Implementing and evaluating group interpersonal therapy for postnatal depression in Lebanon and Kenya - individually randomised superiority trial
| ISRCTN | ISRCTN15154316 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15154316 |
- Submission date
- 14/09/2023
- Registration date
- 27/09/2023
- Last edited
- 27/03/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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 (World Health Organization, 2016). There is research from high-income countries showing that IPT and group-IPT (g-IPT) is an effective treatment for PND but we do not know whether it works in a LMIC context, or whether it also benefits child development. This study aims to explore the effectiveness of g-IPT in two LMIC for women with PND.
The trial directly follows on from two earlier phases of work; conceptual mapping phase and a feasibility study phase. We have used what we have learned from our previous research to inform this full randomised controlled trial that will compare Group Interpersonal Therapy (g-IPT) versus High-Quality Standard Care (HQ-SC).
Who can participate?
New mothers aged 18 years or older who are experiencing post-natal depression and have an infant aged 6-35 weeks old.
What does the study involve?
Mothers who choose to participate will be randomly allocated to one of two groups: treatment (g-IPT) or control (HQ-SC). All participant will initially receive HQ-SC and then those allocated to treatment group will go on to receive 8 sessions of g-IPT. At 8, 13, 24, 36 and 52 weeks after their first clinical contact (the first session of HQ-SC), participants will be contacted to provide some data in the form of questionnaires and interviews. This will include data such as their mental health, depressive symptoms and sleep patterns, as well as their child’s development. The data will then be analysed to assess whether g-ITP has a greater impact than standard care on the effects of post-natal depression on the mother and the development of the child.
What are the possible benefits and risks of participating?
A possible benefit of participating is a reduction in depression symptoms and in turn possible improvement in the child’s development after going through g-ITP. However, a possible risk is that the group discussions might trigger stressful memories or emotions due to the sensitive nature of the topics.
Where is the study run from?
The study takes place in Kenya and Lebanon, with support and supervision from University College London (UK).
When is the study starting and how long is it expected to run for?
October 2022 to December 2024
Who is funding the study?:
National Institute for Health Research (NIHR) Research and Innovation for Global Health Transformation (RIGHT) programme.
Who is the main contact?
Principal Research Coordinator, University College London
Dr Elizabeth Simes, e.simes@ucl.ac.uk
Contact information
Principal Investigator
University College London
26 Bedford Way
London
WC1H 0AP
United Kingdom
| Phone | +44 (0)2076791943 |
|---|---|
| p.fonagy@ucl.ac.uk |
Public
University College London
1-19 Torrington Place
London
WC1E 7HB
United Kingdom
| Phone | +44 (0)2031083254 |
|---|---|
| e.simes@ucl.ac.uk |
Public
University College London
1-19 Torrington Place
London
WC1E 7HB
United Kingdom
| Phone | +44 (0)2031083254 |
|---|---|
| ciara.o'donnell.16@ucl.ac.uk |
Study information
| Study design | Individually randomized superiority trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| 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: SUMMIT (SUpporting Mothers’ Mental health with Interpersonal Therapy) |
| Study acronym | SUMMIT |
| Study objectives | The study aims to assess whether or not culturally-adapted group interpersonal therapy (g-IPT) delivered in community settings in Kenya and Lebanon has a greater impact than high quality standard care (HQ-SC) on child developmental outcomes, maternal depression and the mother-child relationship. |
| Ethics approval(s) |
1. Approved 17/10/2022, University College London Research Ethics Committee (Office of the Vice Provost Research, 2 Taviton Street University College, London, WC1H 0BT, United Kingdom; +44 (0)20 7679 8717; ethics@ucl.ac.uk), ref: ref: 23699/001 2. Approved 29/11/2022, Saint Joseph University Secretariat of the University Ethics Centre (Medical Sciences Campus, Hotel-Dieu de France, B.P 16-6830 Achrafieh, Beyrouth - Liban, Beirut, 1107 2180, Lebanon; +961 (0)1 421229; cue@usj.edu.ib), ref: ref: CEHDF 1854 3. Approved 23/11/2022, Kenyatta National Hospital and University of Nairobi Ethics Committee (KHN-UON ERC) (Kenyatta National Hospital, PO Box 20723, Code 00202; University of Nairobi (KNH – UoN), Faculty of Health Sciences, PO Box 19676, Code 00202, Nairobi, N/A, Kenya; +254 (0)726300 9; uonknh_erc@uonbi.ac.ke), ref: ref: KNH/ERC/Mod&SAE/425 |
| Health condition(s) or problem(s) studied | Post-natal depression |
| Intervention | 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. Group Interpersonal therapy (g-IPT): Interpersonal therapy was designed as a structured and time-limited treatment for depressed adults. The principle of g-IPT is that depressive episodes are triggered by issues in the patient’s interpersonal relations (e.g. loss of a loved one, disputes, social isolation). It has proven to be an effective treatment for common mental health disorders, and one that can be used as a preventative intervention. For this study, g-IPT has been adapted for cultural relevance for Kenya and Lebanon and will be further adapted for new mothers with infants. There will be 8 sessions of g-IPT offered to participants randomised to the intervention arm. High-Quality Standard Care (HQ-SC): 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. This will provide participants with a stress management guide for coping with adversity which equips them with practical skills to cope with stress. |
| Intervention type | Behavioural |
| Primary outcome measure | Infant’s cognitive development measured using the Malawi Developmental Assessment Tool (MDAT) (Gladstone et al. 2010), at 52 weeks (T6) |
| Secondary outcome measures | 1. Severity of depression measured using the Patient Health Questionnaire – depression module (PHQ-9) (Kroenke & Spitzer, 2002) at baseline (T1), 8 weeks (T2), 13 weeks(T3), 24 weeks (T4), 36 weeks (T5) and 52 weeks (T6) 2. Family circumstances assessed using the family circumstances questionnaire at baseline (T1), 13 weeks (T3) and 52 weeks (T6) 3. Maternal sensitivity and indicators of family care assessed using the Family Care Indicator (FCI) (Kariger et al., 2012) at baseline (T1), 8 weeks (T2), 13 weeks(T3), 24 weeks (T4), 36 weeks (T5) and 52 weeks (T6) 4. Early childhood development outcomes measured using the Caregiver Reported Early Development Index (CREDI) long form (McCoy et al., 2018) at baseline (T1), 13 weeks (T3) and 36 weeks (T5) 5. Anxiety measured using the General Anxiety Disorder-7 (GAD-7) (Spitzer et al., 2006) at baseline (T1), 8 weeks (T2), 13 weeks(T3), 24 weeks (T4), 36 weeks (T5) and 52 weeks (T6) 6. Sleep measured using the Sleep Condition Indicator (SCI) (Espie et al., 2014) at baseline (T1), 8 weeks (T2), 13 weeks (T3) and 24 weeks (T4), 36 weeks (T5) and 52 weeks (T6) 7. Infant’s sleep measured using the Brief Infant Sleep Questionnaire – Revised Short form (BISQ) (Mindell et al., 2019) at baseline (T1), 8 weeks (T2), 13 weeks (T3) and 24 weeks (T4), 36 weeks (T5) and 52 weeks (T6) 8. Infant’s physical health measured using the infant physical health questionnaire at baseline (T1), 8 weeks (T2), 13 weeks (T3) and 24 weeks (T4), 36 weeks (T5) and 52 weeks (T6) 9. Breastfeeding assessed using the breastfeeding outcome measure at baseline (T1), 8 weeks (T2), 13 weeks (T3) and 24 weeks (T4), 36 weeks (T5) and 52 weeks (T6) 10. Social isolation assessed using the Lubben Social Network Scale (LSNS-6) (Lubben & Gironda, 2000) at baseline (T1), 13 weeks (T3) and 52 weeks (T6) 11. Relationship satisfaction measured using the Couple Satisfaction Index (CSI-4) (Funk & Rogge, 2007) at baseline (T1), 13 weeks (T3) and 52 weeks (T6) 12. Health outcome assessed using EQ-5D (Soeteman et al., 2008) at baseline (T1), 13 weeks (T3), 24 weeks (T4) and 52 weeks (T6) 13. Capability measured using the ICEpop CAPability measure for Adults (ICECAP-A) (Al-Janabi et al., 2012) at baseline (T1), 13 weeks (T3), 24 weeks (T4) and 52 weeks (T6) 14. Value of intervention measured using the SUMMIT patient cost questionnaire (Rose-Clarke et al., 2020) at 13 weeks (T3) 15. Household economic status measured using the Economic House economic questionnaire at baseline (T1) and household shocks measured at 13 weeks (T3) 16. Demographic information covering socio-economic status, maternal education, maternal parity and teen parent status using the DUMMIT demographic questionnaire at baseline (T1) 17. A brief semi-structured qualitative interview to explore outcomes such as changes in understanding or, or attitudes towards, post-natal depression at baseline (T1), 13 weeks (T3) and 52 weeks (T6) |
| Overall study start date | 17/10/2022 |
| Completion date | 31/12/2024 |
Eligibility
| Participant type(s) | Healthy volunteer, Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 412 |
| Key inclusion criteria | 1. Aged 18 years or older 2. Female 3. Postnatal depression as indicated by a score of 12 or more on the PHQ-9 at baseline 4. Mother with an infant aged 6 - 35 weeks old at the time of screening |
| Key exclusion criteria | 1. Mothers with psychotic conditions including bipolar disorder, anorexia nervosa or substance dependence 2. Mothers whose babies have severe physical health problems or neurodevelopmental problems will also be excluded |
| Date of first enrolment | 02/01/2023 |
| Date of final enrolment | 30/11/2023 |
Locations
Countries of recruitment
- Kenya
- Lebanon
Study participating centres
Nairobi
-
Kenya
Nairobi
-
Kenya
Nairobi
-
Kenya
Nairobi
-
Kenya
Nairobi
-
Kenya
Nairobi
-
Kenya
Beirut
-
Lebanon
Beirut
-
Lebanon
Beirut
-
Lebanon
Beirut
-
Lebanon
Beirut
-
Lebanon
Beirut
-
Lebanon
Beirut
-
Lebanon
Sponsor information
University/education
1-19 Torrington Place
London
WC1E 7HB
England
United Kingdom
| Phone | +44 20 7679 4234 |
|---|---|
| rosemary.varley@ucl.ac.uk | |
| Website | http://www.ucl.ac.uk/ |
"ROR" |
https://ror.org/02jx3x895 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | The results of the study will be disseminated through publications in peer reviewed journals as well as presentations, newsletters, and articles. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 26/03/2024 | 27/03/2024 | Yes | No |
Editorial Notes
27/03/2024: Publication reference added.
17/10/2023: The recruitment end date was changed from 31/10/2023 to 30/11/2023.
22/09/2023: Study's existence confirmed by the University College London Research Ethics Committee.
