scholarly journals Effectiveness of Group Problem Management Plus, a brief psychological intervention for adults affected by humanitarian disasters in Nepal: A cluster randomized controlled trial

PLoS Medicine ◽  
2021 ◽  
Vol 18 (6) ◽  
pp. e1003621
Author(s):  
Mark J. D. Jordans ◽  
Brandon A. Kohrt ◽  
Manaswi Sangraula ◽  
Elizabeth L. Turner ◽  
Xueqi Wang ◽  
...  
Keyword(s):  
Psychological Distress ◽  
Functional Impairment ◽  
Psychological Treatment ◽  
Controlled Trial ◽  
Depression Symptoms ◽  
Ptsd Symptoms ◽  
Problem Management ◽  
Humanitarian Emergencies ◽  
Randomized Controlled ◽  
Cluster Randomized

Background 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. Methods and findings We conducted a cluster randomized controlled trial (cRCT) from November 25, 2018 through September 30, 2019. Participants in both arms were assessed at baseline, midline (7 weeks post-baseline, which was approximately 1 week after treatment in the experimental arm), and endline (20 weeks post-baseline, which was approximately 3 months posttreatment). The intervention was Group Problem Management Plus (PM+), a psychological treatment of 5 weekly sessions, which was compared with enhanced usual care (EUC) consisting of a family psychoeducation meeting with a referral option to primary care providers trained in mental healthcare. The setting was 72 wards (geographic unit of clustering) in eastern Nepal, with 1 PM+ group per ward in the treatment arm. Wards were eligible if they were in disaster-prone regions and residents spoke Nepali. Wards were assigned to study arms based on covariate constrained randomization. Eligible participants were adult women and men 18 years of age and older who met screening criteria for psychological distress and functional impairment. Outcomes were measured at the participant level, with assessors blinded to group assignment. The primary outcome was psychological distress assessed with the General Health Questionnaire (GHQ-12). Secondary outcomes included depression symptoms, posttraumatic stress disorder (PTSD) symptoms, “heart–mind” problems, social support, somatic symptoms, and functional impairment. The hypothesized mediator was skill use aligned with the treatment’s mechanisms of action. A total of 324 participants were enrolled in the control arm (36 wards) and 319 in the Group PM+ arm (36 wards). The overall sample (N = 611) had a median age of 45 years (range 18–91 years), 82% of participants were female, 50% had recently experienced a natural disaster, and 31% had a chronic physical illness. Endline assessments were completed by 302 participants in the control arm (36 wards) and 303 participants in the Group PM+ arm (36 wards). At the midline assessment (immediately after Group PM+ in the experimental arm), mean GHQ-12 total score was 2.7 units lower in Group PM+ compared to control (95% CI: 1.7, 3.7, p < 0.001), with standardized mean difference (SMD) of −0.4 (95% CI: −0.5, −0.2). At 3 months posttreatment (primary endpoint), mean GHQ-12 total score was 1.4 units lower in Group PM+ compared to control (95% CI: 0.3, 2.5, p = 0.014), with SMD of −0.2 (95% CI: −0.4, 0.0). Among the secondary outcomes, Group PM+ was associated with endline with a larger proportion attaining more than 50% reduction in depression symptoms (29.9% of Group PM+ arm versus 17.3% of control arm, risk ratio = 1.7, 95% CI: 1.2, 2.4, p = 0.002). Fewer participants in the Group PM+ arm continued to have “heart–mind” problems at endline (58.8%) compared to the control arm (69.4%), risk ratio = 0.8 (95% CI, 0.7, 1.0, p = 0.042). Group PM+ was not associated with lower PTSD symptoms or functional impairment. Use of psychosocial skills at midline was estimated to explain 31% of the PM+ effect on endline GHQ-12 scores. Adverse events in the control arm included 1 suicide death and 1 reportable incidence of domestic violence; in the Group PM+ arm, there was 1 death due to physical illness. Study limitations include lack of power to evaluate gender-specific effects, lack of long-term outcomes (e.g., 12 months posttreatment), and lack of cost-effectiveness information. Conclusions In this study, we found that a 5-session group psychological treatment delivered by nonspecialists modestly reduced psychological distress and depression symptoms in a setting prone to humanitarian emergencies. Benefits were partly explained by the degree of psychosocial skill use in daily life. To improve the treatment benefit, future implementation should focus on approaches to enhance skill use by PM+ participants. Trial registration ClinicalTrials.gov NCT03747055.

Study Protocol for a Randomized Controlled Trial: Peer to Peer Group Problem Management Plus (PM+) for Adult Syrian Refugees in Turkey

2019 ◽  
Author(s):  
Ersin Uygun ◽  
Zeynep Ilkkursun ◽  
Marit Sijbrandij ◽  
A. Tamer Aker ◽  
Richard Bryant ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Psychological Distress ◽  
Posttraumatic Stress ◽  
Functional Impairment ◽  
Peer Group ◽  
Controlled Trial ◽  
Syrian Refugees ◽  
Problem Management ◽  
Randomized Controlled

Abstract Background: A large proportion of Syrians have been exposed to potentially traumatic events, multiple losses, breakdown of supportive social networks and many of them have sought refuge in host countries where they also face post migration living difficulties such as discrimination or/and integration problems. These adversities may put Syrian refugees at high risk for common mental disorders. In response to this, the World Health Organization (WHO) developed a transdiagnostic scalable psychological intervention called Problem Management Plus (PM+) to reduce psychological distress among populations exposed to adversities. PM+ has been adapted for Syrian refugees and can be delivered by non-specialist peer lay persons in the community. Methods: A randomized controlled trial (RCT) will be conducted with 380 Syrian refugees in Turkey. After providing informed consent, participants with high levels of psychological distress (scoring >15 on the Kessler-10 Psychological Distress Scale (K10)) and functional impairment (scoring >16 on the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)) will be randomly assigned to Group PM+/Enhanced Care As Usual (Group PM+/E-CAU) (n = 190) or enhanced-care-as-usual (E-CAU) (n = 190). Outcome assessments will take place 1-week after the 5 th session (post assessment), 3 months after the 5 th session and 12 months after baseline assessment. The primary outcome is psychological distress as measured by the Hopkins Symptom Checklist (HSCL-25). Secondary outcomes include functional impairment, posttraumatic stress symptoms, self-identified problems, as well as health system and productivity costs. A process evaluation will be conducted to explore the feasibility, challenges and success of the intervention with 25 participants including participants, facilitators, policy makers and mental health professionals. Discussion: The treatment manual of the Syrian-Arabic Group PM+ and training materials will be made available through the WHO once the effectiveness and cost-effectiveness of group PM+ has been established. Keywords: Cognitive behavioural therapy, depression, anxiety, posttraumatic stress, refugee, mental health, group interventions, task shifting, trans-diagnostic

scholarly journals Protocol for a Randomized Controlled Trial: Peer to Peer Group Problem Management Plus (PM+) for Adult Syrian Refugees in Turkey

2020 ◽  
Author(s):  
Ersin Uygun ◽  
Zeynep Ilkkursun ◽  
Marit Sijbrandij ◽  
A. Tamer Aker ◽  
Richard Bryant ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Psychological Distress ◽  
Posttraumatic Stress ◽  
Functional Impairment ◽  
Peer Group ◽  
Controlled Trial ◽  
Syrian Refugees ◽  
Problem Management ◽  
Randomized Controlled

Abstract Background: A large proportion of Syrians have been exposed to potentially traumatic events, multiple losses, breakdown of supportive social networks and many of them have sought refuge in host countries where they also face post migration living difficulties such as discrimination or/and integration problems. These adversities may put Syrian refugees at high risk for common mental disorders. In response to this, the World Health Organization (WHO) developed a transdiagnostic scalable psychological intervention called Problem Management Plus (PM+) to reduce psychological distress among populations exposed to adversities. PM+ has been adapted for Syrian refugees and can be delivered by non-specialist peer lay persons in the community. Methods: A randomized controlled trial (RCT) will be conducted with 380 Syrian refugees in Turkey. After providing informed consent, participants with high levels of psychological distress (scoring >15 on the Kessler-10 Psychological Distress Scale (K10)) and functional impairment (scoring >16 on the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)) will be randomly assigned to Group PM+/Enhanced Care As Usual (Group PM+/E-CAU) (n = 190) or enhanced-care-as-usual (E-CAU) (n = 190). Outcome assessments will take place 1-week after the 5 th session (post assessment), 3 months after the 5 th session and 12 months after baseline assessment. The primary outcome is psychological distress as measured by the Hopkins Symptom Checklist (HSCL-25). Secondary outcomes include functional impairment, posttraumatic stress symptoms, self-identified problems, as well as health system and productivity costs. A process evaluation will be conducted to explore the feasibility, challenges and success of the intervention with 25 participants including participants, facilitators, policy makers and mental health professionals. Discussion: The treatment manual of the Syrian-Arabic Group PM+ and training materials will be made available through the WHO once the effectiveness and cost-effectiveness of group PM+ has been established. Keywords: Cognitive behavioural therapy, depression, anxiety, posttraumatic stress, refugee, mental health, group interventions, task shifting, trans-diagnostic

Does providing personalized depression risk information lead to increased psychological distress and functional impairment? Results from a mixed-methods randomized controlled trial

2020 ◽  
pp. 1-9
Author(s):  
JianLi Wang ◽  
Heidi Eccles ◽  
Molly Nannarone ◽  
Norbert Schmitz ◽  
Scott Patten ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Psychological Distress ◽  
Mixed Methods ◽  
Functional Impairment ◽  
Controlled Trial ◽  
Intervention Group ◽  
Risk Information ◽  
Control Group ◽  
Randomized Controlled ◽  
Depression Risk

Abstract Background Multivariable risk algorithms (MVRP) predicting the personal risk of depression will form an important component of personalized preventive interventions. However, it is unknown whether providing personalized depression risk will lead to unintended psychological harms. The objectives of this study were to evaluate the impact of providing personalized depression risk on non-specific psychological distress and functional impairment over 12 months. Methods A mixed-methods randomized controlled trial was conducted in 358 males and 354 females who were at high risk of having a major depressive episode according to sex-specific MVRPs, and who were randomly recruited across Canada. Participants were assessed at baseline, 6 and 12 months. Results Over 93% of participants were interested in knowing their depression risk. The intervention group had a greater reduction in K10 score over 12 months than the control group; complete-case analysis found a significant between-group difference in mean K10 change score (d = 1.17, 95% CI 0.12–2.23) at 12 months. Participants in the intervention group also reported significantly less functional impairment in the domains of home and work/school activities, than did those in the control group. A majority of the qualitative interviewees commented that personalized depression risk information does not have a negative impact on physical and mental health. Conclusions This study found no evidence that providing personalized depression risk information will lead to worsening psychological distress, functional impairment, and absenteeism. Provision of personalized depression risk information may have positive impacts on non-specific psychological distress and functioning. Trial registration ClinicalTrials.gov NCT02943876

scholarly journals Development of the Therapeutic Alliance and its Association With Internet-Based Mindfulness-Based Cognitive Therapy for Distressed Cancer Patients: Secondary Analysis of a Multicenter Randomized Controlled Trial

10.2196/14065 ◽  
2019 ◽  
Vol 21 (10) ◽  
pp. e14065 ◽  
Author(s):  
Else Bisseling ◽  
Linda Cillessen ◽  
Philip Spinhoven ◽  
Melanie Schellekens ◽  
Félix Compen ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Psychological Distress ◽  
Therapeutic Alliance ◽  
Psychological Treatment ◽  
Controlled Trial ◽  
Well Being ◽  
Treatment Dropout ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
Mental Well Being

Background Mindfulness-based cognitive therapy (MBCT) is an evidence-based group-based psychological treatment in oncology, resulting in reduction of depressive and anxiety symptoms. Internet-based MBCT (eMBCT) has been found to be an effective alternative for MBCT. The therapeutic alliance (the bond between therapist and patient,) is known to have a significant impact on psychological treatment outcomes, including MBCT. A primary concern in the practice of eMBCT is whether a good therapeutic alliance can develop. Although evidence for the beneficial effect of therapist assistance on treatment outcome in internet-based interventions (IBIs) is accumulating, it is still unclear whether the therapeutic alliance is related to outcome in IBIs. Objective This study aimed to (1) explore whether early therapeutic alliance predicts treatment dropout in MBCT or eMBCT, (2) compare the development of the therapeutic alliance during eMBCT and MBCT, and (3) examine whether early therapeutic alliance is a predictor of the reduction of psychological distress and the increase of mental well-being at posttreatment in both conditions. Methods This study was part of a multicenter randomized controlled trial (n=245) on the effectiveness of MBCT or eMBCT for distressed cancer patients. The therapeutic alliance was measured at the start of week 2 (ie, early therapeutic alliance), week 5, and week 9. Outcome measures were psychological distress, measured with the Hospital Anxiety and Depression Scale, and mental well-being, measured with the Mental Health Continuum-Short Form. Results The strength of early therapeutic alliance did not predict treatment dropout in MBCT or eMBCT (B=−.39; P=.21). Therapeutic alliance increased over time in both conditions (F2,90=16.46; Wilks λ=0.732; P<.001). This increase did not differ between eMBCT and MBCT (F1,91=0.114; P=.74). Therapeutic alliance at week 2 predicted a decrease in psychological distress (B=−.12; t114=−2.656; P=.01) and an increase in mental well-being (B=.23; t113=2.651; P=.01) at posttreatment. The relationship with reduction of psychological distress differed between treatments: a weaker early therapeutic alliance predicted higher psychological distress at posttreatment in MBCT but not in eMBCT (B=.22; t113=2.261; P=.03). Conclusions A therapeutic alliance can develop in both eMBCT and MBCT. Findings revealed that the strength of early alliance did not predict treatment dropout. Furthermore, the level of therapeutic alliance predicted reduced psychological distress and increased mental well-being at posttreatment in both conditions. Interestingly, the strength of therapeutic alliance appeared to be more related to treatment outcome in group-based MBCT than in eMBCT. Trial Registration ClinicalTrials.gov NCT02138513; https://clinicaltrials.gov/ct2/show/NCT02138513

scholarly journals Effectiveness of Group Problem Management Plus (Group-PM+) for adults affected by humanitarian crises Nepal: study protocol for a cluster randomised controlled trial (c-RCT)

2019 ◽  
Author(s):  
E van 't Hof ◽  
Manaswi Sangraula ◽  
Nagendra P Luitel ◽  
Elizabeth L. Turner ◽  
Kedar Marahatta ◽  
...  
Keyword(s):  
Psychological Distress ◽  
Controlled Trial ◽  
General Health Questionnaire ◽  
Scale Up ◽  
Secondary Outcome ◽  
Psychological Interventions ◽  
Local Health ◽  
Post Traumatic Stress ◽  
Problem Management ◽  
Randomized Controlled

Abstract 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 5 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: 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 hour 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 consist of a 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 20 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 to further adaptation and implementation of the intervention in diverse settings with communities that require better access to psychological interventions.

scholarly journals Internet-Based Cognitive Behavioral Therapy for Psychological Distress Associated With the COVID-19 Pandemic: A Pilot Randomized Controlled Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Victoria Aminoff ◽  
Malin Sellén ◽  
Elise Sörliden ◽  
Mikael Ludvigsson ◽  
Matilda Berg ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Psychological Distress ◽  
Alcohol Use ◽  
Psychological Treatment ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Secondary Outcome ◽  
Randomized Controlled ◽  
Symptom Profile

Background: The COVID-19 pandemic has been associated with various negative psychological consequences. This is a challenge for the society as regular psychological services cannot be offered to the same extent as before the pandemic. In addition to the requirement of social distancing, there is a need to adjust psychological treatment components like exposure to avoid increasing the spread of the infection. Internet-delivered cognitive behavior therapy (ICBT) has an established evidence base for a range of psychiatric problems and has been suggested as one possible approach to deal with the situation. This study aimed to conduct a randomized controlled pilot trial during the summer of 2020 with a broad focus on psychological distress and a treatment approach that tailors the intervention based on symptom profile and preferences.Methods: Following the advertisement and interview, we included 52 participants with elevated levels of psychological distress. They were randomly allocated to either a 7-week-long individually tailored ICBT (n = 26) or a wait-list control condition (n = 26). Measures of depression and quality of life were used as primary outcomes. We also included secondary outcome measures of anxiety, insomnia, trauma, stress, anger, and alcohol use. For screening, we used the CoRonavIruS Health Impact Survey (CRISIS).Results: Overall moderate to large between-group effects were found at post-treatment in favor of the treatment on measures of both depression [Beck Depression Inventory (BDI); Cohens d = 0.63; Patient Health Questionnaire (PHQ-9): d = 0.62] and anxiety [Generalized Anxiety Disorder-7-item scale (GAD-7); d = 0.82]. This was also observed for stress symptoms [Perceived Stress Scale (PSS-14); d = 1.04]. No effects were seen on measures of quality of life, insomnia, symptoms of post-traumatic stress, and anger. There was an effect on alcohol use [Alcohol Use Disorder Identification Test (AUDIT); d = 0.54], which was not of clinical relevance.Conclusion: Individually tailored ICBT shows initial promise as a way to reduce psychological problems in association with the COVID-19 pandemic. A possible limitation was that the trial was conducted when the effects of the pandemic were decreasing and when fewer people were affected by the restrictions (e.g., the summer of 2020).

scholarly journals Effectiveness of Group Problem Management Plus (Group-PM+) for adults affected by humanitarian crises Nepal: study protocol for a cluster randomised controlled trial (c-RCT)

2019 ◽  
Author(s):  
E van 't Hof ◽  
Manaswi Sangraula ◽  
Nagendra P Luitel ◽  
Elizabeth L. Turner ◽  
Kedar Marahatta ◽  
...  
Keyword(s):  
Psychological Distress ◽  
Controlled Trial ◽  
General Health Questionnaire ◽  
Scale Up ◽  
Secondary Outcome ◽  
Psychological Interventions ◽  
Local Health ◽  
Family Meeting ◽  
Problem Management ◽  
Randomized Controlled

Abstract 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 5 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: 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 hour 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 to further adaptation and implementation of the intervention in diverse settings with communities that require better access to psychological interventions.

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