Brain Injury Coping Skills - Telemedicine: Phase II

NCT04386655 | Completed

• 1 other identifier: 1902473107
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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).

Conditions

Traumatic Brain Injury; Coping Skills; Caregivers

Outcome Measures

Primary Outcomes (1)

• Brain Injury Self-Efficacy Scale (BICS-Q)

  This measure assesses perceived self-efficacy regarding a person's brain injury. Participants respond to each item using a scale from 0 (Not at all) to 4 (Extremely). Items are totaled and higher scores suggest greater perceived self-efficacy.

  Through study completion, up to 5 months

Secondary Outcomes (13)

• The Group Climate Questionnaire (GCQ)

  3 months

• Group Session Rating Scale (GSRS)

  3 months

• Patient-reported outcome measurement information system (PROMIS): General Self-Efficacy

  Through study completion, up to 5 months

• Quality of Life After Brain Injury (TBIQOL)

  Through study completion, up to 5 months

• Patient-reported outcome measurement information system (PROMIS): Health-Related Quality of Life (HRQL) Physical Function

  Through study completion, up to 5 months

Study Arms (2)

Telemedicine Group

EXPERIMENTAL

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

Behavioral: Brain Injur Coping Skills - Telemedicine

In-Person Group

ACTIVE COMPARATOR

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

Behavioral: Brain Injur Coping Skills - Telemedicine

Interventions

Brain Injur Coping Skills - Telemedicine 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; Telemedicine Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Devan Parrott: 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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director and Biostatistician

Model Details: Randomized Control Trial Approximately 50 survivors with brain injury who meet inclusion/exclusion criteria and their caregivers will be recruited. There will be 3 waves within one year. Each wave will be split into 2 groups. Half of the participants in each wave will attend a regular BICS program (in-person), while the other half will participate in a BICS-T program.

Study Record Dates

• First Submitted: August 8, 2019
• First Posted: May 13, 2020
• Study Start: March 28, 2019
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)