Intervention to Promote Survivor Resilience and Adjustment: Efficacy Evaluation

Virginia Commonwealth University (VCU)

Status: Completed

Conditions: Traumatic Brain Injury

Treatments: Behavioral: Resilience/Adjustment Counseling

Study type: Interventional

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

Identifiers

NCT01935583

HM14738

H133A120031 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full description

To design effective resilience interventions, a treatment modality which is effective for traumatic brain injury (TBI) survivors is needed. Virginia Commonwealth University (VCU) researchers have had considerable success in the past several decades developing and evaluating interventions for neurobehavioral, cognitive, and vocational challenges after TBI. Researchers have demonstrated the utility of the curriculum-based (C-B) treatment structure in various settings. Additionally, the efficacy of the C-B structure, independent of postinjury timeframe, allows the flexibility necessary to address the unique consequences of TBI.

The C-B treatment modality offers a promising strategy for the promotion of resilience postinjury. The primary purpose of the study is to evaluate the efficacy of a structured, curriculum-based intervention to promote postinjury resilience and adjustment. Objectives include:

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

Enrollment: 164 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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164 participants in 2 patient groups

Resilience/Adjustment Counseling

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

Treatment:

Behavioral: Resilience/Adjustment Counseling

Waitlist Control

No Intervention group

Description:

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.