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

NCT07500142 | Withdrawn

• 1 other identifier: InternationalIFPRI
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Health Issue

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (9)

• Khat consumption

  Immediately after gPM+ session ends and 12 months later

• Tension reduction checklist

  Immediately after gPM+ session ends and 12 months later

• Brief Cope (shortened to 6 items)

  Immediately after gPM+ session ends and 12 months later

• Multi-dimensional Scale of Perceived Social Support

  Immediately after gPM+ session ends and 12 months later

• New general self-efficacy

  Immediately after gPM+ session ends and 12 months later

Study Arms (4)

Control

NO INTERVENTION

Does not receive any intervention

gPM+

EXPERIMENTAL

Receives gPM+ therapy sessions

Other: group Problem Management Plus

Cash

EXPERIMENTAL

Receives cash transfer

Other: Cash

gPM+ and Cash

EXPERIMENTAL

Receives gPM+ and cash

Other: group Problem Management Plus; Other: Cash

Interventions

group Problem Management Plus OTHER

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.

gPM+; gPM+ and Cash

Cash OTHER

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.

Cash; gPM+ and Cash

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• individuals with signs of severe depression or suicide

Sponsors & Collaborators

• International Food Policy Research Institute: lead
• World Vision, Laterite: collaborator

Study Sites (1)

Rural communities

Addis Ababa, Ethiopia

Location

MeSH Terms

Interventions

CASP8 and FADD-Like Apoptosis Regulating Protein

Intervention Hierarchy (Ancestors)

Death Domain Receptor Signaling Adaptor Proteins; Adaptor Proteins, Signal Transducing; Intracellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Tumor Necrosis Factor Receptor-Associated Peptides and Proteins; Apoptosis Regulatory Proteins; Carrier Proteins; Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: March 30, 2026
• Study Start: June 23, 2022
• Primary Completion: January 30, 2024
• Study Completion: January 30, 2024
• Last Updated: March 30, 2026

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

ET (1)