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| ID | Type | Description | Link |
|---|---|---|---|
| K23MH090245 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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Perinatal depression is a major public health problem, affecting 15% of women during pregnancy through the postpartum period, with adverse consequences for the mother, the fetus, the infant, and the family. Despite increasing evidence of the importance of this critical risk interval, little research has investigated the effects of depression treatment during pregnancy on infant outcomes. The purpose of this study is to test the feasibility, acceptability, and effectiveness of a new intervention, Interpersonal psychotherapy for the mother-infant dyad (IPT-Dyad). This intervention begins during pregnancy and continues with the mother and infant until one year postpartum. The investigators hypothesize that IPT-Dyad will be better than treatment as usual in reducing depressive symptoms, improving psychosocial functioning,increasing parenting self-efficacy, improving infant emotional development, and enhancing mother-infant relationship quality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dyadic Interpersonal Psychotherapy | Experimental | Brief Interpersonal Psychotherapy during pregnancy followed by dyadic mother-infant psychotherapy for one year postpartum |
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| Enhanced Treatment as Usual | Active Comparator | Personalized referral to community resources for depression treatment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dyadic Interpersonal Psychotherapy | Behavioral | This intervention consists of a brief psychotherapeutic intervention, Interpersonal Psychotherapy, during pregnancy. Interpersonal Psychotherapy focuses on improving social relationships and interpersonal communication to improve mood. The postpartum phase also utilizes developmentally appropriate strategies to improve the mother-infant relationship. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Edinburgh Depression Scale From Baseline | Edinburgh Postnatal Depression Scale, a 10-item scale of depression severity, scores range from 0 to 30 with higher scores indicating worse outcome. | Change from baseline at End of pregnancy (between 37-39 weeks gestation); change from baseline at 3 months postpartum; change from baseline at 6 months postpartum; change from baseline at 9 months postpartum; change from baseline at 12 months postpartum |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shannon Lenze, Ph.D. | Washington Univeristy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25604869 | Result | Lenze SN, Rodgers J, Luby J. A pilot, exploratory report on dyadic interpersonal psychotherapy for perinatal depression. Arch Womens Ment Health. 2015 Jun;18(3):485-91. doi: 10.1007/s00737-015-0503-6. Epub 2015 Jan 22. | |
| 28038377 | Result | Lenze SN, Potts MA. Brief Interpersonal Psychotherapy for depression during pregnancy in a low-income population: A randomized controlled trial. J Affect Disord. 2017 Mar 1;210:151-157. doi: 10.1016/j.jad.2016.12.029. Epub 2016 Dec 20. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dyadic Interpersonal Psychotherapy | Brief Interpersonal Psychotherapy during pregnancy followed by dyadic mother-infant psychotherapy for one year postpartum Dyadic Interpersonal Psychotherapy: This intervention consists of a brief psychotherapeutic intervention, Interpersonal Psychotherapy, during pregnancy. Interpersonal Psychotherapy focuses on improving social relationships and interpersonal communication to improve mood. The postpartum phase also utilizes developmentally appropriate strategies to improve the mother-infant relationship. |
| FG001 | Enhanced Treatment as Usual | Personalized referral to community resources for depression treatment Enhanced Treatment as Usual: This intervention consists of personalized referrals to specialty mental health providers, spiritual counselors, or other needed social services. It includes some non-specific supportive techniques delivered primarily via telephone. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Dyadic Interpersonal Psychotherapy | Brief Interpersonal Psychotherapy during pregnancy followed by dyadic mother-infant psychotherapy for one year postpartum Dyadic Interpersonal Psychotherapy: This intervention consists of a brief psychotherapeutic intervention, Interpersonal Psychotherapy, during pregnancy. Interpersonal Psychotherapy focuses on improving social relationships and interpersonal communication to improve mood. The postpartum phase also utilizes developmentally appropriate strategies to improve the mother-infant relationship. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Edinburgh Depression Scale From Baseline | Edinburgh Postnatal Depression Scale, a 10-item scale of depression severity, scores range from 0 to 30 with higher scores indicating worse outcome. | Data shown are for the participants who completed study questionnaires at that time-point. Due to participant drop-out, this number may be less than the overall number of participants analyzed. | Posted | Mean | Standard Deviation | units on a scale | Change from baseline at End of pregnancy (between 37-39 weeks gestation); change from baseline at 3 months postpartum; change from baseline at 6 months postpartum; change from baseline at 9 months postpartum; change from baseline at 12 months postpartum |
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Baseline to 12 months postpartum, ranging from 14 to 40 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dyadic Interpersonal Psychotherapy | Brief Interpersonal Psychotherapy during pregnancy followed by dyadic mother-infant psychotherapy for one year postpartum Dyadic Interpersonal Psychotherapy: This intervention consists of a brief psychotherapeutic intervention, Interpersonal Psychotherapy, during pregnancy. Interpersonal Psychotherapy focuses on improving social relationships and interpersonal communication to improve mood. The postpartum phase also utilizes developmentally appropriate strategies to improve the mother-infant relationship. |
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This is a small pilot study designed to assess feasibility and not efficacy of this intervention. The primary outcome measure was a self-report scale that may not reflect unbiased outcomes. There was a substantial drop-out rate in each study arm.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shannon Lenze | Washington University - School of Medicine | 3143622752 | slenze@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 3, 2014 | May 13, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D019052 | Depression, Postpartum |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D011644 | Puerperal Disorders |
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| Enhanced Treatment as Usual | Other | This intervention consists of personalized referrals to specialty mental health providers, spiritual counselors, or other needed social services. It includes some non-specific supportive techniques delivered primarily via telephone. |
|
| 32479328 | Derived | Lenze SN, Potts MA, Rodgers J, Luby J. Lessons learned from a pilot randomized controlled trial of dyadic interpersonal psychotherapy for perinatal depression in a low-income population. J Affect Disord. 2020 Jun 15;271:286-292. doi: 10.1016/j.jad.2020.03.084. Epub 2020 Apr 15. |
| BG001 | Enhanced Treatment as Usual | Personalized referral to community resources for depression treatment Enhanced Treatment as Usual: This intervention consists of personalized referrals to specialty mental health providers, spiritual counselors, or other needed social services. It includes some non-specific supportive techniques delivered primarily via telephone. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Edinburgh Depression Scale score | 10-item scale, total score reported, minimum score is 0 and maximum score is 30, higher scores indicate worse outcome | Mean | Standard Deviation | units on a scale |
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| OG001 | Enhanced Treatment as Usual | Personalized referral to community resources for depression treatment Enhanced Treatment as Usual: This intervention consists of personalized referrals to specialty mental health providers, spiritual counselors, or other needed social services. It includes some non-specific supportive techniques delivered primarily via telephone. |
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|
| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Enhanced Treatment as Usual | Personalized referral to community resources for depression treatment Enhanced Treatment as Usual: This intervention consists of personalized referrals to specialty mental health providers, spiritual counselors, or other needed social services. It includes some non-specific supportive techniques delivered primarily via telephone. | 0 | 21 | 0 | 21 | 0 | 21 |
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| D011248 |
| Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |