Technology-assisted cognitive-behavior therapy delivered by peers versus standard cognitive behavior therapy delivered by community health workers for perinatal depression: study protocol of a cluster randomized controlled non-inferiority trial.

BACKGROUND: The lack of trained mental health professionals is a key barrier to scale-up of evidence-based psychological interventions in low and middle-income countries. We have developed an app that allows a peer with no prior experience of health-care delivery to deliver the cognitive therapy-based intervention for perinatal depression, the Thinking Healthy Programme (THP). This trial aims to assess the effectiveness and cost-effectiveness of this Technology-assisted peer-delivered THP versus standard face-to-face Thinking Healthy Programme delivered by trained health workers. METHODS: We will employ a non-inferiority stratified cluster randomized controlled trial design comparing the two formats of intervention delivery. A total of 980 women in the second or third trimester of pregnancy with a diagnosis of Major Depressive Episode, evaluated with the Structured Clinical Interview for DSM-V Disorders (SCID), will be recruited into the trial. The unit of randomization will be 70 village clusters randomly allocated in a 1:1 ratio to the intervention and control arms. The primary outcome is defined as remission from major depressive episode at 3 months postnatal measured with the SCID. Data will also be collected on symptoms of anxiety, disability, quality of life, service use and costs, and infant-related outcomes such as exclusive breastfeeding and immunization rates. Data will be collected on the primary outcome and selected secondary outcomes (depression and anxiety scores, exclusive breastfeeding) at 6 months postnatal to evaluate if the improvements are sustained in the longer-term. We are especially interested in sustained improvement (recovery) from major depressive episode. DISCUSSION: This trial will evaluate the effectiveness and cost-effectiveness of a technology-assisted peer-delivered cognitive behavioral therapy-based intervention in rural Pakistan. If shown to be effective, the novel delivery format could play a role in reducing the treatment gap for perinatal depression and other common mental disorders in LMIC. TRIAL REGISTRATION: The trial was registered at Clinicaltrials.gov (NCT05353491) on 29 April 2022.

Non-specialist-delivered psychosocial intervention for prenatal anxiety in a tertiary care setting in Pakistan: a qualitative process evaluation.

OBJECTIVES: A manualised cognitive-behavioural therapy-based psychosocial intervention for prenatal anxiety called Happy Mother Healthy Baby is being tested for its effectiveness through a randomised control trial in Pakistan. The aim of this study was to evaluate the intervention delivery process and the research process. DESIGN: Qualitative methods were used to explore in depth the intervention delivery and research process. SETTING: This process evaluation was embedded within a randomised control trial conducted in a tertiary care facility in Rawalpindi, Pakistan. PARTICIPANTS: Data were collected through in-depth interviews (n=35) with the trial participants and focus group discussions (n=3) with the research staff. Transcripts were analysed using a Framework Analysis. RESULTS: The evaluation of the intervention delivery process indicated that it can be effectively delivered by non-specialist providers trained and supervised by a specialist. The intervention was perceived to be culturally acceptable and appropriately addressing problems related to prenatal anxiety. Lack of awareness of 'talking' therapies and poor family support were potential barriers to participant engagement. The evaluation of the research process highlighted that culturally appropriate consent procedures facilitated recruitment of participants, while incentivisation and family involvement facilitated sustained engagement and retention. Lack of women's empowerment and mental health stigma were potential barriers to implementation of the programme. CONCLUSION: We conclude that non-specialists can feasibly deliver an evidence-based intervention integrated into routine antenatal care in a tertiary hospital. Non-specialist providers are likely to be more cost effective and less stigmatising. Inclusion of family is key for participant recruitment, retention and engagement with the intervention. TRIAL REGISTRATION NUMBER: NCT03880032.

'Those whom I have to talk to, I can't talk to': Perceived social isolation in the context of anxiety symptoms among pregnant women in Pakistan.

Anxiety during pregnancy is highly prevalent in low- and middle-income countries. The relative importance of different sources and types of perceived support in the Pakistani context is unknown. We explored social support during pregnancy and the role of social isolation in Pakistani women's experiences of antenatal anxiety. We conducted semi-structured interviews with 19 pregnant women with symptoms of anxiety and 10 female healthcare providers at a public urban hospital. We used inductive and deductive thematic coding to analyse the data. Many pregnant women reported feelings of physical and social isolation, even when living in joint families with larger social networks. Often fearing censure by their in-laws and peers for sharing or seeking help with pregnancy-related anxieties, women reported relying on husbands or natal family members. Normative expectations around pregnancy such as male gender preference, perceived immutability of wives' domestic responsibilities and expectations of accompanied travel by women may serve as sources of disconnectedness in the antenatal period. Providers viewed social isolation and deficits in social support during pregnancy as contributing to worse anxiety symptoms, reduced access to care and poorer health behaviours. One limitation is that the hospital setting for this study may have resulted in underreporting of abuse or neglect and limited inclusion of pregnant women who do not utilise facility-based antenatal care. In conclusion, husbands and natal families were key in reducing social isolation in pregnancy and mitigating anxiety, while in-laws did not always confer support. Targeted strategies should enhance existing support and strengthen in-law family relationships in pregnancy.

Technology-assisted peer therapy: a new way of delivering evidence-based psychological interventions.

In low-income settings, ninety percent of individuals with clinical depression have no access to evidence-based psychological interventions. Reasons include lack of funds for specialist services, scarcity of trained mental health professionals, and the stigma attached to mental illness. In recent years there have been many studies demonstrating effective delivery of psychological interventions through a variety of non-specialists. While these interventions are cost-effective and less stigmatising, efforts to scale-up are hampered by issues of quality-control, and what has been described by implementation scientists as 'voltage-drop' and 'programme-drift.' Using principles of Human Centred Design in a rural setting in Pakistan, we worked with potential users to co-design a Tablet or Smartphone-based App that can assist a lay-person deliver the Thinking Healthy Programme, a World Health Organization-endorsed evidence-based intervention for perinatal depression. The active ingredients of this cognitive-therapy based intervention are delivered by a virtual 'avatar' therapist incorporated into the App which is operated by a 'peer' (a woman from the neighbourhood with no prior experience of healthcare delivery). Using automated cues from the App, the peer reinforces key therapeutic messages, helps with problem-solving and provides the non-specific but essential therapeutic elements of empathy and support. The peer and App therefore act as co-therapists in delivery of the intervention. The peer can deliver the intervention with good fidelity after brief automated in-built training. This approach has the potential to be applied to other areas of mental health and help bridge the treatment gap, especially in resource-poor settings. This paper describes the process of co-development with end-users and key features of the App.

Cultural adaptation and psychometric validation of the Pregnancy Experience Scale-Brief version (PES-Brief) in Pakistani women with antenatal anxiety symptoms.

Background: Pregnancy experiences influence fetal and birth outcomes. There is scarcity of locally validated tools to assess pregnancy experiences. We aimed to validate the Pregnancy Experience Scale-Brief (PES-Brief) in pregnant Pakistani women with anxiety symptoms. Methods: A two-step process was used including 1) adaptation via translation/back-translation followed by cognitive interviewing with 10 participants and 2) factor analysis and validation with 605 women in Rawalpindi Pakistan who had mild-moderate symptoms of anxiety, attended the antenatal clinic, and were ≤22 weeks of gestation and ≥18 years old. We calculated internal consistency and reliability and conducted exploratory and confirmatory factor analyses. Results: Cultural adaptation led to inclusion of one item of the hassles subscale and exclusion of one item in the uplifts subscale, resulting in 9 uplifts and 11 hassles. Exploratory factor analysis supported a two-factor structure, with the adapted items exhibiting loading values of ≥0.24 for their respective factors. Internal consistency was demonstrated for uplifts (Cronbach's alpha = 0.89) and hassles (Cronbach's alpha = 0.85) subscales. Uplift intensity was moderately correlated with the Hospital Anxiety and Depression Scale anxiety subscale (r = 0.54, 95% CI:0.30-0.77). Conclusion: The Urdu PES-Brief is a reliable and valid tool for use in Pakistani pregnant women with antenatal anxiety. Future studies on its validity are needed on women without symptoms anxiety.

Scalable Screening and Treatment Response Monitoring for Perinatal Depression in Low- and Middle-Income Countries.

Common perinatal mental disorders such as anxiety and depression are a public health concern in low- and middle-income countries. Several tools exist for screening and monitoring treatment responses, which have frequently been tested globally in clinical and research settings. However, these tools are relatively long and not practical for integration into routine data systems in most settings. This study aims to address this gap by considering three short tools: The Community Informant Detection Tool (CIDT) for the identification of women at risk, the 4-item Patient Health Questionnaire (PHQ-4) for screening women at high-risk, and the 4-item Hamilton Depression Rating Scale (HAMD-4) for measuring treatment responses. Studies in rural Pakistan showed that the CIDT offered a valid and reliable key-informant approach for the detection of perinatal depression by utilizing a network of peers and local health workers, yielding a sensitivity of 97.5% and specificity of 82.4%. The PHQ-4 had excellent psychometric properties to screen women with perinatal depression through trained community health workers, with a sensitivity of 93.4% and specificity of 91.70%. The HAMD-4 provided a good model fit and unidimensional construct for assessing intervention responses. These short, reliable, and valid tools are scalable and expected to reduce training, administrative and human resource costs to health systems.

Effectiveness of a technology-assisted, family volunteers delivered, brief, multicomponent parents' skills training intervention for children with developmental disorders in rural Pakistan: a cluster randomized controlled trial.

BACKGROUND: Globally, there is a large documented gap between needs of families and children with developmental disorders and available services. We adapted the World Health Organization's mental health Gap-Intervention Guidelines (mhGAP-IG) developmental disorders module into a tablet-based android application to train caregivers of children with developmental disorders. We aimed to evaluate the effectiveness of this technology-assisted, family volunteers delivered, parents' skills training intervention to improve functioning in children with developmental disorders in a rural community of Rawalpindi, Pakistan. METHODS: In a single-blinded, cluster randomized controlled trial, 30 clusters were randomised (1:1 ratio) to intervention (n = 15) or enhanced treatment as usual (ETAU) arm (n = 15). After screening, 540 children (18 participants per cluster) aged 2-12 years, with developmental disorders and their primary caregivers were recruited into the trial. Primary outcome was child's functioning, measured by Childhood Disability Assessment Schedule for Developmental Disorders (DD-CDAS) at 6-months post-intervention. Secondary outcomes were parents' health related quality of life, caregiver-child joint engagement, socio-emotional well-being of children, family empowerment and stigmatizing experiences. Intention-to-treat analyses were done using mixed-models adjusted for covariates and clusters. RESULTS: At 6-months post-intervention, no statistically significant mean difference was observed on DD-CDAS between intervention and ETAU (mean [SD], 47.65 [26.94] vs. 48.72 [28.37], Adjusted Mean Difference (AMD), - 2.63; 95% CI - 6.50 to 1.24). However, parents in the intervention arm, compared to ETAU reported improved health related quality of life (mean [SD] 65.56 [23.25] vs. 62.17 [22.63], AMD 5.28; 95% CI 0.44 to 10.11). The results were non-significant for other secondary outcomes. CONCLUSIONS: In the relatively short intervention period of 6 months, no improvement in child functioning was observed; but, there were significant improvements in caregivers' health related quality of life. Further trials with a longer follow-up are recommended to evaluate the impact of intervention. Trial registration Clinicaltrials.gov, NCT02792894. Registered April 4, 2016, https://clinicaltrials.gov/ct2/show/NCT02792894.

Intersections between patient-provider communication and antenatal anxiety in a public healthcare setting in Pakistan.

This study explores pregnant women's and healthcare providers' perspectives on the role of patient-provider communication in experiences of antenatal anxiety within a low-resource setting. In 2017-18, we consecutively sampled pregnant women (n = 19) with at least mild anxiety and purposively sampled antenatal care providers (n = 10) from a public hospital in Punjab Province, Pakistan. We then conducted in-depth interviews and thematically coded them with a combination of inductive and deductive coding methodologies. We found that patients expressed a desire for warm, empathetic communication from providers who demonstrate respect, attentiveness, and a shared lived experience. Providers revealed an awareness that their heavy caseloads, high stress levels, and discourteous tones adversely influenced communication with pregnant women and may exacerbate their anxieties, but also reported that compassionately addressing women's concerns, providing financial problem-solving and/or assistance, and moderating conflicting healthcare desires between patients and their families could alleviate anxiety in pregnant women. Patients reported feelings of anxiety stemming from a belief that they received lower quality communication from antenatal providers at public hospitals than patients received from antenatal providers at private hospitals, an experience that they partially attributed to their low socioeconomic status. Meanwhile, some providers disclosed potentially stigmatizing views of women from particular sociocultural backgrounds or low socioeconomic status, including perceptions that appeared to shape communication with these patients in antenatal care encounters. Our findings provide preliminary evidence that communication between pregnant women and antenatal providers that is warm, normalizes patient fears, and integrates patients' interpersonal and financial considerations can mitigate pregnant women's experiences of anxiety and reduce barriers to accessing antenatal care in Pakistan's public healthcare facilities.

Effect of adding a psychological intervention to routine care of common mental disorders in a specialized mental healthcare facility in Pakistan: a randomized controlled trial.

BACKGROUND: In many low resource settings, the provision of government mental health care services is limited to specialized psychiatry units in urban hospital care facilities, where the most common treatment for common mental disorders (CMDs) is pharmacotherapy, occasionally with adjunct nonspecific psychological support. We aimed to evaluate the effectiveness of adding a low intensity, psychological intervention, Problem Management Plus (PM+) for CMDs into routine care in a specialized mental health care facility in Pakistan. METHODS: A two arm, single-blind individual randomized controlled trial (RCT) was carried out with adults (N = 192), referred for psychological support by psychiatrists. The study participants were randomized (1:1) to PM + plus Treatment as Usual (TAU) (n = 96) or TAU only (n = 96). The primary outcomes were symptoms of anxiety and depression, measured by the Hospital Anxiety and Depression Scale (HADS) and functional impairment as measured by WHO Disability Assessment Schedule (WHODAS 2.0) at 20 weeks after baseline. RESULTS: The analysis was done on intention-to-treat principle. The linear mixed model analysis showed that at 20 weeks after baseline, there was a significant reduction in symptoms of anxiety and depression (mean [SD], 16.23 [8.81] vs 19.79 [7.77]; AMD, - 3.10; 95% CI, - 0.26 to - 5.76); p = 0.03 and improvement in functioning (mean [SD], 22.94 [9.37] vs 27.37 [8.36]; AMD, - 4.35; 95% CI, - 1.45 to - 7.24); p = 0.004 in PM + plus TAU versus TAU arm. The follow-up rate was 67% at primary end-point. CONCLUSIONS: Specialized care facilities in LMICs may consider adding brief, evidence-based psychological treatments for CMDs to their routine care. Trial Registration Australian New Zealand Clinical Trials Registry, ACTRN12616000381482. Registered March 23, 2016. Retrospectively registered, https://www.anzctr.org.au/Default.aspx/ ACTRN12616000381482.

Improving access to psychosocial interventions for perinatal depression in low- and middle-income countries: lessons from the field.

Over 90% women with perinatal depression in low and middle-income countries do not receive treatment. Scale-up of evidence-based psychosocial interventions is a key challenge. We developed the Thinking Healthy Programme (THP), a psychosocial intervention that can be delivered by non-specialist providers such as community health workers in primary and secondary care settings. Our research showed that three out of 4 women with perinatal depression who received the programme recovered, and there were beneficial effects on infant outcomes. In over a decade since the original research, policy and practice uptake of the programme globally has been promising. We describe factors contributing to this: the programme is relatively inexpensive and culturally transferable; the intervention can be integrated with existing maternal and child health programmes; the programme is amenable to 'task-sharing' via peers, nurses, community health-workers and other frontline workers; cascaded models of training and supervision, and the use of technology for training and delivery provide exciting future avenues for scaled-up implementation. These innovations are relevant to the neglected field of public mental health, especially in the post COVID19 era when rates of anxiety and depression are likely to rise globally.

"A Woman Is a Puppet." Women's Disempowerment and Prenatal Anxiety in Pakistan: A Qualitative Study of Sources, Mitigators, and Coping Strategies for Anxiety in Pregnancy.

Common mental disorders are highly prevalent among pregnant women in low- and middle-income countries, yet prenatal anxiety remains poorly understood, particularly in the sociocultural context of South Asia. Our study explored sources, mitigators, and coping strategies for anxiety among symptomatic pregnant women in Pakistan, particularly in relation to autonomy in decision-making and social support. We interviewed 19 pregnant married women aged 18-37 years recruited from 2017-2018 at a public hospital in Rawalpindi who screened positive for anxiety. Thematic analysis was based on both inductive emergent codes and deductive a priori constructs of pregnancy-related empowerment. Gender norms emerged as an important dimension of Pakistani women's social environment in both constraining pregnancy-related agency and contributing to prenatal anxiety. Women's avenues of self-advocacy were largely limited to indirect means such as appeals to the husband for intercession or return to her natal home. The levels of autonomy during pregnancy depended on the area of decision-making, and peer/family support was a critical protective factor and enabling resource for maternal mental health. Women's disempowerment is a key contextual factor in the sociocultural experience of prenatal maternal anxiety in South Asia, and further examination of the intersections between empowerment and perinatal mental illness might help inform the development of more context-specific preventive approaches.

Cognitive-behavioral therapy-based intervention to treat symptoms of anxiety in pregnancy in a prenatal clinic using non-specialist providers in Pakistan: design of a randomised trial.

INTRODUCTION: Prenatal anxiety is a prevalent condition that is harmful for women and a strong predictor of postpartum depression. This trial assesses an intervention initiated in early pregnancy to mid pregnancy among women with clinical or subclinical symptoms of anxiety in Pakistan. METHODS AND ANALYSIS: Happy Mother, Healthy Baby (HMHB) is a phase three, two-arm, single-blind, individual randomised clinical trial conducted in the outpatient department of Holy Family Hospital, a large public tertiary care facility affiliated with Rawalpindi Medical University (RMU). Pregnant women (enrolled at ≤22 weeks of gestation) receive six individual HMHB sessions based on cognitive-behavioral therapy (CBT) and relaxation techniques that are administered by non-specialist providers and tailored to address anxiety symptoms. Two to six booster sessions are given between the fifth consecutive weekly core session and the sixth core session that occurs in the third trimester. Apart from baseline data, data are collected in the third trimester, at birth and at 6-weeks postpartum. Primary outcomes include diagnoses of postpartum common mental disorders. Secondary outcomes include symptoms of anxiety and of depression, and birth outcomes including small-for-gestational age, low birth weight and preterm birth. An economic analysis will determine the cost effectiveness of the intervention. ETHICS: Ethics approval was obtained from the Johns Hopkins Bloomberg School of Health Institutional Review Board (Baltimore, USA), the Human Development Research Foundation Ethics Committee (Islamabad, Pakistan), the RMU Institutional Research Forum (Rawalpindi, Pakistan) and the National Institute of Mental Health-appointed Global Mental Health Data Safety and Monitoring Board. DISSEMINATION: Results from this trial will build evidence for the efficacy of a CBT-based intervention for pregnant women delivered by non-specialised providers. Identification of an evidence-based intervention for anxiety starting in early pregnancy to mid pregnancy may be transferable for use and scale-up in other low-income and middle-income countries. TRIAL REGISTRATION NUMBER: NCT03880032.

Using a person-generated mental health outcome measure in large clinical trials in Kenya and Pakistan: Self-perceived problem responses in diverse communities.

Health care should be informed by the physical, socioeconomic, mental, and emotional well-being of the person, and account for social circumstances and culture. Patient-generated outcome measures can contribute positively to mental health research in culturally diverse populations. In this study, we analysed qualitative responses to the Psychological Outcome Profiles (PSYCHLOPS) Questionnaire-a patient-generated outcome measure based on open-ended questions, and compared the qualitative responses gathered to conventional, nomothetic measures used alongside the PSYCHLOPS in two studies. Data were collected as part of outcome research on a psychological intervention in Pakistan (N = 346) and Kenya (N = 521). Two researchers coded the qualitative responses to the PSYCHLOPS and identified overarching themes. We compared the overarching themes identified to the items in the conventional, nomothetic outcome measures to investigate conceptual equivalence. Using the PSYCHLOPS, the most frequently reported problems in Kenya were financial constraints, poor health, and unemployment. In Pakistan, the most frequent problems were poor health and emotional problems. Most of the person-generated problem concepts were covered also in nomothetic measures that were part of the same study. However, there was no item equivalence in the nomothetic measures for the most frequent PSYCHLOPS problem cited in both countries. Response bias and measurement bias may not be excluded. More research on the use of PSYCHLOPS alongside conventional outcome measures is needed to further explore the extent to which it may bring added value. Use of a PSYCHLOPS semistructured interview schedule and efforts to minimise response biases should be considered.

Using technology to scale-up training and supervision of community health workers in the psychosocial management of perinatal depression: a non-inferiority, randomized controlled trial.

BACKGROUND: The Thinking Healthy Programme (THP) is an evidence-based psychological intervention endorsed by the World Health Organization, tailored for non-specialist health workers in low- and middle-income countries. However, training and supervision of large numbers of health workers is a major challenge for the scale-up of THP. We developed a 'Technology-Assisted Cascaded Training and Supervision system' (TACTS) for THP consisting of a training application and cascaded supervision delivered from a distance. METHODS: A single-blind, non-inferiority, randomized controlled trial was conducted in District Swat, a post-conflict area of North Pakistan. Eighty community health workers (called Lady Health Workers or LHWs) were randomly assigned to either TACTS or conventional face-to-face training and supervision by a specialist. Competence of LHWs in delivering THP post-training was assessed by independent observers rating a therapeutic session using a standardized measure, the 'Enhancing Assessment of Common Therapeutic factors' (ENACT), immediately post-training and after 3 months. ENACT uses a Likert scale to score an observed interaction on 18 dimensions, with a total score of 54, and a higher score indicating greater competence. RESULTS: Results indicated no significant differences between health workers trained using TACTS and supervised from distance v. those trained and supervised by a specialist face-to-face (mean ENACT score M  =  24.97, s.d.  =  5.95 v. M =  27.27, s.d.  =  5.60, p  =  0.079, 95% CI 4.87-0.27) and at 3 months follow-up assessment (M  =  44.48, s.d.  =  3.97 v. M =  43.63, s.d.  =  6.34, p  =  0.53, CI -1.88 to 3.59). CONCLUSIONS: TACTS can provide a promising tool for training and supervision of front-line workers in areas where there is a shortage of specialist trainers and supervisors.

Effectiveness of a brief group psychological intervention for women in a post-conflict setting in Pakistan: a single-blind, cluster, randomised controlled trial.

BACKGROUND: Many women are affected by anxiety and depression after armed conflict in low-income and middle-income countries, yet few scalable options for their mental health care exist. We aimed to establish the effectiveness of a brief group psychological intervention for women in a conflict-affected setting in rural Swat, Pakistan. METHODS: In a single-blind, cluster, randomised, controlled trial, 34 community clusters in two union councils of rural Swat, Pakistan, were randomised using block permutation at a 1:1 ratio to intervention (group intervention with five sessions incorporating behavioural strategies facilitated by non-specialists) or control (enhanced usual care) groups. Researchers responsible for identifying participants, obtaining consent, enrolment, and outcome assessments were masked to allocation. A community cluster was defined as neighbourhood of about 150 households covered by a lady health worker. Women aged 18-60 years who provided written informed consent, resided in the participating cluster catchment areas, scored at least 3 on the General Health Questionnaire-12, and at least 17 on the WHO Disability Assessment Schedule were recruited. The primary outcome, combined anxiety and depression symptoms, was measured 3 months after the intervention with the Hospital Anxiety and Depression Scale (HADS). Modified intention-to-treat analyses were done using mixed models adjusted for covariates and clusters defined a priori. The trial is registered with the Australian New Zealand Clinical Trials Registry, number 12616000037404, and is now closed to new participants. FINDINGS: From 34 eligible community clusters, 306 women in the intervention group and 306 women in the enhanced usual care (EUC) group were enrolled between Jan 11, 2016, and Aug 21, 2016, and the results of 288 (94%) of 306 women in the intervention group and 290 (95%) of 306 women in the EUC group were included in the primary endpoint analysis. At 3 months, women in the intervention group had significantly lower mean total scores on the HADS than women in the control group (10·01 [SD 7·54] vs 14·75 [8·11]; adjusted mean difference [AMD] -4·53, 95% CI -7·13 to -1·92; p=0·0007). Individual HADS anxiety scores were also significantly lower in the intervention group than in the control group (5·43 [SD 4·18] vs 8·02 [4·69]; AMD -2·52, 95% CI -4·04 to -1·01), as were depression scores (4·59 [3·87] vs 6·73 [3·91]; AMD -2·04, -3·19 to -0·88). No adverse events were reported in either group. INTERPRETATION: Our group psychological intervention resulted in clinically significant reductions in anxiety and depressive symptoms at 3 months, and might be a feasible and effective option for women with psychological distress in rural post-conflict settings. FUNDING: WHO through a grant from the Office for Foreign Disaster Assistance.

Development of a Psychological Intervention to Address Anxiety During Pregnancy in a Low-Income Country.

Background: One in five women suffer from anxiety during pregnancy. Untreated anxiety is a risk factor for postnatal depression and is associated with adverse birth outcomes. Despite the high prevalence of prenatal anxiety in low- and middle-income countries (LMICs), efforts to develop and evaluate context-specific interventions in these settings are lacking. We aimed to develop a culturally appropriate, feasible, and acceptable psychological intervention for perinatal anxiety in the context of a low-income population in Pakistan. Methods: We conducted this research in Rawalpindi District at the Obstetrics Department of the Holy Family Hospital, Rawalpindi Medical University a government facility catering to a mixture of low-income urban, peri-urban, and rural populations. We used a mixture of research methods to: a) investigate the clinical, cultural, and health-service delivery context of perinatal anxiety; b) select an evidence-based approach that suited the population and health-delivery system; c) develop an intervention with extensive reference documentation/manuals; and d) examine issues involved in its implementation. Qualitative data were collected through in-depth interviews and focus group discussions, and analyzed using framework analysis. Results: Informed by the qualitative findings and review of existing evidence-based practices, we developed the "Happy Mother, Healthy Baby" intervention, which was based on principles of cognitive behavior therapy. Its evidence-based elements included: developing an empathetic relationship, challenging thoughts, behavior activation, problem solving, and involving family. These elements were applied using a three-step approach: 1) learning to identify unhealthy or unhelpful thinking and behavior; 2) learning to replace unhealthy or unhelpful thinking and behavior with helpful thinking and behavior; and 3) practicing thinking and acting healthy. Delivered by non-specialist providers, the intervention used culturally appropriate illustrations and examples of healthy activities to set tasks in collaboration with the women to encourage engagement in helpful behaviors. Feedback from the non-specialist providers indicated that the intervention was acceptable, feasible, and perceived to be helpful by the women receiving it. Conclusion: This new psychosocial intervention for perinatal anxiety, based on principles of cognitive behavior therapy and delivered by non-specialists, has the potential to address this important but neglected condition in LMICs.

Correction to: Problem Management Plus (PM+) in the management of common mental disorders in a specialized mental healthcare facility in Pakistan; study protocol for a randomized controlled trial.

[This corrects the article DOI: 10.1186/s13033-017-0147-1.].

Problem Management Plus (PM+) in the management of common mental disorders in a specialized mental healthcare facility in Pakistan; study protocol for a randomized controlled trial.

BACKGROUND: The World Health Organization (WHO) has developed Problem Management Plus (PM+), a 5-session, psychological intervention program delivered by trained non-specialist that addresses common mental disorders. The objectives of this study are to evaluate effectiveness and cost-effectiveness of PM+ in a specialized mental health care facility in Pakistan. METHODS: A single blind individual randomized controlled trial (RCT) will be carried out in the outpatient department of a specialized mental healthcare facility in Rawalpindi, Pakistan. After informed consent, patients with high psychological distress (General Health Questionnaire-12 (score >2) and functional impairment (WHO Disability Assessment Schedule 2.0 score >16) will be randomised to PM+ plus treatment as usual (n = 96) or TAU only (n = 96). The primary outcome is the psychological distress, measured by levels of anxiety and depression on the Hospital Anxiety and Depression Scale and improvement in functioning as measured by WHODAS at 20 weeks after baseline. Secondary outcomes include improvement in symptoms of depression, post-traumatic stress disorder, levels of social support and cost effectiveness evaluation. Qualitative interviews will be conducted to evaluate the process of implementing PM+ including barriers and facilitators in implementation and possibility of integration of PM+ program in specialized mental health care facilities in Pakistan. DISCUSSION: The results of this study will be helpful in evaluating the effectiveness of the approach of training non specialists, based in the specialized mental health care facilities in delivering evidence based psychological interventions in the low resource settings. Trial registration Australian New Zealand Clinical Trials Registry, ACTRN12616000381482. Registered Retrospectively on March 23, 2016.

Evaluating effectiveness and cost-effectiveness of a group psychological intervention using cognitive behavioural strategies for women with common mental disorders in conflict-affected rural Pakistan: study protocol for a randomised controlled trial.

BACKGROUND: The impact of humanitarian disasters upon mental health is well recognised. The evidence for psychological interventions for mental health is mounting, but few interventions have been rigorously tested in humanitarian settings. To be sustainable in humanitarian settings interventions need to be short, simple, deliverable by nonspecialists under supervision, and adopt a transdiagnostic approach where an array of mental health outcomes are addressed simultaneously. These elements have been incorporated into the newly developed WHO Problem Management Plus (PM+) Group intervention. The aim of this trial is to evaluate the locally adapted PM+ Group intervention for women in Swat, Pakistan. METHODS: This PM+ Group trial is a two-arm, single-blind, cluster randomised controlled trial conducted in a community-based setting with women in rural Pakistan. PM+ is delivered in partnership with the Lady Health Worker (LHW) Programme which provides community-based health care to women in Pakistan. Thirty-four LHW clusters will be randomised in a 1:1 allocation ratio using a permuted-block randomisation method. Participants screened and found to meet the inclusion criteria will be allocated to either the PM+ intervention group (n = 306), or the control arm (n = 306). The manualised PM+ intervention involves five sessions, each lasting 3 h, and introduces four strategies applied by participants to problems that they are facing. It is delivered by local female facilitators with a minimum of 16 years of education who are provided with targeted training and supervision. The primary outcome is individual psychological distress, measured by levels of anxiety and depression on the Hospital Anxiety and Depression Scale at 20 weeks after baseline. Secondary outcomes include major depression, post-traumatic stress disorder, levels of social support, levels of functioning, and economic effectiveness. Intervention acceptability will be explored through an embedded qualitative study. DISCUSSION: The PM+ Group trial will provide important evidence on the effectiveness of an empirically supported psychological treatment delivered by nonspecialists in a humanitarian setting. If proven effective, the qualitative component will inform strategies for PM+ Group scale-up in health systems in other humanitarian settings. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, identifier: ACTRN12616000037404. Registered on 19 January 2016; WHO Protocol ID RPC705, v.4, 2 November 2015.

Effect of a Multicomponent Behavioral Intervention in Adults Impaired by Psychological Distress in a Conflict-Affected Area of Pakistan: A Randomized Clinical Trial.

Importance: The mental health consequences of conflict and violence are wide-ranging and pervasive. Scalable interventions to address a range of mental health problems are needed. Objective: To test the effectiveness of a multicomponent behavioral intervention delivered by lay health workers to adults with psychological distress in primary care settings. Design, Setting, and Participants: A randomized clinical trial was conducted from November 1, 2014, through January 28, 2016, in 3 primary care centers in Peshawar, Pakistan, that included 346 adult primary care attendees with high levels of both psychological distress and functional impairment according to the 12-item General Health Questionnaire and the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0). Interventions: Lay health workers administered 5 weekly 90-minute individual sessions that included empirically supported strategies of problem solving, behavioral activation, strengthening social support, and stress management. The control was enhanced usual care. Main Outcomes and Measures: Primary outcomes, anxiety and depression symptoms, were independently measured at 3 months with the Hospital Anxiety and Depression Scale (HADS). Secondary outcomes were posttraumatic stress symptoms (Posttraumatic Stress Disorder Checklist for DSM-5), functional impairment (WHODAS 2.0), progress on problems for which the person sought help (Psychological Outcome Profiles), and symptoms of depressive disorder (9-item Patient Health Questionnaire). Results: Among 346 patients (mean [SD] age, 33.0 [11.8] years; 78.9% women), 172 were randomly assigned to the intervention and 174 to enhanced usual care; among them, 146 and 160 completed the study, respectively. At baseline, the intervention and control groups had similar mean (SD) HADS scores on symptoms of anxiety (14.16 [3.17] vs 13.64 [3.20]; adjusted mean difference [AMD], 0.52; 95% CI, -0.22 to 1.27) and depression (12.67 [3.27] vs 12.49 [3.34]; AMD, 0.17, 95% CI, -0.54 to 0.89). After 3 months of treatment, the intervention group had significantly lower mean (SD) HADS scores than the control group for anxiety (7.25 [3.63] vs 10.03 [3.87]; AMD, -2.77; 95% CI, -3.56 to -1.98) and depression (6.30 [3.40] vs 9.27 [3.56]; AMD, -2.98; 95% CI, -3.74 to -2.22). At 3 months, there were also significant differences in scores of posttraumatic stress (AMD, -5.86; 95% CI, -8.53 to -3.19), functional impairment (AMD, -4.17; 95% CI, -5.84 to -2.51), problems for which the person sought help (AMD, -1.58; 95% CI, -2.40 to -0.77), and symptoms of depressive disorder (AMD, -3.41; 95% CI, -4.49 to -2.34). Conclusions and Relevance: Among adults impaired by psychological distress in a conflict-affected area, lay health worker administration of a brief multicomponent intervention based on established behavioral strategies, compared with enhanced usual care, resulted in clinically significant reductions in anxiety and depressive symptoms at 3 months. Trial Registration: anzctr.org.au Identifier: ANZCTR12614001235695.