CClinicalTrials.gg
WithdrawnNCT07500142Updated Mar 30, 2026

Evaluation of the Group Problem Management Plus (Group PM+) Pilot Study in Oromia and Amhara Regional States, Ethiopia

An interventional study of group Problem Management Plus and Cash in Mental Health Issue, sponsored by International Food Policy Research Institute. Withdrawn at 1 site in Ethiopia. Open to participants aged 18 Years to 59 Years. Per ClinicalTrials.gov, last updated 2026-03-30.

Sponsored by International Food Policy Research Institute · Not applicable, Interventional, and Other

Why this study was withdrawn
was registered on another registry
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 59 Years
Sex
All
01

Study summary

Mental health disorders are among the leading causes of the global health-related burden. Mental health disorders are exacerbated by poverty and exposure to adversity like conflict and adverse shocks. Despite the high prevalence, adequate care for mental illness is mainly inaccessible in low- and middle-income countries. Given the bidirectional link between poverty and mental health and the limited mental health treatment in many low income settings, combining antipoverty interventions with psychotherapy delivered by non-specialists may be promising. Using a randomized control trial design, this study will compare the impact of a psychotherapy program, group Problem Management plus, with and without a one-time lump sum cash transfer on mental health, daily activities, and economic outcomes among Productive Safety Net Program clients in the regions of Amhara and Oromia.

02

Conditions studied

  • Mental Health Issue
03

Who can participate

Ages eligible
18 Years to 59 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • have signs and symptoms of depression or dysfunction as measured by the PHQ-9 and WHODAS 2;
  • be between 18 and 59 years old,
  • be the main decision-maker or spouse of the main decisionmaker.

Exclusion criteria

Exclusion Criteria:

  • individuals with signs of severe depression or suicide
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • No intervention
    Control

    Does not receive any intervention

  • Experimental
    gPM+

    Receives gPM+ therapy sessions

    Other: group Problem Management Plus

  • Experimental
    Cash

    Receives cash transfer

    Other: Cash

  • Experimental
    gPM+ and Cash

    Receives gPM+ and cash

    Other: group Problem Management Plus · Other: Cash

Interventions

  • Othergroup Problem Management Plus

    Problem Management Plus (PM+) is an intervention developed by WHO in 2013 to address common mental health problems such as depression, stress, and anxiety. It involves problem management (PM) plus (+) selected behavioral strategies to address both psychological issues (e.g., stress, fear, feelings of helplessness) and practical problems (e.g., livelihood problems, conflict in the family) (World Health Organization 2016). It was conceived initially as individual counselling composed of 5 sessions. In villages randomized to the gPM+ treatment, same-sex therapy groups of 3 to 8 individuals will be formed and facilitated by Community Health Facilitators (CHF) for women and Men's Group Facilitators (MGF) for men.

  • OtherCash

    Eligible households in villages randomized to the Cash treatment will also receive a one-time lump sum transfer worth the equivalent value in Birr of $300 USD. While the transfer is unconditional, it will be presented as a 'livelihoods transfer' to support income-generating activities that improve livelihoods.

05

What researchers measure

Primary outcomes

  1. Mental health index

    Mental health index will be composed of 5 mental health indicators listed below. To create the aggregate index, we standardize each indicator using the control mean and standard deviation. The aggregate indices are then simply the equally weighted average of the individual z-scores (Kling et al. 2007). The 5 indicators are: * PHQ-9 - total score from 9 questions, standardized unit using control mean and SD * Perceived stress scale - total score from 10 questions, standardized using control mean and SD * Post-traumatic stress, PCL-C - total score from 6 questions, standardized using control mean and SD * General Anxiety Disorder 7 - total score from 7 questions, standardized using control mean and SD * WHO Disability Assessment Schedule 2.0 - total score from 12 questions, standardized using control mean and SD As a robustness, we will also assess individual indicators that make up the summary index.

    Time frame: We will collect data on indicators above immediately after the gPM+ sessions end (Oct 2022) and 12 months later (Oct 2023). We will assess outcomes at both time periods to see if impacts are sustained.

  2. Economic index

    Economic index will be composed of 4 indicators listed below. To create the aggregate index, we standardize each indicator using the control mean and standard deviation. The aggregate indices are then simply the equally weighted average of the individual z-scores (Kling et al. 2007). The 4 indicators are: * The total value of productive assets- total value transformed using inverse-hyperbolic sine (IHS), then standardized using control mean and SD * Total value of monthly per capita expenditures - total value of food and non-food consumption transformed using HIS, then standardized using control mean and SD * Food insecurity experience scale- total score recoded so higher values indicates more food secure, then standardized unit using control mean and SD * Savings- binary indicator that equals one if money was deposited in savings account, standardized unit using control mean and SD As a robustness, we will also assess individual indicators that make up the summary index

    Time frame: 12 months after the gPM+ sessions end

  3. Time use

    Time use index will be composed of 3 indicators listed below. To create the aggregate index, we standardize each indicator using the control mean and standard deviation. The aggregate indices are then simply the equally weighted average of the individual z-scores (Kling et al. 2007). The 3 indicators that will be used to construct the aggregate time use index are: * Non-economic activities: total hours spent in non-economic activities in the last 24 hours, converted to standardized unit using control mean and SD * Income generating activities: total hours spent in income generating activities in the last week, converted to standardized unit using control mean and SD * Other activities: summation of number of other activities participated, converted to standardized unit using control mean and SD As a robustness, we will also assess individual indicators that make up the summary index.

    Time frame: We will collect data on indicators above immediately after the gPM+ sessions end (Oct 2022) and 12 months later (Oct 2023). We will assess outcomes at both time periods to see if impacts are sustained.

  4. Childcare

    Childcare index will be composed of 3 indicators listed below. To create the aggregate index, we standardize each indicator using the control mean and standard deviation. The aggregate indices are then simply the equally weighted average of the individual z-scores (Kling et al. 2007). The 3 indicators that will be used to construct the aggregate childcare index are: * Childcare - total number of activities, converted to standardized unit using control mean and SD * Child discipline: total score transformed so that higher values equal more favorable outcomes. Total score is then converted to standardized unit using control mean and SD. * Child neglect : total score transformed so that higher values equal more favorable outcomes. Then total score is converted to standardized unit using control mean and SD. As a robustness, we will also assess individual indicators that make up the summary index.

    Time frame: We will collect data on indicators above immediately after the gPM+ sessions end (Oct 2022) and 12 months later (Oct 2023). We will assess outcomes at both time periods to see if impacts are sustained.

Secondary outcomes

  1. Khat consumption

    Number of khat bundles consumed in a typical day

    Time frame: Immediately after gPM+ session ends and 12 months later

  2. Tension reduction checklist

    9-item checklist with response from 0 (not at all) to 4 (all the time). Scores for each item will be summed leading to a total score that ranges from 0-36, with higher values indicating better outcomes.

    Time frame: Immediately after gPM+ session ends and 12 months later

  3. Brief Cope (shortened to 6 items)

    Coping Orientation to Problems Experienced Inventory (Brief -cope). We will recode questions so that higher values represent better coping strategy. We will then take the total score from the 6 questions. Scores will range from 6-24.

    Time frame: Immediately after gPM+ session ends and 12 months later

  4. Multi-dimensional Scale of Perceived Social Support

    The Multidimensional Scale of Perceived Social Support (Zimet et al., 1988) is a 12-item measure of perceived adequacy of social support from three sources: family, friends, \& significant other; using a 5-point Likert scale (0 = strongly disagree, 5 = strongly agree). Scores will be summed across the 12 items, and thus range from 0-60, with higher scores indicating better social support

    Time frame: Immediately after gPM+ session ends and 12 months later

  5. New general self-efficacy

    New General Self-Efficacy Scale is an 8-item measure that assesses how much people believe they can achieve their goals, despite difficulties. Using a 5-point rating scale (1= strongly disagree; 3 = neither agree nor disagree; 5 = strongly agree), respondents show how much they agree with eight statements, such as "Even when things are tough, I can perform quite well." We will then calculate a total score by summing the response of each item. Scores will then range from 8-40, with higher scores indicating more self efficacy.

    Time frame: Immediately after gPM+ session ends and 12 months later

  6. Time and risk preference

    From Global preference survey

    Time frame: Immediately after gPM+ session ends and 12 months later

  7. Value of Investments in last 12 months

    Total value of investments will be assessed through a questionnaire that asks respondents how much they invested in livestock, farming, and non-agriculture activities in the last 12 months. Responses will be totaled across activities.

    Time frame: 12 months after gPM+ ended

  8. Intimate Partner Violence (IPV)

    WHO violence against women instrument. Using this instrument we will create 3 binary indicators: No Emotional IPV: Binary variable =1 if respondent does not report any emotional violence from partner in the last 12 months No Physical IPV: Binary variable =1 if respondent does not report any physical violence from partner in the last 12 months No Sexual IPV: Binary variable =1 if respondent does not report any sexual violence from partner in the last 12 months

    Time frame: 12 months after gPM+ ends

  9. Alcohol use (3 item)

    The Alcohol Use Disorders Identification Test- we asked 3 items from the alcohol use disorders test. We will take the total score that sums up the responses from the 3 items. Total score will range from 0-12, with higher values indicating more alcohol use.

    Time frame: Immediately after gPM+ session ends and 12 months later

06

Study locations

1 site
  • Rural communities
    Addis Ababa, Ethiopia
07

References and documents

Study documents

  • Protocol and statistical analysis plan · Oct 10, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT07500142
Lead sponsor
International Food Policy Research Institute
Collaborators
World Vision, Laterite
Responsible party
Sponsor
First posted
Mar 30, 2026
Start date
Jun 23, 2022
Primary completion
Jan 30, 2024
Completion
Jan 30, 2024
Last update
Mar 30, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion