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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Traumatic Brain Injury, Coping Skills
- 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.
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)
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
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
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
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
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
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
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.
- First posted1 May 2020
- Study start20 Sep 2018
- Primary completion1 Dec 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Rehabilitation Hospital of Indiana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Devan Parrott, Rehabilitation Hospital of Indiana
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemedicine Brain Injury Coping Skills (BICS-T) Support Group for Brain Injury Survivors and Their Caregivers: A Feasibility Study
- ClinicalTrials.gov ID
- NCT04371211
- Acronym / sponsor ID
- BICS-T I / 1808716960
- Conditions
- Traumatic Brain Injury, Coping Skills
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Rehabilitation Hospital of IndianaUniversity, hospital or other
- Study start
- 20 Sep 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 1 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- Feasibility Study
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telemedicine Brain Injury Coping SkillsBICS 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. | Behavioural | – |
Primary outcome
Brain Injury Self-Efficacy Scale
Time frame: Through study completion, up to 5 months
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.
7 secondary outcomes
The Group Climate Questionnaire
Time frame: Through study completion, up to 5 months
The Client Satisfaction Questionnaire
Time frame: Through study completion, up to 5 months
Patient-reported outcome measurement information system (PROMIS): Self-efficacy for managing symptoms
Time frame: Through study completion, up to 5 months
Quality of life after brain injury: scale
Time frame: Through study completion, up to 5 months
Patient-reported outcome measurement information system (PROMIS): Health-related quality of life
Time frame: Through study completion, up to 5 months
Therapeutic Factors Inventory
Time frame: Through study completion, up to 5 months
Technology and Internet Assessment
Time frame: Through study completion, up to 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Traumatic Brain Injury
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.