Study Design
A quantitative research study, using a double-arm quasi-experimental, controlled, pretest-posttest design (Chugani et al., 2020; Huang et al., 2022; Zhang et al., 2022) will be used for comparing two groups [intervention group and wait-list control group]. Randomization will be less feasible in the current study because this will be conducted in a singular setting within a narrow time frame. Rogers and Revesz (2019) claim that in a quasi-experimental study, the researcher evaluates the effect of the intervention and it allows comparison between two groups when blinding and randomization is not possible (Polit & Beck, 2020). This study design will be deemed the best for examining the research question, which will be to evaluate the effectiveness of psychosocial interventions on mental health and well-being in families. The six-month study, which began in March, after getting ERC approval, and ended in August 2023, will be divided into three phases. Phase I involved developing the psycho-social intervention and testing its validity, while Phase II evaluated its effectiveness (Zaheer et al., 2020). Phase III is to assess the feasibility and practicality of the psycho-social interventions.
Phase I: Module Development
This phase comprised the procedure of module development including, objectives, lesson plan, content, activities, and time allocated to each session. The primary investigator developed a 9-hour module per session (6 sessions) based on a literature review of published articles and the input of experts(Zaheer et al., 2020).
Phase II: Intervention and Evaluation Phase
The participants will be divided into two groups.
Wait-list Control Group. The women who fulfilled the eligibility criteria will be recruited in the control arm after obtaining their consent. They will be assessed for demographics, given a preintervention questionnaire at 0 weeks (T1), and will be provided with a booklet on self-care strategies, (refer to Annexure E), data will be allocated at 0 weeks, post-intervention I at 6th week (T2), and Post-intervention II at 12th weeks (T3). They will be given the same treatment after the completion of the study. This strategy will be adopted because it is commonly anticipated that intervention would benefit all parties and would overcome the ethical dilemma of the untreated control group. Ramaswamy et al. (2017) employed a similar strategy to promote cervical health literacy among jailed women in a quasi-experimental study done in Kansas City, United States.
Intervention group. The women who met the eligibility criteria will be recruited in the intervention arm. They will be assessed for demographics and given the pre-intervention questionnaire by the primary investigator at T1. The psychosocial intervention will be provided face to face to each woman in a group of four for about 6 weeks (90 min each) and then post-intervention data I (T2), and post-intervention data II, at the 12th week (T3) will be collected accordingly. The timing of the intervention delivery will be contingent upon the availability of the participants (refer to the tabulated view of the study Plan in Table 1). Furthermore, participants in the experimental group received the same booklet as those in the control group.
Study Population and Study Setting
Study population. The females of bereaved' families (18 years and above, wife, mother, daughters, and sisters) living within the premises of Malir, Karachi (Sindh), Pakistan.
Study setting. For data collection, the tertiary hospital in the metropolitan city of Pakistan, Karachi, boasts a substantial capacity of 750 beds. This choice will be made because a considerable number of women visit the hospital daily for routine checkups. The study will be conducted in the counseling center, in Malir, Karachi. The settings will be selected based on safety concerns and the convenience of participants, as directed by the General Headquarters, Pakistan (refer to Annexure A). For intervention sessions, a calm room, (noise-free) with limited interruption, will be selected.
Participant Eligibility Criteria
The study comprised only women who met the eligibility standards.
Inclusion Criteria
All families (only females) living in Karachi, Pakistan, who satisfied the following criteria will be enrolled in the study.
-
Adult women,18 years and above, Because the official age of puberty in Pakistan is 18 years, this age requirement will be established as the foundation.
-
Experienced the loss of cherished family members within the past 1 to 5 years
-
Females, including a mother, sister, wife, and daughter are mostly highly dependent. Likewise, the literature revealed that women mostly perceived the loss of a loved one as “extremely unnatural" and this will be linked to significant distress (Cozza et al., 2019)
-
Living within the premises of Malir, Karachi, Pakistan.
Exclusion criteria
The following will not included in the study
-
The women with a self-reported history of any mental illness or any chronic illness diagnosed during the last 6 months will not included because treatment of these disorders could have impacted the results.
-
Pregnant Women
-
Participants who scored for depression > 6, anxiety > 5, and stress > 9 on the screening tool (DASS-21) will be referred to a psychiatrist in the mental health department, Malir, and will be not included in the study (refer to Annexure F).
Study duration
The study will be conducted from March 21, 2023, to August 21, 2023, after reviewing consent from designated study sites and the Aga Khan University (AKU) Ethical Review Committee (ERC).
Sample Size Determination
The sample size was determined by estimating Power (80%), level of significance alpha (5%), and effect size (0.59) based on a previous study (Hirani, 2017), anticipating a 20% attrition rate using Open-epi Software and using the Taro Yamane formula, n = N/ (1 + Ne2). (Chaokromthong & Sintao, 2021). The calculated sample size will be 390. In this study, considering the attrition rate of 10% (40),430 women will be included, with 215 in the intervention group and 215 in the control group (Viechtbauer et al., 2015). Moreover, a pilot study will be conducted on 10% (40) of the participants, before the full-scale study (Hertzog, 2008). The research will be completed in two phases over six months (March to August).
Sampling
The non-probability consecutive sampling will be used to choose the study participants, based on the researcher's convenience (Kamau et al., 2020). A consecutive sampling methodology is a non-probability sampling method that entails recruiting participants who meet the eligibility criteria from a readily accessible population, over a specified period or for a specific sample size, hence this will be considered the best option. To avoid contamination, the first three months will be allotted to the control group, while the next two months will be allotted to the intervention group. To control the confounders, this sampling method will be adopted (Rajani, 2014).
Recruitment of the participants
The recruitment of the participants will be carried out in steps,
Step 1 Following permission from the Malir Hospital, the researcher held a meeting with the administration of Malir for the availability of a counseling room for activity sessions with the martyrs’ families,
Step 2 A participant flyer will be used as a recruitment strategy. At the time of registration for their appointment, Interested women will be asked to go to the counseling room adjacent to the registration room.
Step 3 The researcher met them face-to-face in the waiting room and explained the study's procedure and goals and gave them a chance to ask questions and have time to think about participating. Women's informed consent including permission to conduct eligibility screening, contact details, access to medical records, participate in the intervention or control group, and carry out the intervention in a group of 4 will be obtained. Furthermore, women will be asked whether to take the information sheet and consent form to their home.
Step 4. Those potential participants who agreed will be requested to give written informed consent. The women will be then assessed for meeting the eligibility criteria and screened through the DASS-21 questionnaire.
Step 5. Those meeting the full eligibility criteria will be finally included in the study. The participant will be added to a WhatsApp group of bereaved families as depicted in Fig. 2.
Referral
Due to the possibility that the bereaved families might experience emotional trauma as a result of flashbacks, in cases where individuals with any substantial reaction are found they will be referred to psychologists in the Mental health department of Malir for counseling, and, to the psychiatrist for further appropriate management and the cost will be bear by the primary investigator and they will be excluded from the study.
Study Intervention
The Study intervention based on positive psychology intervention focusing on Gratitude (Leong et al., 2020; Stone et al., 2022), mindfulness (Champion, Economides, & Chandler, 2018), physical exercise (Chang et al., 2017), Happiness (Steptoe, 2019), Spirituality (Cook, 2020), and social support (Hirani et al., 2018). The participants received six intervention sessions once a week, in a group of 4 women, since group-based interventions promoted social inclusion and engagement (Mabire et al., 2022). The purpose of this intervention is to create a place for participants to express their emotions and discuss ways to improve their mental health. The technique incorporates supportive counseling and facilitative strategies, as well as compassionate and nonjudgmental listening to the women's difficulties. Offering practical support is akin to providing psychological first aid, and participants are urged to maintain ongoing contact with the study staff, empowering them to seek help when needed. Women's emotional health is regarded to benefit most from consistent assistance. The intervention will be administered by the primary investigator with motivational skills, including techniques such as clarifying, paraphrasing, and reflecting will be employed to ensure a clear understanding of the modules. The emphasis will be on building a strong rapport with the participants, and they will be actively encouraged to express their concerns and problems.
A guide will be developed to provide instructions on how to conduct the intervention. However, it's important to note that this guide will not be rigidly prescriptive; instead, it will serve as a flexible reference. The aim is to maintain a natural conversational style during the sessions, incorporating examples that are culturally relevant to the women involved. While all topics will be covered with the same level of attention, the PI will prioritize ensuring that the key points outlined in the intervention delivery guide are effectively addressed
The intervention involves the following components:
A. Engaging Educational sessions:
Individuals can participate in specifically designed module-based activities while also receiving important education via examples and reflections through this session.
B. Information Brochure:
An instructive brochure, delivered in basic Urdu and accompanied by relevant images, on self-care strategies. It also provides contact information for local emergency and help services.
C. Facilitative Strategies:
Women will be provided the researcher's contact information in the expectation that they may seek support and guidance in dealing with daily stressors or family issues as needed. Empathetic listening and need-based counseling will be provided in a nonjudgmental manner.
Intervention program
The program's main elements will be organized around positive psychology (Proyer et al., 2014; Rooitalab et al., 2021), and the social support framework (Hirani et al., 2018). Based on the recommendation of a study on bereaved wives by Cozza et al. (2019), the intervention will be planned face-to-face, along with telephonic support. The intervention mainly included exercises, brief videos, group discussions, and group activities. The group sessions lasted approximately 90 minutes, in two stages. Stage 1 comprised of lectures (15 min), group discussion (20 min), videos (5min) in Urdu, and (20 min) of group interaction activity in phase 1, followed by (10 min) refreshments, and will hold a designated place in the counseling room. In stage 2, initially, members interacted for about 10 minutes, to encourage them to share their thoughts and feelings, with one another, followed by 10 min follow-up session to address questions and talk about difficulties. Then the group members will be encouraged to give an example relevant to the strategies they had used previously. In the end, home activities will be assigned in each session, which will be assessed at the start of the next session including daily and weekly home practices, for six weeks. The participants also will access the WhatsApp group during the intervention period, which will be utilized to give reminders before the session and to increase retention rates.
Phase IA: Development of the Psycho-social Intervention Module. The module will be developed by an interdisciplinary team, a group that includes mental health nurses, nurse educators, and a team from the Brain and Mind Institute, Aga Khan University, Karachi, Pakistan. The objectives, content, timing, and activities for each module will be developed. The summary of the module's sessions is depicted in Table 2. The module will be reviewed by experts in the mental health department for clarity and appropriateness. The researcher led the intervention with assistance from a volunteer assistant facilitator.
Phase 1 B: Pilot testing of the module. After the module is created, it will be tested for clarity, appropriateness, validity, and language. The pilot test subjects were four participants who provided verbal informed consent but were not a part of the study.
Data collection Tool
Phase A
For the development of the module, experts will be asked about the topics that should be a part of this positive psychology intervention module, as per their proficiency in the content part, as well as the context.
Phase B
Initially, a semi-structured questionnaire will be used to collect demographic information. Multiple scales will be studied during this research study but the Depression, Anxiety, and Stress Scale (DASS-21) for screening while the Warwick Edinburg Mental Wellbeing Scale (WEMWBS), and Satisfaction with Life scale (SWLS) for determining the effect of the psychosocial intervention were found to be more relevant. The authors provided permission to use the tools (refer to Appendix B).
DASS_21. The DASS-21 had already been converted into Urdu, the national language of Pakistan, to judge the perceived stress level and psychological well-being of the Pakistani population in Islamabad, by Bukhari, in 2022 and its internal consistency had been determined (Cronbach's alpha = 0.94) (Bukhari, 2022). The DASS − 21 (Depression, Anxiety, and Stress Scale) will be used as a screening tool. The 21 items of DASS assessed the three variables, i.e., stress, depression, and anxiety, over the preceding week with a set of seven questions. Each question on DASS-21 was scored on a Likert scale, with never = 0, sometimes = 1, frequently = 2, and always = 3. A score of 0 indicated that the participant believed the question "did not relate to them," and a score of 3 meant that they felt the question "applied very much, or most of the time." (Beiter et al., 2015). Women's depression, anxiety, and stress levels will be evaluated using pre-defined cut-off values such as depression < 6, anxiety < 5, and stress < 9 based on the DASS-21 guide (Gomez, 2016).
Warwick Edinburg Mental Wellbeing Scale. Those participants who will be recruited will assessed through the Warwick Edinburg Mental Wellbeing Scale (WEMWBS) before and after the study. The tool had been tested in the Pakistani population using its Urdu version. It had 14 components, that will be rated on a Likert scale from 1 to 5 (Waqas et al., 2015). The Warwick Edinburg Mental Wellbeing Scale (WEMWBS) appeared to be suitable for use in the Pakistani population in its Urdu version, and the findings confirmed its internal reliability for this population sample. Test-retest reliability was found to be 0.93, with a 95% confidence interval of 0.87–0.96, indicating a very high level of reliability. Hence, it proved to be appropriate for use in the Pakistani context and its internal consistency was satisfactory (Cronbach's alpha = .87) (Waqas et al., 2015).
Subjective Wellbeing and Life Satisfaction Scale. The life satisfaction questionnaire had already been validated by Barki et al. (2020) in Lahore, Pakistan (Cronbach's alpha = 0.90). This scale had good psychometric qualities, such as internal consistency = 0.82 (Ramzan & Rana, 2014). It had five components that measured subjective well-being, and it is a part of the trait well-being inventory. Each item will be measured on a 7-point Likert scale ranging from strongly agree to strongly disagree. The permission of the copyright holder had already been taken. The test-retest reliability and construct validity of the tool will be assessed. The reliability statistics reveal a Cronbach's Alpha of 0.907 for a 5-item scale, demonstrating a significant degree of internal consistency among the items and implying they assess the same concept effectively.
Self-Structured Sociodemographic Tool. The sociodemographic tool was divided into three subcategories: sociodemographic variables, family-associated variables, and academic variables. The demographics and socioeconomic portion of the questionnaire was developed with the consensus of the research team (refer to annexure)
Sociodemographic variables. These included gender, age, marital status, mother language, history of mental illness, sleeping hours per day, and family history.
Family-associated variables. This included family history, earning members, financial support system `in the family, and recreational activities
Academic variables. These included academic qualifications
Co-variates. Another variable that can influence the outcome is covariates. Age (18–30 years, 31–40 years, 41–50 years, 51–60 years, > 60 years), relationship with the martyred member (mother, wife, sister, daughter), religion (Muslim, Hindu, Christian, others), years passed since martyred (1–2,3–5,6–8,9–10 years), and the number of children/family members (not any, 1, 2–3, 4–5, > 5) will all considered in this study. This unbalanced distribution of variables across both arms, at the time of analysis, is the limitation of a quasi-experimental study.
Data Collection
Phase A
Experts (Mental health nurses, Psychologists) will be approached, based on their knowledge of both the context and the content, and will be asked for their opinions on the proposed module material.
Phase B
Data will be collected from March to August 2023, a month, after getting approval from ERC. After meeting the inclusion criteria, the written consent will be signed through a formal consent form in the initial session of the questionnaire (refer to Annexure A). The consent form included information about the study, its objective, and the voluntary nature of participation. The potential participants will be directed to the survey questionnaire once they agree to provide consent which was in an easily understandable Urdu language. In case participants have any questions, the researcher's phone number and email address will be provided.
Pre-intervention data (T1) will be collected by the researcher from both groups, after the enrollment of participants in the first session. Demographic variables such as age, economic status, housing style, number of children, relationship with the bereaved, time passed since the bereaved, education, current employment status, and placement will be collected via a self-structured sociodemographic questionnaire. The time required to fill out the questionnaire will be 20–30 minutes. Post-intervention data (T2) will be collected from the Intervention group, after 6 sessions by using the same questionnaire while the 2-week Post-intervention data (T3) will be collected, after 2 weeks of sessions by using the same questionnaire as depicted in Table 3. The duration of the data collection process will be between 6 months, after receiving ethical approval from the ERC, Aga Khan University, Pakistan. The data obtained will be kept in a locked cupboard and a password-protected file on a laptop, and a password-protected backup copy will be saved on Google Drive.
Phase III: Feasibility of the study
The module's acceptability, applicability, and practicality will also be assessed. Furthermore following the completion of the sessions, the participants will asked to fill in the following questions on four Scale Likert Scale
-
How did you find the information?
-
Was the terminology used in the modules comprehensible?
-
Were the strategies effective?
-
How much time did you spend on the positive strategies each week?
-
Was the session enjoyable?
-
Were the activities easy to follow?
Study Rigor
Module
The module will be developed based on existing literature searches and professional judgments. Six Experts (three psychologists and three experts in the Mental Health Stream) evaluated the module's language and content for validity, and 10% of the participants took part in a pilot test. They provided feedback, which will be also taken into consideration.
Tool Validity and Reliability
The tool used for evaluating whether the intervention will be trustworthy and effective has been employed in Pakistan. Furthermore, the content validity index (CVI) will be developed by six mental health nursing professionals, psychologists, and mental health specialists, who reviewed the instrument. CVI will be completed in two stages. In the first step, professionals assessed the questionnaire (tool) for relevancy and clarity with a four-point Likert scale. Expert evaluations will be used to calculate the CVI. According to Yusoff (2019), the researcher should have concrete evaluation evidence of the tool. The rubric also included a Likert scale for relevancy (1 not relevant, 2 = somewhat relevant, 3 = pretty relevant, 4 = very relevant) and clarity (1 = not clear, 2 = somewhat clear, 3 = quite clear, 4 = very clear). While scores one and two will be taken into consideration for adjustments, the evaluators’ three and four will be judged as acceptable. Pilot testing will be conducted on 10% of the sample size, or 4 participants, to ensure reliability; thus, CVI and Cronbach alpha coefficient values statistically ensured the study questionnaire's reliability, validity, and clarity.
Quality check and Data entry
The primary researcher vigilantly managed the data organization. Soon after the data collection process, the researcher will ensure the consistency and completeness of the data on the questionnaire through a quality check. To facilitate data management, serial numbers will be assigned to each participant's data file. Each participant's pre-intervention (T1), post-intervention (T2), and 2-week post-intervention (T3) data will be labeled separately in each file for identification. Data editing will be done in two stages: field editing and office editing. During field editing, after completion, the questionnaire will be checked by the primary researcher for any missing information. Office editing of the data entry will be done by assigning a serial number to each file in the SPSS. The data record will be compared, and shortcomings will be made by consulting the relevant questionnaire. A secured backup file will be made for data storage in a password-protected file.
Statistical Analysis
Data will be analyzed by using IBM SPSS version 24. Data will be entered and it will be double-checked. During the analysis, the focus will be on assessing the effectiveness of the psychosocial support intervention in improving psychological well-being. Percentages, frequencies, and Chi-Square test were calculated for demographic variables (gender, age, years passed since soldier martyred, qualification). Mean, standard deviation, and variance will be calculated for quantitative variables. The independent sample t-test will be applied to measure the difference in the mean values of two independent groups, after assessing the data for normality check, otherwise, a non-parametric test will be used to measure the difference (Rudaz et al., 2020). Analysis of Covariance will be utilized to analyze the influence of intervention on primary outcome with covariate adjustment, baseline measurement, and group allocation.
Pre-testing: Pilot Testing
Pre-testing of the study tool (Urdu and English questionnaire) will be carried out on 10% of the total sample size, on 4 women. These women will not included in the final study. The pre-testing aimed to check the correctness (content, language, strategies, and activities) of the filing of the study questionnaire (Zaheer et al., 2020) and the appropriateness and feasibility of the psycho-social intervention module for the understanding of the women. Furthermore, the goal will also be to predict how long it would take participants to complete the questionnaire and rule out any discrepancies in the tools and modules used to assess the data-gathering methods. All the required amendments were added to the tool based on the responses and suggestions and the tool will finalized after the thesis committee members’ review. During the pilot testing, one participant contacted the researchers and asked them to clarify questions about terminology. The terms in the questionnaire were changed by inserting synonyms in brackets.
Ethical consideration
All the interventions strictly adhered to the principles and procedures specified in the Helsinki Declaration. Furthermore, all experimental protocols were thoroughly reviewed and approved by the Aga Khan University Ethical Review Committee (Attachment file 1). Informed consent will be obtained from all study participants, ensuring that ethical standards are followed throughout the research process.
The Hospital's Ethical Review Committee will contacted for ethical approval. Ethical and safety guidelines recommended by the WHO will be strictly followed(Organization, 2016) The researcher emphasized to the participants that involvement will be optional and that their confidentiality, objectivity, secrecy, protection, and security will be guaranteed throughout the entire study, before getting their informed consent. The participants will be introduced to the areas of the research, its benefits, and its risks, in the native language through a phone call and will be asked to participate. Those willing to participate will be requested to come to a nearby tertiary care hospital and get assessed as per the eligibility criteria. Before the data collection process, the informed consent form will be given to the study participants in Urdu or English, as per their preference. Written informed consent will be obtained from those meeting the inclusion criteria. The participants will have the option to leave the study whenever they choose to do so. Moreover, ethical approval from the specified community department will be obtained. The study is committed to strict adherence to its established protocol, and any deviations from this protocol will be promptly reported to the ethics committee for transparency and accountability. While the likelihood is low, there is a potential risk of women experiencing distress during the study, which may manifest as behaviors like becoming quiet, crying, expressing anger, or appearing distracted. To mitigate this risk, the study will employ trained researchers who can provide appropriate support and assistance to the participants as needed. Moreover, should any participant require or prefer additional support, they will have the opportunity to seek assistance from a qualified psychosocial counselor. Both intervention groups will receive a concise one-page information booklet as part of the study. Additionally, the research outcomes will be submitted for publication in peer-reviewed journals to contribute to the broader scientific knowledge base To preserve information confidentiality, codes will be used for each participant. Moreover, data access will be limited to the primary researcher and the Thesis Committee members. However, for monitoring or audit purposes, an ethics committee or any regulatory body can access the data. Following data collection, the forms will be kept under lock and key, and the data entered on computers will be secured in password-protected folders. The original forms will only be accessible to the researcher and the thesis committee.
The study's findings will be disseminated through various channels. They will be presented at the hospital in Pakistan where the research is conducted, as well as at national and international conferences.
Mitigating Risk During the Study
The study will be carried out by protocol, and any deviations will be formally and immediately reported to the principal investigator and the ethics committee for further action. Conducting a study on sensitive families may cause the researcher psychological strain, which will be mitigated by regular monthly meetings with the research team.