MedTrace Logo

Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability

NCT03421964 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2025-03-27

Study results available
· View outcomes & findings →

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

Conditions

Interventions

BEHAVIORAL

Resilience/Adjustment Counseling

The Resilience and Adjustment Intervention (RAI) consists of seven 60-minute sessions scheduled over seven weeks. Before the first session, participants will be mailed an empty loose-leaf binder to store and organize completed self-assessments, reading materials, and homework assignments from each session. They will be asked to review materials and complete worksheets between sessions. The RAI will be implemented by experienced, licensed therapists.

BEHAVIORAL

Resilience/Adjustment Counseling with Booster Sessions

The Resilience and Adjustment Intervention (RAI) consists of seven 60-minute sessions scheduled over seven weeks. Before the first session, participants will be mailed an empty loose-leaf binder to store and organize completed self-assessments, reading materials, and homework assignments from each session. They will be asked to review materials and complete worksheets between sessions. For the "RAI+" participants, three booster sessions will be implemented. The three weekly booster sessions will be scheduled to start three months following completion of Session 7 of the RAI. The program will be implemented by experienced, licensed therapists.

Sponsors & Collaborators

  • National Institute on Disability, Independent Living, and Rehabilitation Research

    collaborator FED

  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • Nancy HSU · Virginia Commonwealth University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-16
Primary Completion
2023-05-25
Completion
2023-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03421964 on ClinicalTrials.gov