Traumatic brain injury (TBI) is defined as any injury sustained by the head as a result of blunt or penetrating trauma, acceleration or deceleration forces [1]. It remains as a leading cause of mortality and morbidity worldwide [2]. In Malaysia, despite investment in various preventive efforts, the incidence of TBI continues to increase yearly [3]. In 2009, as many as 166,768 trauma cases were recorded in 8 hospitals in Malaysia, most cases (76.8%) being road traffic accidents [4]. A recent study reported an extremely high cost of treatment for patients with TBI in Malaysia. The estimated annual cost of treatment for 49 patients with TBI was as high as MYR 1.5 million (US $313840) [5]. In the long term, this would lead to an adverse impact on the social and economic development of the country.

The effects of TBI depend largely on the severity and location of the injury and the age and personality of the patient [1]. TBI will affect their self-care ability, employment capacity, and social functioning. Upon discharge from hospitals, most patients with moderate to severe levels of TBI would need to move back in with their families to receive the care they need [6,7]. Patients with severe TBI are unlikely to return to their previous employment as they require a significant amount of care [8]. As most of the patients with TBI are highly dependent, their caregivers are tasked with providing the necessary physical care for them. The caregivers are also constantly involved in any ongoing rehabilitation of the patients, for example, encouraging them to perform physiotherapy exercises and reminding them to take medication. Moreover, the caregivers need to deal with difficult behaviors and challenging emotional states of patients with TBI [9-12]. These extra demands can be unfavorable to the health and well-being of the caregivers.

Many studies have highlighted the importance of understanding the dynamics of TBI on caregivers. There is an extensive body of research on the effect of TBI on caregivers globally [13-22]. However, local data are scarce, as only a few studies have been conducted to assess the effects of TBI on Malaysian caregivers [23-25]. The available studies have found that most TBI caregivers in Malaysia reported high burden and poor life satisfaction as a result of caregiving activities [25]. Similarly, there is also a lack of information regarding the needs of caregivers of patients with TBI in developing countries. It was suggested that caregivers of patients with TBI should be provided a postdischarge rehabilitation program to reduce their burden as caregivers [25]. A systematic review has suggested that caregivers of patients with TBI should be prioritized in TBI rehabilitation [26], as evidence abounds on the benefits of intervention programs tailored for caregivers toward patients with TBI [27-30].

In Malaysia, there is a lack of specific or structured intervention programs focusing on the psychological well-being of caregivers of patients with TBI. Identifying caregivers at an increased risk of burden is important for preventing emotional distress and caregiver burden to improve care for both patients and caregivers. Therefore, it is important to design a proper intervention plan to improve the quality of life of caregivers of patients with TBI. Ultimately, this will result in better care and management of patients with TBI.

This study is based on 2 major theories, namely, the Family System Theory (FST) and Cognitive Behavior Therapy (CBT) [31].

The first theory, FST, assumes that the whole family is interconnected to one another [32]. For instance, if a family member is affected by TBI, the whole family system will also be affected [31]. Patients with TBI would most likely depend on their family members for activities of daily living, routine follow-up, rehabilitation, and financial support. This would increase the burden on the caregivers. Family members would also need to look for coping resources to overcome their problems [13,33,34]. As a result of the sudden changes in the family’s functioning, family members often reported a lack of coping skills, in addition to high levels of burden, anxiety, and emotional distress [17,33,35-40], thus resulting in a decrease in psychological well-being [19,41-43]. Therefore, Brain Injury Family Intervention (BIFI) incorporates family therapy techniques such as normalization and validation to assist patients with TBI and their families.

The second theory, CBT, is widely known for its use in treating various types of psychological disorders [44]. Several studies have applied CBT to provide psychological interventions to patients with TBI and their caregivers [28,45-50]. A systematic review revealed that CBT has a significant impact on improving the psychological well-being of TBI caregivers [32,45]. CBT would equip caregivers of patients with TBI with strategies to deal with psychological problems such as depression and anxiety [44]. A specific component of CBT would also be implemented in BIFI that covers important aspects such as psychoeducation, problem-solving skills, management of emotions, setting of realistic goals and expectations, and stress management.

This study aims to assess the effectiveness of BIFI in reducing emotional distress and burden of care, besides fulfilling the needs and increasing the life satisfaction of caregivers of patients with TBI in selected hospitals.

The hypotheses of this study are as follows:

This is a 2-arm, single-blinded, randomized controlled trial (RCT). All participants will be randomly assigned to the intervention group or control group. Only the investigators will be aware of the treatment allocation.

This study will be conducted at Hospital Rehabilitasi Cheras (HRC) and Hospital Sungai Buloh (HSB). These hospitals are the main referral hospitals for patients with TBI. A specific room in each site will be used for data collection. Figure 1 outlines the study flow according to CONSORT (Consolidated Standards of Reporting Trials) 2010.

A total of 100 participants were recruited for this study. Of the 100 participants, 50 (50%) were randomly assigned to the intervention and control groups, respectively. All caregivers of patients with TBI who attend follow-up with patients with TBI at the Neuro Rehabilitation outpatient clinic of HRC and HSB were screened for eligibility to participate in this study.

To be eligible, caregivers of patients with TBI must be citizens or permanent residents of Malaysia and be aged ≥18 years, regardless of their race, ethnicity, and sex. The participants must be able to read or write in Bahasa Malaysia or English. The caregivers can be the parents, spouses, siblings, sons or daughters, or relatives of the patients with TBI. Only 1 caregiver per patient with TBI can be recruited for the program. Time since injury for the patient with TBI must be >3 months and time spent on caring for the patients must be at least 2 hours per day. All types of injury severity were included. However, paid caregivers were excluded.

The participants may choose to withdraw at any point of time without any penalty. The participants may be withdrawn if the investigator believes that it is harmful or risky for the participants to continue.

Sample size estimation is based on the formula for clinical superiority trial [51]:

N=2x (Z_1–α + Z_1–β)² × S² / (δ–δ₀).

The sample size is calculated with 80% power (Z_1–β=0.845) at a significance level (α) of .05, with 95% CI (Z_1–α=1.96), 25% dropout rate, and medium size effect of 0.60. The parameters used in the formula will be based on a previous study [45], including δ²=9.355 (pooled SD) and depression (Beck Depression Inventory [BDI] score) δ–δ₀=5.86 (mean difference). According to the calculation, a total of 50 participants per arm will be needed for this study.

The parameter used to compute the prevalence of caregivers of patients with TBI was taken from the paper titled “Life satisfaction and strain among informal caregivers of patients with traumatic brain injury in Malaysia” [25].

In this formula, n=sample size, z=z statistic for the level of confidence, P=expected prevalence, and d²=allowable error. This formula assumes that P and d² are decimal values but would also hold true if they are percentages, except that the term, 1–P, in the numerator would become 100–P [52]:

N=Z² P (1–P) / d²

Percentage of caregiver’s burden=57.4%, level of significance=5%, power=80%, and d=0.05:

N=(1.96)² 0.574 (1 – 0.574) / 0.05²

N=376

This study aimed to assess eligibility for at least 376 caregivers of patients with TBI.

Data analysis will be performed using SPSS software (version 24.0; IBM Corp). Descriptive statistics will be used to describe the characteristics of participants. Continuous data will be reported as means and SDs or as medians and IQRs. Categorical data will be reported as percentages and frequencies. The comparison of the means between the 2 groups will be performed using a paired samples 2-tailed t test. In addition, 1-way ANOVA and repeated measure ANOVA will be conducted to identify any significant differences in mean scores of emotional distress (BDI), caregiver’s needs (Family Needs Questionnaire [FNQ]), burden of care (Caregiver Strain Index [CSI]), and life satisfaction (Satisfaction With Life Scale [SWLS]) before the intervention, after the intervention, at 3-month follow-up, and at 6-month follow-up between the intervention and control groups. Multivariate regression analysis will be used to determine the predictors of intervention outcomes.

The intention-to-treat analysis will be performed accordingly. Assumptions of normality and homogeneity of variance will be conducted and adjusted where necessary.

The BIFI manual has undergone several stages of thorough forward and backward translation, content review, and revision by a panel of local experts. The expert panel included 2 clinical psychologists, 1 certified translator (psychology content translator), and 2 rehabilitation physicians. All the panels had experience with working in the related fields for >5 years.

On the basis of the experts’ feedback and comments, a few changes were made to the module. The first change was the use of a more simple Malay language. The second change was related to the pictures used in the material. The experts suggested changing to universal pictures, so that they can be adapted locally.

The final product of the manual was revised to match the local population and to ensure the intervention’s fidelity.

A pilot study was conducted to assess the feasibility of the BIFI program among caregivers of patients with TBI in Malaysia. In total, 10 caregivers of patients with TBI participated, and only 8 (80%) managed to complete all 5 sessions. A caregiver withdrew owing to work commitments and another withdrew owing to personal issues. Challenges included (1) punctuality of the participants, (2) duration of the sessions, and (3) homework material.

Overall, participants were satisfied with the content and delivery of the program. Some suggested to increase the duration of the sessions and to reduce the amount of homework given. All feedback was taken into consideration, and slight alterations were performed to accommodate the participants and the program.

BIFI will be the main intervention tool. It is a structured intervention module specifically for patients with TBI and their caregivers, developed by Professor Dr Jeffry Kreutzer and colleagues from Virginia Commonwealth University, United States. This module is based on CBT [44] and FST [53].

This module consists of several objectives: (1) providing patients and caregivers with fundamental information about brain injury, (2) helping caregivers to better understand the effects of brain injury, (3) teaching patients and caregivers about problem-solving skills, (4) teaching coping strategies, (5) recognizing progress and personal strengths and helping them to access community and professional resources, and (6) teaching effective communication skills.

BIFI was designed to be implemented in 5 sessions, with 90 to 120 minutes for each session. In total, 2 or 3 topics will be covered in each session. Using a standardized and family-focused intervention, BIFI was found to be beneficial for caregivers of patients with TBI both immediately and at 3 months after the intervention [31,54,55]. Furthermore, another study also showed that patients with TBI and caregivers reported high ratings of helpfulness, goal attainment, and satisfaction regarding the BIFI program [55].

Several measures will be taken to ensure that all participants comply with the intervention program. The program would also be conducted during weekends to accommodate the schedule of caregivers of patients with TBI. They are also allowed to choose any day during weekends at their convenience. However, they are required to complete all 5 sessions within the stipulated time frame.

The control group or treatment-as-usual group will not receive any additional treatment during the study period. Participants in the control group will receive the usual treatment at their respective hospitals. According to the Malaysian Clinical Practice Guidelines for early management of head injury, all patients who have been discharged are recommended to attend follow-up sessions at the hospital [56]. It is recommended that patients with moderate and severe head injuries are scheduled for routine clinic follow-up. However, patients with a mild head injury can be followed up via clinic visits or telephone calls. Apart from the routine follow-up, other programs tailored for patients with TBI and their caregivers are also considered as treatment as usual in this RCT. For example, the Acquired Brain Injury Rehabilitation Unit in HRC would offer a program known as “Return to Work” for suitable patients and caregivers. A similar program is also available in HSB.

Recruitment for potential participants was conducted by the rehabilitation physicians at both hospitals, who are also the coinvestigators of the study. They screened for potential participants among the caregivers of patients with TBI who attend regular rehabilitation therapy and follow-up at their clinics. These caregivers were then invited to participate in this study. If the caregiver was interested in learning more about the study, they were led to another room, where the investigator explained the study in great detail and answered any questions that the caregivers had. At this stage, a patient information sheet about the nature of the study was provided to the potential participants.

The investigator then left the room for 10 to 15 minutes to allow the caregiver to read the information and to think about whether they would like to participate in the study. If they expressed interest in participating, they were asked to sign the consent form before completing the questionnaire. The same questionnaire used at baseline will be distributed immediately after the intervention, at 3-month follow-up, and at 6-month follow-up. The questionnaire will take approximately 30 to 40 minutes to complete. Data collection was performed between December 2018 and December 2020.

All the screening procedures to identify the participants based on inclusion and exclusion criteria were performed before the intervention program by rehabilitation physicians in the respective hospitals. The recruitment started in November 2018 and was continued until the required sample size was achieved. The BIFI program will be conducted in the Malay or English language depending on the needs of the caregivers. The participants in the intervention group will be divided into smaller groups of 10 people each. Each group will receive a scheduled time and date to attend the program at the hospital. The program will be conducted by the principal investigator, who is also a clinical psychologist. The clinical psychologist must at least have 5 years of experience.

At the baseline of the program (T1), all participants are required to complete the questionnaires (BDI, CSI, PANAS, FNQ, and SWLS). The same questionnaire will be distributed immediately after the intervention program (T2), at 3-month follow-up (T3), and at 6-month follow-up (T4). The average time needed to complete the questionnaire is 30 to 40 minutes. The follow-up sessions (T3 and T4) will be scheduled by the coinvestigators. The session will be conducted at the respective hospitals by the coinvestigators to prevent any bias during follow-up. The participants were also encouraged not to share the intervention materials with other caregivers until data collection is completed.

The intervention group will undergo the BIFI program. The BIFI program will be scheduled for 5 sessions as recommended by the developer of the module. Each session will take approximately 90 to 120 minutes. The participants are required to attend all 5 sessions. A total of 5 weeks is needed for each group to complete the program, and 2 groups will be scheduled every week. All the sessions will start with an overview of the topic and end with the summary and homework assignments. Participants will be required to complete the homework given according to the module. This homework will then be reviewed by the principal investigator in the subsequent session.

For the control group that receives the usual standard treatment, the caregivers will need to complete the questionnaires at similar time points as the intervention group.

Patients were involved during the early stage of cultural adaptation of the intervention program. The patients were invited to give their comments and feedback and review all the materials. Their valuable feedback was taken into account to ensure this program is suitable to the current culture and population.

The findings of this study will be published in an academic or medical journal, and they will be presented at academic conferences. Only the research team has access to the data. As with any anonymously obtained data, the participants will not be named in any of the study’s reports or publications. Permission from the Medical Research and Ethics Commission will be sought before publication.

In this study, we will be evaluating the effectiveness of BIFI in reducing the emotional distress and burden of care, fulfilling the needs, and increasing the life satisfaction of caregivers of patients with TBI. A total of 100 caregivers were recruited in this study. Most of the caregivers are women (70/100, 70%) and the remaining are men (30/100, 30%). The age range of the caregivers was between 22 and 55 years, with a mean age of 39.85 (SD 8.184) years. Most caregivers were Malay (65/100, 65%), followed by Chinese (21/100, 21%), Indians (12/100, 12%), and other races (2/100, 2%). Initial analysis showed promising result where there was significant reduction in emotional distress among caregivers (intervention group) immediately after the program and at the 3-month follow-up as compared with the control group.

This study also has limitations. It was observed that during the implementation of the program, most participants (90/100, 90%) requested the program to be conducted during the weekends, whereas others wanted it to be conducted during the weekdays. This was because some of them needed to arrange for the patient’s care if they were to attend the program. Hence, the program was conducted during weekends and weekdays to accommodate their request. The participants were allowed to choose when they wanted to attend the program. Owing to this issue, the intervention program took a long period to complete.

It is also important to address that data collection was conducted during the COVID-19 pandemic. The intervention program was halted for several months owing to Movement Control Order by the Malaysian Government. Therefore, participants were hesitant to visit the research site owing to fear of contracting COVID-19; the social distancing policy exacerbated this difficulty. It is hoped that future studies might to consider implementing intervention programs over the web to ease the participants. Web-based intervention program is another emerging approach and is more suited to current trends. However, web-based intervention versus physical intervention is still debated, and more studies are needed to answer this question.

To the best of our knowledge, this study would be among the first to use RCT methods to assess the effectiveness of BIFI in improving the psychological functioning of caregivers of patients with TBI in Malaysia. Perhaps, this module could be incorporated into the Return to Work program as standard clinical care and be made available to all. It is hoped that the results will provide more knowledge and scientific evidence to improve the rehabilitation services for patients with TBI and their caregivers.