Mental Health IssueNCT07500142
Evaluation of the Group Problem Management Plus (Group PM+) Pilot Study in Oromia and Amhara Regional States, Ethiopia
A study testing group Problem Management Plus and Cash in people with Mental Health Issue, run by International Food Policy Research Institute at 1 site in Ethiopia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Mental Health Issue
- What is being tested?
- group Problem Management Plus and Cash
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteEthiopia
- Study dates
- 23 Jun 2022to 30 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- individuals with signs of severe depression or suicide
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- group Problem Management Plus, Cash
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
group Problem Management PlusOther
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.
CashOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Does not receive any intervention |
| gPM+ | Experimental | Receives gPM+ therapy sessions Receives: Other: group Problem Management Plus |
| Cash | Experimental | Receives cash transfer Receives: Other: Cash |
| gPM+ and Cash | Experimental | Receives gPM+ and cash Receives: Other: group Problem Management Plus; Other: Cash |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Number of khat bundles consumed in a typical day
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Immediately after gPM+ session ends and 12 months later
Time and risk preference
From Global preference survey
Measured: 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.
Measured: 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
Measured: 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.
Measured: Immediately after gPM+ session ends and 12 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start23 Jun 2022
- Primary completion30 Jan 2024
- Study completion30 Jan 2024
Why it stopped: was registered on another registry
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Food Policy Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- World Vision, Laterite
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07500142
- Sponsor's protocol ID
- InternationalIFPRI
- Status last verified
- Oct 2022
- First submitted
- 14 Oct 2022
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Group Problem Management Plus (Group PM+) Pilot Study in Oromia and Amhara Regional States, Ethiopia
- ClinicalTrials.gov ID
- NCT07500142
- Acronym / sponsor ID
- InternationalIFPRI
- Conditions
- Mental Health Issue
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: was registered on another registry
- Enrolment
- 0 participants (actual)
- Lead sponsor
- International Food Policy Research InstituteUniversity, hospital or other
- Collaborators
- World Vision, Laterite
- Study start
- 23 Jun 2022 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Does not receive any intervention |
| gPM+ | Experimental | Other: group Problem Management PlusReceives gPM+ therapy sessions |
| Cash | Experimental | Other: CashReceives cash transfer |
| gPM+ and Cash | Experimental | Other: group Problem Management Plus, Other: CashReceives gPM+ and cash |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- individuals with signs of severe depression or suicide
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| group Problem Management PlusProblem 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 | gPM+, gPM+ and Cash |
| CashEligible 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. | Other | Cash, gPM+ and Cash |
Primary outcome
Mental health 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.
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 index
Time frame: 12 months after the gPM+ sessions end
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 use
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.
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.
Childcare
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.
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.
9 secondary outcomes
Khat consumption
Time frame: Immediately after gPM+ session ends and 12 months later
Tension reduction checklist
Time frame: Immediately after gPM+ session ends and 12 months later
Brief Cope (shortened to 6 items)
Time frame: Immediately after gPM+ session ends and 12 months later
Multi-dimensional Scale of Perceived Social Support
Time frame: Immediately after gPM+ session ends and 12 months later
New general self-efficacy
Time frame: Immediately after gPM+ session ends and 12 months later
Time and risk preference
Time frame: Immediately after gPM+ session ends and 12 months later
Value of Investments in last 12 months
Time frame: 12 months after gPM+ ended
Intimate Partner Violence (IPV)
Time frame: 12 months after gPM+ ends
Alcohol use (3 item)
Time frame: Immediately after gPM+ session ends and 12 months later
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing group Problem Management Plus and Cash in people with Mental Health Issue, run by International Food Policy Research Institute at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental health 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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.