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Study ended because recruitment goals unmet and further funding unlikely
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| Name | Class |
|---|---|
| Foundation of Hope, North Carolina | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Partner-Assisted Interpersonal Psychotherapy | Active Comparator | Partner-Assisted Interpersonal Psychotherapy is an 8-week series of psychotherapy sessions attended by the patient and her identified partner. |
|
| Treatment as Usual | Other | Treatment prescribed for subjects by the UNC Perinatal Psychiatry clinic physicians according to the clinic algorithm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Partner-Assisted Interpersonal Psychotherapy | Behavioral |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Rating Scale for Depression-17 item version (HRSD-17) | Change from baseline in symptoms of Major Depressive Disorder | Baseline (16-29 weeks pregnancy) until Endpoint (6 months postpartum) |
| Measure | Description | Time Frame |
|---|---|---|
| Dyadic Adjustment Scale (DAS) | Change from baseline in relationship satisfaction | Baseline (16-29 weeks pregnancy) until Endpoint (6 months postpartum) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anna R. Brandon, PhD, MSCS | University of North Carolina, Chapel Hill | Principal Investigator |
| Samantha Meltzer-Brody, MD, MPH | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina Hospitals and Clinics | Chapel Hill | North Carolina | 27599-7160 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23053218 | Background | Brandon AR, Ceccotti N, Hynan LS, Shivakumar G, Johnson N, Jarrett RB. Proof of concept: Partner-Assisted Interpersonal Psychotherapy for perinatal depression. Arch Womens Ment Health. 2012 Dec;15(6):469-80. doi: 10.1007/s00737-012-0311-1. Epub 2012 Oct 4. |
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| Treatment as Usual | Other | Because treatment(s) are prescribed for subjects by the UNC Perinatal Psychiatry physicians, it is impossible for the investigators to list each potential medication and dosage that might be prescribed to women randomized to this condition. The medication regimens are individual, and some women may opt against medication altogether (and still be eligible to enroll). Women who refuse antidepressant medication will attend visits at the same intervals as those in the study arms for evaluation of safety and symptoms. |
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|
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D057832 | Watchful Waiting |
| D000928 | Antidepressive Agents |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D011619 | Psychotropic Drugs |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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