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

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.

Study Overview

• Status: Withdrawn
• Conditions: Mental Health Issue
• Intervention / Treatment: Other: group Problem Management Plus; Other: Cash

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ethiopia
  • Addis Ababa, Ethiopia
    • Rural communities

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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:

• individuals with signs of severe depression or suicide

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Does not receive any intervention
Experimental: gPM+; Receives gPM+ therapy sessions	Other: group 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.
Experimental: Cash; Receives cash transfer	Other: Cash; 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.
Experimental: gPM+ and Cash; Receives gPM+ and cash	Other: group 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.; Other: Cash; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.
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	12 months after the gPM+ sessions end
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.	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.
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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Khat consumption	Number of khat bundles consumed in a typical day	Immediately after gPM+ session ends and 12 months later
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.	Immediately after gPM+ session ends and 12 months later
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.	Immediately after gPM+ session ends and 12 months later
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	Immediately after gPM+ session ends and 12 months later
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.	Immediately after gPM+ session ends and 12 months later
Time and risk preference	From Global preference survey	Immediately after gPM+ session ends and 12 months later
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.	12 months after gPM+ ended
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	12 months after gPM+ ends
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.	Immediately after gPM+ session ends and 12 months later

Collaborators and Investigators

• Sponsor: International Food Policy Research Institute
• Collaborators: World Vision, Laterite

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2022
• Primary Completion (Actual): January 30, 2024
• Study Completion (Actual): January 30, 2024

Study Registration Dates

• First Submitted: October 14, 2022
• First Submitted That Met QC Criteria: March 25, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Peptides; Amino Acids, Peptides, and Proteins; Proteins; Intracellular Signaling Peptides and Proteins; Apoptosis Regulatory Proteins; Carrier Proteins; Death Domain Receptor Signaling Adaptor Proteins; Adaptor Proteins, Signal Transducing; Tumor Necrosis Factor Receptor-Associated Peptides and Proteins; CASP8 and FADD-Like Apoptosis Regulating Protein
• Other Study ID Numbers: InternationalIFPRI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No