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Intervention to Promote Survivor Resilience and Adjustment: Efficacy Evaluation

Primary Purpose

Traumatic Brain Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resilience/Adjustment Counseling
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring traumatic brain injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Resilience/Adjustment Counseling

Waitlist Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 21, 2013
Last Updated
October 5, 2017
Sponsor
Virginia Commonwealth University
Collaborators
Department of Health and Human Services
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1. Study Identification

Unique Protocol Identification Number
NCT01935583
Brief Title
Intervention to Promote Survivor Resilience and Adjustment: Efficacy Evaluation
Official Title
Intervention to Promote Survivor Resilience and Adjustment: Efficacy Evaluation (a Research Project Within the Traumatic Brain Injury Model System Grant)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
September 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
Department of Health and Human Services

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate the short and longer-term efficacy of a structured outpatient intervention program (The Resilience and Adjustment Intervention, RAI) to improve survivors' resilience. To evaluate the impact of treatment on emotional well-being and postinjury adjustment. To evaluate the impact of the intervention on abilities including problem solving, communication, and stress management. To examine the extent to which treatment benefits are sustained in the longer-term.
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: to evaluate the short and longer-term efficacy of a structured outpatient intervention program (The Resilience and Adjustment Intervention, RAI) to improve survivors' resilience to evaluate the impact of treatment on emotional well-being and postinjury adjustment to evaluate the impact of the intervention on abilities including problem solving, communication, and stress management to examine the extent to which treatment benefits are sustained in the longer-term

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
traumatic brain injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
164 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Resilience/Adjustment Counseling
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Resilience/Adjustment Counseling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Connor-Davidson Resilience Scale-10 (CD-RISC-10)
Description
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.
Time Frame
Change from Baseline to Post-Treatment (5 weeks after Baseline)
Secondary Outcome Measure Information:
Title
Mayo Portland Adaptability Inventory-4 (MPAI-4)
Description
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.
Time Frame
Change from Baseline to Post-Treatment (5 weeks after Baseline)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey S Kreutzer, PhD
Organizational Affiliation
Professor, Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Intervention to Promote Survivor Resilience and Adjustment: Efficacy Evaluation

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