Development and validation of home-based psychosocial self-management interventions in schizophrenia and related disorders in low-resource settings: A mixed methods approach

Abstract

Background:

Psychosocial interventions, crucial for recovery in patients with schizophrenia, have often been developed and tested in high income countries. We aimed at developing and validating home-based a booklet based psycho-social intervention with inputs from stakeholders: patients, families, and mental health professionals (MHP) for patients with schizophrenia and related disorders in low resource settings.

Methods:

We developed a preliminary version of psychosocial intervention booklets based on six themes derived from focus group discussions conducted with patients, families, and MHP. Initially, quantitative assessment of content validity was done by MHP on overall and Content Validity Index of individual items of the specific booklets, followed by in-depth interviews about their views. The booklets were modified based on their inputs. Further, pilot testing of manuals was done on the users - nine pairs of patients and caregivers followed by development of a final version of psycho-social intervention.

Results:

The percentage content validity of individual modules and overall booklets was ≥78.5% indicating good validity. Most MHP reported that the manuals were relevant and easy to use but were text-heavy, and lengthy. On pilot testing of modified manuals with patients and their family caregivers, majority (77.8%) of them found booklets useful and suggested that there should be separate booklets for both patients and caregivers for providing information and entering separate response for the activities, integrating helpful tips. Language should be simple. Finally, two sets of booklets (“info book” and “workbook”) named ‘Saksham’ (meaning empowered) were created with specific modules (viz., ‘Medicine adherence’, ‘Daily routine’, ‘Eating right’, ‘Physical activity’, ‘Physical health monitoring’, ‘Self-reliance’, and ‘Psychoeducation’) for patients and caregivers each, in two languages (Hindi and English).

Conclusion:

Booklets with modules for psychosocial interventions for patients with schizophrenia and their caregivers were developed after establishing content validity and pilot testing.

INTRODUCTION

Psychosocial interventions are essential in management of patients with schizophrenia for sustained improvement in symptoms and functional recovery.[1,2] However, such interventions are limited in low-resource settings due to scarcity of mental health resources and predominance of medical models in clinical practice.[3] On extrapolating the model of psychosocial intervention, originally developed in high-income countries (HICs) to low- and middle-income countries (LMICs), it was seen that participants’ lower education, caregivers’ unavailability, and difficulty in follow-up were the major barriers in the feasibility of carrying out these interventions. Nevertheless, acceptability of such intervention was supported by higher participation rates and satisfaction levels.[4] A frequently employed and tested psychosocial intervention in psychosis is psychoeducation with little research on other types of interventions.[5,6,7]

Psychosocial intervention delivered in hospital settings, which is the most common setting of help seeking, may be limited by logistic difficulties, like infrequent visits, time, and travel costs. Home-based interventions, on the other hand, are convenient, inexpensive, and likely to enable treatment for longer duration.[8] Home-based care has shown a positive outcome in terms of feasibility, reduced rates of rehospitalization, and overall improvement in illness severity and has especially been proposed for low-resource settings (LRSs).[9,10] Till date, two studies have assessed the feasibility of home-based psychosocial intervention in India among patients with psychosis.[8,9] Both the studies assessed home-based cognitive retraining with clinician-delivered psychoeducation sessions at regular intervals (2-weekly or monthly) and provided home-based cognitive retraining modules. The feasibility and changes in clinical status were assessed at the end of each study (8 and 12 weeks, respectively). The two aforementioned studies did not encompass an assessment of the module content nor addressed the potential incorporation of family caregiver feedback regarding the content and utility of said modules. Moreover, the participants involved in both studies exhibited a relatively stable condition, being either individuals experiencing their first episode of psychosis or schizophrenia patients with low scores on the Scale for Assessment of Positive Symptoms, that is, SAPS (0.5), and the Scale for Assessment of Negative Symptoms, that is, SANS (4.5), indicative of mild symptomatology.

As part of NIHR Global Health Research Group on Psychosis Outcomes, the Warwick-India-Canada (WIC) Network comprising of Warwick University, UK; McGill University, Canada; and All India Institute of Medical Sciences (AIIMS), New Delhi in North India; and Schizophrenia Research Foundation (SCARF) in South India, we aimed to find affordable, sustainable, and standard home-based psychosocial care programs for patients with schizophrenia by incorporating locally available resources and strengths, for example, family caregivers. The proposal was carried out in three phases, namely, identifying the needs of stakeholders, developing and validating the modules derived from incorporating findings of the first phase, and testing feasibility of the program in the target population. The details of rationale, background, and overall methodology of the WIC program have been described elsewhere.[11]

In order to understand the level of knowledge and expectations/needs of stakeholders, we carried out qualitative interviews with them.[12] The findings of that study led to develop the intervention modules for the current study. We thus aimed at developing and validating home-based psychosocial self-management intervention for patients with schizophrenia and related disorders (PwSs) in low-resource settings, codesigned with inputs from stakeholders (patients, caregivers, and mental health professionals, i.e. MHPs),[11] for continuity of care from hospital to home. Content validity of the modules in the intervention and information booklet was established to examine whether the various domains of the booklet targeted some of the relevant aspects of psychosocial functioning and self-management at home.

METHODS

Settings and participants

This study was conducted at the outpatient department of the public-funded general hospital psychiatric unit in North India. The target population consisted of family members, PwSs, and MHPs. PwSs were defined as those who met diagnostic criteria for schizophrenia, persistent delusional disorder, schizo-affective disorder, and other and unspecified psychosis on International Classification of Diseases–10, with a duration of illness of ≥2 years and a duration of treatment ≥6 months from our center, those having persistent psychopathology and dysfunction, and those who could speak and read Hindi or English. The caregivers (spouse/parent/sibling/offspring) included had to fulfil any three of the following criteria: living with the PwS in the same house, had most frequent contact with the PwS, helped to support the PwS financially, had most frequently participated in the treatment of PwS, and was to be contacted by treatment staff in case of an emergency. Caregivers included could be of either gender, aged ≥18 years, and able to read and write in English/Hindi. Those who had a history of any psychiatric illness (except nicotine/caffeine dependence) or were unwilling to participate were excluded. The MHP group included psychiatrists, clinical psychologists, occupational therapists, and psychiatric nurses, all of whom had ≥3 years of experience in dealing with PwSs. Further details on the selection criteria are available in our previous publications.[12]

Development of booklets

We conducted focused group discussions (FGDs) with family members, patients, and MHPs (n = 8) to identify key components of psychosocial self-management interventions needed for PwSs. The findings of FGDs have been explained elsewhere.[1] The study team developed a preliminary version of intervention and information booklets for home-based care on the basis of the themes derived from FGDs conducted and the evidence base. The themes identified for the intervention were (i) maintaining medication compliance, (ii) physical health monitoring, (iii) enabling individuals for routine daily activities (including basic activities like hygiene/grooming/eating and complex activities like traveling by self/ability to handle finances/assisting in household chores like cooking, laundering, housekeeping, etc.), (iv) healthy eating habits, and (v) need for psychoeducation.

Bilingual (English and Hindi) intervention and information booklets containing modules for all the target domains were developed with a separate copy each for caregivers and patients. Six modules were classified as ‘medication adherence’, ‘physical health monitoring’, ‘activities of daily living’, ‘instrumental activities of daily living’, ‘dietary regulation’, and ‘psychoeducation’. Each module consisted of relevant information in simple language for easy understanding of the patient and the caregiver, followed by specific steps to follow the module. At the end of each module, a chart to monitor the activity was provided. A section was devoted in the end to provide feedback and mention the difficulties faced while using the module.

Establishing content validity of the modules in each booklet by the experts

The experts recruited for content validity evaluation were mental health professionals (psychiatrists/psychologists). The details of the mental health professionals involved in establishing content validity are provided in the supplementary material [Supplementary Table 1]. Since content validation was the primary aim of the study, two different methods (qualitative and quantitative) were employed to establish the same.

Supplementary Table 1.

Characteristics of professionals involved in content validation of the modules

Experts		Highest Educational Qualification		Years of Experience as MHP
Expert 1		M.D Psychiatry		8
Expert 2		PhD Clinical Psychology		9
Expert 3		M.D Psychiatry		6
Expert 4		M.D Psychiatry		5
Expert 5		M.D Psychiatry		4
Expert 6		M.D Psychiatry		2.5
Expert 7		M.D Psychiatry		2

Interview guide

What is the relevance of this module for the patient and the caregivers, according to you?

Do you think the content of this module is suitable and relevant?

Would adding this module have a practical applicability in their life?

Would it be feasible to follow this module in day-to-day life?

Any potential difficulties or barriers that the patients and caregivers might experience in using these modules?

Can you comment on the ease of using these modules and its practical implications?

Any suggestions on modification or improvement of these modules?

Quantitative assessment

Two quantitative methods were employed to calculate content validity, namely, (i) assessment of the Content Validity Index of individual items and six modules using rating by experts on a Likert scale[13] and (ii) assessment of content validity of six modules using questionnaires.[14,15]

The first assessment is based on the following:

• Item-level Content Validity Index (I-CVI): Inter-rater agreement for the individual items in the module was examined using the Individual - Content Validity Index, which indicates the percentage of judges who agree on particular aspects of an instrument when analyzed on an individual item basis. Each rater provides a score on a Likert scale ranging from 1 (not representative) to 4 (representative), corresponding to the extent to which they believe the intended construct is represented by the item in question. I-CVI = the number of experts giving a rating of either 3 or 4 divided by the total number of experts.

• Content Validity Index for Scales (S-CVI) = the sum of I-CVIs/the number of items in each module. An instrument must have a minimum S-CVI of 0.90 to be considered representative. According to Lynn (1986), the minimum I-CVI of 0.77 (for 6 to 10 experts) and the minimum S-CVI of 0.90 are required for an excellent content validity.

The second method of measuring validity was the overall content validity of all the six modules using the formula suggested by Noah and Ahmad, which is derived from Russell formula (1974).[14,15] A questionnaire containing five items, which are scored using 5-point Likert Scale from 1 (strongly disagree) to 5 (strongly agree), is used. Feedback regarding the proposed module is also taken in the questionnaire. The total score given by each expert is divided by the total maximum score of the Likert scale and then multiplied by 100. If the percentage of content validity achieved is more than 70%, it is considered as good content validity. If it is less than 70%, it is advisable to recheck the content according to the objective of study.

Qualitative assessment

The MHPs who participated in rating the intervention and information booklets in quantitative assessment were further requested to participate in the interviews to gain in-depth information about their views and perspectives, such as perceived relevance of each module for the patients and their families, feasibility of implementation of the interventions and their practical use in daily life, barriers and difficulties that may be experienced by the users in adopting these interventions, suitability of content, ease of use of data entry processes, and practical implications of use of modules. Further, the MHPs were also asked to suggest the edits or improvements in the content of modules.

Pilot testing of booklets

Following the principles of instrument validation, service users played a vital role in validating the instrument in question.[16] To ensure robust development and content validation of the modules, content experts, that is, MHPs, undertook the initial phase. Subsequently, nine pairs of patients (PwSs) and their primary caregivers were recruited (through purposive sampling) to pilot test the modules, thereby providing an initial assessment of the face validity of the booklets. PwSs were defined in the same way as for the previously conducted FGDs[12] and were included if they could speak and read Hindi or English.

Upon expressing their readiness to engage with the modules at home, each patient–caregiver pair was instructed to utilize the respective modules designed for them over a period of 2 weeks. At the conclusion of this duration, participants were interviewed to gather their feedback on their experience with the booklets. The interviews consisted of questions regarding overall experience, ease of use, language clarity, relevance, identification of any missing features, and suggestions for practical enhancements of the modules. Participants who did not initiate or complete the modules were also interviewed, and their reasons were documented for further analysis.

Data analysis

All qualitative interviews were audio-recorded and transcribed verbatim. The data were analyzed to identify the themes related to the perception of the above target areas of exploration using thematic analysis.[17] The coding frames were developed; themes and subthemes were identified. Themes reflected broad areas of exploration, and the subthemes contain the subcategories. The themes that occurred at least three times (i.e. coded three times across all interviews) or that appeared important were included in the final results.

Approval was taken from the Institute Ethics Committee (IEC 252/05.05.2017).

RESULTS

Content validation of booklets

Quantitative assessment of content validity [Table 1]

Table 1.

Quantitative assessment of content validity of modules

Modules		Individual items of the module		I-CVI (patient version)		I-CVI (caregiver version)		S-CVI (patient version)		S-CVI (caregiver version)		Validity using Noah and Ahmad’s questionnaire
Physical health monitoring		1. What is physical health monitoring?		0.85		1		0.95		0.95		0.79
		2. Why is physical health monitoring important for you?		1		0.85
		3. Reasons for increased physical health monitoring in schizophrenia?		1		1
		4. Why should we do regular physical monitoring in patients with schizophrenia?		0.85		1
		5. Monitoring of physical health parameters		0.85		1
		6. List of relevant blood investigations		0.85		0.85
		7. Table for charting blood investigations of patients		1		1
Medication adherence		1. What is medication adherence?		1		1		1		1		0.81
		2. Why do you need medication adherence?		1		1
		3. Benefits of medication adherence		1		1
		4. What is poor medication adherence?		1		1
		5. Harms of poor medication adherence?		1		1
		6. Why does poor medication adherence occur?		1		1
		7. Steps to improve medication adherence?		1		1
		8. Personalized medication grid (PMG) for charting adherence		1		1
Dietary modification		1. What is balanced diet?		0.85		0.85		0.88		0.93		0.84
		2. Why is it important to have a balanced diet?		1		1
		3. Components of balanced diet?		0.85		1
		4. Basic food groups		1		1
		5. Dietary regulation-related figures		0.85		1
		6. Why diet is important for patients of schizophrenia?		0.85		0.85
		7. How can we improve our dietary habits?		0.85		1
		8. Diet planning chart/guideline		0.85		0.85
		9. Table for charting diet for patients		0.85		0.85
Activities of daily living		1. Introduction (included description, importance, instructions on how to perform)		1		1		1		0.94		0.81
		2. Getting up in the morning		1		1
		3. Brushing teeth		1		0.85
		4. Taking bath		1		1
		5. Taking meals		1		1
		6. Leisure activities		1		1
		7. Walking		1		0.85
		8. Sleeping		1		0.85
Instrumental Activities of Daily Living (IADL)		1. What is IADL?		0.71		1		0.78		1		0.79
		2. Why they are important?		0.71		1
		3. What do IADL include?		0.85		1
		4. Instructions for IADL		1		1
		5. Using public transport		0.85		1
		6. Ability to use telephone		0.85		1
		7. Meal preparation		0.85		1
		8. Laundry		1		1
		9. Housekeeping		0.71		1
		10. Table for Charting IADL for patients		1		1

Each individual item in the specific module obtained an I-CVI score of at least 0.77, except three items in instrumental activities of daily living module in the patient booklet. The overall content validity, that is, S-CVI of patient and caregiver versions, respectively, was high for all modules.

The overall content validity of the six modules (both patient and caregiver versions) based on the formula suggested by Noah and Ahmad (2005) was found to range between 78.5% (physical health monitoring) and 84.2% (dietary modifications)

Qualitative assessment

Table 2 shows the key themes and subthemes from interviews with MHPs. Qualitative interviews with the MHPs revealed booklets to be relevant and easy to use and expressed willingness to use these module sin clinical settings. However, certain modules were considered relevant only for the families, like monitoring patients’ physical health, employing instrumental activities of daily living in patients’ routine, and planning the diet management at home. Additional feedbacks included booklets being text-heavy and lengthy, possibility of using illustrations/figures, possibility of using rewarding methods of adding patients’ response instead of putting a tic mark. Uncertainty was raised regarding patients regularly following the information and validity of the responses entered by the patients in the booklets.

Table 2.

Qualitative assessment of the modules by mental health professionals

Module		Themes		Subthemes		No. of times the theme was coded
Medication adherence		Relevance		Highly relevant for families Would help patients in maintaining a record of medication intake Motivation associated with a record showing adherence		7 6 4
		Feasibility of using data entry tables		Easy to enter Make the process of entering data more interesting (not just ticks)		7 3
		Content in information sheet		Content is lengthy It is text heavy for patients		6 5
		Barriers		Miss to enter information How to check the validity of information		4 3
		Likelihood of using this module for my patient group		Will use it		7
Physical health monitoring		Relevance		Relevant for families to track the physical health indicators Relevance for patients is not clear Keep only a few tests. All the test findings need not be recorded.		7 4 4
		Feasibility of using data entry tables		Difficult to follow for patients		6
		Content in information sheet		Simplify the content for patients		3
		Barriers		Data entry in the tables may be difficult for people		6
		Likelihood of using this module for my patient group		Will use it with modifications to the module		6
Activities for daily living		Relevance		Highly relevant for families Relevant for patients and caregivers who have a problem in managing daily activities		7 7
		Feasibility of using data entry tables		Easy to enter Make the process of entering data more interesting (not just ticks)		7 3
		Content in information sheet		Content can be shortened		5
		Barriers		How to check the validity of information		3
		Likelihood of using this module for my patient group		Will use it with patients and families		7
Diet management		Relevance		Highly relevant for families Not clear relevance for patients as most patients do not cook/decide the diet plan of home		7 3
		Feasibility of using data entry tables		Difficult to follow for patients Use of technical units is difficult to understand		7 6
		Content in information sheet		Content is difficult to follow Need to simplify the information		7 7
		Barriers		Difficult to follow for patients and families/Use of technical language		7
		Likelihood of using this module for my patient group		Will use if the content is simplified		4
		Suggested changes		Simplify the content Use more illustrations		7 2
Instrumental activities of daily living		Relevance		Not relevant IADL needs to be taught in real setting Patients may need advanced cognitive training to learn these activities		5 4 3
		Feasibility of using data entry tables		Not feasible for patients Practical barriers		5 3
		Content in information sheet		Not relevant for patients Content does not cater to varying needs of the patients’ group		5 5
		Barriers		Skills building at multiple levels is required for patients to learn the activities Require more practical and hands-on training		5 4
		Likelihood of using this module for my patient group		Difficult to use with patients Difficult to adopt to patients’ diverse needs Can use with families to educate them		6 5 3
		Suggested edits		Include more practical information for families Reduce the information for patients Adopt to patients’ diverse needs		4 3 5
Psychoeducation		Relevance		Highly relevant for families Relevant for both patients and caregivers		7 7
		Content in information sheet		Content can be shortened Simplify the language		7 3
		Barriers		People who have limited reading skills Patients may not read lengthy text		4 5
		Likelihood of using this module for my patient group		Will use it with patients and families Will use a simplified version with my patients		4 3
		Suggested edits		Simplify Keep the text brief for patients		4 5

Changes were made in the booklets incorporating the suggestions from experts. A professional graphic designer was employed, who added cartoon stick figure drawings. The content in each module of the booklet was shortened and simplified. Small ‘smiley stickers’ were added to fill responses in the booklets. Due to lower content validity scores being obtained on a few items of instrumental activities of daily living, the module on instrumental activities of daily living and the module on activities of daily living were clubbed and the new module was labeled ‘activities of daily routine’. In addition to basic activities (e.g. getting, bathing, brushing, having meals), certain instrumental activities were added (e.g. exercise, cycling, swimming, etc.).

Pilot testing of the modules

After the modifications in the booklets to accommodate the suggestions by the MHPs, the final booklets were pilot-tested on nine pairs of patients and caregivers to incorporate their feedbacks. The median age of patients was 28 years (range: 22–38 years), the majority being males (n = 5), unmarried (n = 5), and unemployed (n = 6). Six patients were educated up to 10^th standard (GCSE equivalent), and three were graduate. Diagnostic categories of the patients as per ICD-10 were schizophrenia (n = 6), psychosis NOS (n = 2), and schizoaffective disorder (n = 1). The duration of illness ranged from 3 to 18 years. The median age of caregivers was 52 years (range 28–60) years. All but one caregiver were parents, while one was a spouse. Two caregivers were retired, four were homemakers, and two were skilled workers.

Table 3 shows the feedback obtained from the family members. A majority of the participants found the booklets easy to use and relevant to improve adherence and activity scheduling and procure information, but it was partially filled by a few participants. Common reasons for incomplete entries were forgetting to enter the response despite following the schedule. Certain suggestions included separate booklets for providing information and entering response for the activities followed for each stakeholder (i.e., patient and caregiver), integrating helpful tips, and simplifying the headings of modules.

Table 3.

Pilot testing of the modules

Medication adherence Questions/Nodes/Themes		Codes and Frequency (caregiver)		Codes and Frequency (patient)
Adherence/Completion of datasheet		Yes: 7 No: 2		Yes: 7 No: 2
“Experience of using the module (content, data sheets)”		Easy to use: 7 No problem experienced: 2		Easy to use: 6 No problem experienced: 3
“Time when you entered the data”		End of the day: 4 Any time during the day: 3 Soon after taking medicine: 0 Did not enter: 2		End of day: 2 Anytime that I remembered: 3 As soon as I took medicine: 2 Did not enter: 2
“Relevance of module”		Relevant to improve medication adherence: 7 Acts as a check of medication adherence: 7 Improves trust: 3 Cannot say: 2		Improves medication adherence: 7 Need reminder to take medicine on time: 5 Motivator: 5 Cannot say: 2
“Were there any barriers/problems that you faced”		No problem faced: 2 Checking the genuineness of data entered by patient: 4 Forget to enter the data sometimes: 3		No problem: 4 Forget to enter the data sometimes: 5
“Improvement in this module that will help you”		Helpful tips on importance of medicine: 3 Helpful tips on diet/exercise: 2 Separate booklets for providing information and monitoring routine: 3		Integrate helpful tips: 2

Taking into account the feedback, two booklets were formulated, namely, “info book” and “workbook”, for each patient and caregiver in both English and Hindi. Modules were renamed “eating right” (instead of “dietary management”) or “daily routine” (instead of “activities of daily routine”). The background content in the info book mainly included the brief description of the target area of intervention, need for the intervention, and the key intervention techniques. An additional section was added, labeled “self-reliance”, which illustrated how to learn a new skill step-by-step using pictures and dialogue boxes. Tips were added in the beginning of booklet, like “set an alarm to remember maintaining this workbook” or “ask a family member or friend to remind you”. The booklets were named ‘Saksham’ (meaning empowered). Supplementary Figure 1 shows the cover of the English booklets developed for patients and caregivers.

DISCUSSION

A home-based psychosocial self-management intervention developed in the current study was codesigned based on the findings from qualitative interviews with different stakeholders in our previous study.[12] While the content of the booklet was driven by the service users (PwS and their caregivers), the development and validation of the content were done by the service providers (MHPs). The feedback taken from the pilot testing on service users helped in further modification to make the intervention more acceptable and feasible.

Two types of booklets were developed, namely, info book and workbook, for both caregivers and patients. The qualitative and quantitative assessment of content validity of all the modules rated by MHPs was high (≥70%), indicating good validity. Such methods of establishing content validity have been used by different authors in the past in development and validation of modules for behavior and psychological intervention of different populations.[18,19]

Feedback from the stakeholders – both service providers and service users led to prolific changes in the booklets, which made them simpler and more attractive to use, increasing the chance of acceptability. It has been seen that involvement of service users in the research enhances the quality of the research and the same has been employed by researchers in development and validation of assessment tools.[20]

Another unique feature of this intervention is that the booklets were developed separately for patients and caregivers to improve monitoring and adherence. In a situation where the mental health resource is a scarcity, families form a valuable yet underutilized support system and resource. Clinicians in India and the subcontinent do routinely take time to educate family members of a patient about the illness and the importance of medication, but apart from this information exchange, the utilization of family in treatment is minimal.[21] This psychosocial self-management intervention tries to tap the potential of involving family members integrally so as to improve delivery and effectiveness.

A majority of the nonpharmacological and psychosocial interventions have been developed in the Western population and are highly resource-intensive. Since psychosocial interventions are delivered in the context of sociocultural background and are contingent on availability of resources, they become difficult to be translated in an LMIC setting.[4,22] Culture has been shown to determine the family functioning, communication patterns, and resilience, which are essential to consider while formulating intervention programs which involve family members.[21,23] Considering that the intervention and information booklets were developed within an LRS and underwent validation and pilot testing on relevant stakeholders, it is reasonable to anticipate that cultural factors influenced their development process. Therefore, these booklets are designed to be suitable for the targeted population, considering their cultural context.

In the Indian context, a previous study implemented a 9-month psychoeducation program in a hospital setting for caregivers and patients with schizophrenia, demonstrating a significant improvement in psychopathology severity. Only two studies have explored home-based psychosocial interventions, specifically cognitive remediation.[8,9] The potential burden placed on caregivers in executing assigned tasks was also highlighted in one of these studies. However, neither of the two studies established the inclusion of service users’ feedback or conducted a thorough examination of the content within the intervention modules.

The present study holds significant clinical implications, particularly within the framework of LRS. Incorporating stakeholders’ input, the intervention was tailored to address-specific needs and challenges faced by service users, resulting in more personalized and effective treatments, which is likely to enhance treatment engagement by increasing acceptability and relevance for service users. Culturally appropriate interventions are facilitated through the incorporation of stakeholders’ perspectives. This promotes better understanding and adherence among diverse populations. The user-friendly nature of the booklets, achieved through stakeholders’ feedback, may play a role in improving treatment adherence as service users find it easier to comprehend and implement the strategies provided. It is also likely to foster empowerment and autonomy, acknowledging their expertise and experiences.

In addition to being one of the few Indian studies to develop and the first of its kind to validate home-based psychosocial self-management interventions in PwS, our study has several other strengths. To ensure content validity of the modules, our study employed a comprehensive approach that combined qualitative and quantitative methods. We sought to establish the appropriateness and relevance of the module content by incorporating feedback from mental health experts in the field. Their expertise and insights played a crucial role in refining the modules and ensuring their alignment with the specific needs and requirements of the target population. Subsequently, the modified booklets underwent pilot testing with service users, allowing for their direct involvement and input in the evaluation process. This iterative approach enabled us to gather valuable feedback from service users regarding the usability, clarity, and effectiveness of the modules. Their perspectives and suggestions were carefully considered to further refine and tailor the booklets to better meet their specific requirements. By employing a combination of qualitative and quantitative methods, along with the active involvement of mental health experts and service users, we ensured that the modules underwent a rigorous validation process, resulting in content that is both valid and responsive to the needs of the intended audience. The intervention is unique in its attempt to develop a comprehensive and culturally informed psychosocial self-management intervention targeting PwS and their caregivers.

However, it is important to acknowledge certain limitations associated with the current findings. First, the effectiveness of the modules on psychopathology was not assessed, and thus, the impact of the interventions on symptom severity remains unknown. Another critical limitation is that the revalidation or pilot testing of the booklets was not done for their final version. Another limitation is the composition of the mental health professional team involved in the development and content validation of the modules. The team primarily consisted of psychiatrists and one psychologist, without the inclusion of psychiatric social workers and psychiatric nurses. This limitation reflects the staffing constraints commonly observed in LRS,[24] such as India, where pharmacological and psychosocial management is predominantly carried out by psychiatrists.[25,26] Addition of other mental health professionals could have reduced the possibility of skewed opinion in FGDs pertaining largely to physical health, diet, adherence, and so on and little focus on supported employment and assertive community training, which are largely the expertise of nonpsychiatrist mental health professionals. Moreover, the home-based intervention was designed to be implemented by patients visiting psychiatric outpatient services, with assistance from their caregivers at home. Given that psychiatrists had the most extensive contact with the target population and caregivers, they were considered the most suitable experts to assess the content validity of the booklets. Psychosocial intervention techniques and strategies target behavioral, cognitive, emotional, interpersonal, social, and environmental factors with the aim of improving functioning and well-being. We could not develop and assess all the factors in a single study and focused on a few, particularly behavioral and environmental.

While these limitations are noteworthy, they provide valuable insights for future research to address these gaps and further enhance the applicability and generalizability of the developed interventions in different settings and with a broader range of mental health professionals. Since India has wide cultural variations, the modules from the current study can be adapted to other settings and places in future. Future studies may also focus upon studying the effectiveness of such interventions in the rehabilitation of the PwS.

CONCLUSION

The development and validation of modules targeting key areas within low-resource settings have yielded promising results. The high content validity of the individual items and the overall booklets, along with the incorporation of feedback from service users, suggests their suitability for application within the target population. These findings indicate that the booklets can be effectively utilized in further research to explore their feasibility and subsequently test their effectiveness. This underscores the potential of these booklets to address the specific needs of the target population and lays the foundation for future investigations into their practical implementation and impact on mental health outcomes.

Financial support and sponsorship

This study was funded by the National Institute for Health Research, UK (Project number: 16/137/107) and was part of NIHR Global Health Research Group on Psychosis Outcomes: the WarwickIndiaCanada (WIC) Network comprising of Warwick University, UK; McGill University, Canada, and All India Institute of Medical Sciences, New Delhi in North India and Schizophrenia Research Foundation in South India. SPS is part funded by the NIHR Global Health Group WIC and by the West Midlands Applied Research Collaboration (ARC). SNI is supported by a salary award from the Canadian Institutes of Health Research. The views expressed are those of the author (s) and not necessarily those of the NIHR or the Department of Health and Social Care.

Conflicts of interest

There are no conflicts of interest.