Perinatal DepressionSM-ARTNCT04694261
Development and Evaluation of SM-ART Intervention (SM-ART)
A study testing SM-ART in people with Perinatal Depression and Resilience, run by Aga Khan University at 1 site in Pakistan.
Trial summary
The approach of this intended research is to help pregnant women practice constructive coping and proactive skills that focus on positive adaptation for safe motherhood through our developed intervention. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perinatal Depression, Resilience, Anxiety
- What is being tested?
- SM-ART
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jul 2019to 31 Dec 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All participants should provide written consent, be 18+ years of age
- All participants should be currently married at a gestational age of 12 to 30 weeks: by 12th week, pregnancy is confirmed, they do visit health clinic and upper bar is set to 30 weeks so there should be adequate time to provide the intervention and observe the effectiveness.
- Participants should speak and understand urdu, as all our assessments and intervention will be in local language.
Who cannot join
- Participants with a history of mental illness and/or physical illness will be excluded as will those taking antianxiety, antidepressant, anti psychotic medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Resilience, Depression And Anxiety Among Pregnant Women In Pakistan: Development And Testing Of Intervention
The approach of this intended research is to help pregnant women practice constructive coping and proactive skills that focus on positive adaptation for safe motherhood through our developed intervention.
The objective of this two phases Randomized Control Trial is to develop contextually based "SM-ART" intervention [Safe Motherhood ART: Accessible Resilience Training] and evaluate the effectiveness of "SM-ART" intervention in a sample of pregnant women living in low socioeconomic urban areas of Karachi, Pakistan.
It is hypothesized that the SM-ART intervention will enhance resilience and marital harmony and decrease symptoms of depression, anxiety in pregnant women.
Read the detailed description
The prevalence of perinatal depression and anxiety in South Asia are among the highest in the world. In Pakistan, approximately 18% to 60% of women experienced depressive symptoms at some point during their pregnancy. Early intervention for the management of mental illness in pregnancy is imperative as the effects of perinatal mental ill-health is not only limited to mothers but also can negatively impact child health outcomes. In a public health context, positive psychological interventions should be promoted as it reduces the burden of treatment, and enhance cost effective approaches in resource poor countries such as Pakistan.
As in Pakistan, no program has been planned and tested to enhance the positive psychological wellbeing among pregnant women that is based on individual strengths, that can be learnt, sustained and low cost as well. Hence, this study aims to facilitate pregnant women in practicing constructive coping and proactive skills which will help them to focus more on the positive approach of life rather than looking for the negative situations that is carried out in their daily lives.
The study will carried out in two phases:
Phase I: The objective of phase one is study is to develop "SM-ART" intervention [Safe Motherhood ART: Accessible Resilience Training]
Phase II: The objective of phase two is to test the effectiveness of "SM-ART" intervention [Safe Motherhood ART: Accessible Resilience Training] to improve resilience, marital harmony and decrease depression and pregnancy related anxiety in a sample of pregnant women presenting to Koohi Goth Hospital of Karachi, Pakistan
- Conditions
- Perinatal Depression, Resilience, Anxiety, Marital Conflict
- Being tested
- SM-ART
- Keywords
- Resilience, Perinatal mental health, Depression
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SM-ARTBehavioural
Intervention is a group based training delivered by midwives on SM-ART module. These training will consist of 6 sessions, one per week for 90 to 120 minutes each.
| Study group | Role | What they receive |
|---|---|---|
| SM-ART Intervention | Experimental | Intervention group will receive SM-ART module training along with the flyers on resilience building tips. Receives: Behavioral: SM-ART |
| Control Group | No intervention | Control group will only receive flyer on resilience building tips |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Resilience Score
Resilience Scale 14: This is a 14 items scale which score ranges from 14 to 98. It represent all five characteristics of resilience: A purposeful life, Perseverance, Equanimity, Self-reliance and Existential aloneness. A higher total score indicates higher resilience. The scale also have cutoffs as well. The scale is validated in Pakistani population by the current study principle investigator.
Measured: Baseline ( at the time of enrolment) and Post assessment (within two weeks of intervention)
Secondary outcomes (3)
Change in Depression score
Edinburgh Postnatal Depression Scale (EPDS):10-item; range 0-30, cut-off 13; across 15 countries including some LMIC Cronbach's α=.73-.87; 3 to 12 week test-retest=.53-.74) measures depression.
Measured: Baseline ( at the time of enrolment) and Post assessment (within two weeks of intervention)
Change in Pregnancy related Anxiety score
Pregnancy-related anxiety scale-revised, (10 items; range 10-40; Cronbach's α=.78) evaluates feelings about health during pregnancy, health of fetus/infant, and labour and delivery.
Measured: Baseline ( at the time of enrolment) and Post assessment (within two weeks of intervention)
Change in Marital Adjustment score
Locke Wallace Marital Adjustment Test (15 Items) It focuses on the aspects like participation in shared activities, display of affection and spouse agreement on important matters related to marital adjustment. It is an extensively used self-report measure of adjustment in marriage. The scale scores range from 2-158. A score less than 100 indicate marital distress.
Measured: Baseline ( at the time of enrolment) and Post assessment (within two weeks of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start1 Jul 2019
- Primary completion30 Jun 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perinatal 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
- Model description
- The assessments will be carried out parallel in the intervention and the control arm.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent
- Responsible party
- Principal investigator, Shireen Shehzad Bhamani, Aga Khan University
- Investigators
- Shireen S Bhamani, PhD Student, Principal investigator, Aga Khan University School of Nursing & MidwiferyOlivier Degomme, Study chair, University GhentAn-Sofie Van Parys, Study director, University GhentDavid Arthur, Study director, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04694261
- Sponsor's protocol ID
- 5312-SON-ERC-18.
- Other IDs
- 70345 (182015SONAM)
- Acronym
- SM-ART
- Status last verified
- Feb 2022
- First submitted
- 31 Dec 2020
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be analyzed using unique identifier and only the password protected data may be shared with the supervisory team of researchers.
Publications
Bhamani SS, Van Parys AS, Arthur D, Letourneau N, Wagnild G, Degomme O. Promoting mental wellbeing in pregnant women living in Pakistan with the Safe Motherhood-Accessible Resilience Training (SM-ART) intervention: a randomized controlled trial. BMC Pregnancy Childbirth. 2024 Jun 29;24(1):452. doi: 10.1186/s12884-024-06629-2.
PubMed 38951777
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resilience, Depression And Anxiety Among Pregnant Women In Pakistan: Development And Testing Of Intervention
- ClinicalTrials.gov ID
- NCT04694261
- Acronym / sponsor ID
- SM-ART / 5312-SON-ERC-18.
- Conditions
- Perinatal Depression, Resilience, Anxiety, Marital Conflict
- Keywords
- Resilience, Perinatal mental health, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- University Ghent
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 5 Jan 2021 (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.
The approach of this intended research is to help pregnant women practice constructive coping and proactive skills that focus on positive adaptation for safe motherhood through our developed intervention.
The objective of this two phases Randomized Control Trial is to develop contextually based "SM-ART" intervention [Safe Motherhood ART: Accessible Resilience Training] and evaluate the effectiveness of "SM-ART" intervention in a sample of pregnant women living in low socioeconomic urban areas of Karachi, Pakistan.
It is hypothesized that the SM-ART intervention will enhance resilience and marital harmony and decrease symptoms of depression, anxiety in pregnant women.
Detailed description
The prevalence of perinatal depression and anxiety in South Asia are among the highest in the world. In Pakistan, approximately 18% to 60% of women experienced depressive symptoms at some point during their pregnancy. Early intervention for the management of mental illness in pregnancy is imperative as the effects of perinatal mental ill-health is not only limited to mothers but also can negatively impact child health outcomes. In a public health context, positive psychological interventions should be promoted as it reduces the burden of treatment, and enhance cost effective approaches in resource poor countries such as Pakistan.
As in Pakistan, no program has been planned and tested to enhance the positive psychological wellbeing among pregnant women that is based on individual strengths, that can be learnt, sustained and low cost as well. Hence, this study aims to facilitate pregnant women in practicing constructive coping and proactive skills which will help them to focus more on the positive approach of life rather than looking for the negative situations that is carried out in their daily lives.
The study will carried out in two phases:
Phase I: The objective of phase one is study is to develop "SM-ART" intervention [Safe Motherhood ART: Accessible Resilience Training]
Phase II: The objective of phase two is to test the effectiveness of "SM-ART" intervention [Safe Motherhood ART: Accessible Resilience Training] to improve resilience, marital harmony and decrease depression and pregnancy related anxiety in a sample of pregnant women presenting to Koohi Goth Hospital of Karachi, Pakistan
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The assessments will be carried out parallel in the intervention and the control arm.
| Arm | Type | Receives |
|---|---|---|
| SM-ART Intervention | Experimental | Behavioral: SM-ARTIntervention group will receive SM-ART module training along with the flyers on resilience building tips. |
| Control Group | No intervention | –Control group will only receive flyer on resilience building tips |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All participants should provide written consent, be 18+ years of age
- All participants should be currently married at a gestational age of 12 to 30 weeks: by 12th week, pregnancy is confirmed, they do visit health clinic and upper bar is set to 30 weeks so there should be adequate time to provide the intervention and observe the effectiveness.
- Participants should speak and understand urdu, as all our assessments and intervention will be in local language.
Key exclusion criteria (1 listed)
- Participants with a history of mental illness and/or physical illness will be excluded as will those taking antianxiety, antidepressant, anti psychotic medication.
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 |
|---|---|---|
| SM-ARTIntervention is a group based training delivered by midwives on SM-ART module. These training will consist of 6 sessions, one per week for 90 to 120 minutes each. | Behavioural | SM-ART Intervention |
Primary outcome
Change in Resilience Score
Time frame: Baseline ( at the time of enrolment) and Post assessment (within two weeks of intervention)
Resilience Scale 14: This is a 14 items scale which score ranges from 14 to 98. It represent all five characteristics of resilience: A purposeful life, Perseverance, Equanimity, Self-reliance and Existential aloneness. A higher total score indicates higher resilience. The scale also have cutoffs as well. The scale is validated in Pakistani population by the current study principle investigator.
3 secondary outcomes
Change in Depression score
Time frame: Baseline ( at the time of enrolment) and Post assessment (within two weeks of intervention)
Change in Pregnancy related Anxiety score
Time frame: Baseline ( at the time of enrolment) and Post assessment (within two weeks of intervention)
Change in Marital Adjustment score
Time frame: Baseline ( at the time of enrolment) and Post assessment (within two weeks of intervention)
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 3 Mar 2022.
- Derived from this study: PubMed 38951777Bhamani SS, Van Parys AS, Arthur D, Letourneau N, Wagnild G, Degomme O. Promoting mental wellbeing in pregnant women living in Pakistan with the Safe Motherhood-Accessible Resilience Training (SM-ART) intervention: a randomized controlled trial. BMC Pregnancy Childbirth. 2024 Jun 29;24(1):452. doi: 10.1186/s12884-024-06629-2.
- Individual participant dataSharing planned: No. Data will be analyzed using unique identifier and only the password protected data may be shared with the supervisory team of researchers.
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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.
Shireen S Bhamani, PhD Student principal investigator
Aga Khan University School of Nursing & Midwifery
Olivier Degomme study chair
University Ghent
An-Sofie Van Parys study director
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SM-ART in people with Perinatal Depression and Resilience, run by Aga Khan University at 1 site in Pakistan.
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: finished, as of the sponsor's last update on 3 Mar 2022. 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?
Change in Resilience Score (time frame: Baseline ( at the time of enrolment) and Post assessment (within two weeks of intervention)). 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 NCT04694261, which also lists 1 linked publication.
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 3 Mar 2022.