Brain Injury Coping Skills - Telemedicine: Phase II

NCT ID: NCT04386655

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-28
• Study Completion Date: 2020-08-01

Brief Summary

For phase II, the objective is to compare the effectiveness of BICS-T with the well-established BICS in-person group. Information gained from phase I (the feasibility study) was used to make necessary changes to the BICS-T protocol.

The purpose of this study is to provide survivors of brain injury and caregivers greater support and teach adaptive coping strategies, through a designed and studied a coping skills group specifically for brain injury survivors and their caregivers at the Rehabilitation Hospital of Indiana (RHI) called the Brain Injury Coping Skills group (BICS).

Detailed Description

Brain injury can be devastating for both patients and family members and can result in chronic difficulties in vocational, social, financial, as well as physical functioning. The occurrence of emotional and neurobehavioral challenges in individuals with brain injury is also common with research consistently showing links between these challenges and a person's overall rehabilitation outcome. Additionally, family functioning and caregiver well-being has been shown to influence rehabilitation outcome for a survivor after brain injury. In fact, individuals with families and caregivers who receive support and services, as well as learn adaptive coping strategies, are less likely to exhibit these marked levels of psychological distress.

In order to provide patients and caregivers greater support and teach adaptive coping strategies, the authors of this grant designed and studied a coping skills group specifically for brain injury survivors and their caregivers at the Rehabilitation Hospital of Indiana (RHI) called the Brain Injury Coping Skills group (BICS). BICS is a 12 session (one session per week), manualized, cognitive-behavioral treatment group designed to provide support, coping skills, and psychoeducation aimed to improve perceived self-efficacy (PSE) and emotional functioning. Perceived self-efficacy is the belief or confidence in one's ability to deal with the challenges related to a specific situation (e.g., brain injury). PSE has been found to be strongly linked to social participation, increased positive regard toward the caregiving role, and was found to be the greatest contributing factor to predicting life satisfaction. Cicerone and Azulay found that the greatest contribution to predicting life satisfaction was the person's PSE for managing their cognitive challenges.

Telemedicine is one possible option for rural patients. With increases in the availability of internet and electronic communication, patients now have immediate access to experts and treatment providers who specialize in brain injury. In fact, results from a needs assessment from Ricker and colleagues in 2002 identified telemedicine as a desired need of the brain injury community. To date, several studies have used telemedicine as an avenue to address brain injury rehabilitation for rural patients and caregivers.

For phase II, the objective is to compare the effectiveness of BICS-T with the well-established BICS in-person group. Information gained from phase I (the feasibility study) was used to make necessary changes to the BICS-T protocol.

Conditions

Traumatic Brain Injury; Coping Skills; Caregivers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Telemedicine Group

BICS-T is the intervention that will take place over telemedicine software on the iPad provided to participants

Group Type: EXPERIMENTAL

Brain Injur Coping Skills - Telemedicine

Intervention Type: BEHAVIORAL

BICS sessions (both in-person and telemedicine) will occur once a week for 12 weeks. Each session will last two hours.

Modules of BICS include: Introduction to Brain Injury, Expectations for Recovery, Tips on Managing Challenging Problems, Learning about Depression after the Brain Injury, The 4 R's of Stress Management, Communicating Effectively with Professionals

In-Person Group

Participants a part of the in-person BICS group will then come to the NRC for the following BICS sessions. This group is the traditional, in-person, BICS group

Group Type: ACTIVE_COMPARATOR

Brain Injur Coping Skills - Telemedicine

Intervention Type: BEHAVIORAL

BICS sessions (both in-person and telemedicine) will occur once a week for 12 weeks. Each session will last two hours.

Modules of BICS include: Introduction to Brain Injury, Expectations for Recovery, Tips on Managing Challenging Problems, Learning about Depression after the Brain Injury, The 4 R's of Stress Management, Communicating Effectively with Professionals

Interventions

Brain Injur Coping Skills - Telemedicine

BICS sessions (both in-person and telemedicine) will occur once a week for 12 weeks. Each session will last two hours.

Modules of BICS include: Introduction to Brain Injury, Expectations for Recovery, Tips on Managing Challenging Problems, Learning about Depression after the Brain Injury, The 4 R's of Stress Management, Communicating Effectively with Professionals

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Participants enrolled in the study will be (1) persons with a history of brain injury (e.g., Traumatic Brain Injury; TBI) or acquired BI (e.g., stroke, hypoxia, ruptured aneurysm, or metabolic encephalopathy) OR a caregiver of a brain injury survivor; (2) 18 years of age and older; and (3) at least six months post-injury. Since there is no reason to believe that treatment effectiveness varies with chronicity, no maximum has been set for time post-injury.

Exclusion Criteria

• Participants will not be included in the study if they present with the following: (1) at imminent risk of psychiatric breakdown, or in imminent danger of hurting themselves or others; (2) active psychosis; (3) aphasia that limits group participation; or (4) significant neurobehavioral difficulties that would be deemed disruptive to group participation.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Devan Parrott

OTHER

Sponsor Role: lead

Responsible Party

Devan Parrott

Director and Biostatistician

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Rehabilitation Hospital of Indiana

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

1902473107

Identifier Type: -

Identifier Source: org_study_id