Traumatic Brain InjuryBICS-T-2NCT04386655
Brain Injury Coping Skills - Telemedicine: Phase II
A study testing Brain Injur Coping Skills - Telemedicine in people with Traumatic Brain Injury and Coping Skills, run by Devan Parrott at 1 site in United States.
Trial 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. 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, Caregivers
- What is being tested?
- Brain Injur Coping Skills - Telemedicine
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2019to 1 Aug 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
- 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.
Who cannot join
- 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.
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 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.
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).
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.
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
- Being tested
- Brain Injur Coping Skills - Telemedicine
- 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.
Brain Injur Coping Skills - TelemedicineBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine Group | Experimental | BICS-T is the intervention that will take place over telemedicine software on the iPad provided to participants Receives: 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 Receives: Behavioral: Brain Injur Coping Skills - Telemedicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, up to 5 months
Secondary outcomes (13)
The Group Climate Questionnaire (GCQ)
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).
Measured: 3 months
Group Session Rating Scale (GSRS)
This is a 4-item questionnaire that assesses a person's feelings and perceptions towards the group content and relationships. Items are measured on an analog scale, ranging from 1-10. The four items measure four different aspects of the group environment including: Relationship, Goals, Acceptability, and Overall Fit.
Measured: 3 months
Patient-reported outcome measurement information system (PROMIS): General Self-Efficacy
This measures a person's confidence in managing daily activities, emotions, medications/treatments, social interactions, and symptoms. Participants respond to each item using a scale from 1 (I am not at all confident) to 5 (I am very confident). Higher scores suggest higher perceived self-efficacy.
Measured: Through study completion, up to 5 months
Quality of Life After Brain Injury (TBIQOL)
This is a quality of life measure designed specifically for patients with brain injury. Participants respond to how satisfied they feel about each item using the following scale: 1 (Not at all), 2 (Slightly), 3 (Moderately), 4 (Quite), 5 (Very). Item scores are added and higher scores suggest higher perceived quality of life after brain injury.
Measured: Through study completion, up to 5 months
Patient-reported outcome measurement information system (PROMIS): Health-Related Quality of Life (HRQL) Physical Function
This is a part of an evaluation on a person's overall quality of life based on physical limitations and ability to participate socially. Participants rate each statement from 1 (unable to do) to 5 (without any difficulty). Higher scores suggest greater physical functioning ability.
Measured: Through study completion, up to 5 months
Patient-reported outcome measurement information system (PROMIS): Health-Related Quality of Life (HRQL) Anxiety scale
This is a part of an evaluation on a person's overall quality of life based on physical limitations and ability to participate socially. Participants rate each statement from 1 (Never) to 5 (Always). Higher scores suggest greater anxiety.
Measured: Through study completion, up to 5 months
Patient-reported outcome measurement information system (PROMIS): Health-Related Quality of Life (HRQL) Depression scale
This is a part of an evaluation on a person's overall quality of life based on physical limitations and ability to participate socially. Participants rate each statement from 1 (Never) to 5 (Always). Higher scores suggest greater depressive symptoms.
Measured: Through study completion, up to 5 months
Patient-reported outcome measurement information system (PROMIS): Health-Related Quality of Life (HRQL) Fatigue scale
This is a part of an evaluation on a person's overall quality of life based on physical limitations and ability to participate socially. Participants rate each statement from 1 (Not at all) to 5 (Very much). Higher scores suggest greater fatigue.
Measured: Through study completion, up to 5 months
Patient-reported outcome measurement information system (PROMIS): Health-Related Quality of Life (HRQL) Sleep Disturbance scale
This is a part of an evaluation on a person's overall quality of life based on physical limitations and ability to participate socially. Participants rate each statement from 1 (Not at all) to 5 (Very much). Higher scores suggest greater sleep disturbance (worse sleep).
Measured: Through study completion, up to 5 months
Patient-reported outcome measurement information system (PROMIS): Health-Related Quality of Life (HRQL) Ability to Participate in Social Roles and Activities scale
This is a part of an evaluation on a person's overall quality of life based on physical limitations and ability to participate socially. Participants rate each statement from 1 (Always) to 5 (Never). Higher scores suggest greater ability to participate in social roles and activities.
Measured: Through study completion, up to 5 months
Patient-reported outcome measurement information system (PROMIS): Health-Related Quality of Life (HRQL) Pain Interference scale
This is a part of an evaluation on a person's overall quality of life based on physical limitations and ability to participate socially. Participants rate each statement from 1 (Not at all) to 5 (Very much). Higher scores suggest greater likelihood that pain is interfering with the participant's every functioning.
Measured: Through study completion, up to 5 months
Patient-reported outcome measurement information system (PROMIS): Health-Related Quality of Life (HRQL) Pain Intensity scale
This is a part of an evaluation on a person's overall quality of life based on physical limitations and ability to participate socially. Participants rate their pain on a 0 to 10 scale (0 = no pain, 10 = worse pain imaginable).
Measured: Through study completion, up to 5 months
Therapeutic Factors Inventory (TFI)
This a 7-point Likert scale for group settings. It measures one's feeling of acceptance in a group setting, as well as sense of belonging, working together, trust, and caring. The scale ranges from 1 (Strongly Disagree) to 7 (Strongly Agree). Higher scores suggest greater positivity about group acceptance, trust, caring, and working together.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start28 Mar 2019
- Primary completion1 Aug 2020
- Study completion1 Aug 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Devan Parrott
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Devan Parrott, Rehabilitation Hospital of Indiana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04386655
- Sponsor's protocol ID
- 1902473107
- Acronym
- BICS-T-2
- Status last verified
- Nov 2025
- First submitted
- 8 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 Caregivers
- ClinicalTrials.gov ID
- NCT04386655
- Acronym / sponsor ID
- BICS-T-2 / 1902473107
- Conditions
- Traumatic Brain Injury, Coping Skills, Caregivers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Devan ParrottUniversity, hospital or other
- Study start
- 28 Mar 2019 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 13 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Telemedicine Group | Experimental | Behavioral: Brain Injur Coping Skills - TelemedicineBICS-T is the intervention that will take place over telemedicine software on the iPad provided to participants |
| In-Person Group | Active comparator | Behavioral: Brain Injur Coping Skills - TelemedicineParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Brain Injur Coping Skills - TelemedicineBICS 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 | Behavioural | In-Person Group, Telemedicine Group |
Primary outcome
Brain Injury Self-Efficacy Scale (BICS-Q)
Time frame: Through study completion, up to 5 months
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.
13 secondary outcomes
The Group Climate Questionnaire (GCQ)
Time frame: 3 months
Group Session Rating Scale (GSRS)
Time frame: 3 months
Patient-reported outcome measurement information system (PROMIS): General Self-Efficacy
Time frame: Through study completion, up to 5 months
Quality of Life After Brain Injury (TBIQOL)
Time frame: Through study completion, up to 5 months
Patient-reported outcome measurement information system (PROMIS): Health-Related Quality of Life (HRQL) Physical Function
Time frame: Through study completion, up to 5 months
Patient-reported outcome measurement information system (PROMIS): Health-Related Quality of Life (HRQL) Anxiety scale
Time frame: Through study completion, up to 5 months
Patient-reported outcome measurement information system (PROMIS): Health-Related Quality of Life (HRQL) Depression scale
Time frame: Through study completion, up to 5 months
Patient-reported outcome measurement information system (PROMIS): Health-Related Quality of Life (HRQL) Fatigue scale
Time frame: Through study completion, up to 5 months
Patient-reported outcome measurement information system (PROMIS): Health-Related Quality of Life (HRQL) Sleep Disturbance scale
Time frame: Through study completion, up to 5 months
Patient-reported outcome measurement information system (PROMIS): Health-Related Quality of Life (HRQL) Ability to Participate in Social Roles and Activities scale
Time frame: Through study completion, up to 5 months
Patient-reported outcome measurement information system (PROMIS): Health-Related Quality of Life (HRQL) Pain Interference scale
Time frame: Through study completion, up to 5 months
Patient-reported outcome measurement information system (PROMIS): Health-Related Quality of Life (HRQL) Pain Intensity scale
Time frame: Through study completion, up to 5 months
Therapeutic Factors Inventory (TFI)
Time frame: 3 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
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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 Brain Injur Coping Skills - Telemedicine in people with Traumatic Brain Injury and Coping Skills, run by Devan Parrott 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 1 inclusion and 1 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 (BICS-Q) (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.