DepressionMEWE-EENCT05598697

Economic Evaluation of the MEWE Intervention

A study testing Life Skills Building (LSB) curriculum for males, Life Skills Building (LSB) curriculum for females and Cash transfer to adult females in people with Depression and Mental Health Issue, run by London School of Economics and Political Science at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 15 to 49 yearsHealthy volunteers can take part
Conditions the study is for: Depression, Mental Health Issue, Intimate Partner Violence
What is being tested?: Life Skills Building (LSB) curriculum for males, Life Skills Building (LSB) curriculum for females and Cash transfer to adult females
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,536 participants
Where: 1 sitePakistan
Study dates: 15 Sep 2021to 30 Nov 2022
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 15 to 49 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

In receipt of Benazir Income Support Program (BISP) cash transfers (CTs)
Parity: have at least one child, at least 18 months old

Who cannot join

Plan for the family to migrate out of the village within the next 2 years

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

Mirpur Sakro
Thatta, Sindh

Other trials in Pakistan

About this study

Official title: Economic Evaluation of the Men Engagement in Women Empowerment (MEWE) Intervention (MEWE-EE)

Cash transfers have shown promise in preventing intimate partner violence, and in reducing recipients' stress levels. Cash transfers with behavioral or psychological interventions have shown limited effectiveness at reducing stress in some African countries. Little is known of the cost-effectiveness of interventions delivered alongside cash transfer programs. The MEWE economic evaluation sub-study (MEWE-EE) runs alongside MEWE, a three-arm cluster-randomized controlled trial in Sindh, Pakistan. MEWE-EE will assess the costs and cost-effectiveness of delivering a cash-transfer program (BISP-CT) combined with a life-skills building curriculum (LSB curriculum), compared to the BISP-CT alone. The LSB curriculum is offered to either women who receive BISP-CT, or to women who receive BISP-CT and their husbands.

Conditions: Depression, Mental Health Issue, Intimate Partner Violence, Domestic Violence, Gender-based Violence, Rape Sexual Assault
Being tested: Life Skills Building (LSB) curriculum for males, Life Skills Building (LSB) curriculum for females, Cash transfer to adult females
Keywords: violence, abuse, coercion, assault, aggression, gender, women, girl, wife, partner, spouse, sexual, physical, psychological, economic
Medical subject headings: Depression, Aggression, Coitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Life Skills Building (LSB) curriculum for malesBehavioural
Also called MEWE males
The LSB curriculum offers ten weekly 90-minute sessions. Topics include effective communication, gender roles, power dynamics in the household; work-life balance and time management; conflict resolution; household decision making. The LSB teachers are trained in facilitation techniques to deliver the sessions.
All male study participants attending LSB curriculum classes are married to BISP-CT clients.
For men, the MEWE intervention provides access to the LSB curriculum only.
Life Skills Building (LSB) curriculum for femalesBehavioural
Also called MEWE females
The LSB curriculum offers ten weekly 90-minute sessions. Topics include effective communication, gender roles, power dynamics in the household; work-life balance and time management; conflict resolution; household decision making. The LSB teachers are trained in facilitation techniques to deliver the sessions.
All female study participants attending LSB curriculum classes are BISP-CT clients.
For females, the MEWE intervention comprises access to LSB curriculum + BISP CTs.
Cash transfer to adult femalesOther
Also called BISP-CT
The BISP intervention offers access to quarterly unconditional cash transfers to adult females.

Study groups in NCT05598697
Study group	Role	What they receive
Cash Transfers only	Active comparator	Participants allocated to this arm receive cash transfers. They are clients of a nation-wide cash transfer program. Receives: Other: Cash transfer to adult females
Cash Transfers + LSB curriculum for females clients only	Experimental	Participants allocated to this arm receive cash transfers and access to LSB curriculum training. Female cash transfer recipients attend 10 life-skills building sessions. Sessions are held weekly and are 90 minutes long. Two trained facilitators run the session for groups of 10 women over a ten-week period. Receives: Behavioral: Life Skills Building (LSB) curriculum for females; Other: Cash transfer to adult females
Cash Transfers + LSB curriculum for females clients and their husbands	Experimental	Participants allocated to this arm receive cash transfers and access to LSB curriculum training in gender-segregated groups. Men and women attend 10 life-skills building sessions in parallel. Sessions are held weekly and are 90 minutes long. Two trained facilitators, whose gender matches the participants', run the session for groups of 10 women or men over a ten-week period. Receives: Behavioral: Life Skills Building (LSB) curriculum for males; Behavioral: Life Skills Building (LSB) curriculum for females; Other: Cash transfer to adult females

What is being measured

The primary outcome is the main question the study is designed to answer.

Incremental cost incurred per disability adjusted life year (DALY) averted: provider perspective
Incremental cost per disability-adjusted life year (DALY) averted by the intervention compared to the control group from a provider perspective at 12 months from baseline. DALYs and costs will also be modelled up to a ten-year horizon using a Markov model.
Measured: 12 months post randomisation
Incremental cost incurred per disability adjusted life year (DALY) averted: societal perspective
Incremental cost per disability-adjusted life year (DALY) averted by the intervention compared to the control group from a societal perspective at 12 months from baseline. DALYs and costs will also be modelled up to a ten-year horizon using a Markov model.
Measured: 12 months post randomisation

Secondary outcomes (6)

Mean cost of intervention delivery
Cost of intervention delivery for different intervention models per patient, by category, annuitised
Measured: 12 months post randomisation
Mean cost of LSB session
Average cost of LSB session delivery for different intervention models, annuitised
Measured: 12 months post randomisation
Total incremental cost of the intervention in a research setting
Total additional cost of the intervention compared to the BISP-CT only for the study population and by intervention type during the research period.
Measured: 12 months post randomisation
Total incremental cost of the intervention in the modelling cohort
Total additional cost of the intervention for the modelling cohort by intervention type over a ten-year period.
Measured: 12 months post randomisation
Incremental cost incurred per disability adjusted life year (DALY) averted at scale: provider perspective
Incremental cost per disability-adjusted life year (DALY) averted by the intervention compared to the control group from a provider perspective at scale.
Measured: 12 months post randomisation
Incremental cost incurred per disability adjusted life year (DALY) averted at scale: societal perspective
Incremental cost per disability-adjusted life year (DALY) averted by the intervention compared to the control group from a societal perspective at scale.
Measured: 12 months post randomisation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Sep 202130 Nov 2022

First posted28 Oct 2022
Study start15 Sep 2021
Primary completion30 Jun 2022
Study completion30 Nov 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for DepressionStudies 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,536 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05598697
Sponsor's protocol ID: 108137
Acronym: MEWE-EE
Status last verified: Dec 2023
First submitted: 25 Oct 2022
Last updated: 7 Dec 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Economic Evaluation of the Men Engagement in Women Empowerment (MEWE) Intervention (MEWE-EE)
ClinicalTrials.gov ID: NCT05598697
Acronym / sponsor ID: MEWE-EE / 108137
Conditions: Depression, Mental Health Issue, Intimate Partner Violence, Domestic Violence, Gender-based Violence, Rape Sexual Assault
Keywords: violence, abuse, coercion, assault, aggression, gender, women, girl
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,536 participants (actual)
Lead sponsor: London School of Economics and Political ScienceUniversity, hospital or other
Collaborators: Aga Khan University, Bill and Melinda Gates Foundation
Study start: 15 Sep 2021 (actual)
Primary completion: 30 Jun 2022 (actual)
Study completion: 30 Nov 2022 (actual)
First posted: 28 Oct 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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Cash Transfers only	Active comparator	Other: Cash transfer to adult femalesParticipants allocated to this arm receive cash transfers. They are clients of a nation-wide cash transfer program.
Cash Transfers + LSB curriculum for females clients only	Experimental	Behavioral: Life Skills Building (LSB) curriculum for females, Other: Cash transfer to adult femalesParticipants allocated to this arm receive cash transfers and access to LSB curriculum training. Female cash transfer recipients attend 10 life-skills building sessions. Sessions are held weekly and are 90 minutes long. Two trained facilitators run the session for groups of 10 women over a ten-week period.
Cash Transfers + LSB curriculum for females clients and their husbands	Experimental	Behavioral: Life Skills Building (LSB) curriculum for males, Behavioral: Life Skills Building (LSB) curriculum for females, Other: Cash transfer to adult femalesParticipants allocated to this arm receive cash transfers and access to LSB curriculum training in gender-segregated groups. Men and women attend 10 life-skills building sessions in parallel. Sessions are held weekly and are 90 minutes long. Two trained facilitators, whose gender matches the participants', run the session for groups of 10 women or men over a ten-week period.

Who may qualify

Ages: 15 to 49 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (2 listed)

In receipt of Benazir Income Support Program (BISP) cash transfers (CTs)
Parity: have at least one child, at least 18 months old

Key exclusion criteria (1 listed)

Plan for the family to migrate out of the village within the next 2 years

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
Life Skills Building (LSB) curriculum for malesAlso: MEWE malesThe LSB curriculum offers ten weekly 90-minute sessions. Topics include effective communication, gender roles, power dynamics in the household; work-life balance and time management; conflict resolution; household decision making. The LSB teachers are trained in facilitation techniques to deliver the sessions. All male study participants attending LSB curriculum classes are married to BISP-CT clients. For men, the MEWE intervention provides access to the LSB curriculum only.	Behavioural	Cash Transfers + LSB curriculum for females clients and their husbands
Life Skills Building (LSB) curriculum for femalesAlso: MEWE femalesThe LSB curriculum offers ten weekly 90-minute sessions. Topics include effective communication, gender roles, power dynamics in the household; work-life balance and time management; conflict resolution; household decision making. The LSB teachers are trained in facilitation techniques to deliver the sessions. All female study participants attending LSB curriculum classes are BISP-CT clients. For females, the MEWE intervention comprises access to LSB curriculum + BISP CTs.	Behavioural	Cash Transfers + LSB curriculum for females clients and their husbands, Cash Transfers + LSB curriculum for females clients only
Cash transfer to adult femalesAlso: BISP-CTThe BISP intervention offers access to quarterly unconditional cash transfers to adult females.	Other	Cash Transfers + LSB curriculum for females clients and their husbands, Cash Transfers + LSB curriculum for females clients only, Cash Transfers only

Primary outcome

Incremental cost incurred per disability adjusted life year (DALY) averted: provider perspective
Time frame: 12 months post randomisation
Incremental cost per disability-adjusted life year (DALY) averted by the intervention compared to the control group from a provider perspective at 12 months from baseline. DALYs and costs will also be modelled up to a ten-year horizon using a Markov model.
Incremental cost incurred per disability adjusted life year (DALY) averted: societal perspective
Time frame: 12 months post randomisation
Incremental cost per disability-adjusted life year (DALY) averted by the intervention compared to the control group from a societal perspective at 12 months from baseline. DALYs and costs will also be modelled up to a ten-year horizon using a Markov model.

6 secondary outcomes

Mean cost of intervention delivery
Time frame: 12 months post randomisation
Mean cost of LSB session
Time frame: 12 months post randomisation
Total incremental cost of the intervention in a research setting
Time frame: 12 months post randomisation
Total incremental cost of the intervention in the modelling cohort
Time frame: 12 months post randomisation
Incremental cost incurred per disability adjusted life year (DALY) averted at scale: provider perspective
Time frame: 12 months post randomisation
Incremental cost incurred per disability adjusted life year (DALY) averted at scale: societal perspective
Time frame: 12 months post randomisation

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 7 Dec 2023.

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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.

Giulia Ferrari, PhD principal investigator

London School of Economics & Political Science

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 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: finished, as of the sponsor's last update on 7 Dec 2023. 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 Pakistan. 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?

Incremental cost incurred per disability adjusted life year (DALY) averted: provider perspective (time frame: 12 months post randomisation). The study lists 2 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 NCT05598697.

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 7 Dec 2023.