Clinical trial NCT04371211: Telemedicine Brain Injury Coping Skills (BICS-T) Support Group for Brain Injury Survivors and Their Caregivers
Official title: Telemedicine Brain Injury Coping Skills (BICS-T) Support Group for Brain Injury Survivors and Their Caregivers: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Coping Skills
Lead sponsor: Rehabilitation Hospital of Indiana
Sponsor class: OTHER
First posted: 2020-05-01
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feasibility Study
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Brain Injury Self-Efficacy Scale
timeFrame: Through study completion, up to 5 months
Secondary outcomes:
measure: The Group Climate Questionnaire
timeFrame: Through study completion, up to 5 months
measure: The Client Satisfaction Questionnaire
timeFrame: Through study completion, up to 5 months
measure: Patient-reported outcome measurement information system (PROMIS): Self-efficacy for managing symptoms
timeFrame: Through study completion, up to 5 months
measure: Quality of life after brain injury: scale
timeFrame: Through study completion, up to 5 months
measure: Patient-reported outcome measurement information system (PROMIS): Health-related quality of life
timeFrame: Through study completion, up to 5 months
measure: Therapeutic Factors Inventory
timeFrame: Through study completion, up to 5 months
measure: Technology and Internet Assessment
timeFrame: Through study completion, up to 5 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Rehabilitation Hospital of Indiana
state: Indiana
Study officials:
References: