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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH074919 | U.S. NIH Grant/Contract | View source | |
| R01MH074636 | U.S. NIH Grant/Contract | View source | |
| DSIR 83-ATP |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This study will evaluate the effectiveness of antidepressant medication alone and interpersonal psychotherapy alone in treating women with postpartum depression.
Postpartum depression (PPD) occurs in approximately 13% of postpartum women. The impact of PPD is significant, including emotional distress for the woman as well as disturbances in infant development. Common signs of depression after childbirth may include anxiety, irritability, low energy, and lack of concern for self or infant. If left untreated, PPD may last for more than 1 year, causing strain on family life and the mother's relationship with her infant. Infants of depressed mothers are also at a higher risk for developmental delays, behavioral problems, and difficulty eating and sleeping. Despite the public health significance of PPD, relatively little research has been done to determine the most effective treatments. Specifically, there is a lack of research concerning the use of antidepressant medication for treating PPD. Interpersonal psychotherapy (IPT), which focuses on interpersonal issues related to depression, has been more thoroughly studied for the treatment for PPD, but it has not been compared to the other treatment. This study will evaluate the effectiveness of antidepressant medication alone and IPT alone in treating women with PPD.
Participation in this double-blind study will last 9 months. Participants will first undergo initial assessments, which include interviews about depressive symptoms, self-report forms about medical history, blood tests, and a pregnancy test. Participants will then be randomly assigned to one of three treatments: sertraline, placebo, or IPT. All three treatments will be administered over 13 weeks. Participants assigned to take sertraline or placebo will attend nine 30-minute sessions over the 13-week treatment period. During these sessions, participants will be administered the study medication and will be assisted with parenting issues and skills by a psychiatrist. Participants receiving IPT will attend weekly 50-minute sessions over the 13-week treatment period. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills. All participants will also complete interviews and questionnaires about their depression once a month. Following the 13 weeks of treatment, participants will undergo follow-up assessments at Months 3 and 6 post-treatment. Follow-up assessments will repeat initial interviews and questionnaires and will include a form about the infant's nature.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 (Placebo) | Placebo Comparator | Participants receiving placebo pill with clinical management plus mothercrafting |
|
| 2 (Sertraline) | Active Comparator | Participants receiving active medication sertraline with clinical management plus mothercrafting |
|
| 3 (IPT) | Active Comparator | Participants receiving interpersonal psychotherapy (IPT) alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sertraline | Drug | Participants assigned to sertraline treatment will take 25 to 50 mg daily for Weeks 1 through 3, and dosage will be increased to 100 to 150 mg daily in Weeks 4 through 10. Participants will be titrated up to 200 mg daily at Week 11 for the final 2 weeks of treatment. In addition, at each week participants will receive specific "mother-crafting" techniques keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information to the mother about infant care. |
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Depression Rating Scale (HAM-D) | Measure total ranges from 0 to 50, with lower scores indicating better outcomes. | Measured at baseline; post-treatment; and Months 3 and 6 of follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Depression Illness Severity Based on Beck Depression Inventory (BDI) | Measure total ranges from 0 to 56, with lower scores indicating better outcomes. | Measured at baseline; post-treatment; and Months 3 and 6 of follow-up |
| Global Illness Severity Based on Clinical Global Impression (CGI) Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Caron Zlotnick | Women and Infants Hospital | Principal Investigator |
| Scott Stuart, MD | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa | Iowa City | Iowa | 52242 | United States | ||
| Women and Infants Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30447565 | Derived | O'Hara MW, Pearlstein T, Stuart S, Long JD, Mills JA, Zlotnick C. A placebo controlled treatment trial of sertraline and interpersonal psychotherapy for postpartum depression. J Affect Disord. 2019 Feb 15;245:524-532. doi: 10.1016/j.jad.2018.10.361. Epub 2018 Oct 31. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1 (Placebo) | Participants receiving placebo pill with clinical management plus mothercrafting Placebo: Participants taking the placebo will follow the same titration schedule as those taking sertraline. In addition, the participates will receive the same specific "mother-crafting" techniques as those taking sertraline. Clinical management: Clinical management includes treatment as usual for those receiving medication for depression. Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Participants taking the placebo will follow the same titration schedule as those taking sertraline. In addition, the participates will receive the same specific "mother-crafting" techniques as those taking sertraline. |
|
| Interpersonal psychotherapy (IPT) | Behavioral | IPT will be administered in 13 individual 50-minute sessions over 13 weeks. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills. |
|
| Clinical management | Behavioral | Clinical management includes treatment as usual for those receiving medication for depression. |
|
| Mothercrafting | Behavioral | Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care |
|
Measure total ranges from 1 to 7, with lower scores indicating better outcomes. |
| Measured at baseline; post-treatment; and Months 3 and 6 of follow-up |
| Social Functioning Based on Postpartum Adjustment Questionnaire (PPAQ) | Measure total ranges from 1 to 5, with lower scores indicating better outcomes. | Measured at baseline; post-treatment; and Months 3 and 6 of follow-up |
| Hamilton Anxiety Rating Scale (HARS) | Measure total ranges from 0 to 56, with lower scores indicating better outcomes. | Measured at baseline; post-treatment; and Months 3 and 6 of follow-up |
| Providence |
| Rhode Island |
| 02905 |
| United States |
| FG001 | 2 (Sertraline) | Participants receiving active medication sertraline with clinical management plus mothercrafting Sertraline: Participants assigned to sertraline treatment will take 25 to 50 mg daily for Weeks 1 through 3, and dosage will be increased to 100 to 150 mg daily in Weeks 4 through 10. Participants will be titrated up to 200 mg daily at Week 11 for the final 2 weeks of treatment. In addition, at each week participants will receive specific "mother-crafting" techniques keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information to the mother about infant care. Clinical management: Clinical management includes treatment as usual for those receiving medication for depression. Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care |
| FG002 | 3 (IPT) | Participants receiving interpersonal psychotherapy (IPT) alone Interpersonal psychotherapy (IPT): IPT will be administered in 13 individual 50-minute sessions over 13 weeks. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 1 (Placebo) | Participants receiving placebo pill with clinical management plus mothercrafting Placebo: Participants taking the placebo will follow the same titration schedule as those taking sertraline. In addition, the participates will receive the same specific "mother-crafting" techniques as those taking sertraline. Clinical management: Clinical management includes treatment as usual for those receiving medication for depression. Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care |
| BG001 | 2 (Sertraline) | Participants receiving active medication sertraline with clinical management plus mothercrafting Sertraline: Participants assigned to sertraline treatment will take 25 to 50 mg daily for Weeks 1 through 3, and dosage will be increased to 100 to 150 mg daily in Weeks 4 through 10. Participants will be titrated up to 200 mg daily at Week 11 for the final 2 weeks of treatment. In addition, at each week participants will receive specific "mother-crafting" techniques keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information to the mother about infant care. Clinical management: Clinical management includes treatment as usual for those receiving medication for depression. Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care |
| BG002 | 3 (IPT) | Participants receiving interpersonal psychotherapy (IPT) alone Interpersonal psychotherapy (IPT): IPT will be administered in 13 individual 50-minute sessions over 13 weeks. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | 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 | Hamilton Depression Rating Scale (HAM-D) | Measure total ranges from 0 to 50, with lower scores indicating better outcomes. | Posted | Mean | Standard Deviation | units on a scale | Measured at baseline; post-treatment; and Months 3 and 6 of follow-up |
|
|
| |||||||||||||||||||||||||||||||||
| Secondary | Depression Illness Severity Based on Beck Depression Inventory (BDI) | Measure total ranges from 0 to 56, with lower scores indicating better outcomes. | Posted | Mean | Standard Deviation | units on a scale | Measured at baseline; post-treatment; and Months 3 and 6 of follow-up |
| |||||||||||||||||||||||||||||||||||
| Secondary | Global Illness Severity Based on Clinical Global Impression (CGI) Scale | Measure total ranges from 1 to 7, with lower scores indicating better outcomes. | Posted | Mean | Standard Deviation | units on a scale | Measured at baseline; post-treatment; and Months 3 and 6 of follow-up |
| |||||||||||||||||||||||||||||||||||
| Secondary | Social Functioning Based on Postpartum Adjustment Questionnaire (PPAQ) | Measure total ranges from 1 to 5, with lower scores indicating better outcomes. | Posted | Mean | Standard Deviation | units on a scale | Measured at baseline; post-treatment; and Months 3 and 6 of follow-up |
| |||||||||||||||||||||||||||||||||||
| Secondary | Hamilton Anxiety Rating Scale (HARS) | Measure total ranges from 0 to 56, with lower scores indicating better outcomes. | Posted | Mean | Standard Deviation | units on a scale | Measured at baseline; post-treatment; and Months 3 and 6 of follow-up |
|
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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 | 1 (Placebo) | Participants receiving placebo pill with clinical management plus mothercrafting Placebo: Participants taking the placebo will follow the same titration schedule as those taking sertraline. In addition, the participates will receive the same specific "mother-crafting" techniques as those taking sertraline. Clinical management: Clinical management includes treatment as usual for those receiving medication for depression. Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care | 7 | 53 | 20 | 53 | ||
| EG001 | 2 (Sertraline) | Participants receiving active medication sertraline with clinical management plus mothercrafting Sertraline: Participants assigned to sertraline treatment will take 25 to 50 mg daily for Weeks 1 through 3, and dosage will be increased to 100 to 150 mg daily in Weeks 4 through 10. Participants will be titrated up to 200 mg daily at Week 11 for the final 2 weeks of treatment. In addition, at each week participants will receive specific "mother-crafting" techniques keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information to the mother about infant care. Clinical management: Clinical management includes treatment as usual for those receiving medication for depression. Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care | 8 | 56 | 19 | 56 | ||
| EG002 | 3 (IPT) | Participants receiving interpersonal psychotherapy (IPT) alone Interpersonal psychotherapy (IPT): IPT will be administered in 13 individual 50-minute sessions over 13 weeks. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills. | 8 | 53 | 16 | 53 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal ideations or thoughts of self-harm | Psychiatric disorders | Systematic Assessment |
| ||
| Attempted suicide | Psychiatric disorders | Systematic Assessment |
| ||
| Infant hospitalized - bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Infant hospitalized - bronchiolitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Participant hospitalized - gall bladder removal | Surgical and medical procedures | Systematic Assessment |
| ||
| Participant hospitalized - kidney infection | Infections and infestations | Systematic Assessment |
| ||
| Participant hospitalized - bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Worsening of neurovegetative symptoms | Psychiatric disorders | Systematic Assessment |
| ||
| Infant hospitalized - dehydration, fever, vomiting (viral infection) | Infections and infestations | Systematic Assessment |
| ||
| Participant hospitalized - hernia surgery | Surgical and medical procedures | Systematic Assessment |
| ||
| Infant hospitalized - RSV | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Participant hospitalized - chest pain | General disorders | Systematic Assessment |
| ||
| Participant hospitalized - kidney stone removal | Surgical and medical procedures | Systematic Assessment |
| ||
| Infant hospitalized - croup cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Participant hospitalized - dehydration from excessive vomiting | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
| ||
| Participant hospitalized - hyperemesis gravidarum | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
| ||
| Infant hospitalized - urinary infection and hand, foot, and mouth infection | Infections and infestations | Systematic Assessment |
| ||
| Infant hospitalized - high fever | General disorders | Systematic Assessment |
| ||
| Infant hospitalized - reaction to Enfamil | General disorders | Systematic Assessment |
| ||
| Infant hospitalized - scheduled surgery for hydrocephalus | Surgical and medical procedures | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Participant reported experiencing headaches | General disorders | Systematic Assessment |
| ||
| Participant reported experiencing insomnia | General disorders | Systematic Assessment |
| ||
| Participant reported experiencing decreased libido | General disorders | Systematic Assessment |
| ||
| Patient reported experiencing severe fatigue/sleepiness | General disorders | Systematic Assessment |
| ||
| Worsening of symptoms | Psychiatric disorders | Systematic Assessment | Worsening of depressive or other psychiatric symptoms |
| |
| Participant reported experiencing severe agitation | General disorders | Systematic Assessment |
| ||
| Participant reported increased conflict with spouse or partner | Social circumstances | Systematic Assessment |
| ||
| Patient reported experiencing delayed orgasm | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Patient reported hair loss | General disorders | Systematic Assessment |
| ||
| Patient reported mild loss of appetite | General disorders | Systematic Assessment |
| ||
| Participant ER visit - sprained ankle | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Participant reported ear infection | Infections and infestations | Systematic Assessment |
| ||
| Participant reported experiencing toothaches | General disorders | Systematic Assessment |
| ||
| Participant had 3 wisdom teeth removed | Surgical and medical procedures | Systematic Assessment |
| ||
| Infant experiencing "mild" excessive drowsiness | General disorders | Systematic Assessment |
| ||
| Participant reported that infant did not sleep (due to congestion) and is irritable | General disorders | Systematic Assessment |
| ||
| Participant contracted ringworm from daughter | Infections and infestations | Systematic Assessment |
| ||
| Participant screened positive on pregnancy test | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
| ||
| Participant reported experiencing dizziness/vertigo | General disorders | Systematic Assessment |
| ||
| Participant reported fainting | General disorders | Systematic Assessment |
| ||
| Infant had fever and diarrhea | General disorders | Systematic Assessment |
| ||
| Participant had outpatient surgery on an existing hernia | Surgical and medical procedures | Systematic Assessment |
| ||
| Participant injured eye while playing paintball - consulted doctor and healing well | Eye disorders | Systematic Assessment |
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| Participant ER visit - experiencing abdominal pain | General disorders | Systematic Assessment |
| ||
| Participant reported experiencing itching and palpitations | General disorders | Systematic Assessment | resolved 1-2 days after stopping medication |
| |
| Infant increased crying/fussiness, poor sleep, eating less, less frequent stool, less muscle tone | General disorders | Systematic Assessment | resolved when mother stopped breastfeeding for a day and discontinued use of study medication |
| |
| Participant experienced rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Participant reported severe nervousness | General disorders | Systematic Assessment |
| ||
| Participant experienced kidney infection | Infections and infestations | Systematic Assessment |
| ||
| Increased conflict with other family and friends | Social circumstances | Systematic Assessment |
| ||
| Infant experienced increased colic | General disorders | Systematic Assessment |
| ||
| Separation from spouse | Social circumstances | Systematic Assessment |
| ||
| Participant experienced sinus infection | Infections and infestations | Systematic Assessment |
| ||
| Participant experienced pain due to having an IUD placed | General disorders | Systematic Assessment |
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| Participant ER visit - sinusitis | Infections and infestations | Systematic Assessment |
| ||
| Participant diagnosed with 2 bulging discs causing back and leg pain | General disorders | Systematic Assessment |
| ||
| Participant ER visit - shortness of breath, deemed likely to be anxiety related | Psychiatric disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Caron Zlotnick | Women and Infants Hospital | 401-455-6529 | czlotnick@butler.org |
| ID | Term |
|---|---|
| D019052 | Depression, Postpartum |
| D003863 | Depression |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D020280 | Sertraline |
| D000079062 | Interpersonal Psychotherapy |
| ID | Term |
|---|---|
| D015057 | 1-Naphthylamine |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| 3-Month Follow-up |
|
| 6-Month Follow-up |
|
| OG002 | 3 (IPT) | Participants receiving interpersonal psychotherapy (IPT) alone Interpersonal psychotherapy (IPT): IPT will be administered in 13 individual 50-minute sessions over 13 weeks. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills. |
|
|
| OG002 | 3 (IPT) | Participants receiving interpersonal psychotherapy (IPT) alone Interpersonal psychotherapy (IPT): IPT will be administered in 13 individual 50-minute sessions over 13 weeks. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills. |
|
|
| OG002 | 3 (IPT) | Participants receiving interpersonal psychotherapy (IPT) alone Interpersonal psychotherapy (IPT): IPT will be administered in 13 individual 50-minute sessions over 13 weeks. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills. |
|
|
| OG002 | 3 (IPT) | Participants receiving interpersonal psychotherapy (IPT) alone Interpersonal psychotherapy (IPT): IPT will be administered in 13 individual 50-minute sessions over 13 weeks. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills. |
|
|