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Trial details
Supporting Mothers’ Mental Health with Interpersonal Therapy
Current status:
Approved
|
Date registered:
23/05/2022
Trial version(s)
Current: 13/07/2021
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Main Information
Primary registry identifying number
LBCTR2022024840
Protocol number
ISRCTN52076264
MOH registration number
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Prospective
Date of registration in national regulatory agency
13/07/2021
Primary sponsor
University College of London (UCL)
Primary sponsor: Country of origin
UK
Public title
Supporting Mothers’ Mental Health with Interpersonal Therapy
Acronym
SUMMIT
Scientific title
Evaluating the impact of group interpersonal psychotherapy compared to high-quality standard care for mothers with postnatal depression in Lebanon and Kenya on child developmental outcomes, maternal depression and the mother-child relationship
Acronym
Brief summary of the study: English
Background and study aims Depression is the most common mental health issue affecting women of childbearing age. 20%-25% of women in low and middle-income countries (LMICs) experience depression during pregnancy or shortly after childbirth. This can be very distressing and affects not only the mother but also her child. Women with depression often struggle to respond to their children’s needs. Research shows that as a result of this children of women with postnatal depression (PND) have poorer learning, or cognitive development, and more emotional and behaviour problems as they grow up. This is especially true in LMICs, where families may also be struggling with many other challenges that can affect children’s development negatively. Many women in LMICs have very little contact with healthcare services, so antenatal services can be a key opportunity to reach women in need of mental health support. However, currently treatment for PND is rarely available in many LMICs. The World Health Organisation recommends a therapy called interpersonal psychotherapy (IPT) to treat depression. There is research from high-income countries showing that IPT and group-IPT (g-IPT) is an effective treatment for PND, but it is not known whether it works in an LMIC context, or whether it also benefits child development. This study aims to explore the feasibility of conducting a randomised controlled trial to study the effectiveness of g-IPT in two LMIC for women with PND. The study consists of two phases: conceptual mapping and a feasibility study. In the first phase, researchers in Kenya and Lebanon will work with the core team in the UK to explore how members of the community think about maternal depression, and how local factors may affect maternal mental health and access to treatment. With input from service users, a group-based adapted version of g-IPT will be developed to fit the local culture and setting of both countries. In the second phase a feasibility randomised control trial (RCT) will be conducted comparing g-IPT to high-quality standard care (HQ-SC). The initial aim of the study is to assess the feasibility of critical elements of a trial to evaluate g-IPT as a form of treatment for post-natal depression in women living in LMICs.
Brief summary of the study: Arabic
الدراسة البحثية تهدف إلى اكتشاف ما إذا كان العلاج النفسي الذي يُعرف بالعلاج العلائقي الجماعي فعّالاً أم لا للنساء اللواتي الحديثات الإنجاب اللواتي يعانين من الاكتئاب أم لا. كما نودُّ أن نعرف ما إذا كان هذا النوع من المساعدة يساهم في تحسين علاقة الأم بطفلها وفي تعزيز نمو الطفل. وعلى الرغم من أن الدراسات التي أُجريت في الدول ذات الدخل المرتفع أظهرت فعالية هذا العلاج في معالجة اكتئاب ما بعد الولادة، نود أن نعرف ما إذا كان هذا فعّالًا في السياق المحلي. سوف نقارن بين مجموعتَين من الأمهات والأطفال، تخضع إحداها للعلاج العلائقي الجماعي فيما تتلقى الثانية خدمات رعاية أخرى متاحة في منطقتك لكي نرى أي خيار هو الأفضل.
Health conditions/problem studied: Specify
Maternal Depression - Child Development - Mother-Child Relationship
Interventions: Specify
Following the completion of the baseline outcome measures, participants will be randomly allocated to either Group Interpersonal therapy (g-IPT) or High-Quality Standard Care (HQ-SC), using a secure, web-based platform. Intervention arm: g-IPT has proven to be an effective treatment for common mental health disorders, and one that can be used as a preventative intervention. The principle of g-IPT is that depression is triggered and worsened by interpersonal problems and adversities. It focuses on the recovery from the current depressive episode through clarification of the relationship between the onset of current depressive symptoms and interpersonal problems and skill-building that lead to more effective management of these problems. The mothers in the intervention arm will receive 3 months of adapted g-IPT, to include (a) a focus on the mother-infant relationship and (b) support via SMS or WhatsApp. Control arm: All participants will receive psychoeducation in the form of a guided introduction to a WHO-approved self-help illustrated guide to coping with adversity together with information on nutrition for mothers and babies.
Key inclusion and exclusion criteria: Inclusion criteria
Kenya inclusion criteria: 1. Mothers who have recently given birth, living in one of the two research sites 2. Fathers who have recently had a child, living in one of the two research sites 3. Healthcare workers without mental health expertise, who work in one of the two research sites 4. Healthcare workers with mental health expertise, who work in one of the two research sites 5. Religious leaders working in one of the two research sites 6. Traditional midwives working in one of the two research sites 7. Key informants, such as staff working in local or national organisations in a related field (mental health, maternal health and early childhood health)
Key inclusion and exclusion criteria: Gender
Female
Key inclusion and exclusion criteria: Age minimum
18
Key inclusion and exclusion criteria: Age maximum
45
Key inclusion and exclusion criteria: Exclusion criteria
Participant exclusion criteria Feasibility trial: 1. Mothers with psychotic conditions including bipolar disorder, anorexia nervosa or substance dependency 2. Mothers whose babies have severe physical health problems or neurodevelopmental problems
Type of Study
Type
Interventional
Type of intervention
Behavioral treatment
Trial scope
Therapy
Trial scope: Specify scope
Study design: Allocation
Randomized controlled trial
Study design: Masking
Blinded (masking used)
Study design: Control
Active
Study phase
0 (explanatory trials)
Study design: Purpose
Supportive care
Study design: Assignment
Single
Pharmaceutical class
Not Applicable
Therapeutic indication
There is research from high-income countries showing that interpersonal psychotherapy (IPT) and group-IPT (g-IPT) is an effective treatment for postnatal depression (PND), but it is not known whether it works in low to middle-income countries (LMIC) contexts, or whether it also benefits child development. This study aims to determine the feasibility of conducting a randomised controlled trial of the effectiveness of g-IPT in two LMIC for women with PND through a conceptual mapping process and feasibility trial.
Therapeutic benefit
The main benefits of g-IPT are a reduction in depression levels and a possible benefit to child developmental outcomes and the mother-child relationship.
Biospecimen retention
None retained
Biospecimen description
not applicable
Target sample size
35
Actual enrollment target size
35
Date of first enrollment: Type
Anticipated
Date of first enrollment: Date
01/02/2022
Date of study closure: Type
Anticipated
Date of study closure: Date
31/12/2022
Recruitment status
Pending
Date of completion
IPD sharing statement plan
No
IPD sharing statement description
The data-sharing plans for the current study are unknown and will be made available at a later date
Additional data URL
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
Sources of Monetary or Material Support
Name
The National Institute for Health Research (NIHR)- UK
Secondary Sponsors
Name
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Pardi
Maradian
Bsalim
Lebanon
03-723070
pardi.maradian@nmhp-lb.com
NMHP-MoPH
Scientific
Rabih
El Chammay
Achrafieh
Lebanon
03-390935
rabih.chammay@nmhp-lb.com
NMHP-MoPH
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Makased primary health center in Msaytbeh area
Dr Rabih El Chammay
psychiatrist
Approved
Lebanese Red Cross Center
Dr Rabih El Chammay
psychiatrist
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Hotel Dieu de France
28/06/2021
Virginia El Khoury
cue@usj.edu.ib
+961 (0)1 421229
Countries of Recruitment
Name
Lebanon
Kenya
Health Conditions or Problems Studied
Condition
Code
Keyword
Maternal Depression
Mental disorder, not otherwise specified (F99)
PND
Interventions
Intervention
Description
Keyword
group interpersonal psychotherapy g-IPT
g-IPT has proven to be an effective treatment for common mental health disorders, and one that can be used as a preventative intervention. The principle of g-IPT is that depression is triggered and worsened by interpersonal problems and adversities. It focuses on the recovery from the current depressive episode through clarification of the relationship between the onset of current depressive symptoms and interpersonal problems and skill-building that lead to more effective management of these problems.
g-IPT
Primary Outcomes
Name
Time points
Measure
Severity of depression
baseline and at 8 (T2), 13 (T3), and 24 (T4) weeks post-treatment
Patient Health Questionnaire- depression module (PHQ-9)
Key Secondary Outcomes
Name
Time points
Measure
Family circumstances
baseline (T1) and 13 weeks (T3)
family circumstances questionnaire
Height and weight measures of infants
baseline (T1) and 13 weeks (T3)
following WHO guidelines
Early childhood development outcomes
baseline (T1), 8 weeks (T2), 13 weeks (T3) and 24 weeks (T4)
Caregiver Reported Early Development Index (CREDI) long form
Depression
baseline (T1), 8 weeks (T2), 13 weeks (T3) and 24 weeks (T4)
Hamilton Depression Rating Scale (HRSD)
Anxiety
baseline (T1), 8 weeks (T2), 13 weeks (T3) and 24 weeks (T4)
General Anxiety Disorder-7 (GAD-7)
Sleep
baseline (T1), 8 weeks (T2), 13 weeks (T3) and 24 weeks (T4)
Sleep Condition Indicator (SCI)
Generic health status
baseline (T1), 8 weeks (T2), 13 weeks (T3) and 24 weeks (T4)
Short-Form Health Survey (SF-36)
Infant’s sleep
baseline (T1), 8 weeks (T2), 13 weeks (T3) and 24 weeks (T4)
Brief Infant Sleep Questionnaire – Revised Short form (BISQ)
Infant’s physical health
baseline (T1), 8 weeks (T2), 13 weeks (T3) and 24 weeks (T4)
infant physical health questionnaire
Infant’s cognitive development
24 weeks (T4)
Malawi Developmental Assessment Tool (MDAT)
Breastfeeding
baseline (T1), 8 weeks (T2), 13 weeks (T3) and 24 weeks (T4)
breastfeeding outcome measure
Social isolation
baseline (T1) and 13 weeks (T3)
Lubben Social Network Scale (LSNS-6)
Relationship satisfaction
baseline (T1) and 13 weeks (T3)
Couple Satisfaction Index (CSI-16)
Health outcome
baseline (T1) and 13 weeks (T3)
EQ-5D
Capability
baseline (T1), 13 weeks (T3) and 24 weeks (T4)
ICEpop CAPability measure for Adults (ICECAP-A)
Value of intervention
baseline (T1) and 13 weeks (T3)
SUMMIT patient cost questionnaire
Decision making
baseline (T1) and 13 weeks (T3)
Adreoni questionnaire
Household economic status
baseline (T1) and household shocks measured at 13 weeks (T3)
Economic House economic questionnaire
Participants’ experience of the treatment
baseline (T1) and 13 weeks (T3)
emi-structured interview
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
Download as PDF
Save a PDF copy of the summary of the trial