Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability

Not Applicable

Completed

Conditions: Traumatic Brain Injury

Interventions: Behavioral: Resilience/Adjustment Counseling
Behavioral: Resilience/Adjustment Counseling with Booster Sessions

Registration Number: NCT03421964

Lead Sponsor: Virginia Commonwealth University

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

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. to evaluate the short and long-term impact of intervention on emotional well-being and postinjury adjustment with the RAI vs. the RAI+

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

Detailed Description: Participants will be assigned to either of two treatment groups: (1) Resilience and Adjustment Intervention (RAI), or (2) RAI+. After randomization, a second appointment will be scheduled. All participants will begin the 7-session treatment during their second appointment. The intervention consists of seven 60-minute sessions scheduled over seven weeks (see attached RAI Implementation Manual). The intervention will be implemented by experienced, licensed therapists (Ph.D. level Interventionists). Participants will be randomly assigned to one of the therapists.

The RAI and RAI+ groups will both complete the post-treatment measures immediately after the seventh treatment session and then 3, 4, and 9 months later. Data collection at 3, 4, and 9 months post-treatment will be completed via phone.

Furthermore, the RAI+ group will complete 3 booster sessions, spaced approximately 7-10 days apart, beginning 3 months after completion of the seventh treatment session (booster sessions will occur between the 3 and 4 month data collection described above).

Data will be analyzed to identify any therapist effects, as well as treatment effects. For the RAI and RAI+ groups, demographic, injury severity, and history information will be collected at intake using standard procedures and protocols. All participants will complete the 4 outcome measures (Connor-Davidson Resilience Scale, CD-RISC; Mayo Portland Adaptability Inventory-4, MPAI-4; 13 Item Stress Test; and Brief Symptom Inventory-18, BSI-18) at 5 time points (intake, post-treatment, and 3, 4 and 9 month follow-up).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 184

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Resilience/Adjustment Counseling	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 traumatic brain injury address issues related to resilience and adjustment to injury. The RAI is implemented in seven, 60-minute, virtual sessions.
Resilience/Adjustment Counseling with Booster Sessions	Resilience/Adjustment Counseling with Booster Sessions	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Mayo Portland Adaptability Inventory-4 (MPAI-4)	Change from Baseline to Follow-Up (11 months after Baseline)	Adjustment Subscale reflects emotional self-regulation; items relate to anxiety, depression, irritability, anger, social interaction, and self-awareness. Raw scores range from 0-46. Ability Subscale reflects cognitive and physical abilities, including verbal and nonverbal communication and problem-solving abilities. Raw scores range from 0-47. Adjustment Subscale: higher scores indicate greater severity. Ability Subscale: higher scores indicate greater problem severity. T scores between 40 and 60 would be considered average of people involved in rehabilitation following brain injury. T-scores between 40 and 50 may be considered in the mild to moderate range of overall severity compared to other people with ABI.; T-scores between 50 and 60, in the moderate to severe range. T-scores above 60 would suggest severe limitations even as compared to other people with ABI. T-scores between 30 and 40 suggest mild limitations. T-scores below 30 represent relatively good outcomes.
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)	The BSI-18 is used because of its sound psychometric properties, and global assessment of psychological issues commonly found in individuals with TBI. Frequency ratings for items in three primary symptom dimensions (Somatization, Depression, and Anxiety) are added to yield the Global Severity Index (GSI). The GSI score reflects the overall distress level and is the focus of the present investigation. Frequency ratings for items in three primary symptom dimensions (Somatization, Depression, and Anxiety) are added to yield the Global Severity Index (GSI). T-scores are calculated based on community norms (50 indicates the population mean with a standard deviation of 10). Higher T scores are indicative of greater symptom severity. Somatization subscale: (Raw scores range from 0-19+), Depression subscale: (Raw scores range from 0-23+), Anxiety subscale: (Raw scores range from 0-20+), Global Severity Index: (Raw scores range from 0-53+)
13 Item Stress Test	Change from Baseline to Follow-Up (11 months after Baseline)	This self-report measure was developed more than a decade ago for clinical research studies on stress management with survivors and caregiving family members. Sample items include, "I have more to do than I can handle," "I'm pushing myself too hard," and "I can't stand living like this." Items are rated as True (+1) or False (0) with higher scores indicating higher stress levels. The measure has been shown to be sensitive to family intervention after TBI.63,64 The Total Score is the measure of interest in the present investigation. Total raw score ranges from 0-13. Higher raw scores are indicative of increased distress. There are no subscales used in this measure.