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

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

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07500142
Enrollment
0
Registered
2026-03-30
Start date
2022-06-23
Completion date
2024-01-30
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental Health Issue

Brief 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.

Interventions

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.

Sponsors

International Food Policy Research Institute
Lead SponsorOTHER
World Vision, Laterite
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 59 Years
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

* individuals with signs of severe depression or suicide

Design outcomes

Primary

MeasureTime frameDescription
Mental health indexWe 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.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.
Economic index12 months after the gPM+ sessions endEconomic 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 useWe 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.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.
ChildcareWe 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 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.

Secondary

MeasureTime frameDescription
Khat consumptionImmediately after gPM+ session ends and 12 months laterNumber of khat bundles consumed in a typical day
Tension reduction checklistImmediately after gPM+ session ends and 12 months later9-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.
Brief Cope (shortened to 6 items)Immediately after gPM+ session ends and 12 months laterCoping 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.
Multi-dimensional Scale of Perceived Social SupportImmediately after gPM+ session ends and 12 months laterThe 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
New general self-efficacyImmediately after gPM+ session ends and 12 months laterNew 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 and risk preferenceImmediately after gPM+ session ends and 12 months laterFrom Global preference survey
Value of Investments in last 12 months12 months after gPM+ endedTotal 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.
Intimate Partner Violence (IPV)12 months after gPM+ endsWHO 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
Alcohol use (3 item)Immediately after gPM+ session ends and 12 months laterThe 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.

Countries

Ethiopia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026