N/A
Completed N=184
Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability
Source: ClinicalTrials.gov NCT03421964 ↗Enrolled (actual)
184
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcomePrimary: 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
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
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 | — |
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.
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. Informational only — not medical advice.