Abstract
Background
Family caregivers of individuals with substance use disorder (SUD) face significant challenges that can impact their well-being, coping abilities, and cognitive functioning. However, the empowerment of these caregivers often goes unnoticed, highlighting the need for supportive interventions.
Purpose
To develop and evaluate the effectiveness of a one-on-one intervention program for family caregivers of SUD patients using pre-test and post-test assessments.
Methods
A pilot study was conducted using a randomized controlled trial design with 40 family caregivers of individuals with SUD. Through a lottery method, participants were randomly assigned to either the control or experimental groups, with each group consisting of 20 caregivers. The intervention program consisted of 12 one-on-one sessions. Pre-test and post-test assessments utilized the Ryff Psychological Well-being Scale, Ways of Coping, revised by Lazarus and Folkman, the Hamilton Anxiety Rating Scale, and the Kingston Caregiver Stress Scale. Descriptive and inferential statistics were analyzed using SPSS software.
Results
Significant differences were observed between the control and experimental groups in psychological well-being, cognitive functioning, coping, anxiety, and stress (p < .01). The one-on-one intervention program significantly improved well-being and coping skills while reducing anxiety and stress levels. Consequently, the program empowered caregivers and enhanced their psychological resilience in the caregiving process.
Conclusion
The findings support the effectiveness of the one-on-one intervention program in enhancing the well-being, coping skills, cognitive functioning, anxiety, and stress levels of family caregivers of individuals with SUD. This intervention program has the potential to empower caregivers and enable them to better cope with the challenges they face in providing care.
Keywords
Introduction
Substance abuse and addiction have significant effects on family dynamics, causing disruptions in various negative ways. When a family member struggles with a substance use disorder (SUD), it often evokes a range of adverse emotions among other family members. Observing a loved one’s dependency on substances can be excruciatingly frustrating for family and friends. It is a typical response for family members to feel helpless as they witness their loved one sinking deeper into addiction. This helplessness is compounded by their uncertainty about effectively supporting their family member or addressing the issue. Family and friends of individuals struggling with substance use experience distress, feel overwhelmed, and are unsure of how to assist due to the complex nature of addiction. Family members and close friends closely connected to a substance user commonly experience a sense of powerlessness and confusion. It is crucial to acknowledge the emotional toll that SUDs take on the entire family system and the need for comprehensive support and intervention to address the challenges faced by family caregivers in these circumstances.1, 2
Family members who care for individuals with SUDs encounter a broad range of challenges. Caregiving brings forth a unique set of difficulties that significantly impact their lives. These challenges encompass experiencing high levels of stress and emotional burden. The constant worry and responsibility of caring for someone with SUD can take a toll on their mental and emotional well-being. Additionally, there is often a significant financial burden associated with providing care for a loved one with a SUD. Costs can result from medical expenses, therapy or treatment fees, and a potential loss of income due to reduced work capacity. This financial strain intensifies the stress and pressure experienced by family caregivers. Caring for someone with a SUD can also lead to social isolation, as family caregivers may find it challenging to connect with others who truly understand their experiences. 2 The stigma surrounding SUDs contributes to this isolation, as individuals may experience judgment or misunderstanding from their social circles. Furthermore, family caregivers may face a lack of knowledge and resources in understanding and managing the specific needs of individuals with SUDs, leaving them feeling ill-equipped and uncertain about the most effective ways to provide support. Balancing the role of the caregiver with other responsibilities, such as work, family, and personal obligations, presents another challenge. The demands of caregiving strain relationships and make it difficult for caregivers to find time for self-care and maintain a healthy work-life balance. Lastly, societal pressures and stigma associated with SUDs further compound the challenges faced by family caregivers, who may feel judged or blamed for their loved one’s addiction, adding an additional layer of emotional burden.2, 3
Moreover, studies have indicated that caregivers of individuals with SUDs experience cognitive failures, including difficulties with attention, memory, and decision-making, which can negatively impact their ability to provide effective care.4, 5 The family remains an essential source of connection and socialization in our society. Therefore, the impact of substance abuse problems on families and individuals necessitates careful consideration. The actions of substance users have wide-ranging effects on their loved ones, including disregarding fundamental needs such as disrupted connections, financial troubles, legal issues, emotional suffering, and even cruelty. Consequently, solely treating the individual with the dynamic condition of addiction is insufficient. 5 This approach disregards the impact of SUD patients on the family structure, leaving them untreated, and fails to recognize the family as a potential source of support for change. 2
A substance-dependent family member is affected by nearly every aspect of daily living, including interpersonal and social relationships, leisure activities, and finances. Substance dependence exacerbates conflicts, negatively impacts relatives, and burdens families.6, 7 The financial burden, a significant factor, is often borne by the patient’s family due to loss of income and the use of assets to acquire necessary medications. Indirect misfortunes can include the untimely death of an individual due to disease progression, injuries, or self-destructive behaviors associated with addiction, placing an additional burden on the family.8, 9 However, traditional treatment and intervention approaches for individuals with SUDs recognize the effectiveness of a family-focused approach. 10 Family intervention not only facilitates the entry of affected family members into treatment but also improves family functioning. It is crucial to address the needs of the family as part of the treatment process by providing support and guidance and enhancing the skills of family members. Family caregivers experience burdens due to time constraints, placing them at risk of various complications such as stress, anxiety, depression, communication problems, financial issues, and social deprivation, all of which can significantly impact their quality of life. 11 Therefore, the aim of the present study is to investigate the effects of psychosocial intervention and psychoeducation on family caregivers of individuals with SUDs.
Methods
The study comprised 40 family caregivers residing in Chennai, India, who were providing care for individuals diagnosed with SUD. A random sampling method was employed to select the participants, ensuring a fair representation of the population (Table 1). The research design used in the study was a randomized controlled trial where participants were randomly assigned to either the experimental or control groups. The experimental group received a proposed psychosocial intervention program consisting of 12 weekly sessions, each 60 min in duration. On the other hand, the control group received psychoeducation for the same duration and frequency.
Demographic Details of the Caregivers (n = 40).
The study involved the participation of caregivers who provided care to patients with SUDs, including those related to alcohol and tobacco (e.g., chewing or smoking). The inclusion criteria required that the patient be cared for by a family member who experienced moderate to severe burden in their caregiving role. The study included caregivers between the ages of 25 and 40 who were able to communicate effectively in Tamil or English. These criteria were established to ensure that the sample consisted of caregivers who were most affected by the burden of providing care for patients with SUDs.
The study excluded caregivers who provided care to other psychiatric patients with cannabis, hallucinogens, inhalants, opioids, sedatives, hypnotics, or other substances and only included those who provided care to patients with SUDs. Caregivers who experienced mild burdens in their caregiving roles were also excluded from the study. Furthermore, caregivers who were below 25 or above 40 years of age and those who could not speak or write fluently in Tamil or English were excluded from the study.
Procedure
Prior to enrollment in the study, participants received an explanation of the intervention and provided their consent after meeting the inclusion criteria. They were assured of their privacy and that their data would be used solely for scientific research purposes. A total of 40 family caregivers of individuals with SUD patients were enrolled in this study, and they were randomly assigned using the lottery method to either the experimental group (n = 20) or the control group (n = 20) using a randomized control trial. The experimental group received the psychosocial intervention, while the control group received the psychoeducation program.
The study was conducted over a period of 3 months, and data was collected before and after the intervention to examine its impact on family caregivers. Each group received 12 one-on-one sessions, with each session lasting 1 hour in a comfortable environment. Pre-test and post-test were conducted to assess the psychological well-being (PWB), cognitive functioning, caregiver stress, anxiety, and coping strategies of the caregivers. Both groups received 12 one-hour sessions of psychosocial intervention focusing on self-care, self-motivation, and self-healing, with PWB. Whereas the psychoeducation program focuses on understanding addiction and the role of family members. The intervention was designed for caregivers experiencing moderate-to-severe burdens.
Psychoeducation
It involves imparting knowledge about psychological concepts, specific problems, and the relationship between thinking, emotions, and behavior. The psychoeducation components of this study include information on the patient’s illness, treatment, relationship dynamics, communication, stress management, emotional regulation, acceptance and commitment, assertiveness, mindfulness-based stress reduction, and mindfulness-based cognition. The aim of this intervention is to enhance the interpersonal and intrapersonal skills of family caregivers.
The first session of the program is focused on pre-assessment, where the caregivers’ PWB, stress, anxiety, and coping methods are evaluated. The session also educates caregivers on understanding the illness of the patient, including the factors influencing SUD such as biological, psychological, and social factors. In the second session, the caregivers are provided with a recap of the previous session, and the focus is on educating primary caregivers on the symptoms and treatment of the illness. The third session further builds on the previous sessions by educating caregivers on understanding the behavior and changes in emotion of the patient and the treatment given to them.
The next three sessions are focused on developing healthy relationships, effective communication, and stress management. In the fourth session, caregivers are educated on the importance of maintaining healthy relationships with others, and in the fifth session, the focus shifts to communication and its role in caregiving. The sixth session aims to help caregivers understand the concept of stress management and the different techniques they can use to manage stress. The next two sessions focus on coping with reactive emotions and stress. The seventh session educates caregivers on understanding emotion and reactive emotion, along with techniques to reduce reactive emotion and dynamic emotional reactivity. The eighth session is focused on coping mechanisms and strategies to overcome negative situations.
In the ninth session, the focus shifts to assertiveness in communication and the benefits of assertive behavior, including stress reduction and better communication skills. The next two sessions focus on acceptance and commitment and mindfulness-based cognitive therapy. The 10th session encourages individuals to accept negative experiences and move on from them, while the 11th session focuses on cultivating awareness of thoughts, feelings, and emotions through mindfulness. The final session, mindfulness-based stress reduction, encourages caregivers to develop new hobbies and habits to deal with stressors in daily life, leading to improved interpersonal relationships and PWB.
Psychosocial Intervention
The intervention is based on Carol Ryff’s six-factor model of PWB. This model includes factors such as positive self-talk, self-acceptance, personal growth, personal mastery, positive relationships with others, autonomy, and purpose and meaning in life. Additionally, the intervention includes six components, namely self-exploration, coping skills, meditation, and time management. PWB is believed to be achieved by attaining a state of balance between challenging and rewarding life events. The strategies included in the intervention aim to reduce the stress and burden of caregiving and promote effective coping, which may help protect the caregiver’s health and well-being.
The 12 sessions in this intervention aim to help caregivers of individuals with SUD. In the first session, caregivers undergo a pre-assessment to determine their PWB, caregiver stress, anxiety, and coping strategies. The session covers the factors that influence SUD, such as biological, psychological, and social factors. The second and third sessions focus on positive self-talk and self-acceptance, respectively. The importance of personal growth is tackled in the fourth session, with an emphasis on gratitude toward life. In the fifth session, caregivers learn the benefits of meditation, its techniques, and a 5-min meditation activity. The sixth session tackles environmental mastery and how to manage life in negative surroundings. The seventh and eighth sessions focus on autonomy and self-exploration, respectively. Caregivers learn about the importance of positive relationships with others in the ninth session.
The 10th session focuses on coping skills, where caregivers learn about coping mechanisms and their types. They are encouraged to write about their strengths and weaknesses. The 11th session is about time management, and caregivers learn about the important factors of planning, prioritizing, and performing, and how managing time is equal to managing stress. In the last session, caregivers are introduced to the purpose and meaning of life, and they undergo relaxation and visualization activities. Overall, the 12 intervention sessions provide caregivers with various strategies to improve their PWB, cope with stress, and promote personal growth. The sessions utilize different methods, such as lectures, PowerPoint presentations, individual discussions, and individual activities, to cater to different learning styles. By learning these strategies, caregivers can better support their loved ones with SUD and maintain their emotional well-being.
Measures
Ryff’s PWB Scale
The Ryff’s Psychosocial Scale, developed by Carol D. Ryff, consists of 42 items measuring PWB. In this study, a shortened version of the scale comprising 18 items was used. The scale assesses six aspects of well-being and happiness: autonomy, environmental mastery, personal development, positive relationships with others, purpose in life, and self-acceptance. The reliability of the scale was established with a range of 0.70–0.78, and construct validity was confirmed. 12 Participants were asked to rate their level of agreement with each item using a response scale ranging from strongly agree (1) to strongly disagree (7). To calculate the subscale scores, the responses to each item within the subscale were summed for each participant. Higher scores on the scale indicated greater levels of PWB among the participants.13, 14
Ways of Coping
The Ways of Coping (WOC) scale was designed by Lazarus and Folkman. It serves as a measure of the coping processes utilized in specific stressful situations. It comprises 66 items that assess various coping strategies, including confrontation, distancing, self-control, social support, accepting responsibility, avoidance, problem-solving, and positive re-evaluation. The reliability of this scale ranged from 0.60 to 0.75 for each dimension. 15 To determine the total score for each subscale, the item scores within each scale were summed. The resulting total score for each subscale indicates the level of coping style, with higher scores indicating greater levels of coping ability among the participants. 16
Hamilton Anxiety Rating Scale
The Hamilton Anxiety Rating Scale (HARS) was developed by Hamilton as a measure of the severity of anxiety symptoms. The scale consists of 14 items, each defined by a series of symptoms, and it assesses both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complications related to anxiety). The reliability scores for psychic anxiety, somatic anxiety, and the overall scale are 0.74, 0.73, and 0.70, respectively. Concurrent validity has also been established for this scale. 17 Responses on the scale range from “not present” (0) to “very severe” (4). Each item is rated on a scale from 0 to 4, resulting in a total score ranging from 0 to 56. A score of 17 suggests mild severity, while scores of 18–24 indicate mild to moderate severity, and scores of 25–30 indicate moderate to severe anxiety. 18
Kingston Caregiver Stress Scale
The Kingston Caregiver Stress Scale (KCSS) was developed by R.W. Hopkins and L.A. Kilik as a measure of caregiver stress. It comprises 10 items that assess three categories: caregiver issues, family issues, and financial issues. Participants respond to each item on a scale ranging from 1 (no stress) to 5 (extreme stress), with higher scores indicating higher levels of caregiver stress. The scale has demonstrated construct validity and reliability, with an overall scale reliability of 0.88.19, 20
Cognitive Failure Questionnaire
The questionnaire assesses cognitive failures experienced in daily life, specifically focusing on perception, memory, and motor performance. The scale comprises 25 items and demonstrates a reliability of 0.71, indicating predictive and criterion validity. 21 Subsequent research has identified additional factors related to cognitive failures. Wallace et al. proposed a four-factor solution consisting of Memory, Distractibility, Blunders, and Names. Similarly, Rast et al. found the CFQ to have three factors: Forgetfulness, Distractibility, and False Triggering. To calculate scores for each factor, the scores of the individual items can be summed. The CFQ can be scored by totaling the ratings of the 25 individual items.22, 23
Statistical Analysis
The comparison between the control and experimental groups was examined by utilizing various statistical methods, including t-tests, and descriptive statistics. This analysis was conducted using IBM SPSS 26.0.
Results
Table 1 shows the demographic characteristics of the 40 caregivers who participated in the study, with 20 caregivers in the experimental group and 20 caregivers in the control group. In terms of gender, the experimental group had six males (30%) and 14 females (70%), while the control group had eight males (40%) and 12 females (60%). In terms of age, the highest percentage of participants in both groups were aged 31–35, with 11 caregivers (55%) in the experimental group and 12 caregivers (60%) in the control group. Regarding education qualifications, the experimental group had 11 caregivers (55%) with Bachelor’s degrees and nine caregivers (45%) with Master’s degrees, while the control group had eight caregivers (40%) with Bachelor’s degrees and 12 caregivers (60%) with Master’s degrees. In terms of socioeconomic status, the majority of caregivers in both groups belonged to the lower middle class, with 13 caregivers (65%) in the experimental group and 14 caregivers (70%) in the control group. The experimental group had three caregivers (15%) in the upper class, three caregivers (15%) in the upper middle class, and one caregiver (5%) in the lower class, while the control group had two caregivers (10%) in the upper class, four caregivers (20%) in the upper middle class, and none in the lower class. In terms of marital status, the experimental group had nine caregivers (45%) who were single and 11 caregivers (55%) who were married, while the control group had 12 caregivers (60%) who were single and eight caregivers (40%) who were married. Finally, in terms of relationship with the patient, the majority of caregivers in both groups were spouses, with 12 caregivers (60%) in the experimental group and ten caregivers (50%) in the control group, followed by siblings with five caregivers (25%) in the experimental group and six caregivers (30%) in the control group, and parents with three caregivers (15%) in the experimental group and four caregivers (20%) in the control group.
Table 2 presents the results of the pre-test and post-test of the PWB of family caregivers in the experimental and control groups. The results showed a significant improvement in the PWB of family caregivers in the experimental group for all domains of PWB (autonomy, environmental mastery, personal growth, positive relations, purpose in life, and self-acceptance), with t-values ranging from 4.94 to 9.00 and p-values ranging from 0.000 to 0.004. However, in the control group, there was only a significant improvement in the domains of personal growth and positive relations (t = 3.84, p = .012 and t = 3.250, p = .023, respectively). The independent t-test revealed that the mean scores of PWB in the experimental group were significantly higher than those in the control group for all domains of PWB (autonomy, environmental mastery, personal growth, positive relations, purpose in life, and self-acceptance), with t-values ranging from 6.10 to 9.00 and p-values ranging from .001 to .002. Therefore, it can be concluded that the intervention had a significant positive effect on the PWB of family caregivers in the experimental group compared to the control group.
Results of Pre-test and Post-test of Family Caregivers Psychological Well-being (n = 40).
Table 3 presents the results of the pre-test and post-test of family caregivers’ ways of coping in both the experimental and control groups. The results showed that the experimental group had significant improvements in confrontive coping (t = 6.22, p = .002), self-controlling coping (t = 2.835, p = .036), social support coping (t = 4.66, p = .006), and positive reappraisal coping (t = 5.93, p = .000) after the intervention. On the other hand, the control group did not show any significant changes in these coping styles. For the other coping styles, the experimental group did not show significant changes in distancing, accepting responsibility, or escape avoidance coping after the intervention. Similarly, the control group did not show significant changes in any of the coping styles. In conclusion, the psychosocial intervention program was effective in improving some coping styles of family caregivers of individuals with SUD.
Results of Pre-test and Post-test of Family Caregivers Ways of Coping (n = 40).
Table 4 presents the results of the pre-test and post-test of family caregivers’ stress and anxiety levels in both the experimental and control groups. The psychosocial intervention was effective in reducing the stress and anxiety levels of family caregivers of individuals with SUD. The experimental group showed significant improvements in stress (t = 3.24, p = .023) and anxiety (t = 12.47, p = .000) from the pre-test to the post-test. In contrast, the control group showed no significant changes in stress (t = 0.22, p = .833) and only marginal changes in anxiety (t = 3.37, p = .020) from the pre-test to the post-test.
Results of Pre-test and Post-test of Family Caregivers Stress and Anxiety (n = 40).
Table 5 presents the results of the three types of cognitive failures that were assessed: forgetfulness, distractibility, and false triggering. The pre-test mean scores for all three types of cognitive failures were similar between the experimental and control groups. However, after the intervention program, the experimental group had significantly lower mean scores for all three types of cognitive failures compared to the control group. Specifically, the experimental group showed significant improvements in forgetfulness (t = 5.05, p < .001), distractibility (t = 2.32, p < .001), and false triggering (t = 2.32, p = .025) compared to the control group. The post-test mean scores for forgetfulness and false triggering were significantly lower in the experimental group compared to the control group, but there was no significant difference between the two groups in the post-test mean scores for distractibility. Overall, the results suggest that the psychosocial intervention program was effective in reducing cognitive failures among family caregivers of individuals with SUDs.
Results of Pre-test and Post-test of Family Caregivers Cognitive Failures (n = 40).
Discussion
The presented study aimed to examine the effectiveness of a psychosocial intervention program and psychoeducation on the PWB, coping styles, stress, anxiety levels, and cognitive functioning of family caregivers of individuals with SUD. The study involved 40 caregivers, 20 in the experimental group (psychosocial intervention) and 20 in the control group (psychoeducation). The results showed that both groups had similar demographic characteristics in terms of gender, age, and marital status. However, there were some differences in education and socioeconomic status between the two groups. The experimental group had a higher percentage of caregivers with Master’s degrees and a higher percentage of caregivers belonging to the lower middle class compared to the control group. These differences could be considered as a potential confounding factor that may affect the results of the intervention.
The findings of the pre-test and post-test of PWB in both groups revealed that the experimental group showed significant improvements in all domains of PWB after the intervention, while the control group only showed significant improvements in personal growth and positive relations. The independent t-test showed that the mean scores of PWB in the experimental group were significantly higher than those in the control group in all domains. Similarly, the findings of the pre-test and post-test of coping styles in both groups showed that the experimental group had significant improvements in confrontive coping, self-controlling coping, social support coping, and positive reappraisal coping after the intervention, while the control group did not show any significant changes in these coping styles.
Stress and anxiety levels in both groups of the pre-test and post-test showed that the experimental group had significant improvements in stress and anxiety levels after the psychosocial intervention, while the control group only showed marginal improvements in anxiety levels. Similarly, forgetfulness, distractibility, and false triggering in both groups of the pre-test and post-test showed that the experimental group had significant improvements after the psychosocial intervention.
This study is the first to provide evidence of the impact of psychosocial intervention and psychoeducation on family caregivers of individuals with SUDs. The 12-week intervention program resulted in improved well-being and a significant reduction in anxiety and stress among caregivers. While a previous study also focused on improving caregiver well-being and reducing anxiety and stress, our study showed a greater reduction in anxiety. Caregivers in other studies had higher levels of distress 24 and mild depressive symptoms than those in our study, indicating that psychosocial interventions were effective in reducing caregiver stress. Our study showed an enhancement in various aspects of mental health and PWB, including coping strategies and stress management. Similar pilot studies have also explored the impact of interventions on caregiver stress and reported positive outcomes. For instance, Oken et al. conducted a randomized trial that utilized a mindfulness-based therapy program, with two active comparison groups and a respite-only group serving as a pragmatic control. 25
Numerous studies have demonstrated that various psychosocial interventions can improve the mental health of caregivers by reducing their burden. However, the effectiveness of these interventions varies significantly due to the magnitude of caregiver burden. 18 Given in the magnitude of the caregiver burden. Surprisingly, very few interventions translated into clinical practice. The financial burden of complex psychosocial in the community practice. Compared to previous reports, our pilot study results suggest that daily practice of the techniques can lead to an improvement in mental health.
Overall, the findings of this study suggest that the psychosocial intervention program was effective in improving the PWB, coping styles, stress, and anxiety levels of family caregivers of individuals with SUD. These findings have important implications for developing effective interventions to support the mental health and well-being of family caregivers of individuals with SUD. However, potential confounding factors such as education and socioeconomic status should be considered in future studies to strengthen the validity of the findings.
Conclusion
Based on the data presented in the study, it can be concluded that the psychosocial intervention program had a significant positive effect on the PWB, coping styles, stress and anxiety levels, and cognitive failures of family caregivers of individuals with SUD compared to the control group. The experimental group showed significant improvements in all domains of PWB, including confrontive coping, self-controlling coping, social support coping, positive reappraisal coping, stress, anxiety, and cognitive failures, while the control group only showed improvements in some domains of PWB, personal growth and positive relations, and marginal changes in anxiety levels.
The study had some limitations, including a small sample size of only 40 participants, reliance on self-reported measures, and a lack of follow-up beyond the post-test assessment. Future research should address these limitations by replicating the study with larger and more diverse samples, combining self-report measures with objective measures, and assessing the long-term effects of the intervention by following up with participants beyond the post-test assessment.
Footnotes
Abbreviations
CFQ, Cognitive Failures Questionnaire; HARS, Hamilton Anxiety Rating Scale; IBM, International Business Machines; KCSS, Kingston Caregiver Stress Scale; PWB, Psychological Well-being; SPSS, Statistical Package for the Social Sciences; SUD, Substance Use Disorder; WOC, Ways of Coping.
Authors’ Contributions
AK developed the study idea, collected, and prepared the manuscript, while CNR supervised the study and edited the manuscript. SS contributed to the preparation of the manuscript. KK analyzed the data and contributed to manuscript preparation.
Statement of Ethics
The study received approval from the Institutional Human Ethics Committee (IHEC-II/0157/22). Informed consent was obtained from all individual participants before they participated in the research.
Declaration of Conflicting Interests
The author declared no potential conflicts of interest with respect to the research, authorship and/or publication of this article.
Funding
The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The Chettinad Academy of Research and Education provided funding for this research through their Junior Research Fellowship (CARE-JRF) program with grant number 083/CARE/AR(Research@-Ph.D.-Program)/2020-16.
ICMJE Statement
This article complies with the International Committee of Medical Journal Editors (ICMJE) uniform requirements for the manuscript.
