Depressive SymptomsPM+FMNCT05627206
The Impact of PM+For Moms Intervention on Improving Mother's Mental Health in Zambia (PM+FM)
A study testing Problem Management + For Moms in people with Depressive Symptoms and Anxiety, run by Swiss Tropical & Public Health Institute at 1 site in Zambia.
Trial summary
CMHD are particularly prevalent among women, posing a major threat to their own and their children's wellbeing. Despite the high prevalence of CMHD and the existence of effective treatments, interventions supporting women living in low-resourced settings remain limited. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Depressive Symptoms, Anxiety, Trauma, Psychological
- What is being tested?
- Problem Management + For Moms
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteZambia
- Study dates
- 15 Nov 2022to 1 Dec 2023
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women participating in ZamCharts parent study
- SRQ-20 >7 (clinically significant symptoms of depression or/anxiety),
- not planning to move within the next 6 months,
- with capacity to consent
- not receiving current mental health care.
Who cannot join
- Women with active suicidal ideation (determined by Paykel=4 OR 5),
- severe substance use (ACOK-SUD >4),
- mania or psychotic symptoms
Trial locations and contacts
1 site in 1 country.
About this study
CMHD are particularly prevalent among women, posing a major threat to their own and their children's wellbeing.
Despite the high prevalence of CMHD and the existence of effective treatments, interventions supporting women living in low-resourced settings remain limited.
This study builds on a parent study (Zamcharts NCT03991182), which identified a high prevalence of women with anxiety and/or depression. We propose to design, test, and validate a community-based intervention nested within the public primary health system in Zambia, to identify and treat women with mild-to-severe CMHDs.
- Conditions
- Depressive Symptoms, Anxiety, Trauma, Psychological
- Being tested
- Problem Management + For Moms
- Keywords
- women, low-resourced settings, psychosocial intervention
- Medical subject headings
- Depression, Anxiety Disorders, Psychological Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Problem Management + For MomsBehavioural
Psychosocial intervention conducted by a trained Wellbeing-Community health worker. Adapted from Problem Management +, thinking healthy and Strong Minds-Strong Communities intervention to target women with small children and mental health symptoms living in low-resourced settings. Combines several evidence-based strategies such us psychoeducational, motivational interviewing, cognitive restructuring and relaxation exercises. Organized in 10 weekly sessions (8 individual 2 in group) provided in-person, by phone or virtually.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Not described |
| Intervention | Experimental | Not described Receives: Behavioral: Problem Management + For Moms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mental health symptoms. SRQ-20
20 items measuring risk of common mental health problem.
Measured: Change between Baseline (at enrollment) and 6 months after enrollment
Feasibility of the study
% of 1 or more sessions completed. Qualitative feedback from participants and providers.
Measured: Assessed 4 months after enrollment
Acceptability
% of participants completing more than 6 sessions. Qualitative feedback from participants and providers.
Measured: Assessed 4 months after enrollment
Secondary outcomes (4)
Change in Mental health symptoms. PSYCHLOPS
Psychological Outcome Profiles (5 items)
Measured: Used for the pre-post treatment analysis. Change between Baseline (at enrollment) and 4 months after enrollment
Functionality
WHO-DAS2
Measured: Used for the pre-post treatment analysis. Change between Baseline (at enrollment) and 4 months after enrollment
World Bank's Toolkit and Inventory
Selected measures from the World Bank Toolkit to address mother-child interactions and child early development.
Measured: Used for the pre-post treatment analysis. Change between Baseline (at enrollment) and 4 months after enrollment
Change in Anxiety and Depression symptoms.
HSCL-25. 10 questions anxiety, 15 depression; (α = 0.90).
Measured: Used for the pre-post treatment analysis. Change between Baseline (at enrollment) and 4 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2022
- Study start15 Nov 2022
- Primary completion1 Oct 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Depressive SymptomsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Tropical & Public Health Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Innovations for Poverty Action
- Responsible party
- Principal investigator, Irene Falgas Bague, Swiss Tropical & Public Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05627206
- Sponsor's protocol ID
- PM+FMZam
- Acronym
- PM+FM
- Status last verified
- Apr 2024
- First submitted
- 7 Nov 2022
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fink G, Melero-Dominguez M, Chembe M, de Vernisy-Romero D, Tembo T, Billima T, Paul R, Alegria M, Parkerson D, Rockers PC, Banda Z, Lungu G, Sikazwe D, Falgas-Bague I. Feasibility and acceptability of the Problem Management for Moms programme for improving maternal mental health in Zambia: an open-label trial. Lancet Psychiatry. 2024 Dec;11(12):965-974. doi: 10.1016/S2215-0366(24)00256-6. Epub 2024 Nov 5.
PubMed 39515361Falgas-Bague I, Melero-Dominguez M, de Vernisy-Romero D, Tembo T, Chembe M, Lubozha T, Paul R, Parkerson D, Rockers PC, Sikazwe D, Fink G. Testing the feasibility, acceptability, and exploring trends on efficacy of the problem management plus for moms: Protocol of a pilot randomized control trial. PLoS One. 2024 Jan 5;19(1):e0287269. doi: 10.1371/journal.pone.0287269. eCollection 2024.
PubMed 38181004
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of PM+For Moms Intervention on Improving Mother's Mental Health in Zambia (PM+FM)
- ClinicalTrials.gov ID
- NCT05627206
- Acronym / sponsor ID
- PM+FM / PM+FMZam
- Conditions
- Depressive Symptoms, Anxiety, Trauma, Psychological
- Keywords
- women, low-resourced settings, psychosocial intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Swiss Tropical & Public Health InstituteUniversity, hospital or other
- Collaborators
- Innovations for Poverty Action
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 25 Nov 2022 (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.
CMHD are particularly prevalent among women, posing a major threat to their own and their children's wellbeing.
Despite the high prevalence of CMHD and the existence of effective treatments, interventions supporting women living in low-resourced settings remain limited.
This study builds on a parent study (Zamcharts NCT03991182), which identified a high prevalence of women with anxiety and/or depression. We propose to design, test, and validate a community-based intervention nested within the public primary health system in Zambia, to identify and treat women with mild-to-severe CMHDs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | – |
| Intervention | Experimental | Behavioral: Problem Management + For Moms |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women participating in ZamCharts parent study
- SRQ-20 >7 (clinically significant symptoms of depression or/anxiety),
- not planning to move within the next 6 months,
- with capacity to consent
- not receiving current mental health care.
Key exclusion criteria (3 listed)
- Women with active suicidal ideation (determined by Paykel=4 OR 5),
- severe substance use (ACOK-SUD >4),
- mania or psychotic symptoms
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 |
|---|---|---|
| Problem Management + For MomsPsychosocial intervention conducted by a trained Wellbeing-Community health worker. Adapted from Problem Management +, thinking healthy and Strong Minds-Strong Communities intervention to target women with small children and mental health symptoms living in low-resourced settings. Combines several evidence-based strategies such us psychoeducational, motivational interviewing, cognitive restructuring and relaxation exercises. Organized in 10 weekly sessions (8 individual 2 in group) provided in-person, by phone or virtually. | Behavioural | Intervention |
Primary outcome
Change in Mental health symptoms. SRQ-20
Time frame: Change between Baseline (at enrollment) and 6 months after enrollment
20 items measuring risk of common mental health problem.
Feasibility of the study
Time frame: Assessed 4 months after enrollment
% of 1 or more sessions completed. Qualitative feedback from participants and providers.
Acceptability
Time frame: Assessed 4 months after enrollment
% of participants completing more than 6 sessions. Qualitative feedback from participants and providers.
4 secondary outcomes
Change in Mental health symptoms. PSYCHLOPS
Time frame: Used for the pre-post treatment analysis. Change between Baseline (at enrollment) and 4 months after enrollment
Functionality
Time frame: Used for the pre-post treatment analysis. Change between Baseline (at enrollment) and 4 months after enrollment
World Bank's Toolkit and Inventory
Time frame: Used for the pre-post treatment analysis. Change between Baseline (at enrollment) and 4 months after enrollment
Change in Anxiety and Depression symptoms.
Time frame: Used for the pre-post treatment analysis. Change between Baseline (at enrollment) and 4 months after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Derived from this study: PubMed 39515361Fink G, Melero-Dominguez M, Chembe M, de Vernisy-Romero D, Tembo T, Billima T, Paul R, Alegria M, Parkerson D, Rockers PC, Banda Z, Lungu G, Sikazwe D, Falgas-Bague I. Feasibility and acceptability of the Problem Management for Moms programme for improving maternal mental health in Zambia: an open-label trial. Lancet Psychiatry. 2024 Dec;11(12):965-974. doi: 10.1016/S2215-0366(24)00256-6. Epub 2024 Nov 5.
- Derived from this study: PubMed 38181004Falgas-Bague I, Melero-Dominguez M, de Vernisy-Romero D, Tembo T, Chembe M, Lubozha T, Paul R, Parkerson D, Rockers PC, Sikazwe D, Fink G. Testing the feasibility, acceptability, and exploring trends on efficacy of the problem management plus for moms: Protocol of a pilot randomized control trial. PLoS One. 2024 Jan 5;19(1):e0287269. doi: 10.1371/journal.pone.0287269. eCollection 2024.
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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 Problem Management + For Moms in people with Depressive Symptoms and Anxiety, run by Swiss Tropical & Public Health Institute at 1 site in Zambia.
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 30 Apr 2024. 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 Zambia. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Mental health symptoms. SRQ-20 (time frame: Change between Baseline (at enrollment) and 6 months after enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05627206, which also lists 2 linked publications.
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 Apr 2024.