Intervention to Promote Survivor Resilience and Adjustment: Efficacy Evaluation

Intervention to Promote Survivor Resilience and Adjustment: Efficacy Evaluation (a Research Project Within the Traumatic Brain Injury Model System Grant)

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.

Study Overview

• Status: Completed
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Behavioral: Resilience/Adjustment Counseling

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 164
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Resilience/Adjustment Counseling; 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.	Behavioral: 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: Waitlist Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Connor-Davidson Resilience Scale-10 (CD-RISC-10)	During the past decade, researchers have developed resilience measurement scales, and a recent review suggested that Connor and Davidson have been most successful. The authors first developed a 25 item scale (CD-RISC) reflecting resilience characteristics identified by Kobasa and Rutter. Normative studies including factor analyses indicated that the CD-RISC is reliable, valid, and sensitive to treatment effects. More recently, a 10-item version was developed using exploratory and confirmatory factors analyses. Respondents are presented with a series of descriptors (e.g., "I am able to adapt and change," "Coping with stress can strengthen me") and rate themselves on a 0 - 4 scale ranging from rarely true (0) to true nearly all the time (4). Campbell-Sills and colleagues have characterized the 10-item version, to be used in the present study, as demonstrating excellent psychometric properties, namely reliability, internal consistency, and construct validity.	Change from Baseline to Post-Treatment (5 weeks after Baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mayo Portland Adaptability Inventory-4 (MPAI-4)	The MPAI-4 is comprised of 30 items rated from 0 - 4 with higher scores indicating greater problem severity. Items are subdivided into three subscales reflecting emotional and behavioral self-regulation (Adjustment Index), cognitive and physical abilities (Ability Index), and community integration (Participation Index). T-scores are obtained based on norms derived from a brain injury sample. The present investigation will focus on the former two subscales. Adjustment Index items relate to anxiety, depression, irritability, anger, social interaction, and self-awareness. The Ability Index includes items relating to verbal and nonverbal communication and problem solving ability. Research has provided evidence of good concurrent, construct, and predictive validity as well as satisfactory internal consistency. Sensitivity to treatment-related change has also been substantiated.	Change from Baseline to Post-Treatment (5 weeks after Baseline)

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: Department of Health and Human Services

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (ACTUAL): October 1, 2016
• Study Completion (ACTUAL): September 30, 2017

Study Registration Dates

• First Submitted: August 21, 2013
• First Submitted That Met QC Criteria: August 30, 2013
• First Posted (ESTIMATE): September 5, 2013

Study Record Updates

• Last Update Posted (ACTUAL): October 6, 2017
• Last Update Submitted That Met QC Criteria: October 5, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: traumatic brain injury
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: HM14738; H133A120031 (OTHER_GRANT: NIDILRR)