- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00282776
Identification and Therapy of Postpartum Depression
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Depression is a serious illness that can interfere with everyday life. Researchers believe that it is one of the most common complications during and after pregnancy. Depression after pregnancy is called postpartum depression and may be caused by a rapid change in hormone levels during and immediately after pregnancy. Postpartum depression can occur anytime within the first year after childbirth and can negatively affect both mothers and their children. Mothers with postpartum depression may experience low energy, difficulty concentrating, irritability, and inability to meet their children's needs for love and affection. As a result, women with postpartum depression may feel guilty and lose confidence in themselves as parents. Research shows that children of mothers with postpartum depression may have delays in language development, difficulty with emotional bonding to others, behavioral problems, lower activity levels, sleep problems, and distress. This study will evaluate the effectiveness of a telephone-based depression screening and care management program in treating depression in postpartum women.
Participants in this single blind study will be randomly assigned to receive either enhanced treatment as usual or telephone-based care management for the first year postpartum. All participants will have a 90-minute in-home interview upon study entry to assess depressive symptoms, functional status, medical history, and post-pregnancy plans. Participants assigned to care management will receive two calls in the first month postpartum, followed by monthly calls for the remainder of the first postpartum year. During each 10- to 20-minute call, participants will be asked to provide information regarding current depressive symptoms, steps they have taken to seek depression-related care, and any barriers they have encountered in the process. In addition, a care manager will act as an advocate for the participants and assist in obtaining specialized services as necessary throughout the year. Participants assigned to receive enhanced treatment as usual will not receive monthly phone calls or tailored care management. All participants will receive follow-up calls at 3, 6, and 12 months postpartum to assess outcome measures; these calls will last about 30 minutes.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 3
Kontakter och platser
Studieorter
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Pennsylvania
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Pittsburgh, Pennsylvania, Förenta staterna, 15213
- Women's Behavioral HealthCARE Program, Suite 410, 3501 Forbes Ave
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- 4-6 weeks postpartum
- English-speaking
- Score of at least 10 on the Edinburgh Postnatal Depression Scale
Exclusion Criteria:
- DSM-IV diagnosis of bipolar disorder or psychotic episode
- Active substance abuse within 6 months prior to study entry
- Has not received obstetrical care
- History of a suicide attempt within 6 months of study entry
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: TAU
Deltagarna kommer att få behandling som vanligt
|
Participants receive treatment as usual for postpartum depression.
Women assigned to this arm receive research assessments at 3, 6, and 12 months postpartum.
At the baseline home visit where diagnostic assessments are completed women are given information about community and health plan resources if they choose to seek care for depression symptoms.
Women are also given phone contact numbers for the research program.
|
Experimentell: DCM
Participants will receive care management for postpartum depression
|
Depression Care Manager calls postpartum women and encourages women to seek appropriate depression care.
In this context the depression care manager helps the women to identify barriers to appropriate care, her preferred method of care, and resources available.
Calls are made initially at 2 calls per month, followed by one call per month and calls every other month for women who are doing well.
Women assigned to this group receive research assessments at 3, 6, and 12 months postpartum.
They also receive information about community and health plan resources available for women with depression.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Depressive symptoms, social functioning, and health
Tidsram: Measured at Months 3, 6, and 12 postpartum
|
Measured at Months 3, 6, and 12 postpartum
|
Preferences for depression treatment
Tidsram: Measured at baseline and Month 12
|
Measured at baseline and Month 12
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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Katherine L. Wisner, MD, RN, University of Pittsburgh
Publikationer och användbara länkar
Allmänna publikationer
- Wisner KL, Sit DKY, McShea M, Luther JF, Eng HF, Dills JL, Moses-Kolko EL, Wisniewski SR. Telephone-Based Depression Care Management for Postpartum Women: A Randomized Controlled Trial. J Clin Psychiatry. 2017 Nov-Dec;78(9):1369-1375. doi: 10.4088/JCP.15m10563.
- Clark CT, Sit DK, Driscoll K, Eng HF, Confer AL, Luther JF, Wisniewski SR, Wisner KL. DOES SCREENING WITH THE MDQ AND EPDS IMPROVE IDENTIFICATION OF BIPOLAR DISORDER IN AN OBSTETRICAL SAMPLE? Depress Anxiety. 2015 Jul;32(7):518-26. doi: 10.1002/da.22373. Epub 2015 Jun 8.
- Wisner KL, Sit DK, McShea MC, Rizzo DM, Zoretich RA, Hughes CL, Eng HF, Luther JF, Wisniewski SR, Costantino ML, Confer AL, Moses-Kolko EL, Famy CS, Hanusa BH. Onset timing, thoughts of self-harm, and diagnoses in postpartum women with screen-positive depression findings. JAMA Psychiatry. 2013 May;70(5):490-8. doi: 10.1001/jamapsychiatry.2013.87.
- Sit D, Seltman H, Wisner KL. Seasonal effects on depression risk and suicidal symptoms in postpartum women. Depress Anxiety. 2011 May;28(5):400-5. doi: 10.1002/da.20807. Epub 2011 Mar 4.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- R01MH071825 (U.S.S. NIH-anslag/kontrakt)
- DSIR 82-SEMS (Annan identifierare: National Institute of Mental Health)
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