Intervention to Promote Survivor Resilience and Adjustment: Efficacy Evaluation

NCT01935583 | Completed

• 2 other identifiers: HM14738H133A120031
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.To evaluate the impact of treatment on emotional well-being and postinjury adjustment.
3. 3.To evaluate the impact of the intervention on abilities including problem solving, communication, and stress management.
4. 4.To examine the extent to which treatment benefits are sustained in the longer-term.

Conditions

Traumatic Brain Injury

Keywords

traumatic brain injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Mayo Portland Adaptability Inventory-4 (MPAI-4)

  Change from Baseline to Post-Treatment (5 weeks after Baseline)

Study Arms (2)

Resilience/Adjustment Counseling

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.

Behavioral: Resilience/Adjustment Counseling

Waitlist Control

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.

Interventions

Resilience/Adjustment Counseling BEHAVIORAL

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.

Resilience/Adjustment Counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• mild, moderate, or severe TBI
• able to understand and provide consent

You may not qualify if:

• active substance abusers (e.g., intoxicated at arrival to intake)
• at imminent risk of psychiatric hospitalization
• in imminent danger of hurting themselves or others

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Department of Health and Human Services: collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Jeffrey S Kreutzer, PhD

  Professor, Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2013
• First Posted: September 5, 2013
• Study Start: January 1, 2013
• Primary Completion: October 1, 2016
• Study Completion: September 30, 2017
• Last Updated: October 6, 2017

Record last verified: 2017-10

Locations

US (1)