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

NCT04617262 | Completed DMC

• 1 other identifier: 2020-91-PM+
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Depression; Anxiety Disorders; Psychological Distress

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• World Health Organization Disability Assessment Scale 2.0; Unabbreviated scale title "World Health Organization Disability Assessment Scale 2.0"

  1 week post-intervention

• World Health Organization Quality of Life Questionnaire-BREF; Unabbreviated scale title "World Health Organization Quality of Life Questionnaire-BREF"

  1 week post-intervention

• EuroQoL 5-dimension 5-level; Unabbreviated scale title "EuroQoL 5-dimension 5-level"

  1 week post-intervention

• Pittsburgh Sleep Quality Index; Unabbreviated scale title "Pittsburgh Sleep Quality Index"

  1 week post-intervention

• Somatic Symptom Scale-8; Unabbreviated scale title "Somatic Symptom Scale-8"

  1 week post-intervention

Study Arms (1)

Remote Problem Management Plus

EXPERIMENTAL

Five individual sessions of low-intensity psychological intervention

Behavioral: Remote Problem Management Plus

Interventions

Remote Problem Management Plus BEHAVIORAL

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

Remote Problem Management Plus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The New School: lead
• George Washington University: collaborator

Study Sites (1)

The New School

New York, New York, 10011, United States

Location

Related Publications (4)

• 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.

  PMID: 28809935 BACKGROUND

• 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.

  PMID: 27863515 BACKGROUND

• 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.

  PMID: 27265713 BACKGROUND

• 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.

  PMID: 26407793 BACKGROUND

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Adam Brown, PhD

  The New School

  PRINCIPAL INVESTIGATOR

• Brandon Kohrt, MD, PhD

  George Washington University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 5, 2020
• Study Start: March 4, 2021
• Primary Completion: February 20, 2023
• Study Completion: May 20, 2023
• Last Updated: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Materials, de-identified patient data and results will be shared after publication of primary results, anticipated May 20, 2024.
• Access Criteria: Contact investigators.

Locations

US (1)