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Traumatic Brain InjuryBICS-T INCT04371211

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

A study testing Telemedicine Brain Injury Coping Skills in people with Traumatic Brain Injury and Coping Skills, run by Rehabilitation Hospital of Indiana at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Traumatic Brain Injury, Coping Skills
What is being tested?
Telemedicine Brain Injury Coping Skills
How many people
13 participants
Where
1 siteUnited States
Study dates
20 Sep 2018to 1 Jan 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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);
  • 18 years of age and older;
  • at least six months post-injury; and
  • able to speak English fluently.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Rehabilitation Hospital of Indiana

    Indianapolis, Indiana, 46268

Other trials in United States

About this study

Official title: Telemedicine Brain Injury Coping Skills (BICS-T) Support Group for Brain Injury Survivors and Their Caregivers: A Feasibility Study

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.

Read the 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.

Fourteen participants will be recruited. Participants with brain injury or caregivers of brain injury survivors who meet inclusion/exclusion criteria will be recruited by the research associate. At baseline, participants will be asked to come to the Rehabilitation Hospital of Indiana's Neuro Rehabilitation Center (RHI NRC) to collect study equipment and complete baseline data collection. First, participants will be provided an IPad and training on using the IPad and study software. Specifically, participants will be trained on turning on the IPad, finding the app for the study groups, signing into the app, and using the app to participate in the group sessions. A simulation session will also be provided to ensure participants can login, access the software, and interact during a session. After training, participants will be provided take home instructions and contact information for the research assistant for at home troubleshooting if needed. Also after training, the research assistant will ask participants to provide feedback on the training. The research assistant will also ask participants to complete some questionnaires during this visit including a survey including demographics as well as primary and secondary outcome measures. The visit is expected to take between one and two hours and this portion of the study will be completed face to face. Participants will then be asked to participate in BICS-T. BICS-T is a group intervention that will take place over telemedicine software on the IPad provided to participants. Sessions will occur once a week for 12 weeks. Each session will last two hours. This portion of the study is completed 100% on the IPad and will not require any transportation to NRC. After BICS-T is over (after all 12 sessions = 12 weeks), participants will be asked to return to RHI NRC to complete post-test surveys and return the equipment that participants receive after participants have completed the program. This final session is expected to take approximately two hours.

Being tested
Telemedicine Brain Injury Coping Skills
Medical subject headings
Brain Injuries, Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telemedicine Brain Injury Coping SkillsBehavioural

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Through study completion, up to 5 months

Secondary outcomes (7)
  1. The Group Climate Questionnaire

    This measure is the most commonly used group process instrument. It is a self-report, 12-item questionnaire that assesses the person's perceptions of the group's therapeutic environment. Items are scored on a 7-point Likert scale ranging from "Not at all" to "Extremely." The three subscales includes Engagement (the level of positive working group atmosphere), Conflict (the level of anger and tension in the group), and Avoidance (the level of behaviors indicating avoidance of personal responsibility of group work by the members). Higher scores are linked with greater perceived group cohesiveness and positive environment.

    Measured: Through study completion, up to 5 months

  2. The Client Satisfaction Questionnaire

    This measure determines perceived satisfaction with the program (e.g., To what extent has the investigator's program met your needs?) Have the services you received helped you to deal more effectively with your problems?) Scores range from 8-32 (higher scores indicate higher satisfaction).

    Measured: Through study completion, up to 5 months

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

    This measures a person's confidence in managing one's daily activities, emotions, medications/treatments, social interactions, and symptoms. Participants rate their level of confidence for various items on a scale of 1 (I am not at all confident) to 5 (I am very confident). Higher scores suggest greater self-efficacy.

    Measured: Through study completion, up to 5 months

  4. Quality of life after brain injury: scale

    This is a quality of life measure designed specifically for patients with brain injury. It measures patient's reported quality of life after their brain injury. Participants respond to items, indicating how satisfied they are with the items, using a scale from 1 (Not at all) to 5 (Very). Item scores are added up. Higher scores suggest greater quality of life.

    Measured: Through study completion, up to 5 months

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

    This is an evaluation of a person's overall quality of life based on physical limitations and ability to participate socially. Participants respond to various items using a scale of 1 (I am not at all confident) to 5 (I am very confident). Higher scores suggest greater quality of life.

    Measured: Through study completion, up to 5 months

  6. Therapeutic Factors Inventory

    This measures one's feeling of acceptance in a group setting, as well as sense of belonging, working together, trust, and caring. Participants respond to various items using a scale of 1 (Strongly disagree) to 7 (Strongly agree). Greater scores suggest greater feelings of support and group cohesion.

    Measured: Through study completion, up to 5 months

  7. Technology and Internet Assessment

    This is an assessment that evaluates a participant's strengths and weaknesses in understanding computers, the Internet, and information technology skills. Higher scores indicate greater use of and skills with the internet and technology.

    Measured: Through study completion, up to 5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2020
  2. Study start20 Sep 2018
  3. Primary completion1 Dec 2019
  4. Study completion1 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Feasibility Study
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04371211
Sponsor's protocol ID
1808716960
Acronym
BICS-T I
Status last verified
Nov 2025
First submitted
7 Aug 2019
Last updated
25 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Telemedicine Brain Injury Coping Skills in people with Traumatic Brain Injury and Coping Skills, run by Rehabilitation Hospital of Indiana at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Brain Injury Self-Efficacy Scale (time frame: Through study completion, up to 5 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.

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