Depressive and anxiety disorders, also referred to as common mental disorders (CMD), are widely prevalent in primary care settings in low- and middle-income countries (LAMIC) 1 and are associated with significant levels of disability, increased health care costs and reduced economic productivity 2–4. Although substantial proportions of primary care attenders in LAMIC suffer from a CMD — estimates vary from 10 to 30% 1,5– the vast majority of patients do not receive effective treatments 6. This treatment gap persists even as a growing evidence base demonstrates that there are efficacious treatments that are feasible in LAMIC settings 7–10. To address this treatment gap, integration of mental health services into primary care is widely acknowledged as the most feasible strategy 11. While we now have encouraging evidence that specific treatments for CMD work in LAMIC, the challenge is to integrate these in a comprehensive intervention package within routine primary care systems. This is one of the key research priorities for CMD in LAMIC 12. A recent review of evidence from high-income countries highlighted the components that are necessary for the effective integration of services for depression in primary care settings 13. These were the routine screening of patients, education for primary health care staff, skilled mental health providers delivering a stepped-care intervention and the active collaboration of mental health specialists in the programme. The adaptation of these principles in LAMIC primary care settings presents several challenges. These include limited skilled mental health resources, vastly different social and cultural contexts and an already constrained primary care system 14–16. Other barriers to possible integration include the low recognition rates of CMD by primary care doctors 17, limited primary health care staff and large numbers of patients, infrequent and/or inadequate use of antidepressants 18 and the frequent use of medications such as vitamin injections which are prescribed for their supposedly “restorative” properties 19. Low adherence to medication regimens further minimizes the gains of treatment. In addition, few patients receive psychosocial treatments, typically because of a scarcity of personnel with the time and skills to deliver these 20. The MANAS project is an effectiveness trial of a multi-component, comprehensive intervention to integrate the treatment of CMD in primary care facilities in Goa, a state on the West coast of India which has been the setting for a number of studies on the epidemiology and treatment of CMD 21–23. The original intervention plan was based on two principles: first, the treatments selected would be based on evidence from published trials in LAMIC and, thus, include psychoeducation 24,25, antidepressants 7,9 and group interpersonal therapy (IPT) 8,10; and, second, the intervention would address the challenges highlighted earlier and be based on the best global evidence available 13. The intervention would involve a reconfiguration of both the human resources and the principles of care delivery in primary care. The personnel would comprise a low cost, skilled mental health care provider working in the clinics (the “health counselor”), who, along with the existing primary care doctor, would detect and provide treatments for CMD with the support and supervision of a visiting psychiatrist. The treatments provided would be matched to the needs of the patient (stepped care) 7, including brief psychoeducation as the first step, with the more intensive treatments (antidepressants and IPT) being available for those with more severe problems (Table 1). We refer to this collaborative, stepped care intervention as the MANAS intervention. As a word, MANAS means “humanity” in the local Konkani language. It is also an acronym for MANAShanty Sudhar shodh (“project to promote mental health”). Our aim is, ultimately, to evaluate the MANAS intervention in a cluster randomized controlled trial in primary care settings in Goa, India. This trial is now in progress. In this paper, we describe the preparatory stage (October 2005 – December 2006), in which the feasibility and acceptability of the intervention was evaluated systematically, in keeping with the current recommendations for the conduct of complex intervention trials 26. The preparatory stage had three distinct phases: a) consultation with stakeholders; b) formative research to evaluate key components of the intervention; and c) piloting of the entire intervention. Each stage is described sequentially, with a focus on the methods and key findings, and questions which arose which were then addressed in the subsequent stage. The objective of this phase was to consult with local, national and international stakeholders from the public, private and academic sectors about the feasibility of the proposed intervention. A total of 14 consultation meetings were held at primary health care centres and conference venues with the local stakeholders. A total of 145 doctors from the Directorate of Health Services and private practitioners participated, in addition to the primary health care staff. During these meetings, a key member of the team described the MANAS intervention. Group exercises were undertaken to get feedback on the relevance and need of the programme in primary care, on the feasibility of implementing the intervention and on the specific problems and solutions that were likely to occur in these settings. A meeting of national and international collaborators involved with the trial was held in early 2006, during which results of the previous consultations were presented and further inputs of this group were considered. Doctors suggested that the routine screening results for detection of CMD be presented to them in a simple manner that would also be of assistance in providing feedback to patients. Psychoeducation (Step 1) should be brief, emphasize the connection between the stressors and the symptoms, and be delivered in an empathic manner. The health counselor should avoid using terms that could be stigmatizing. Public sector doctors wanted the antidepressant to be made available free of cost, in keeping with usual care practices and in order to improve adherence rates. The participants suggested that the group psychological intervention be delivered either in primary health care centres or in community locations (e.g., temple courtyards or local schools), for men and women separately and in the evenings to maximize attendance. Furthermore, concerns were expressed that many patients would not find group sessions acceptable or convenient, and that an individual treatment format should also be offered as a choice. Many of the participants felt that including yoga as one of the group activities would make the intervention more culturally acceptable. It was agreed that a set of yoga techniques, selected on the basis of their efficacy for anxiety and depression, would be utilized in the MANAS intervention. It was proposed that the yoga sessions be available to all primary health care attendees and staff, in addition to the patients receiving the intervention, so as to destigmatize the overall program. According to the original formulation of the program, doctors would provide patients with a choice of antidepressants or psychological treatments. However, the stakeholders felt that, in the context of the strong medical model in current care, this would lead to most patients receiving antidepressants. It was recommended that the effectiveness and appropriateness of psychological treatments be emphasized in the training of doctors, to make the process of choice more balanced. Furthermore, doctors felt there should be a distinction in guidelines for mildly ill patients from those who are severely ill (based either on screening questionnaire data or clinical assessment), so that the latter can be moved straight to a higher step on their first presentation. Considering the multiple responsibilities of the health counselor, the decision was made to separate the roles of screening and intervention delivery. Thus, two additional full-time staff would be based in facilities, one to screen and, where needed, to register patients (whom we refer to as the “health assistant”) and one to be the case manager for the MANAS intervention (the health counselor). The health counselor was seen as the most important human resource of the program, and most of the participants were of the opinion that she should be a woman, be fluent in the local languages, have excellent communication skills and be available for consultations on a regular basis in the clinics. Many also wanted her to be called the “salagar” (advisor), to reflect local understandings and improve her acceptability. The objective of the formative phase was to evaluate the feasibility and acceptability of the specific treatments in the intervention. The formative research was conducted over 16 weeks (April – July 2006) in four primary health care centres and four private general practice facilities. The primary health care centres, which were staffed by 3–5 doctors backed up by nursing and administrative personnel, offered outpatient care 6 days a week, as well as limited inpatient facilities. The private general practice clinics were in urban and rural areas and were run by a single doctor with or without inpatient facilities in single rooms or in small hospitals referred to locally as “nursing homes”. None of these facilities had counsellors or health educators and specialty mental health care was accessible only through referrals. In keeping with the recommendations made during the consultation phase, 10 women (4 health counselors and 6 health assistants) were recruited. The health counselors were trained to deliver the various treatments, including counseling skills, psychoeducation, yoga and IPT; their training was based on a draft manual developed for the intervention. The health assistants were trained in the use of the screening instrument chosen for the trial. The final training exercise for the doctors was conducted either individually or in small groups. This focused on the recognition and management of CMD, with a particular emphasis on the rational use of antidepressants and avoidance of non-evidence based medications. A set of materials were developed for patients and program staff, including a “patient card” for the reporting of the screening results to the doctor, handouts for various symptom management strategies and a doctor's guide on the use of antidepressants. The health counselor and health assistant were then placed in facilities where they implemented the specific treatments. Two types of data were collected for the assessment of the formative phase: Process indicators. These were the total number of attendees in each facility; the number who were excluded from undergoing screening on the basis of a priori exclusion criteria (<18 years old, inability to speak any of the local languages, in need of urgent medical care, attending the clinic within 2 weeks of the initial screening and therefore not eligible for screening at this contact, refusal to answer); the number who screened as having possible CMD; the number who met the health counselor after consulting the doctor during their initial visit; and the number who returned for follow-up sessions. These data were collected on a daily basis by the health counselor and collated weekly; analysis was carried out using the SPSS14 package. Qualitative data. In-depth, semi-structured interviews with key stakeholders (doctors, facility staff, health counselors and patients) were conducted to document their perspectives about the feasibility, utility and acceptability of various aspects of the intervention. Since we wanted to elicit specific information from each of the groups, different interviews were developed for each group. For example, the interviews for patients focused on their recollection of the process of the intervention and their opinion about the utility of the treatments; the interviews for primary care physicians elicited their perceptions of the feasibility of the intervention and the individual treatments as well as their role in the overall process. The thematic method of analysis of qualitative data was used to generate results. A total of 7473 patients attended the primary care facilities during the formative phase (Table 2). Of those who were screened, 899 (31.6%) were positive for CMD. Of these cases, 70.6% were women; the average age was 41 years (SD 13.5). Among them, 53% actually received the first session of psychoeducation and only 24.3% of those who had received the initial session returned for further follow-up appointments. IPT was offered (all opted for the individual format) to 16 patients, 11 of whom (68%) attended at least four sessions and only 3 (19%) completed six or more sessions. A total of 89 interviews were completed with doctors (n=10), patients (n=50), staff in the facilities (n=17) and the intervention team (n=12). Clinic and programme staff spoke of problems in providing counselors with work space that offered an acceptable level of privacy, especially in the smaller general practice clinics. Facility staff and the counselors consistently suggested that a systematic mapping of the physical infrastructure and the personnel in the facility be conducted prior to implementing the intervention. This would orient counselors to the usual care processes in their clinics, and help them identify any potential difficulties in positioning the intervention. Doctors and staff in the facilities also mentioned the need for counselors to be visible members of the facility. Several strategies to achieve this goal were suggested, including meetings between the counselors and the doctors every day before and after the outpatient clinic, regular meetings with other facility staff, and counselors’ attendance at the scheduled review meetings with the staff of the primary health care was in that women with excellent communication skills were the choice for being effective health A majority of patients screening to be a as they were about which were not patients felt that the of the screening was and the clinic staff not that the on the usual care The psychoeducation session was described as by most patients, with the majority to the of the the role of in to their health and were the suggested to improve their In the and about and were felt to be the most components of the psychoeducation this was also by the health The to deliver IPT met with limited as a of problems in for treatment on a in particular the of and the of to the important specific to the group was concerns about the of the being and that other members of the who in the community about their problems to In the formative research suggested that, with the of the group IPT specific treatments of the MANAS intervention were feasible and acceptable to patients and We were that the locally and trained health counselors had prior mental health could provide the intervention We agreed that facilities that a private space for the health counselor could not in the program. A before delivery was as an important exercise for the team to with the physical of the clinic, the staff and usual patients felt that the intervention was the follow-up rates that would be a to the of the intervention. To generate an and effective adherence management was felt that an in of the for from the was was the large number of patients who not the health counselor after being screened and seen by the doctor, and were to the program. to this by to the care in the clinic an The of the phase were to and evaluate the intervention, and to the for implementing to improve follow-up rates. The intervention was in four primary health care centres between and In this phase, the MANAS intervention, as was in the a adherence management was the role of the health counselors was so that they would also provide for social difficulties (e.g., by keeping a register of community for social the focus of IPT was from group to individual a for the supervision of the health counselor by the visiting was a of process that would the clinical to support and the of the intervention was developed (Table and qualitative data were collected during this phase by using the process and by semi-structured interviews to patients who provided to describe their of the intervention and for adherence or two of participants who were in their who were and who were not two or sessions and not A guide each through the process of the MANAS intervention and for adherence or was also on the about the utility of the adherence management The qualitative data were and by using thematic analysis A total of patients attended the primary health care centres during the piloting phase and, of were as possible Of the patients by were and the average age was years (SD The adherence management both the rates of patients receiving the first psychoeducation session and those attending follow-up for further consultation (Table 2). and were the was also encouraging and suggested that these would be important adherence management during the trial. Our to provide IPT in a group format were not in and inadequate local facilities made to of a of patients. However, the health counselors with to deliver IPT in an individual adherence a of patients who were offered only attended the first of whom only 2 completed all of the sessions. Health counselors conducted a total of yoga daily sessions in the selected primary health care four of them were for the staff of the centres, three were conducted for patients and members of the local yoga were well attended and most participants for the days of the on the use of antidepressant medication were collated the formative and the Of patients who had screened were prescribed Of those who received the only returned for a This is an because patients prescribed antidepressants in the of the phase are likely their medication after the of the of process indicators. Of the patients selected for the of for could be The most frequent for not being were that the was not at and the team not have the address The results of this are in and The most for not to the health counselor was patients were daily and could not to the clinic during the working Other for care and with for to the doctor and health after receiving and treatments the exercise was a for The of patients to for follow-up as a key In to the patients who were with treatment of whom the as a for the majority of patients that they had not been any who were that one of the most important for was that their problems were by the intervention who to them in a manner within a patients also being by the social of their and other in both the and had of the process of the program, and there were few in the they the acceptability of the For example, most the screening process as being in them an of their especially the of The majority of patients the of the initial psychoeducation session with the health counselor, and that on the the of and problems was the most patients that they had an active role to in which their of and over their In the of the piloting phase was the of the feasibility of the MANAS intervention, in and of the adherence management and supervision in However, a number of were a) the of an adherence management in the initial assessment of the possible for and the of a plan to improve adherence at every step of the process of care b) group IPT with individual IPT; c) the use of in a of sessions delivered over as a of the intervention was a culturally acceptable mental health yoga could also improve the overall acceptability of the the use of to supervision and of the program by the visiting psychiatrist. To the best of this is the first systematic in a to a complex intervention for the care of CMD into routine primary care. These studies were carried out prior to the effectiveness of the MANAS intervention in a cluster randomized trial. We used a method for the of the intervention. This method provided a systematic at the time being to that from each stage questions and the of the subsequent stage. We that such is in the feasibility and acceptability of complex and to identify a number of challenges which need to be addressed before an effectiveness trial. Each of the three was a and in in the of the final intervention. We have been to the need for such an intervention, by that about of all primary care attendees are from a CMD. Although the final intervention to use the specific treatments that we had there have been a number of key to improve their feasibility and acceptability. are in this we had IPT as a group intervention with based on the evidence available from the trial in However, we that the group format and number of sessions were likely to be in the social context of primary care in thus, we have had to the IPT to be delivered in an individual format over 6 to sessions. adherence management moved from being a of the intervention to a the intervention from the first psychoeducation session with a set of we had that the health counselor would out both screening and delivery of the intervention. This to be and we an human resource (the health to the screening the of the health counselors’ role to include a of additional such as adherence and being a between the health and existing resources in the we had for facilities, from of the facility. However, we that the of a private space for the health counselor was a for a facility to be the important role of yoga was as a means to both promote mental health and destigmatize the MANAS intervention. we that the intervention should have a phase, during which the team a mapping process to with the primary health care and, thus, to identify and address potential physical and the process to set and for the delivery and of the intervention. The preparatory phase also provided feedback the and of the training for the team as well as the and format of the materials used for the intervention. We have not described in in this to space these are available from the We to the of a preparatory phase as a step before clinical trials of complex in mental In the MANAS intervention has been at least in terms of feasibility and as a of this We that these help the overall effectiveness of the intervention, being conducted in first phase in primary health care centres in In complex for CMD are best delivered by who are and have in supervision and strong to improve their This a of the roles of each member of the team and to and The preparatory phase has the to a that the and of the subsequent program. The MANAS project is by the through a clinical research to The project is implemented through a collaboration between the of and and three the Directorate of Health Services of and the Health of
No takes yet. Share an insight, caveat, or question.
Chatterjee et al. (2008) studied this question.