Overview

This trial is active, not recruiting.

Condition traumatic brain injury
Treatment resilience/adjustment counseling
Sponsor Virginia Commonwealth University
Collaborator Department of Health and Human Services
Start date January 2013
End date October 2016
Trial size 164 participants
Trial identifier NCT01935583, H133A120031, H133A120031A

Summary

1. To evaluate the short and longer-term efficacy of a structured outpatient intervention program (The Resilience and Adjustment Intervention, RAI) to improve survivors' resilience.

2. To evaluate the impact of treatment on emotional well-being and postinjury adjustment.

3. To evaluate the impact of the intervention on abilities including problem solving, communication, and stress management.

4. To examine the extent to which treatment benefits are sustained in the longer-term.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Intervention to promote resilience and adjustment (RAI) - The RAI was developed based upon considerable clinical experience and research review. The RAI is a structured approach to helping individuals after brain injury address issues related to resilience and adjustment to injury. The RAI is implemented in seven, 60-minute, in-person sessions.
resilience/adjustment counseling
Intervention to promote individual's resilience and adjustment (RAI) - The RAI is a structured approach to helping individuals after brain injury address issues related to resilience and adjustment. The RAI is implemented in seven sessions. Each session is in-person and lasts for 60 minutes.
(No Intervention)
Individuals are randomly assigned to the treatment group or waitlist control (WLC) group. Individuals will complete the study measures on 2 occasions, 5 weeks apart. In fairness, WLC participants will then be offered the opportunity to participate in the intervention.

Primary Outcomes

Measure
Connor-Davidson Resilience Scale-10 (CD-RISC-10)
time frame: Change from Baseline to Post-Treatment (5 weeks after Baseline)

Secondary Outcomes

Measure
Mayo Portland Adaptability Inventory-4 (MPAI-4)
time frame: Change from Baseline to Post-Treatment (5 weeks after Baseline)

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - mild, moderate, or severe TBI - able to understand and provide consent Exclusion Criteria: - active substance abusers (e.g., intoxicated at arrival to intake) - at imminent risk of psychiatric hospitalization - in imminent danger of hurting themselves or others

Additional Information

Official title Intervention to Promote Survivor Resilience and Adjustment: Efficacy Evaluation (a Research Project Within the Traumatic Brain Injury Model System Grant)
Principal investigator Jeffrey S Kreutzer, PhD
Description To design effective resilience interventions, a treatment modality which is effective for traumatic brain injury (TBI) survivors is needed. Virginia Commonwealth University (VCU) researchers have had considerable success in the past several decades developing and evaluating interventions for neurobehavioral, cognitive, and vocational challenges after TBI. Researchers have demonstrated the utility of the curriculum-based (C-B) treatment structure in various settings. Additionally, the efficacy of the C-B structure, independent of postinjury timeframe, allows the flexibility necessary to address the unique consequences of TBI. The C-B treatment modality offers a promising strategy for the promotion of resilience postinjury. The primary purpose of the study is to evaluate the efficacy of a structured, curriculum-based intervention to promote postinjury resilience and adjustment. Objectives include: 1. to evaluate the short and longer-term efficacy of a structured outpatient intervention program (The Resilience and Adjustment Intervention, RAI) to improve survivors' resilience 2. to evaluate the impact of treatment on emotional well-being and postinjury adjustment 3. to evaluate the impact of the intervention on abilities including problem solving, communication, and stress management 4. to examine the extent to which treatment benefits are sustained in the longer-term
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Virginia Commonwealth University.