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NCT01732055 · ClinicalTrials.gov registry record · Phase 1
Partner-Assisted Interpersonal Psychotherapy or Antidepressant Medication for Antenatal Depression
A Phase 1 study, sponsored by University of North Carolina, Chapel Hill.
- Terminated
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT01732055 is a Phase 1 study that was terminated before completion, run by University of North Carolina, Chapel Hill. The registered enrollment target is 2 participants.
The verdict
NCT01732055, a Phase 1 study, was terminated before completion, sponsored by University of North Carolina, Chapel Hill.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
Purpose: To compare a novel psychotherapy, Partner-Assisted Interpersonal Psychotherapy (PA-IPT), with treatment as usual (TAU) in a sample of pregnant women seeking treatment for Major Depressive Disorder (MDD) at the University of North Carolina at Chapel Hill (UNC-CH) Perinatal Psychiatry Program. Participants: 52 women, ages 18-45, who are 16-29 weeks pregnant and experiencing a depressive episode, and their partners. Methods: Women and their identified partners will complete a diagnostic interview, complete measures of depressive symptom severity at baseline, and be randomized to treatment with PA-IPT or TAU. Women randomized to TAU will be treated by UNC physicians according to the UNC-CH Perinatal Psychiatry Program's algorithm for treatment of prenatal MDD (usually one of a number of antidepressant medications, tailored to the individual, although some women may opt against medication altogether and still be eligible to enroll). Women randomized to PA-IPT will participate in 8 therapy sessions with their identified partner over a 12-week period, along with one refresher session at or around 6 weeks postpartum. Women and partners will be assessed for change in depressive symptoms and relationship satisfaction during pregnancy at visits 4 and 8, and postpartum at 6-week and 6-month visits. Hypothesis: The investigators anticipate notable improvement in both groups similar in magnitude, however it is hypothesized that couples participating in PA-IPT will have higher relationship satisfaction post-treatment (controlling for baseline satisfaction) than those receiving TAU.
Interventions
- OTHER Treatment as Usual
- BEHAVIORAL Partner-Assisted Interpersonal Psychotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2012-11 |
| Est. Completion | 2013-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01732055
The ClinicalTrials.gov registry entry for NCT01732055 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Treatment as Usual is the first listed.
NCT01732055 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01732055 about?
NCT01732055 is a clinical study titled "Partner-Assisted Interpersonal Psychotherapy or Antidepressant Medication for Antenatal Depression". Purpose: To compare a novel psychotherapy, Partner-Assisted Interpersonal Psychotherapy (PA-IPT), with treatment as usual (TAU) in a sample of pregnant women seeking treatment for Major Depressive Disorder (MDD) at the University of North Carolina at Chapel Hill (UNC-CH) Perinatal Psychiatry Program...
What is the current status of trial NCT01732055?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2012-11. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01732055?
The interventions under investigation include: Treatment as Usual (OTHER), Partner-Assisted Interpersonal Psychotherapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT01732055?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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