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

Last registered on October 17, 2022

Pre-Trial

Trial Information

General Information

Title
Evaluation of the Group Problem Management Plus (Group PM+) pilot study in Oromia and Amhara Regional States, Ethiopia
RCT ID
AEARCTR-0010201
Initial registration date
October 11, 2022

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
October 17, 2022, 5:18 PM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

Primary Investigator

Affiliation
IFPRI

Other Primary Investigator(s)

PI Affiliation
IFPRI
PI Affiliation
IFPRI
PI Affiliation
IFPRI
PI Affiliation
Addis Ababa University
PI Affiliation
World Vision

Additional Trial Information

Status
On going
Start date
2022-05-02
End date
2023-12-31
Secondary IDs
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
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.
External Link(s)

Registration Citation

Citation
Alderman, Harold et al. 2022. "Evaluation of the Group Problem Management Plus (Group PM+) pilot study in Oromia and Amhara Regional States, Ethiopia." AEA RCT Registry. October 17. https://doi.org/10.1257/rct.10201-1.0
Experimental Details

Interventions

Intervention(s)
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.

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.
Intervention Start Date
2022-08-01
Intervention End Date
2022-12-23

Primary Outcomes

Primary Outcomes (end points)
Mental health:
- PHQ-9 – a measure of depressive symptoms – total score from 9 questions converted to standardized unit using control mean and SD
- Perceived stress scale (PSS-10) – total score from 10 questions converted to standardized unit using control mean and SD
- Post-traumatic stress, PCL-C – total score from 6 questions converted to standardized unit using control mean and SD
- General Anxiety Disorder 7 (GAD-7-) – total score from 7 questions converted to standardized unit using control mean and SD
- WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) – total score from 12 questions converted to standardized unit using control mean and SD
Economic:
- The total value of productive assets- total value transformed using inverse-hyperbolic sine transformation and then standardized using control mean and SD (1-year post endline only)
- Total value of monthly per capita expenditures – total value of food and non-food consumption transformed using inverse-hyperbolic sine transformation and then standardized using control mean and SD (1-year post endline only)
- Food insecurity experience scale- total score converted to standardized unit using control mean and SD (1-year post endline only)
- Savings- binary indicator that equals one if individual deposited any money in the last 12 months in any type of savings account, converted to standardized unit using control mean and SD (1-year post endline only)
Time use and childcare:
- 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
- Childcare – total number of activities, converted to standardized unit using control mean and SD
- Child discipline: total score, converted to standardized unit using control mean and SD
- Child neglect : total score, converted to standardized unit using control mean and SD
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
Alcohol and Khat consumption
Tension reduction checklist
Brief Cope (shortened to 6 items) – instrument to measure coping with stressful life events
Multi-dimensional Scale of Perceived Social Support (MSPSS)
General self-efficacy
Time preference (Global preference survey)
Risk preference (Global preference survey)
Value of Investments in last 12 months
Intimate Partner Violence (WHO violence against women instrument)
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
The impact of gPM+ will be assessed through a two-stage cluster randomized control trial (cRCT) design. In the first stage, 70 kebeles will be randomized to receive cash or no cash. Randomization of the cash treatment is at the kebele level in order to reduce the risk of spillovers, contamination, and resentment. Randomization of kebeles will be stratified by woreda. In the second stage, within each kebele, up to 6 villages will then be randomized to receive either gPM+ or not receive it , leading to the following four intervention arms across 252 villages:
• Arm-1: control
• Arm-2: gPM+ only
• Arm-3: lump-sum cash transfer only
• Arm-4: lump-sum cash transfer and gPM+.
Study participants in all intervention arms will receive information on locally available mental health services and be PSNP public works clients. Arm 2 will additionally provide study participants with the gPM+ therapy, Arm 3 will additionally provide a one-time lump sum cash transfer, and Arm 4 will provide both the gPM+ and cash transfer.

The evaluation will include a baseline survey conducted before implementing the gPM+ or cash transfer intervention (July-August 2022). The endline survey will be conducted on the same individuals right after the gPM+ intervention but before the cash is rolled out (September-October 2022). A one-year post-intervention survey will be conducted approximately one year after the end-line, approximately one year after the gPM+ sessions and 9 months after the cash transfer (September-October 2023).
Experimental Design Details
Randomization Method
Randomization was conducted in STATA by the research team using the randtreat command. First, 70 kebeles were stratified by woreda, and randomized to either the Cash or No-Cash treatment. Second, 252 villages were stratified by kebele and randomized to either receive or not receive the gPM+ intervention. At each stage, misfits were randomly assigned within each strata, leading to slightly unequal number of villages per treatment arm.
Randomization Unit
1st stage randomization: Kebele
2nd stage randomization: Villages
Was the treatment clustered?
Yes

Experiment Characteristics

Sample size: planned number of clusters
70 kebeles
252 villages
Sample size: planned number of observations
3024 individuals
Sample size (or number of clusters) by treatment arms
35 cash kebeles and 35 non-cash kebeles
63 villages in control, 63 villages in gPM+, 63 villages in cash, 63 villages in gPM+ and cash
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
0.22 standard deviations for PHQ-9 score 0.25 standard deviations for value of productive assets
IRB

Institutional Review Boards (IRBs)

IRB Name
IFPRI IRB
IRB Approval Date
2022-06-12
IRB Approval Number
PHND-22-0631
IRB Name
Ethiopian Public Health Association
IRB Approval Date
2022-06-27
IRB Approval Number
EPHA/OG/875/22
Analysis Plan

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Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials