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DepressionPM+NCT04617262

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

A study testing Remote Problem Management Plus in people with Depression and Anxiety Disorders, run by The New School at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Remote Problem Management Plus
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteUnited States
Study dates
4 Mar 2021to 20 May 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • English-speaking
  • Help- or treatment-seeking
  • Access to a device for conducting sessions via Zoom (e.g., smartphone, tablet, laptop or personal computer)

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • The New School

    New York, New York, 10011

Other trials in United States

About this study

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

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.

Read the detailed description

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.

Being tested
Remote Problem Management Plus
Medical subject headings
Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Remote Problem Management PlusBehavioural

    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

Study groups in NCT04617262
Study groupRoleWhat they receive
Remote Problem Management PlusExperimentalFive individual sessions of low-intensity psychological intervention
Receives: Behavioral: Remote Problem Management Plus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 1 week post-intervention

  2. 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

    Measured: 1 week post-intervention

  3. 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

    Measured: 1 week post-intervention

Secondary outcomes (5)
  1. 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

    Measured: 1 week post-intervention

  2. 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

    Measured: 1 week post-intervention

  3. 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

    Measured: 1 week post-intervention

  4. 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

    Measured: 1 week post-intervention

  5. 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

    Measured: 1 week post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2020
  2. Study start4 Mar 2021
  3. Primary completion20 Feb 2023
  4. Study completion20 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04617262
Sponsor's protocol ID
2020-91-PM+
Acronym
PM+
Status last verified
May 2024
First submitted
2 Nov 2020
Last updated
22 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data will be available through National Institute of Mental Health Data Archive after publication of primary results.

Publications

  • Bryant RA, Schafer A, Dawson KS, Anjuri D, Mulili C, Ndogoni L, Koyiet P, Sijbrandij M, Ulate J, Harper Shehadeh M, Hadzi-Pavlovic D, van Ommeren M. Effectiveness of a brief behavioural intervention on psychological distress among women with a history of gender-based violence in urban Kenya: A randomised clinical trial. PLoS Med. 2017 Aug 15;14(8):e1002371. doi: 10.1371/journal.pmed.1002371. eCollection 2017 Aug.

    PubMed 28809935
  • Dawson KS, Schafer A, Anjuri D, Ndogoni L, Musyoki C, Sijbrandij M, van Ommeren M, Bryant RA. Feasibility trial of a scalable psychological intervention for women affected by urban adversity and gender-based violence in Nairobi. BMC Psychiatry. 2016 Nov 18;16(1):410. doi: 10.1186/s12888-016-1117-x.

    PubMed 27863515
  • Rahman A, Riaz N, Dawson KS, Usman Hamdani S, Chiumento A, Sijbrandij M, Minhas F, Bryant RA, Saeed K, van Ommeren M, Farooq S. Problem Management Plus (PM+): pilot trial of a WHO transdiagnostic psychological intervention in conflict-affected Pakistan. World Psychiatry. 2016 Jun;15(2):182-3. doi: 10.1002/wps.20312. No abstract available.

    PubMed 27265713
  • Dawson KS, Bryant RA, Harper M, Kuowei Tay A, Rahman A, Schafer A, van Ommeren M. Problem Management Plus (PM+): a WHO transdiagnostic psychological intervention for common mental health problems. World Psychiatry. 2015 Oct;14(3):354-7. doi: 10.1002/wps.20255. No abstract available.

    PubMed 26407793

Questions about this trial

What is this clinical trial studying?

A study testing Remote Problem Management Plus in people with Depression and Anxiety Disorders, run by The New School at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Psychological Outcomes Profile; Unabbreviated scale title "Psychological Outcomes Profile" (time frame: 1 week post-intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04617262, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024.

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