; -1.9	—

Summary

The aims of this traumatic brain injury (TBI) study are: 1. to evaluate the short and long-term efficacy of two structured outpatient intervention programs, Resilience and Adjustment Intervention (RAI) vs. RAI with follow up booster sessions (RAI+) on resilience 2. to evaluate the short and long-term impact of intervention on emotional well-being and postinjury adjustment with the RAI vs. the RAI+ 3. to evaluate the short and long-term impact of the RAI and the RAI+ on abilities including problem solving, communication, and stress management 4. to determine if demographic, lifestyle, injury, or treatment response information can predict maintenance of gains

Eligibility Criteria

Inclusion Criteria

Mild, moderate, or severe TBI defined as: damage to brain tissue caused by an external mechanical force as evidenced by loss of consciousness due to brain trauma, post-traumatic amnesia (PTA), skull fracture, or objective neurological findings that can be reasonably attributed to TBI on physical examination or mental status examination.
At least 3 months post-TBI.

Exclusion Criteria

Active substance abusers (e.g., intoxicated at arrival to intake).
Individuals at imminent risk of psychiatric hospitalization, or in imminent danger of hurting themselves or others, as judged by the investigators, will be excluded from the study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03421964). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.