Health TrialsbyHealthPanel

Integration of Stepped Care for Perinatal Mood and Anxiety Disorders Among Women Attending MCH Clinics

ConditionsDepression, AnxietyAntenatal DepressionPostnatal Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age14+
SponsorKenyatta National Hospital

About this trial

Perinatal mood and anxiety disorders (PMAD), defined as depression and anxiety during pregnancy or up to 1 year postpartum, account for substantial morbidity and mortality among birthing people globally especially in low- and middle-income countries. Several evidence-based interventions are recommended for identification and management of PMAD by non-specialist providers in resource-limited settings. This cluster-randomized trial seeks to evaluate the effect of a stepped-care intervention for screening and treatment of PMAD among perinatal women, on clinical and implementation outcomes.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Pregnant and ≥28 weeks gestation

Attending ANC care at the facility

≥14 years old

Screen positive for PMAD symptoms (PHQ-2≥3 and/or GAD-2≥3)

Disqualifiers

Less than 28 weeks gestation

Any woman at high risk of self-harm based on a study self-harm assessment protocol,

Has cognitive impairments or psychotic symptoms

Trial design

Design model

Parallel

Treatments tested in this trial

  • Integrated Perinatal Mental health program (systematic screening for PMAD, PM+ and tele-psychiatry)

    Behavioral

    The intervention includes systematic screening for PMAD symptoms using PHQ-2 and GAD-2, non-specialist delivery of PM+ for participants with likely depression (PHQ-9≥10) or anxiety (GAD-7≥10) and in-facility tele-linkage to mental health specialist for participants with severe depressive symptoms (PHQ-9≥15), those who endorse suicidality, or non-responders to PM+

Treatment groups

2,970 Participants
are divided into 2 treatment groups
Group A: Control arm: Enhanced Standard of careNo intervention 0 interventions
Group B: Intervention arm: Integrated Perinatal Mental Health Program (IPMH)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Depression

Patient Health Questionnaire-9 (PHQ-9). Score range 0-27. Higher score indicates more severe depression symptoms; score ≥10 indicates symptoms of moderate-to-severe depression

Time frame
6-months postpartum
2

Anxiety

Generalised Anxiety Disorder-7 item (GAD-7). Score range 0-21. Higher score indicates more severe anxiety symptoms; score ≥10 indicates symptoms of moderate-to-severe anxiety

Time frame
6-months postpartum

Secondary outcomes

1

Quality of life

World Health Organisation Quality-of-Life Brief Version (WHOQOL-BREF) score. Score range 0 - 100. Higher scores indicate higher quality of life.

Time frame
6-months postpartum
2

Adverse pregnancy outcomes

Any adverse pregnancy outcomes defined as the following: Pregnancy loss, stillbirth, pre-term birth, low birth weight, intrauterine growth restriction, neonatal hospital admission and neonatal death

Time frame
6-weeks postpartum
3

Mechanism of action for PM+ (use of behavioral and psychosocial coping skills)

Reducing Tension Checklist. Score range 0 - 40. Higher score indicates more use of behavioral and psychosocial coping skills.

Time frame
6-weeks postpartum

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kenyatta National Hospital

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov
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