Pilot Feasibility Study of Remote Problem Management Plus for Adults Affected by COVID-19

Study Overview
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Brief Summary
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This is a pilot feasibility study of remotely delivered Problem Management Plus, a low-intensity psychological intervention, delivered in five sessions to adults affected by crisis. The current study will evaluate the feasibility and acceptability of the intervention when delivered remotely via Zoom to community members in New York City impacted by the COVID-19 pandemic. The investigator's goal is to use qualitative and quantitative approaches to inform procedures for a subsequent cluster randomized control trial of Problem Management Plus versus enhanced usual care. A mixed-methods design will be used to evaluate the feasibility, acceptability, perceived utility, and impact of the remotely delivered PM+ intervention, to determine recruitment and retention rates, to assess ethics and safety of trial procedures. Additionally, the study will evaluate the acceptability, feasibility and fidelity of the remote training and supervision of helpers trained to deliver the intervention.

Detailed Description
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Problem Management Plus (PM+) is recommended as part of the World Health Organization Mental Health Gap Action Program for communities affected by adversity. It is a low-intensity, scalable manualized intervention that was designed according to a task-sharing model of care. PM+ has four core features that make the intervention suitable for populations exposed to adversities in low-resource settings. First, it is a brief intervention (five sessions); second, it can be delivered by paraprofessionals (trained, non-specialist workers, lay or peer providers under the supervision of a mental health professional), using the principle of task shifting/task sharing; third, it is designed as a trans-diagnostic intervention to address a range of client-identified emotional (e.g. depression, anxiety, traumatic stress, general stress) and practical problems; and, fourth, it is designed for communities affected by any kind of adversity (e.g. violence, disasters) in low-income countries. The intervention was originally developed for adults affected by humanitarian crises and tested in low-income countries. A number of randomized controlled trials in Kenya, Pakistan, Nepal, as well as the Netherlands have indicated that PM+ delivered by non-specialist helpers is effective in decreasing symptoms of psychological distress (including depression, anxiety and post-traumatic stress disorder symptoms) and improving functioning; however, empirical evidence of the feasibility and efficacy of the remote training and delivery of PM+ is limited. In May 2020, the United Nations released a policy brief emphasizing inclusion of mental health and psychosocial support (MHPSS) in national response plans including scaling up access to remote support (UN, 2020). The brief was released in response to emerging concerns of the negative mental health and psychosocial impacts arising from the health and societal consequences of COVID-19. Extant population-based research is showing high rates of anxiety, depression, and general distress in the US, while at the same time MHPSS provision has been disrupted or halted due to social distancing measures. Remote delivery forms of PM+ may serve as an important mechanism to facilitate access to care during the ongoing pandemic and into the future. Furthermore, there is very limited research with PM+ in high-income countries where specialized mental health interventions are available, but where access for certain populations or during periods of public health crisis is limited due to systemic and practical barriers. Even in high income countries, only 22.4% of those with depression receive minimally adequate care; however, 64.9% of those with depression perceive a need for treatment. The treatment gap may be considerably higher among marginalized groups and economically disadvantaged communities. COVID-19 continues to bring on widespread mental health disparities, particularly among vulnerable and underserved communities that are disproportionately affected by COVID-19. Brief, low-intensity interventions designed to be implemented by non-specialists represent a promising and scalable approach to minimize this treatment gap in under-served US populations by partnering with community-based organizations (CBO) to train and supervise staff already involved in social and public health services. An important first step before investing resources in training and implementation with CBOs is to evaluate the feasibility, acceptability and effectiveness of remotely delivered PM+ with relevant community samples. This is the first study to evaluate remotely delivered PM+ implemented by helpers whose training and supervision was conducted entirely online, as well as one of the first trials evaluating PM+ with community samples in the US. The aims of this pilot feasibility study are to a) assess interest from perspective beneficiaries by partnering with community-based organizations in New York City to recruit participants; b) to gather and evaluate information about the feasibility, acceptability and safety of the intervention, in particular when implemented via remote delivery; c) to identify whether the clinical and content adaptations that were made during the remote training, adaptation and conduct of initial practice cases are appropriate for the setting; and d) to assess possible problems of recruitment, delivery of the intervention and retention to ensure that procedures are adequate for a cluster randomized control trial. Additionally, the investigators will employ a single-arm, uncontrolled design in order to begin to examine the effectiveness and impact of remotely delivered PM+ among community members in New York City who are experiencing symptoms of common mental health problems. Lastly, trainees' knowledge and perceived self-efficacy in a) foundational helping skills based on common therapeutic factors and b) intervention-specific competencies will be evaluated pre-training, post-training and post-supervision.

Official Title
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Pilot Feasibility Study of Remote Problem Management Plus to Improve Well-being and Functioning of Adults Affected by COVID-

Conditions
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Depression, Anxiety Disorders, Psychological Distress

Intervention / Treatment
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* Behavioral: Remote Problem Management Plus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English-speaking Help- or treatment-seeking Access to a device for conducting sessions via Zoom (e.g., smartphone, tablet, laptop or personal computer) Exclusion Criteria: Acute medical conditions or severe cognitive impairment (e.g., severe intellectual disability or dementia) Imminent suicide risk or expressed acute needs/protection risks (e.g., intimate partner violence risk) Presence of severe mental disorder (e.g., psychotic disorders) Hazardous substance use, substance dependency or substance use disorder (assessed using the Drug Abuse Screening Test (DAST-10) and Alcohol Use Disorders Identification Test (AUDIT-C)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remote Problem Management Plus<br>Five individual sessions of low-intensity psychological intervention | Behavioral: Remote Problem Management Plus<br>* Five sessions of low-intensity, trans-diagnostic psychological intervention including the teaching and practice of the following strategies: stress management, problem solving, behavioral activation, and strengthening social support<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychological Outcomes Profile; Unabbreviated scale title Psychological Outcomes Profile | 4-item measure of personalized distress and client-generated problems, function and wellbeing; minimum value = 0, maximum value = 20; higher scores mean greater distress | 1 week post-intervention | 
| Patient Health Questionnaire; Unabbreviated scale title Patient Health Questionnaire | 9-item measure of depression symptoms; minimum value = 0, maximum value = 27; higher scores mean more severe depression symptoms | 1 week post-intervention | 
| Generalized Anxiety Disorder Scale; Unabbreviated scale title Generalized Anxiety Disorder 7-item Scale | 7-item measure of anxiety symptoms; minimum value = 0 and maximum value = 21; higher scores mean more severe anxiety symptoms | 1 week post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| World Health Organization Disability Assessment Scale 2.0; Unabbreviated scale title World Health Organization Disability Assessment Scale 2.0 | 12-item measure of ability to engage in daily activities and functioning; minimum value = 0, maximum value = 48; higher scores mean worse disability outcomes | 1 week post-intervention | 
| World Health Organization Quality of Life Questionnaire-BREF; Unabbreviated scale title World Health Organization Quality of Life Questionnaire-BREF | 26-item quality of life assessment of physical health, psychological health, social, relationships and environment; minimum value = 26 and maximum value = 130; higher scores mean better quality of life | 1 week post-intervention | 
| EuroQoL 5-dimension 5-level; Unabbreviated scale title EuroQoL 5-dimension 5-level | 5-item assessment of dimensions of health status: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; minimum= 5, maximum = 25; higher score mean worse health outcomes | 1 week post-intervention | 
| Pittsburgh Sleep Quality Index; Unabbreviated scale title Pittsburgh Sleep Quality Index | 19-item measure of sleep quality and disturbance; 19 items combined to form 7 component scores, each of which has a range of 0-3 points, 7 component scores are added to yield one global global score; minimum value = 0 and maximum value = 21; higher score means greater difficulty sleeping | 1 week post-intervention | 
| Somatic Symptom Scale-8; Unabbreviated scale title Somatic Symptom Scale-8 | 8-item assessment of the presence and severity of common somatic symptoms; minimum value = 0, maximum value = 32; higher score means more severe somatic symptoms | 1 week post-intervention |