Effectiveness of Group Problem Management Plus, a brief psychological intervention for adults affected by humanitarian disasters in Nepal: A cluster randomized controlled trial.
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SUBMITTER: Jordans MJD
PROVIDER: S-EPMC8211182 | biostudies-literature | 2021 Jun
REPOSITORIES: biostudies-literature
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Effectiveness of Group Problem Management Plus, a brief psychological intervention for adults affected by humanitarian disasters in Nepal: A cluster randomized controlled trial.
Jordans Mark J D MJD Kohrt Brandon A BA Sangraula Manaswi M Turner Elizabeth L EL Wang Xueqi X Shrestha Pragya P Ghimire Renasha R Van't Hof Edith E Bryant Richard A RA Dawson Katie S KS Marahatta Kedar K Luitel Nagendra P NP van Ommeren Mark M
PLoS medicine 20210617 6
<h4>Background</h4>Globally, 235 million people are impacted by humanitarian emergencies worldwide, presenting increased risk of experiencing a mental disorder. Our objective was to test the effectiveness of a brief group psychological treatment delivered by trained facilitators without prior professional mental health training in a disaster-prone setting.<h4>Methods and findings</h4>We conducted a cluster randomized controlled trial (cRCT) from November 25, 2018 through September 30, 2019. Part ...[more]
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Project description:BACKGROUND:Globally, the lack of availability of psychological services for people exposed to adversities has led to the development of a range of scalable psychological interventions with features that enable better scale-up. Problem Management Plus (PM+) is a brief intervention of five sessions that can be delivered by non-specialists. It is designed for people in communities in low- and middle-income countries (LMIC) affected by any kind of adversity. Two recent randomized controlled trials in Pakistan and Kenya demonstrated the effectiveness of individually delivered PM+. A group version of PM+ has been developed to make the intervention more scalable and acceptable. This paper describes the protocol for a cluster randomized controlled trial (c-RCT) on locally adapted Group PM+ in Nepal. METHODS/DESIGN:This c-RCT will compare Group PM+ to enhanced usual care (EUC) in participants with high levels of psychological distress recruited from the community. The study is designed as a two-arm, single-blind c-RCT that will be conducted in a community-based setting in Morang, a flood affected district in Eastern Nepal. Randomization will occur at ward level, the smallest administrative level in Nepal, with 72 enrolled wards allocated to Group PM+ or to EUC (ratio 1:1). Group PM+ consists of five approximately 2.5-h sessions, in which participants are taught techniques to manage their stressors and problems, and is delivered by trained and supervised community psychosocial workers (CPSWs). EUC consists of a family meeting with (a) basic information on adversity and mental health, (b) benefits of getting support, (c) information on seeking services from local health facilities with mhGAP-trained staff. The primary outcome measure is levels of individual psychological distress at endline (equivalent to 20?±?1?weeks after baseline), measured by the General Health Questionnaire (GHQ-12). Secondary outcome measures include levels of functioning, depressive symptoms, post-traumatic stress disorder symptoms, levels of social support, somatic symptoms, and ways of coping. We hypothesize that skills acquired will mediate any impact of the intervention. DISCUSSION:This c-RCT will contribute to the growing evidence-base for transdiagnostic psychological interventions delivered by non-specialists for people in communities affected by adversity. If Group PM+ is proven effective, the intervention manual will be released for use, giving the opportunity for further adaptation and implementation of the intervention in diverse settings with communities that require better access to psychological interventions. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03747055.
| S-EPMC7168994 | biostudies-literature
Project description:BackgroundThe prevalence of common mental disorders increases in humanitarian emergencies while access to services to address them decreases. Problem Management Plus (PM+) is a brief five-session trans-diagnostic psychological WHO intervention employing empirically supported strategies that can be delivered by non-specialist lay-providers under specialist supervision to adults impaired by distress. Two recent randomized controlled trials in Pakistan and Kenya demonstrated the efficacy of individually delivered PM+. To make PM+ more scalable and acceptable in different contexts, it is important to develop a group version as well, with 6-8 participants in session. A study is needed to demonstrate the feasibility and acceptability of both the intervention in a new cultural context and the procedures to evaluate Group PM+ in a cluster randomized controlled trial.MethodsThis protocol describes a feasibility trial to Group PM+ in Sindhuli, Nepal. This study will evaluate procedures for a cluster randomized controlled trial (c-RCT) with Village Development Committees (VDCs), which are the second smallest unit of government administration, as the unit of randomization. Adults with high levels of psychological distress and functional impairment will receive either Group PM+ (n = 60) or enhanced usual care (EUC; n = 60). Psychological distress, functional impairment, depression symptoms, posttraumatic stress disorder (PTSD) symptoms, and perceived problems will be measured during screening, pre-treatment baseline, and 7-10 days after the intervention. Qualitative data will be collected from beneficiaries, their families, local stakeholders, and staff to support quantitative data and to identify themes reporting that those involved and/or effected by Group PM+ perceived it as being acceptable, feasible, and useful. The primary objective of this trial is to evaluate the acceptability and feasibility of the intervention; to identify issues around implementation of local adaptation methods, training, supervision, and outcomes measures; and to assure that procedures are adequate for a subsequent effectiveness c-RCT.DiscussionOutcomes from this trial will contribute to optimizing feasibility and acceptability through cultural adaptation and contextualization of the intervention as well as refining the design for a c-RCT, which will evaluate the effectiveness of Group PM+ in Nepal.Trial registrationClinicalTrials.gov identifier: NCT03359486.
| S-EPMC6052626 | biostudies-literature
Project description:AIMS:Psychological interventions that are brief, acceptable, effective and can be delivered by non-specialists are especially necessary in low- and middle-income countries, where mental health systems are unable to address the high level of psychosocial needs. Problem Management Plus (PM+) is a five-session intervention designed for those impaired by psychological distress while living in communities affected by adversity. Individual PM+ has demonstrated effectiveness in reducing distress in Kenya and Pakistan, and a group version of PM+ (Group PM+) was effective for conflict-affected women in Pakistan. This paper describes a feasibility and acceptability trial of locally adapted Group PM+ for women and men in an earthquake-affected region of rural Nepal. METHODS:In this feasibility cluster randomised controlled trial, participants in the experimental arm were offered five sessions of Group PM+ and participants in the control arm received enhanced usual care (EUC), which entailed brief psycho-education and providing referral options to primary care services with health workers trained in the mental health Gap Action Programme Intervention Guide (mhGAP-IG). A mixed-methods design was used to assess the feasibility and acceptability of Group PM+. Feasibility was assessed with criteria including fidelity and retention of participants. Acceptability was assessed through in-depth interviews with participants, family members, programme staff and other stakeholders. The primary clinical outcome was depression symptoms assessed using the Patient Health Questionnaire (PHQ-9) administered at baseline and 8-8.5 weeks post-baseline (i.e. after completion of Group PM+ or EUC). RESULTS:We recruited 121 participants (83% women and 17% men), with equal allocation to the Group PM+ and EUC arms (1:1). Group PM+ was delivered over five 2.5-3 hour sessions by trained and supervised gender-matched local non-specialists, with an average attendance of four out of five sessions. The quantitative and qualitative results demonstrated feasibility and acceptability for non-specialists to deliver Group PM+. Though the study was not powered to assess for effectiveness, for all five key outcome measures, including the primary clinical outcome, the estimated mean improvement was larger in the Group PM+ arm than the EUC arm. CONCLUSION:The intervention and trial procedures were acceptable to participants, family members, and programme staff. The communities and participants found the intervention to be beneficial. Because feasibility and acceptability were established in this trial, a fully powered randomised controlled trial will be conducted for larger scale implementation to determine the effectiveness of the intervention in Nepal.
| S-EPMC7264859 | biostudies-literature
Project description:BackgroundSyrian refugees resettled in Turkey show a high prevalence of symptoms of mental disorders. Problem Management Plus (PM+) is an effective psychological intervention delivered by non-specialist health care providers which has shown to decrease psychological distress among people exposed to adversity. In this single-blind pilot randomised controlled trial, we examined the methodological trial procedures of Group PM+ (gPM+) among Syrian refugees with psychological distress in Istanbul, Turkey, and assessed feasibility, acceptability, perceived impact and the potential cost-effectiveness of the intervention.MethodsRefugees with psychological distress (Kessler Psychological Distress Scale, K10 > 15) and impaired psychosocial functioning (World Health Organization Disability Assessment Schedule, WHODAS 2.0 > 16) were recruited from the community and randomised to either gPM+ and enhanced care as usual (E-CAU) (n = 24) or E-CAU only (n = 22). gPM+ comprised of five weekly group sessions with eight to ten participants per group. Acceptability and feasibility of the intervention were assessed through semi-structured interviews. The primary outcome at 3-month follow-up was symptoms of depression and anxiety (Hopkins Symptoms Checklist-25). Psychosocial functioning (WHODAS 2.0), symptoms of posttraumatic stress disorder and self-identified problems (Psychological Outcomes Profiles, PSYCHLOPS) were included as secondary outcomes. A modified version of the Client Service Receipt Inventory was used to document changes in the costs of health service utilisation as well as productivity losses.ResultsThere were no barriers experienced in recruiting study participants and in randomising them into the respective study arms. Retention in gPM+ was high (75%). Qualitative analyses of the interviews with the participants showed that Syrian refugees had a positive view on the content, implementation and format of gPM+. No adverse events were reported during the implementation. The study was not powered to detect an effect. No significant difference between gPM+ and E-CAU group on primary and secondary outcome measures, or in economic impacts were found.ConclusionsgPM+ delivered by non-specialist peer providers seemed to be an acceptable, feasible and safe intervention for Syrian refugees in Turkey with elevated levels of psychological distress. This pilot RCT sets the stage for a fully powered RCT.Trial registrationClinicalTrials.gov Identifier NCT03567083 ; date: 25/06/2018.
| S-EPMC8728921 | biostudies-literature
Project description:Humanitarian workers are at an elevated risk of occupational trauma exposure and its associated psychological consequences, and experience increased levels of anxiety, depression, and post-traumatic stress disorder (PTSD) compared to the general population. Psychological first aid (PFA) aims to prevent acute distress reactions from developing into long-term distress by instilling feelings of safety, calmness, self- and community efficacy, connectedness and hope. Group PFA (GPFA) delivers PFA in a group or team setting. This research sought to understand 'What works, for whom, in what context, and why for group psychological first aid for humanitarian workers, including volunteers?' A rapid realist review (RRR) was conducted. Initial theories were generated to answer the question and were subsequently refined based on 15 documents identified through a systematic search of databases and grey literature, in addition to the inputs from a core reference panel and two external experts in GPFA. The findings generated seven programme theories that addressed the research question and offered consideration for the implementation of GPFA for the humanitarian workforce across contexts and age groups. GPFA enables individuals to understand their natural reactions, develop adaptive coping strategies, and build social connections that promote a sense of belonging and security. The integrated design of GPFA ensures that individuals are linked to additional supports and have their basic needs addressed. While the evidence is sparce on GPFA, its ability to provide support to humanitarian workers is promising.
| S-EPMC7913971 | biostudies-literature
Project description:AimsDespite high levels of psychological distress, mental health service use among Syrian refugees in urban settings is low. To address the mental healthcare gap, the World Health Organization developed group problem management plus (gPM+), a scalable psychological intervention delivered by non-specialist peer facilitators. The study aimed to evaluate the effectiveness of gPM+ in reducing symptoms of depression and anxiety among Syrian refugees in Istanbul, Türkiye.MethodsA randomized controlled trial was conducted among 368 distressed (Kessler Psychological Distress Scale, K10 > 15) adult Syrian refugees with impaired functioning (World Health Organization Disability Assessment Schedule, WHODAS 2.0 > 16). Participants were recruited between August 2019 and September 2020 through a non-governmental organization providing services to refugees. Participants were randomly allocated to gPM+ and enhanced care as usual (gPM+/E-CAU) (184 participants) or E-CAU only (184 participants). Primary outcomes were symptoms of depression and anxiety (Hopkins Symptom Checklist (HSCL-25)) at 3-month follow-up. Secondary outcomes were post-traumatic stress disorder (PTSD) symptoms (PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5; PCL-5), functional impairment (WHODAS 2.0), and self-identified problems (psychological outcome profiles).ResultsIntent-to-treat analyses showed no significant effect of gPM+ on symptoms of anxiety, depression, PTSD and self-identified problems. Yet, there was a significant reduction in functional impairment in gPM+/E-CAU compared to E-CAU at 3-month follow-up (adjusted mean difference 1.66, 95 % CI 0.04, 3.27, p = 0.045, d = 0.19). Post-hoc subgroup analyses among participants with probable baseline depression or anxiety showed that there was a small but significant reduction in depression (adjusted mean difference -0.17, 95 % CI -0.32, -0.02, p = 0.028, d = 0.27) and anxiety (adjusted mean difference -0.21, 95 % CI -0.37, -0.05, p = 0.009, d = 0.30) symptoms comparing gPM+/E-CAU to E-CAU only at 1-week post assessment, but not at 3-month follow-up. There was a significant difference between conditions on functional impairment at 3-month follow-up, favouring gPM+/E-CAU condition (adjusted mean difference -1.98, 95 % CI -3.93, -0.02, p = 0.048, d = 0.26).ConclusionIn this study in an urban setting in Türkiye, gPM+ did not alleviate symptoms of depression and anxiety among Syrian refugees experiencing psychological distress and daily living difficulties. However, participants with higher distress at baseline seemed to benefit from gPM+, but treatment gains disappeared in the long term. Current findings highlight the potential benefit of tailored psychosocial interventions for highly distressed refugees in volatile low-resource settings.
| S-EPMC11464952 | biostudies-literature
Project description:IntroductionInternational humanitarian aid during disasters should be needs-based and coordinated in response to appeals from affected governments. We identify disaster and population factors associated with international aid appeal during disasters and hence guide preparation by international humanitarian aid providers.MethodsIn this retrospective database analysis, we searched the Emergency Events Database for all disasters from 1995 to 2015. Disasters with and without international aid appeals were compared by location, duration, type of disaster, deaths, number of people affected, and total estimated damage. Logistic regression was used to examine the association of each factor with international aid appeal.ResultsOf 13,961 disasters recorded from 1995 to 2015, 168 (1.2%) involved international aid appeals. Aid appeals were more likely to be triggered by disasters which killed more people (OR 1.29 [95% confidence interval (CI) 1.02-1.64] log10 persons), affected more people (OR 1.85 [95%CI 1.57-2.18] / log10 persons), and occurred in Africa (OR 1.67 [95%CI 1.06-2.62). Earthquakes (OR 4.07 [95%CI 2.16-7.67]), volcanic activity (OR 6.23 [95%CI 2.50-15.53]), and insect infestations (OR 12.14 [95%CI 3.05-48.35]) were more likely to trigger international aid appeals. International aid appeals were less likely to be triggered by disasters which occurred in Asia (OR 0.46 [95%CI 0.29-0.73]) and which were transport accidents (OR 0.12 [95%CI 0.02-0.89]).ConclusionInternational aid appeal during disasters was associated with greater magnitude of damage, disasters in Africa, and specific types of disasters such as earthquakes, volcanic activity, and insect infestations. Humanitarian aid providers can focus preparation on these identified factors.
| S-EPMC10234527 | biostudies-literature
Project description:AimsCollege students experience high rates of problem and pathological gambling, yet little research has investigated methods for reducing gambling in this population. This study sought to examine the efficacy of brief intervention strategies.DesignRandomized trial.SettingCollege campuses.ParticipantsA total of 117 college student problem and pathological gamblers.InterventionsStudents were assigned randomly to: an assessment-only control, 10 minutes of brief advice, one session of motivational enhancement therapy (MET) or one session of MET, plus three sessions of cognitive-behavioral therapy (CBT). The three interventions were designed to reduce gambling.MeasurementsGambling was assessed at baseline, week 6 and month 9 using the Addiction Severity Index-gambling (ASI-G) module, which also assesses days and dollars wagered.FindingsCompared to the assessment-only condition, those receiving any intervention had significant decreases in ASI-G scores and days and dollars wagered over time. The MET condition decreased significantly ASI-G scores and dollars wagered over time, and increased the odds of a clinically significant reduction in gambling at the 9-month follow-up relative to the assessment-only condition, even after controlling for baseline indices that could impact outcomes. The Brief Advice and MET+CBT conditions had benefits on some, but not all, indices of gambling. None of the interventions differed significantly from one another. Conclusions These results suggest the efficacy of brief interventions for reducing gambling problems in college students.
| S-EPMC2758481 | biostudies-literature
Project description:BackgroundBrief interventions have been increasingly investigated to promote early intervention in gambling problems; an accurate estimate of the impact of these interventions is required to justify their widespread implementation. The goal of the current investigation was to evaluate the efficacy of in-person brief interventions for reducing gambling behaviour and/or problems, by quantifying the aggregate effect size associated with these interventions in the published literature to date.MethodsRandomized controlled trials including the following design features were identified via systematic review: an adult sample experiencing problems associated with gambling; an in-person individual psychosocial intervention of brief duration (≤3 sessions); a control/comparison group; and an outcome related to gambling behaviour and/or problems.ResultsFive records compared brief interventions to assessment only control; using a random effect model, brief interventions were associated with a small but statistically significant reduction in gambling behaviour across short-term follow-up periods versus assessment only control (g = -.19, 95% CI [-.37, -.01]). Aggregate effect sizes for gambling problems and long-term follow-up periods were not statistically significant. Five records compared brief interventions to longer active interventions; there was no significant difference between brief interventions and longer active interventions.ConclusionsResults supported the efficacy of brief interventions for problem gambling compared to inactive control in the reduction of gambling behaviour; no differences were found across brief versus longer interventions for both gambling behaviour and problems. While these findings must be interpreted in the context of the limited number of studies and small magnitude of the combined effect sizes, the current meta-analysis supports the further investigation of the public health impact of these cost-effective interventions.
| S-EPMC6469774 | biostudies-literature
Project description:BackgroundHelping the large number of problem drinkers who will never seek treatment is a challenging issue. Public health initiatives employing educational materials or mass media campaigns have met with mixed success. However, clinical research has developed effective brief interventions to help problem drinkers. This project will employ an intervention that has been validated in clinical settings and then modified into an ultra-brief format suitable for use as a public health intervention. The major objective of this study is to conduct a randomized controlled trial to establish the effectiveness of an ultra-brief, personalized feedback intervention for problem drinkers.Methods/designProblem drinkers recruited on a baseline population telephone survey conducted in a major metropolitan city in Canada will be randomized to one of three conditions - a personalized feedback pamphlet condition, a control pamphlet condition, or a no intervention control condition. In the week after the baseline survey, households in the two pamphlet conditions will be sent their respective pamphlets. Changes in drinking will be assessed post intervention at three-month and six-month follow-ups. Drinking outcomes will be compared between experimental conditions using Structural Equation Modeling. The primary hypothesis is that problem drinkers from households who receive the personalized feedback pamphlet intervention will display significantly improved drinking outcomes at three and six-month follow-ups as compared to problem drinkers from households in the no intervention control condition. Secondary hypotheses will test the impact of the intervention on help seeking, and explore the mediating or moderating role of perceived drinking norms, perceived alcohol risks and the problem drinker's social reasons for drinking.DiscussionThis trial will provide information on the effectiveness of a pamphlet-based personalized feedback intervention for problem drinkers in a community setting.Trial registrationClinicalTrials.gov registration #NCT00688584.
| S-EPMC2528012 | biostudies-literature