Developing a Booster Session for Problem Management Plus in the Bahamas: A Pilot Randomized Controlled Trial

NCT07208851 | Recruiting

• 1 other identifier: 24-352-1244
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Therapists at the Grand Bahama Resilience Center (GBRC) will be trained to deliver Problem Management Plus (PM+), a WHO intervention. Then, those therapists will deliver PM+ (5 one-on-one skills-based sessions) to a total of 50 adult clients experiencing mild to moderate mental health difficulties (excluding anyone with cognitive difficulties or psychosis). Participants will complete (de-identified) self-report survey assessments before PM+, after PM+, 3 months later, and 6 months later. After receiving 5 sessions of PM+, participants will be randomized to either receive a one-time booster session of PM+ (to be co-created by the PI and the GBRC providers) three months later or to a control group which will receive a phone call reminding them that they will receive their third assessment soon.

Conditions

Depression Symptoms; Anxiety Symptoms

Keywords

PM+; Task-sharing interventions; Scalable mental health; Global mental health; Bahamian Mental Health; Hurricane; Climate Change

Outcome Measures

Primary Outcomes (1)

• Hospital Anxiety and Depression Scale

  Hospital Anxiety and Depression Scale (HADS) (Zigmond \& Snaith, 1983) is a 14-item scale, which consists of two subscales of seven items each. One subscale measures symptoms of anxiety (HADS-A) and the other measures symptoms of depression (HADS-D). Responses are reported a four-point Likert scale, from 0-3, which pertain to different levels of symptom severity, depending on the question. Responses are summed to produce a total score, where higher scores indicate greater levels of anxiety and depression. Subscale scores may also be totaled to separate depression and anxiety symptoms. This scale has been used widely throughout the world and across many cultures, including in the US and in South America (Herrmann, 1997).

  From enrollment, again at week5, again at week 18 and finally at week 30

Secondary Outcomes (8)

• PHQ-9

  At enrollment, again at week 5, again at week 18, and finally at week 30

• GAD-7

  At enrollment, again at week 5, again at week 18, and finally at week 30

• PSYCHLOPS

  At enrollment, at week 1, 2, 3, 4, and 18

• PCL-5

  At enrollment, again at week 5, again at week 18, and finally at week 30

• WHODAS-2.0

  At enrollment, again at week 5, again at week 18, and finally at week 30

Study Arms (2)

Booster Session Arm

EXPERIMENTAL

This group will receive a one-time PM+ booster session three months after finishing the PM+ program

Behavioral: Problem Management Plus booster session

Control

NO INTERVENTION

This group will receive the full PM+ program but no booster session or meeting thereafter.

Interventions

Problem Management Plus booster session BEHAVIORAL

A 60-minute session designed to refresh participants on the PM+ strategies (diaphragmatic breathing, problem management, behavioral activation, strengthening social support). Session consists of practicing strategies and developing plans for the future.

Booster Session Arm

Eligibility Criteria

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

You may qualify if:

• Adults of 18 years or above
• English-speaking
• A score of \<91 on Global Assessment of Functioning
• Located in the Bahamas

You may not qualify if:

• ● Imminent suicide risk (assessed at screening using Columbia Suicide-Severity Rating Scale, see document titled " Screener updated 10-30- 24")
• Severe mental disorder (e.g. psychotic disorders)
• Severe cognitive impairment (e.g. severe intellectual disability or dementia)

Sponsors & Collaborators

• The New School: lead

Study Sites (1)

Grand Bahama Resilience Center

Freeport, Grand Bahama, The Bahamas

RECRUITING

Related Publications (3)

• Rahman A, Hamdani SU, Awan NR, Bryant RA, Dawson KS, Khan MF, Azeemi MM, Akhtar P, Nazir H, Chiumento A, Sijbrandij M, Wang D, Farooq S, van Ommeren M. Effect of a Multicomponent Behavioral Intervention in Adults Impaired by Psychological Distress in a Conflict-Affected Area of Pakistan: A Randomized Clinical Trial. JAMA. 2016 Dec 27;316(24):2609-2617. doi: 10.1001/jama.2016.17165.

  PMID: 27837602 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

• 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

Related Links

• Link to PM+ Manual

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Adam Brown D Brown, PhD

  The New School

  STUDY CHAIR

Central Study Contacts

Caroline McEneaney L McEneaney, JD, MA

CONTACT

12039521482; mcenc047@newschool.edu

Adam Brown D Brown, PhD

CONTACT

646-831-8657; brownad@newschool.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Because the intervention and control groups involve receiving or not receiving a booster session, neither participants nor providers can be blinded. Because the administration and data collection is being completed by the PI, who is also responsible for study administration, the PI cannot be blinded. Instead, randomization occurs after delivery of PM+ to avoid bias in PM+ delivery, and contact between the study administrator is limited to emailing questionnaires (with standardized language that does not differ between groups).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate, Clinical Psychology

Model Details: Each participant will receive the full PM+ program (5 individual sessions), completers of the PM+ program will be randomized to receive a one-time booster session three months post-PM+, or to the control group, which will not receive the booster session. Both groups will be assessed at 3 months post-PM+ and 6 months post PM+ (the endline).

Study Record Dates

• First Submitted: September 27, 2025
• First Posted: October 6, 2025
• Study Start: October 16, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: January 6, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)