Integrating mental health into primary care: Implementation outcomes and clinical impact of the Health Action for Psychiatric Problems In Nigeria including Epilepsy and SubstanceS (HAPPINESS) intervention

doi:10.21203/rs.3.rs-3148682/v1

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Integrating mental health into primary care: Implementation outcomes and clinical impact of the Health Action for Psychiatric Problems In Nigeria including Epilepsy and SubstanceS (HAPPINESS) intervention

https://doi.org/10.21203/rs.3.rs-3148682/v1

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Background

Access to mental health care in low- and middle-income countries like Nigeria remains suboptimal. Integrating mental health care into primary care using a stepped-care, task-sharing approaches improves access. Research evidence on best model to scale up these approaches are needed. The Health Action for Psychiatric Problems In Nigeria including Epilepsy and SubstanceS (HAPPINESS) intervention is a multi-component, community-based, mobile technology-supported intervention developed to integrate mental health into primary health care centers in Nigeria using the World Health Organization's Mental Health Gap Action Programme-Intervention Guide (mhGAP-IG). This study evaluates the implementation outcomes and patient-level clinical impact of the HAPPINESS intervention.

Methods

Using a quasi-experimental design (single cohort with pre- and post- measures) and the Wilcoxon Signed Rank Test, Mann-Whitney U and Kruskal Wallis tests we assessed changes in psychiatric symptoms among patients treated for mental, neurological and substance use disorders through the HAPPINESS intervention using their scores on the Patient Health Questionnaire-9 and Brief Psychiatric Rating Scale at baseline and 6 months post-intervention. The implementation outcomes (feasibility, adoption, and fidelity) were assessed using Proctor’s implementation outcome framework.

Results

The HAPPINESS intervention implementation demonstrated high feasibility with robust site recruitment and 100% training completion rate. The adoption rate was high with 84% of the sites actively implementing the HAPPINESS intervention at 12 months. Fidelity to the intervention protocol (screening, assessment, treatment, follow up, referrals and consultation) was 81%. Patients’ retention rate in care at 6 months was 91% and at 12 months was 86%. The Wilcoxon Signed Rank Test showed a statistically significant reduction in PHQ-9 scores from baseline (Md = 9.5) to 6 months (Md = 3.0) post-intervention (z = 80.5, p < 0.001), with a large effect size (r = 0.8) and statistically significant reduction in BPRS scores from baseline (Md = 36.0) to 6 month (Md = 17.0) post-intervention (z = 128.5, p < 0.001), with a large effect size (r = 0.9).

Conclusion

This study adds to the growing evidence of the feasibility, effectiveness, role of mobile technology and potential for mhGAP-IG-based efforts to scale up mental health services through primary health care to increase access to evidence-based interventions in Nigeria.

Nigeria

mental health

mhGAP

pilot

implementation

feasibility

training

primary care

With only 250 psychiatrists for a population of about 200 million people (1), Nigeria exemplifies the severe lack of psychiatrists and mental health specialists in low and middle-income countries (LMICs)(2). The reasons for this paucity of mental health specialists are multifactorial, but an effective approach to mitigating the shortage is training non-mental health professionals to deliver packages of mental health care in a collaborative, stepped-care, task-sharing approach(3–5).

In line with this approach, Nigeria’s strategic policy on mental health articulated in 1991 and revised in 2013 is to integrate mental health care into primary, secondary and tertiary care settings with the responsibility of implementation delegated to local governments (6). The policy was revised in 2013 to accommodate logistic challenges of integrating mental health care within the primary health system and to make specific recommendations for primary, secondary, and tertiary care (7). These recommendations included: a) at the primary care level, having psychotropic medications from the essential drug list, strengthening community outreach, awareness, rehabilitation, and referral/consultation processes; b) at the secondary care level, setting up inpatient and outpatient mental health services at all hospitals and strengthening inter-sectoral governance structures to manage mental, neurological and substance use (MNS) disorder services; and (c) at the tertiary care level, supporting secondary care services with mental health expertise. Furthermore, the revised policy encouraged the use of public-private partnerships to further innovate mental health service delivery. Finally, it recommended adequate training, retraining, and continuing professional development activities on screening, identification, treatment and referral of MNS disorders at all levels of care for all direct care medical personnel.

Despite these long-standing, well-articulated policy goals, mental health integration into general health settings in Nigeria has not been fully implemented due to factors related to funding, training, and supervision of trained non-mental health specialist (8, 9). Only a few states in Nigeria (Benue, Lagos, Osun, and Ogun) have implemented state-wide mental health training for primary health care workers(10–13).

The World Health Organization’s Mental Health Gap Action Programme-Intervention Guide (mhGAP-IG), which supports this approach to scale up treatment and services for MNS disorders in LMICs, has been contextualized and piloted in Nigeria and utilized in programme implementation in these states(14–16). Core components of the mhGAP-IG approach are Primary Healthcare Center (PHC)-level screening and identification of MNS disorders, training for non-mental health specialists, specialist supportive supervision for the trainees, and strengthening referral pathway between trained health care workers and specialists (17). However, some implementation research questions have not been addressed. For instance, few studies have focused on fidelity to the mhGAP-IG protocols and other manualized processes for assessment, treatment and referral delivered by trained, non-specialist workers (12, 18). There is also a need to identify how best to efficiently access specialist support, supervision, consultation and referral for trained clinicians providing mental health care in non-mental health specialist centers(19).

Furthermore, there is limited data on the rate of adoption of mhGAP-IG-based collaborative care models in primary, secondary and tertiary care centers in Nigeria(20).

This study evaluates the implementation and patient-level clinical impact of the mhGAP-IG-based HAPPINESS (Health Action for Psychiatric Problems including Epilepsy and SubstanceS) intervention pilot integrating mental health into primary health centers in Imo State Nigeria from October 2019 to September 2021. We hypothesized that the HAPPINESS intervention will be delivered with fidelity by the trainees and that the intervention will lead to improvement in patients’ symptoms as measured by the 9-item Patient Health Questionnaire (PHQ-9) and Brief Psychiatric Rating Scale (BPRS).

Study Design

This study used a quasi-experimental design (single cohort with pre- and post- measures) to assess changes in psychiatric symptoms using patients’ scores on the Patient Health Questionnaire (PHQ-9) and Brief Psychiatric Rating Scale (BPRS), which were documented at baseline and 6 months post-intervention. PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression(21). BPRS is a rating scale used to measure psychiatric symptoms such as psychosis, depression, and anxiety(22). Measures of HAPPINESS intervention feasibility (site recruitment, training completion), adoption (rate of implementation), and fidelity (delivery of screening, assessment, treatment, referral and consultation according to the intervention protocol) were assessed through administrative data review completed at 12 months post HAPPINESS intervention roll out at each primary care site (Appendix 1).

Setting

Imo state has a population of about 4 million people (23) with 527 primary health centers (PHCs) staffed by 453 nurses, 76 community health officers, and 864 community health extension workers spread across the State's urban and rural areas. Data obtained during a needs assessment indicated that each center had a part-time or full-time covering physician. During planning meetings, 3 additional PHCs were added to the initial 10 PHCs from five local government areas of the state that were selected for the pilot study. The PHCs were selected based on the availability of staff in the clinics and geopolitical representation across the state. A total of 25 nurses (10 with prior in-service psychiatric training and 15 with no prior in-service psychiatric training) from 13 participating PHCs were invited for the HAPPINESS intervention mhGAP-IG 5-day training and 1-day 6-month refresher training, including training on the use of the mobile apps for continuing medical education, specialist consultation and referral.

Study population and sample

The target population for the study was all patients attending primary health centers for routine medical care and services in the participating 13 PHCs. Medical records reviewed during the planning phase of the project showed that the PHCs served a total of 2,756 adult patients in the preceding 12 months. These patients came for services like antenatal care, immunization, and general medical care. The study sample included adults who screened positive for MNS disorders based on clinical assessment, PHQ-9 and BPRS scores.

Summary of the HAPPINESS Intervention

Healthcare workers training

Details of the HAPPINESS intervention components, including Training, Refresher Training, Clinical Practice, Support Supervision, Community Engagement, and the Drug Revolving Fund (Appendix 2), have been previously published and summarized in Fig. 1 (24). In summary, for the mhGAP-IG training, we chose the following modules: Essential Care and Practice, Depression, Psychoses/Mania, Epilepsy, and Substance Use Disorders and made relevant adaptations based on local needs and context. The training was delivered in-person, facilitated by mhGAP-IG master and trained trainers. It was an 8-hour per day, 5-day training (with scheduled breaks) with didactics, group workshops, and role-plays. Post-training certification was based on 100% attendance to all training activities, a score of at least 90% on the post-training knowledge test, and a “pass” grade on the observed practice session as scored by trainers according to pre-set competency rubrics (patient assessment, patient education, diagnosis, and treatment).

Post-training support supervision, consultation, and referral

Supportive supervision was conducted in person (when feasible) and virtually (WhatsApp® video call/regular mobile phone call) with the covering psychiatrist completing at least once a month, one-hour check-in with the PHC teams. Consultation and referral between the PHC team and supporting psychiatrists were conducted using three mobile applications: WhatsApp® Messaging, voice or video call,“one2one” and VULA health app (25, 26) depending on internet availability. Continuing medical education was conducted at least once a month using WhatsApp®Group Messaging or Zoom® Meetings.

Clinical Tool Kit and Standard Operating Procedure.

The HAPPINESS intervention Clinical Tool Kit and Standard Operating Procedure outlined screening, assessment, and treatment protocol. It also included clinical documentation, data entry, appointments management, referral, and consultations processes (Appendix 1 and 2).

Data Collection

Using the HAPPINESS project implementation checklists, guided by Proctor et al.’s implementation outcomes framework (27) and chart review, data were abstracted from training reports, PHC monthly reports, clinic registers of new patients, and notes on treatment and follow-ups. Patients’ diagnoses and scores on PHQ-9 and BPRS questionnaires at baseline and 6 months post-intervention were documented and collated using a project data sheet.

Data analysis for clinical outcomes

We conducted the Mann-Whitney U and Kruskal Wallis tests, which are non-parametric statistical tests used to compare medians of independent samples, to compare differences between sex, marital status, presence of anxiety and/or depression and nurse type for baseline or post-intervention PHQ-9 and BPRS scores, separately. We also conducted the Wilcoxon signed-rank test, which is a non-parametric test used to compare medians of dependent samples to compare baseline or post-intervention median scores for the PHQ-9 and BPRS overall and separately per category. We used the R statistical software (28) to conduct all analyses and calculated associated effect sizes, which are the rank-biserial correlation coefficient (r) for Wilcoxon Signed-Rank, the standardized difference between two groups' ranks (dividing the test statistic by its maximum value, which is the product of the Ns for the two groups) for Mann-Whitney U (29) and eta-squared (η2) for Kruskal Wallis.

The study was approved by Yale University Institutional Review Board (#2000022691) and Imo State University Teaching Hospital’s Ethics Committee.

All invited 25 primary care nurses from 13 primary care clinics, drawn from 5 out of the 27 Local Government Areas of Imo State, completed the HAPPINESS intervention training in the assessment and management of the following MNS priority conditions: depression, mania/psychosis, epilepsy, and substance use disorders. The HAPPINESS intervention was successfully implemented in 11 out of the 13 primary care clinics (84%). Out of the expected 132 monthly reports, 6 were missing from one clinic and 126 reports were obtained from the 11 active clinics over the 12-month pilot period (completion rate of 95%).

A total of 1573 primary care clients were screened for MNS disorders over the 12-month period, with 196 identified and treated for MNS conditions. At 6 months, 178 patients (91%) were engaged in treatment and at 12 months, 168 patients (86%) were still engaged in treatment.

A random chart review of 44 patient records (4 from each clinic) to assess fidelity to the HAPPINESS intervention protocol using the clinical tool kit checklist (Appendix 1) showed completion of Assessments, Treatments, Follow ups and Documentation in 36 of the records (81%).

Out of the data collected from 196 patients, only 178 had complete records of baseline and post-intervention PHQ-9 and BPRS and could be used in the analysis. Table 1 shows demographic and other relevant clinical characteristics of the overall sample and the analytical sample. The analytical sample’s mean age was 37.5 years, 53.4% of individuals identified as female, and most individuals were single (52.2%) or married (42.7%). Over a quarter of the patients received care from the HAPPINESS intervention mhGAP-trained nurses with prior psychiatric in-service training (Psych Nurses) (26.4%), and the rest received care from HAPPINESS intervention mhGAP-trained nurses with no prior psychiatric in-service training (Non-Psych Nurses) (73.6%). For psychological diagnoses, 36% of the sample had anxiety and/or depression, 39.3% had psychosis, 21.3% had epilepsy, and 7.9% had substance-use-disorder. Table 2 show mean and median overall PHQ-9 and BPRS scores at baseline and at 6 months post-intervention for the original and analytical sample. Overall, PHQ-9 and BPRS mean and median scores decreased post-intervention, with slightly higher scores in the analytical sample.

The data for PHQ-9 and BPRS were not normally distributed and skewed, as assessed by Shapiro-Wilk tests for pre- (baseline) and 6 months post-intervention (pre-PHQ-9: W = 0.957, p < 0.001 and post-PHQ-9: W = 0.827, p < 0.001; pre-BPRS: W = 0.917, p < 0.001 and post-BPRS: W = 0.886, p < 0.001) thus our decision to conduct Mann-Whitney U(30) and Kruskal Wallis tests (31).

Table 1

Demographic and medical characteristics of the original and analytical sample.
	Original Sample (N = 196)	Analytical Sample (N = 178)
Age
Mean (SD)	37.4 (15.0)	37.5 (15.2)
Median [Min, Max]	37.0 [2.00, 80.0]	36.5 [2.00, 80.0]
Sex
Female	106 (54.1%)	95 (53.4%)
Male	90 (45.9%)	83 (46.6%)
Marital Status
Divorced	1 (0.5%)	1 (0.6%)
Married	85 (43.4%)	76 (42.7%)
Separated	6 (3.1%)	5 (2.8%)
Single	101 (51.5%)	93 (52.2%)
Widowed	3 (1.5%)	3 (1.7%)
Nurse Type
Non-Psych Nurses	135 (68.9%)	131 (73.6%)
Psych Nurses	61 (31.1%)	47 (26.4%)
Psychiatric Diagnoses
Depression	65 (33.2%)	64 (36.0%)
Anxiety	36 (18.4%)	35 (19.7%)
Anxiety and Depression	36 (18.4%)	35 (19.7%)
Dementia	7 (3.6%)	7 (3.9%)
Psychosis	83 (42.3%)	70 (39.3%)
Substance Use Disorder	16 (8.2%)	14 (7.9%)
Epilepsy	40 (20.4%)	38 (21.3%)
*Presence of General Medical Diagnosis**	8 (4.1%)	7 (3.9%)
Note: the number of individuals and percent of the sample are reported in parentheses. *Medical diagnoses included malaria, hypertension, diabetes, and chronic pain

Table 2

Overall means and averages of PHQ-9 and BPRS Scores.
	Original Sample (N = 196)	Analytical Sample (N = 178)
Baseline PHQ-9
Mean (SD)	9.64 (6.51)	10.5 (6.14)
Median [Min, Max]	9.00 [0, 26.0]	9.50 [1.00, 26.0]
6 month (post) PHQ-9
Mean (SD)	3.76 (2.82)	4.14 (2.68)
Median [Min, Max]	3.00 [0, 16.0]	3.00 [1.00, 16.0]
Baseline BPRS
Mean (SD)	38.4 (18.3)	39.5 (18.3)
Median [Min, Max]	35.0 [0, 101]	36.0 [7.00, 101]
6 month (post) BPRS
Mean (SD)	17.8 (9.15)	18.3 (9.28)
Median [Min, Max]	16.5 [0, 56.0]	17.0 [6.00, 56.0]

Results from the Wilcoxon Signed Rank Test (Table 3) showed a statistically significant reduction in PHQ-9 scores from baseline (Md = 9.5) to 6 months (Md = 3.0) post-intervention (z = 80.5, p < 0.001), with a large effect size (r = 0.8). It also showed a statistically significant reduction in BPRS scores from baseline (Md = 36.0) to 6 month (Md = 17.0) post-intervention (z = 128.5, p < 0.001), with a large effect size (r = 0.9). The same was seen for each sex category and nurse type, with significant differences between baseline and post-intervention scores that have a large effect size.

Table 3

Wilcoxon Signed Rank Test results for baseline and post-intervention, overall and by sex and nurse type.
Category	Baseline Score Median [min, max]	Post-Intervention Score Median [min, max]	Z-statistic	P-value	Effect Size, r
Overall
PHQ-9	9.50 [1.00, 26.0]	3.00 [1.00, 16.0]	80.5	4.94e-26*	0.826
BPRS	36.0 [7.00, 101]	17.0 [6.00, 56.0]	128.5	7.36e-30*	0.852
Female
PHQ-9	10.0 [1.00, 26.0]	4.00 [1.00, 16.0]	31.0	7.38e-15*	0.834
BPRS	38.0 [7.00, 101]	18.0 [6.00, 56.0]	4.0	2.97e-17*	0.866
Male
PHQ-9	9.00 [1.00, 21.0]	3.00 [1.00, 12.0	16.5	1.04e-12*	0.815
BPRS	33.0 [7.00, 91.0]	15.0 [6.00, 55.0]	61.0	3.37e-14*	0.836
Psychiatric Nurse
PHQ-9	7.00 [1.00, 25.0]	3.00 [1.00, 12.0]	15.5	4.04e-07*	0.777
BPRS	36.0 [19.0, 91.0]	19.0 [10.0, 43.0]	25.5	1.87e-08*	0.829
Non-Psychiatric Nurse
PHQ-9	10.0 [1.00, 26.0]	4.00 [1.00, 16.0]	25.5	2.41e-20*	0.840
BPRS	36.0 [7.00, 101]	14.0 [6.00, 56.0]	44.0	8.36e-23*	0.858
Note: effect sizes close to 1 suggests a strong association (close to 0 suggests a weak or no association). *Denotes a significant p-value at the 0.05 level

The results of the Mann-Whitney U and Kruskal Wallis tests (Table 4) show that baseline PHQ-9 scores alone were not significantly different by sex, nurse type, or marital status categories. It was, however, significantly different between those with and without a depression or anxiety diagnosis, with a large effect size (U = 4471, p < 0.05, effect size = 0.613). Baseline BPRS scores were not significant for any of the categories.

On the other hand, post-intervention PHQ-9 scores alone were not significantly different by sex or depression or anxiety diagnosis. However, they were significantly different by nurse type with a moderate effect size (U = 2462, p < 0.05, effect size = 0.400) and marital status with a small effect size (χ²(4) = 10, p < 0.05, η2 = 0.0346). Post-intervention BPRS scores were not significantly different by sex, depression or anxiety diagnosis, or marital status. However, they were significantly different by nurse type with a large effect size (U = 4323, p < 0.05, effect size = 0.702).

Table 4

Mann-Whitney U and Kruskal-Wallis test results for baseline and post-intervention scores by sex, nurse type, depression or anxiety diagnosis, and marital status.
Baseline				Post-Intervention
Category	U statistic	P-value	Effect Size	U statistic	P-value	Effect Size
Sex
PHQ-9	4336	0.25	0.550	4336	0.20	0.550
BPRS	4428	0.20	0.562	4184	0.50	0.531
Nurse Type
PHQ-9	2838	0.40	0.461	2462	0.04*	0.400
BPRS	2892	0.50	0.47	4323	4e-05*	0.702
Marital Status
	Kruskal-Wallis Chi-Squared	P-Value	Effect Size, η2	Kruskal-Wallis Chi-Squared	P-Value	Effect Size,η2
PHQ-9	6.159	0.1876	0.0125	10	0.03*	0.0346
BPRS	5.996	0.1995	0.0115	8	0.1	0.0219
Note: all comparisons for two sub-categories (sex, nurse type, depression, or anxiety) were analyzed using the Mann-Whitney U test. Marital status included more than two categories; thus, it was analyzed using the Kruskal-Wallis test. For the Mann-Whitney, effect sizes near 1 suggests a large difference between the groups (close to 0 suggest small or negligible differences). For Kruskal-Wallis, η2 between 0.01 and 0.06 indicates small effect), between 0.06 and 0.14 is moderate and greater than 0.14 is large. *Denotes a significant p-value at the 0.05 level

Results from the pilot implementation of the HAPPINESS intervention showed a high rate of adoption (84%), penetration (95%), and fidelity (81%) as well as patient engagement (91%) and retention in care at 12 months (86%). These promising results add to the initial findings of high acceptability and feasibility of the HAPPINESS intervention (24). They are also in keeping with other studies of mhGAP-based integration of mental health into primary care in Nigeria and other LMICs (9, 12). These implementation outcomes also provide needed data and basis for further development and testing of the HAPPINESS intervention in a larger cluster randomized controlled trial to determine its effectiveness compared to usual care and potential for sustainment and scale up nationally.

The HAPPINESS intervention also led to significant improvements in patients’ BPRS and PHQ-9 scores at 6 months post-intervention across all demographics and diagnoses. This finding adds to the growing evidence that collaborative, task-shifting, stepped-care model of mental health care delivery using the WHO’s mhGAP-IG can be an effective approach to scaling up mental health in Nigeria and increasing access to evidence-based care in the community for people with common mental disorders (10, 32). The HAPPINESS intervention is particularly relevant as its key components: remote specialists’ supervision, consultation, and referral as well continuing medical education for the trainees, utilized telemedicine and mobile technology. This model of remote expert clinical support and continuing education has been well-studied in the Project ECHO (Extension for Community Healthcare Outcomes) model in high, low and middle-income countries (33, 34). This model offers a pathway for many psychiatrists and mental health specialists from LMICs in the diaspora to potentially support clinical education, capacity building and mental health care delivery in their home countries.

When looking at improvement in patients’ scores on the PHQ-9 and BPRS across time, patients who were treated by nurses with prior psychiatric experience and those who were treated by nurses without prior psychiatric experience had significantly different baseline and post-intervention scores, showing that both groups of patients benefited from the intervention over time. However, further comparison of post-intervention PHQ-9 and BPRS scores between the two groups of patients show that the treating nurses with prior psychiatric experience had a substantial impact on the scores. The baseline and post-intervention medians, along with the results of the Mann-Whitney U (Tables 2 and 4) show that there is a high probability that a randomly chosen patient who was treated by a nurse with prior psychiatric experience will have a lower (and more favorable) post-intervention score than a randomly chosen patient who did not receive care from a nurse with prior psychiatric experience. The magnitude of this effect was larger for BPRS than PHQ-9. Altogether, this means that although patients treated by either nurse type improved over time, post-intervention scores were lower among individuals who received care from nurses with prior psychiatric experience (a difference that was not present at baseline). While we are unable to determine exactly the reason for this difference, we speculate that prior experience in treating patients with mental illness, including the use of sublime skills gained through specialized training and practice, may have contributed to the nurses’ capacity to provide more robust psychosocial support. It also highlights the need for the trainees to continue to practice the skills they learned during this pilot project to solidify their learning and further enhance their clinical competence (35).

As expected, baseline PHQ-9 scores significantly differed between those with and without a depression/anxiety diagnosis, with a moderate effect size. This difference was not seen in post-intervention scores, indicating that improvement in symptoms following treatment for those with depression or anxiety led to reduced PHQ-9 scores and the psychosocial support delivered as part of the HAPPINESS intervention benefitted even those without depression or anxiety. This supports the need to include psychosocial support and counseling as part of a basic package of care for people with mental, neurological and substance use (MNS) disorders, irrespective of specific diagnoses. Post-intervention PHQ-9 scores were also significantly different by marital status, but the small effect size indicates that only a small proportion of the variance in the PHQ-9 scores can be explained by marital status.

Limitations

First, this was a quasi-experimental study with baseline and 6 months post-intervention assessments. Therefore, there is a risk of confounding, which limits the confidence in establishing causality compared to a randomized controlled trial (RCT). However, the study provides robust data to support a larger cluster RCT that can support measures to mitigate against confounders.

Second, due to the non-normal nature of the data, we could not conduct parametric tests (i.e., a mixed ANOVA) to compare the main and interaction effects between time (baseline and post-intervention) and different categories or factors of interest (e.g., gender).

Third, although we attempted to include representative primary care centers from the three geopolitical zones of the state, this was a relatively small patient sample size compared to the general population of the state. Thus, we are unable to confidently generalize the findings.

Lastly, although there were significant improvements in PHQ-9 scores among patients who received treatment, we were unable to determine if the improvement in symptoms of anxiety, depression or psychosis were due to psychosocial support plus medication or psychosocial support alone. In depression for example, the general recommendation is “watchful waiting” and psychoeducation for PHQ-9 score of 5–9 and counselling, follow-up and/or pharmacotherapy for PHQ-9 score of 10–14 and above, however, the data entry in our pilot sites did not differentiate those who received psychoeducation plus medication or psychoeducation/counseling alone based on their scores. In our subsequent planned, larger randomized controlled trial, we plan to gather more details to enable evaluation of the effects of psychosocial support versus the addition of medication management.

This pilot implementation study shows that it is feasible to integrate mental health into primary care with fidelity and a high adoption rate. It also shows that primary care nurses trained with mhGAP-IG and provided specialist clinical support physically and remotely using mobile technology can lead to improvement in patients’ symptoms with a high rate of retention and engagement in care.

LMIC = Low and middle income countries

HAPPINESS – Health Action for Psychiatric Problems In Nigeria including Epilepsy and SubstanceS
MNS – Mental, Neurological, and Substance Use

mhGAP-IG – Mental Health Gap Action Programme – Implementation Guide

PHQ-9- Patient Health Questionnaire

BPRS- Brief Psychiatry Rating Scale

ECHO- Extension for Community Healthcare Outcomes

Ethics approval and consent to participate.

Ethical approval was granted by Yale University's Institutional Review Board and Imo State Teaching Hospital's ethics committee. Both institutions assessed that the research posed no more than minimal risk of harm to subjects and involves no procedures other than administrative, clinical chart review and data abstraction.

All participants provided verbal consent to participate.

Consent for publication

Not applicable.

Availability of data and materials

The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

Competing interests

The authors claim that they have no competing interests.

Funding

Funding was provided by CBM UK, Yale Global Mental Health Program and Yale Institute of Global Health Hecht Faculty Award.

Authors' contributions

TI, CA, EN, and CD were responsible for the design of the HAPPINESS intervention and training. TI and CA were part of data collection. CC and TI conducted data collation and data analysis. All authors provided input for and approved the final manuscript.

Author Information

Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA

Theddeus Iheanacho & Charles Dike

Yale School of Public Health, New Haven, CT, USA

Casey Chu

Department of Medicine, Imo State University, Owerri, Imo State, Nigeria

Chinyere M. Aguocha & Emeka Nwefoh

CMB UK, Country Office, Abuja, Nigeria

Emeka Nwefoh

Acknowledgments

We are grateful to our volunteer project support staff especially Ms Obianuju Ukaigwe for her dedication and diligence in coordinating data collection from all participating primary health care centers. We also acknowledge the support provided by CBM UK, Imo State Primary Care Development Agency, Imo State University Teaching Hospital, Imo State Ministry of Health, Yale Global Mental Health Program, Yale Institute of Global Health, and HHC Foundation.

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No competing interests reported.

Appendix1.pdf
Appendix 1: The HAPPINESS Project Standard Operating Procedure (SOP) Appendix 1.pdf Description: SOP for clinical record-keeping and reporting for primary care nurses.
Appendix2.pdf
Appendix 2: The HAPPINESS Project Drug Revolving Fund Appendix 2.pdf Description: Outlines the project's Drug Revolving Fund scheme.

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Integrating mental health into primary care: Implementation outcomes and clinical impact of the Health Action for Psychiatric Problems In Nigeria including Epilepsy and SubstanceS (HAPPINESS) intervention

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Abstract

Background

Methods

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Introduction

Methods

Study Design

Setting

Study population and sample

Summary of the HAPPINESS Intervention

Healthcare workers training

Post-training support supervision, consultation, and referral

Data Collection

Data analysis for clinical outcomes

Results

Discussion

Limitations

Conclusion

Abbreviations

Declarations

References

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