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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe New School

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adults of 18 years or above

English-speaking

A score of <91 on Global Assessment of Functioning

Located in the Bahamas

Disqualifiers

● 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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Booster Session ArmExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

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).

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

Secondary outcomes

1

PHQ-9

Patient Health Questionnaire (PHQ-9) (Kroenke et al., 1999) is a nine-item tool which measures depression severity. Responses are reported on a four-point Likert scale (from 0-3 with 0 indicating "not at all" and 3 indicating "extremely so"). Scoring is done by taking the sum of all nine items to produce a final score. Depression scores range from minimal (0-4), mild (5-9), moderate (10-18), moderately severe (19-26), to severe (≥27). While the PHQ-9 was designed as a diagnostic tool (Keoenke et al., 1999), it is frequently used to assess depression outcomes in studies of task-sharing interventions including PM+ (e.g., Rahman et al., 2016; Khan et al., 2019; Jordans et al., 2021; Nyongesa et al, 2022; Marchetti et al., 2024).

Time frame
At enrollment, again at week 5, again at week 18, and finally at week 30
2

GAD-7

Generalized Anxiety Disorder Assessment (GAD-7) (Spitzer et al., 2006) is a seven-item tool designed to assess the severity of anxiety symptoms. Similar to the PHQ-9, responses are reported on a four-point Likert scale from 0-3 (with 0 indicating "not at all" and 3 indicating "nearly every day"). Responses are summed to produce a total final score. Scores indicate the severity of anxiety symptoms and range from minimal(0-4), mild (5-9), moderate (10-14), to severe (≥15). The GAD-7 is also commonly used to evaluate anxiety symptoms in studies of PM+ (Nyongesa et al., 2022; Luzano et al., 2023; Marchetti et al., 2024), despite being originally developed as a diagnostic tool (Spitzer et al., 2006)

Time frame
At enrollment, again at week 5, again at week 18, and finally at week 30
3

PSYCHLOPS

Psychological Outcomes Profile (PSYCHLOPS) (Ashworth et al., 2005) measures personally identified problems and stressors. The measure is administered as an interview and consists of four questions across three domains (problems, functioning, and wellbeing). Participants are asked to identify two problems, and one area of functioning in free-form text format. A six-point Likert scale (0-5) assesses how much the respondent has been affected by each. Respondents identify the problems and area of functioning at pre-intervention and are asked to assess each item during every session of PM+. In the proposed study, participants in the intervention arm will complete the PSYCHLOPS during the booster session as well. Scores are totalled and range from 0-20 with greater scores indicating greater distress related to personally identified problems.

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

PCL-5

PTSD Checklist for DSM-5 (PCL-5) (Weathers et al., 2013) is a 20-item checklist used to measure symptoms of PTSD based on the diagnostic criteria of the DSM-5. Each item is rated on a 5-point Likert scale (0-4, with 0 indicating "not at all" and 4 indicating "extremely"). Scores are summed and total scores range from 0-80 with higher scores indicating greater PTSD symptom severity. Following previous PM+ studies, the measure will be adapted to ask about symptoms in the past week rather than the past month to ensure sensitivity to detect changes at three- and six-month follow-ups.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.