Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability

NCT03421964 | Completed Results

• 2 other identifiers: HM2001184090DPTB0005
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

Brief Summary

The aims of this traumatic brain injury (TBI) study are:

1. 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. 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. 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. 4.to determine if demographic, lifestyle, injury, or treatment response information can predict maintenance of gains

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• Number of Subjects Completing the Two Structured Outpatient Intervention Programs Resilience and Adjustment Intervention (RAI) vs. RAI With Follow-up Booster Sessions (RAI+) on Resilience

  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. The RAI is implemented in a seven-session format with two or three topics covered during each 60-minute session. Sessions focus on skill-building to help clients enhance existing skills and develop new skills; psychological support through offering empathy, encouragement, and hope; and education via instruction and discussion. This measure is being quantitatively measured by the number of subjects that completed the assessment for each arm.

  Data collection will be after the 7th treatment session and at 3,4 and 9 months post-treatment

Secondary Outcomes (3)

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

  Change from Baseline to Follow-Up (11 months after Baseline)

• Brief Symptom Inventory-18 (BSI-18), 18-item Self-report Instrument Was Developed to Quantify Psychological Distress in the General Population

  Change from Baseline to Follow-Up (11 months after Baseline)

• 13 Item Stress Test

  Change from Baseline to Follow-Up (11 months after Baseline)

Study Arms (2)

Resilience/Adjustment Counseling

ACTIVE COMPARATOR

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 traumatic brain injury address issues related to resilience and adjustment to injury. The RAI is implemented in seven, 60-minute, virtual sessions.

Behavioral: Resilience/Adjustment Counseling

Resilience/Adjustment Counseling with Booster Sessions

EXPERIMENTAL

Intervention to promote resilience and adjustment (RAI) is implemented in seven, 60-minute, virtual sessions; however individuals within this study arm will receive three additional 60-minute, virtual sessions three months after completing the seven initial sessions. The three booster sessions provide an opportunity for individuals to review course content, consolidate gains, and discuss challenges.

Behavioral: Resilience/Adjustment Counseling with Booster Sessions

Interventions

Resilience/Adjustment Counseling BEHAVIORAL

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.

Also known as: RAI

Resilience/Adjustment Counseling

Resilience/Adjustment Counseling with Booster Sessions BEHAVIORAL

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.

Also known as: RAI+

Resilience/Adjustment Counseling with Booster Sessions

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 defined as: damage to brain tissue caused by an external mechanical force as evidenced by loss of consciousness due to brain trauma, post-traumatic amnesia (PTA), skull fracture, or objective neurological findings that can be reasonably attributed to TBI on physical examination or mental status examination.
• At least 3 months post-TBI.

You may not qualify if:

• Active substance abusers (e.g., intoxicated at arrival to intake).
• Individuals at imminent risk of psychiatric hospitalization, or in imminent danger of hurting themselves or others, as judged by the investigators, will be excluded from the study.

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• National Institute on Disability, Independent Living, and Rehabilitation Research: 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

Results Point of Contact

• Title: Nancy Hsu, PsyD, PI
• Organization: Virginia Commonwealth University

nancy.hsu@vcuhealth.org

804-327-1166

Study Officials

• Nancy HSU

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: January 29, 2018
• First Posted: February 5, 2018
• Study Start: February 16, 2018
• Primary Completion: May 25, 2023
• Study Completion: May 31, 2023
• Last Updated: March 27, 2025
• Results First Posted: March 27, 2025

Record last verified: 2025-03

Locations

US (1)