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NCT03500978 · ClinicalTrials.gov registry record · NA
Factors Predicting Ineffective Contraception Use
A NA study of Contraception Behavior, sponsored by Temple University.
- Completed
- Registry status
- NA
- Development phase
- 133
- Enrollment target
- 1
- Study location
NCT03500978 is a NA study of Contraception Behavior that has completed, run by Temple University. The registered enrollment target is 133 participants, below the 853-participant average among 11 other Contraception Behavior trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03500978, a NA study of Contraception Behavior, has completed, sponsored by Temple University.
- COMPLETED
- Registry status
- NA
- Development phase
- 133 participants
- Enrollment target
- 1
- Study location
Study Summary
Unintended pregnancy (UP), defined as a mistimed or unwanted pregnancy, is a significant and prevalent public health problem, particularly among low-income women. Over half of all pregnancies are reportedly unintended and UP has been linked to adverse health outcomes in mothers and their children. Correct and consistent use of effective contraception is the primary method to prevent UP. Research has shown that low self-esteem and elevated depressive symptoms increase women's risk for ineffective contraception use and, by extension, for UP. This project examines the feasibility and possible efficacy of reducing ineffective contraception using an intervention that addresses depressive symptoms and self concept among young, low-income, predominantly minority women at risk for UP. Traditional cognitive behavioral therapy (CBT) is effective in reducing depressive symptoms and improving self concept; but limited utilization, poor response, and low adherence to CBT is common among low-income and minority women. A more acceptable method for delivering CBT is needed for the target population. This project will use peer-specialists to deliver a CBT-based intervention to women at risk for UP. Because peer specialists are drawn from the same community as the target population and share some similar life experiences, the intervention may be more acceptable and effective than one offered by trained professionals. This project will examine the effectiveness of a 9 week (8-session) peer-specialist led CBT-based intervention compared to an observational control condition to reduce depressive symptoms, improve self-esteem, and improve consistent contraceptive use to prevent UP. The weekly intervention sessions are delivered by telephone by a trained peer specialist. The study will evaluate the effectiveness of the intervention to improve consistent contraceptive use (primary outcome) and decrease depressive symptoms and increase self-esteem (secondary outcomes).
Conditions Studied
Interventions
- BEHAVIORAL Peer CBT Intervention
Study Locations (1)
Pennsylvania
- Temple University School of Medicine OB/GYN - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 133 participants |
| Start Date | 2018-03-19 |
| Est. Completion | 2019-05-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03500978
The ClinicalTrials.gov registry entry for NCT03500978 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 133 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 853-participant average among 11 other Contraception Behavior trials with a reported enrollment target (84% lower). The listed sponsor is Temple University, which has 163 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Contraception Behavior appearing as the primary indexed condition, and to 1 intervention - of which Peer CBT Intervention is the first listed.
NCT03500978 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03500978 about?
NCT03500978 is a clinical study titled "Factors Predicting Ineffective Contraception Use". Unintended pregnancy (UP), defined as a mistimed or unwanted pregnancy, is a significant and prevalent public health problem, particularly among low-income women. Over half of all pregnancies are reportedly unintended and UP has been linked to adverse health outcomes in mothers and their children. C...
What is the current status of trial NCT03500978?
This trial is currently completed. It is a NA study. The enrollment target is 133 participants. The study started on 2018-03-19. Estimated completion is 2019-05-31.
What conditions does trial NCT03500978 study?
This clinical trial studies the following conditions: Contraception Behavior.
What interventions are being tested in trial NCT03500978?
The interventions under investigation include: Peer CBT Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT03500978?
This trial is sponsored by Temple University, which has 163 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03500978 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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