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NCT03932760: TePOP

Telehealth Group Intervention for Perinatal Depressive Symptoms

Completed NA Results posted Last updated 4 June 2024
What this trial tests

NA trial testing UPLIFT Program in Perinatal Depression in 99 participants. Completed in 1 March 2023.

Timeline
1 May 2020
Primary endpoint
1 March 2023
1 March 2023

Quick facts

Lead sponsorUniversity of Utah
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment99
Start date1 May 2020
Primary completion1 March 2023
Estimated completion1 March 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Utah

Who can join

18 and older, female only, with Perinatal Depression. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Depressive Symptoms Over Time Primary · Time 1 = pre-intervention (Baseline); T2 = immediately following week 9 of group intervention classes (Post), T3= 2 months post-intervention; T4= 4 months post-intervention; T5 = 6 months post-intervention; T6 = 8 post-intervention

Self-completed: Edinburgh Postnatal Depression Scale measures depression symptoms during pregnancy and postpartum. The instrument will measure depressive symptoms at 6 time points during pregnancy and postpartum. The instrument is on a scale of 0-30, with 0 indicating no symptoms, and 30 indicating the highest severity of symptoms. Scores \< 10 = no depressive symptoms; 10-15 = mild; 16-20 = moderate; \> 20 = severe.

Baseline
GroupValue95% CI
UPLIFT Program11.11± 3.85
Pregnancy Skills Group10.52± 4.52
Post
GroupValue95% CI
UPLIFT Program7.34± 2.79
Pregnancy Skills Group7.69± 3.92
2 months
GroupValue95% CI
UPLIFT Program8.84± 3.45
Pregnancy Skills Group8.90± 5.31
4 months
GroupValue95% CI
UPLIFT Program8.52± 4.62
Pregnancy Skills Group7.10± 4.80
6 months
GroupValue95% CI
UPLIFT Program8.16± 5.52
Pregnancy Skills Group6.35± 4.49
8 months
GroupValue95% CI
UPLIFT Program6.70± 2.90
Pregnancy Skills Group6.33± 3.88
Change in Anxiety Symptoms Over Time Secondary · Time 1 = pre-intervention; T2 = immediately following week 9 of group intervention classes (post-intervention), T3= 2 months post-intervention; T4= 4 months post-intervention; T5 = 6 months post-intervention; T6 = 8 post-intervention

Self-completed: Generalized Anxiety Disorder - 7 Item scale measures symptoms of anxiety. The instrument will measures anxiety symptoms at 6 time points during pregnancy and postpartum. The instrument is on a scale of 0-21, with 0 indicating no symptoms, and 21 indicating the highest severity of symptoms. Scores of \< 5 = no anxiety; 5-9 = mild; 10-14 = moderate; \> 15 = severe.

Baseline
GroupValue95% CI
UPLIFT Program6.97± 3.01
Pregnancy Skills Group6.97± 3.01
Post
GroupValue95% CI
UPLIFT Program5.17± 3.34
Pregnancy Skills Group5.17± 3.34
2 months
GroupValue95% CI
UPLIFT Program6.31± 4.04
Pregnancy Skills Group6.31± 4.04
4 months
GroupValue95% CI
UPLIFT Program5.45± 3.34
Pregnancy Skills Group5.45± 3.34
6 months
GroupValue95% CI
UPLIFT Program4.74± 4.18
Pregnancy Skills Group4.74± 4.18
8 months
GroupValue95% CI
UPLIFT Program4.35± 2.68
Pregnancy Skills Group4.35± 2.68

Sponsor's own description

The goal of the project is to evaluate for the first time, the effectiveness of using a telehealth approach to reducing perinatal depressive symptoms in diverse groups of childbearing women; urban and rural-dwelling, and from Hispanic and predominantly North European Descent populations. Pregnant women connect for one hour weekly, for 8 weeks, using their own electronic device, from whatever location they choose (e.g. home), to attend videoconference groups facilitated by a mental health professional. The approach is cost effective and reduces barriers to access to mental health services, particularly for women living in rural, low-resource, and minority communities, and those without adequate transportation, financial resources, childcare, or work release time.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. A Randomized Controlled Trial of a Telehealth Group Intervention to Reduce Perinatal Depressive Symptoms: A Mixed Methods Analysis.
    Iacob E, Kausler R, Williams M, Dorn U, et al · · 2025 · cited 1× · PMID 40450703 · DOI 10.1111/jmwh.13767
  2. Protocol for a randomized controlled trial to evaluate the effectiveness of a telehealth group intervention to reduce perinatal depressive symptoms.
    Iacob E, Kausler R, Williams M, Simonsen S, et al · · 2024 · cited 1× · PMID 39542133 · DOI 10.1016/j.cct.2024.107738
  3. Latina Mothers Recommendations on a Mindfulness-Based Cognitive Behavioral Therapy Group Intervention for Perinatal Depression
    Merced K, Parameswaran UD, Dearden S, Pentecost R, et al · · 2021 · DOI 10.21203/rs.3.rs-1028850/v1

Verify or expand the search:

Other recruiting trials for Perinatal Depression

Currently open trials in the same condition.

Other University of Utah trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03932760.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing