Actively Recruiting

Phase Not Applicable
Age: 15Years - 45Years
FEMALE
ID06253676

Sensing Technologies for Maternal Depression Treatment in Low-Resource Settings

Led by George Washington University · Updated on 2025-06-25

120

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

G

George Washington University

Lead Sponsor

T

Transcultural Psychosocial Organization Nepal

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to evaluate the acceptability and clinical effectiveness of the StandStrong intervention, a digital, non-specialist mental health program for mothers with postpartum depression in Nepal. The study compares this technology-informed approach with a standard non-specialist intervention to optimize psychosocial care in low- and middle-income country settings, where untreated postpartum depression poses significant risks to mothers and their children. Participants are randomly assigned to one of two groups. The experimental group receives the StandStrong intervention, which uses passive sensing technology like smartphones and GPS beacons to collect data on maternal and infant activity, analyzed by machine learning and shared with trained helpers to tailor sessions. The comparator group receives the standard Problem Management Plus (PM+) intervention without passive sensing data. Both groups undergo five in-person sessions with trained non-specialist providers using cognitive behavioral strategies. During the study, participants will be assessed on depression severity using the Patient Health Questionnaire-9 (PHQ-9) and other measures like anxiety and disability at 20 weeks after baseline. Researchers will monitor symptom changes, quality of life, and intervention acceptability. Participation involves regular sessions with helpers, data collection through technology for the experimental group, and ongoing evaluation of mental health outcomes and intervention delivery up to 20 weeks.

CONDITIONS

Brief Title

Sensing Technologies for Maternal Depression Treatment in Low-Resource Settings

Who Can Participate

Age: 15Years - 45Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Mother aged between 15 and 39 years
  • Infant is within the first 1000 days of life
  • Mother has a PHQ-9 depression score of 8 or higher
  • Access to a technology charging method at home
  • Will remain in the study area for at least 6 months after enrollment
Not Eligible

You will not qualify if you...

  • Mother has a PHQ-9 depression score less than 8
  • Mother and infant live in different permanent residences at recruitment
  • Acute medical needs or hospitalization of mother or infant at recruitment
  • Presence of psychotic symptoms at recruitment as indicated by the Community Informant Detection Tool

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - Duration of the five intervention sessions

Participants undergo five in-person intervention sessions with trained non-specialist providers delivering the Problem Management Plus (PM+) behavioral program. Depending on the assigned group, the intervention may be informed by passive sensing data collected via smartphone and GPS beacon or delivered in the standard manner without sensing data integration.

5 in-person visits

Follow-up

Duration - Up to 20 weeks following baseline assessment

Participants are assessed for outcomes related to depression, anxiety, psychological distress, and disability at 20 weeks following the baseline assessment.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

Transcultural Psychosocial Organization Nepal

Kathmandu, Nepal, 44600

Actively Recruiting

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Research Team

B

Brandon A Kohrt, MD PhD

S

Sauharda Rai, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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