Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability

Virginia Commonwealth University (VCU)

Status: Completed

Conditions: Traumatic Brain Injury

Treatments: Behavioral: Resilience/Adjustment Counseling with Booster Sessions; Behavioral: Resilience/Adjustment Counseling

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03421964

HM20011840

90DPTB0005 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full 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).

Enrollment: 188 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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188 participants in 2 patient groups

Resilience/Adjustment Counseling

Active Comparator group

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

Treatment:

Behavioral: Resilience/Adjustment Counseling

Resilience/Adjustment Counseling with Booster Sessions

Experimental group

Description:

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.

Treatment:

Behavioral: Resilience/Adjustment Counseling with Booster Sessions