Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability

Traumatic Brain Injury Clinical Trial

Official title:

Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03421964
• Other study ID #: HM20011840
• Secondary ID: 90DPTB0005
• Status: Completed
• Phase: N/A
• Start date: February 16, 2018
• Est. completion date: May 31, 2023

Study information

• Verified date: June 2023
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: May 31, 2023
• Est. primary completion date: May 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury

Intervention

Behavioral:
• Resilience/Adjustment Counseling
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.
• Resilience/Adjustment Counseling with Booster Sessions
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.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	National Institute on Disability, Independent Living, and Rehabilitation Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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, used in the present study, as demonstrating excellent psychometric properties, namely reliability, internal consistency, and construct validity.	Change from Baseline to Follow-Up (11 months after Baseline)
Secondary	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 focuses 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 Follow-Up (11 months after Baseline)
Secondary	Brief Symptom Inventory-18 (BSI-18)	This 18-item self-report instrument was developed to quantify psychological distress in the general population. A number of investigators have used the measure to quantify distress after TBI. In particular, researchers have used the BSI to monitor change in psychological status in response to treatment and general change in status over time. The BSI-18 is often used because of its sound psychometric properties, brevity, ease of administration, 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). T-scores are calculated based on community norms. The GSI score reflects the overall distress level and is the focus of the present investigation.	Change from Baseline to Follow-Up (11 months after Baseline)
Secondary	13 Item Stress Test	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.	Change from Baseline to Follow-Up (11 months after Baseline)