Telemedicine Brain Injury Coping Skills (BICS-T) Support Group for Brain Injury Survivors and Their Caregivers

NCT04371211 | Completed

• 1 other identifier: 1808716960
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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.

Conditions

Traumatic Brain Injury; Coping Skills

Outcome Measures

Primary Outcomes (1)

• Brain Injury Self-Efficacy Scale

  Assesses perceived self-efficacy regarding a person's brain injury and proved responsive to treatment effects in the original BICS study. Participants identify how confident they are about various statements from 0 (Not at all) to 4 (Extremely). Item scores are totaled and higher scores suggest higher reported self-efficacy.

  Through study completion, up to 5 months

Secondary Outcomes (7)

• The Group Climate Questionnaire

  Through study completion, up to 5 months

• The Client Satisfaction Questionnaire

  Through study completion, up to 5 months

• Patient-reported outcome measurement information system (PROMIS): Self-efficacy for managing symptoms

  Through study completion, up to 5 months

• Quality of life after brain injury: scale

  Through study completion, up to 5 months

• Patient-reported outcome measurement information system (PROMIS): Health-related quality of life

  Through study completion, up to 5 months

Interventions

Telemedicine Brain Injury Coping Skills BEHAVIORAL

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. 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. For this study, the Brain Injury Coping Skills (BICS) group intervention will be administered electronically in a web-based group telemedicine platform, BICS-T. The purpose of this phase is to test the feasibility, participant training protocol, and ease of use of equipment and technology.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Persons with a history of brain injury (e.g., Traumatic Brain Injury; TBI) or acquired BI such as stroke, hypoxia, ruptured aneurysm, or metabolic encephalopathy);
• years of age and older;
• at least six months post-injury; and
• able to speak English fluently.

You may not qualify if:

• at imminent risk of psychiatric breakdown, or in imminent danger of hurting themselves or others;
• active psychosis;
• aphasia that limits group participation;
• significant neurobehavioral difficulties that would be deemed disruptive to group participation.

Sponsors & Collaborators

• Rehabilitation Hospital of Indiana: lead

Study Sites (1)

Rehabilitation Hospital of Indiana

Indianapolis, Indiana, 46268, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director and Biostatistician

Model Details: Feasibility Study

Study Record Dates

• First Submitted: August 7, 2019
• First Posted: May 1, 2020
• Study Start: September 20, 2018
• Primary Completion: December 1, 2019
• Study Completion: January 1, 2020
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)