- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01935375
Multidisciplinary Model of Nurse Midwife
Multidisciplinary Model of Nurse Midwife Psychotherapy for Postpartum Depression
HYPOTHESES:
The hypotheses are that:
- nurse midwives will be able to safely deliver interpersonal psychotherapy by telephone to women with postpartum depression
- women receiving interpersonal psychotherapy will have less symptoms of postpartum depression, better functioning, better bonding with their babies, and better relationships with their partners
- women with postpartum depression will be more satisfied with their care than women in the group that was referred to a mental health center.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
The specific aims of this pilot non-randomized clinical trial are to evaluate among women with PPD recruited between 6 and 24 weeks postpartum:
- The (a) feasibility, (b) acceptability and (c) safety of a psychological intervention (Interpersonal Psychotherapy [IPT]) provided by nurse midwives in collaboration with a mental health team (psychiatrist team leader and a licensed social worker) for treatment of PPD in a pilot two-armed non-randomized clinical trial.
- The preliminary evidence of efficacy of IPT in decreasing depressive symptoms when administered via telephone by nurse-midwives/ women's health nurse practitioner
The proposed study will also evaluate preliminary evidence for the efficacy of IPT administered by nurse midwives in
- Improving the general level of maternal functioning
- Specific improvement in marital adjustment
- Increase in maternal infant bonding
This pilot study is the first step in developing an intervention to decrease depressive symptoms, improve functioning, improve interpersonal relationships between mother and spouse and infant, improve access to care, and improve treatment engagement among postpartum women diagnosed with PPD. The intervention will be cost-effective, brief and acceptable to both patients and nurse midwives for incorporation into current midwifery practice. If the IPT program is found to be feasible, acceptable and safe with preliminary evidence of efficacy, a postpartum IPT manual for advanced practice nurses will be finalized in order to test whether other advanced practice nurses such as pediatric nurse practitioners and family nurse practitioners can also safely and effectively administer IPT in a full-scale randomized clinical trial
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Pennsylvania
-
Phila, Pennsylvania, Förenta staterna, 19102
- Drexel University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- 6 to 24 weeks postpartum
- 16 years and older
- English-speaking
- Have access to a telephone
- Consents to enter the trial
- Postpartum onset of postpartum depression
- Current use of antidepressant medication as long as dose does not have to be adjusted by subject's healthcare provider during clinical trial
Exclusion Criteria:
- Infant complications requiring medical care beyond 6 weeks postpartum
- Infant birth defects
- Infant being placed for adoption by 6 weeks postpartum
- Maternal mental retardation
- Current use of antidepressant medication that requires dosage adjustment by subject's healthcare provider during clinical trial
- Diagnosis of depression prior to postpartum period
- Active substance or alcohol abuse or dependence
- Active suicidality, homicidality, or current psychosis as assessed by the MINI
- Disabling pain that interferes with the ability to carry out activities of daily living
- Concurrent serious medical co-morbidities (e.g. active lupus, multiple sclerosis, severe cardiac disease severe hypertension, cancer, etc).
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: CNM Interpersonal Psychotherapy
CNM Interpersonal psychotherapy
|
Eight Weekly 50 minute sessions CNM Interpersonal Psychotherapy
|
Aktiv komparator: Treatment as Usual
Treatment as Usual is psychotherapy with a mental health provider
|
Treatment as Usual is psychotherapy provided by a mental health provider
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Hamilton Rating Scale for depression
Tidsram: 12 weeks
|
Measure of depression severity
|
12 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Global Assessment of functioning
Tidsram: 12 weeks
|
Measure of functional status
|
12 weeks
|
Dyadic Adjustment Scale
Tidsram: 12 weeks
|
Measure of dyadic adjustment of marital couple
|
12 weeks
|
Social Support Questionnaire
Tidsram: 12 weeks
|
Measure of improvement in social support
|
12 weeks
|
Client Satisfaction Questionnaire
Tidsram: 12 weeks
|
Measure of client satisfaction with midwife counseling
|
12 weeks
|
Edinburgh Postnatal Depression Scale
Tidsram: 12 weeks
|
Measure of severity of postpartum depression
|
12 weeks
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Barbara E Posmontier, PHD, Drexel University
- Huvudutredare: Richard Neugebauer, PhD, Columbia University
- Huvudutredare: Rita Shaughnessy, PhD, MD, Drexel University
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
- 18981
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Postpartum depression
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Women's Health Research...AvslutadPostpartum depression | Perinatal sjukdom | Postpartum sjukdom | Perinatal depression | Postpartum ångest | Postnatal depressionKanada
-
British Columbia Children's HospitalAktiv, inte rekryterande
-
University of RochesterMae Stone Goode FoundationAvslutadPostpartum depression | Postpartum ångestFörenta staterna
-
Hacettepe UniversityAvslutadLivskvalité | Postpartum depression | Omvårdnad karies | Sjuksköterskans roll | Postpartum sjukdom | Postpartum ångestKalkon
-
Women's College HospitalCanadian Institutes of Health Research (CIHR); Michael Garron HospitalAvslutadPostpartum depression | Postpartum ångest | Blues efter förlossningen | Postpartum humörstörningKanada
-
University of Cape TownNational Institute of Mental Health (NIMH)AvslutadPostpartum depression | Klinisk depression | Måttlig depressionSydafrika
-
Northwestern UniversityNational Institute on Minority Health and Health Disparities (NIMHD)AvslutadPostpartum depression | Perinatal depressionFörenta staterna
-
Northwestern UniversityNational Institute on Minority Health and Health Disparities (NIMHD)AvslutadDepression | Postpartum depression | Perinatal depressionFörenta staterna
-
Peking University First HospitalPeking University International Hospital; Women's Hospital School Of Medicine... och andra samarbetspartnersAvslutadPostpartum depression | Ketamin | Prenatal depressionKina
-
Peking University First HospitalPeking University International Hospital; Women's Hospital School Of Medicine... och andra samarbetspartnersAvslutadPostpartum depression | Ketamin | Prenatal depressionKina
Kliniska prövningar på CNM Interpersonal Psychotherapy
-
Boston CollegeNational Institute of Mental Health (NIMH)RekryteringKunskap, attityder, praktikFörenta staterna
-
Clene NanomedicineClene Australia Pty LtdAvslutadÅterkommande förlöpande multipel skleros | Optisk neuropati | Optisk; Neurit, med demyeliniseringFörenta staterna, Kanada, Australien
-
Clene NanomedicineClene Australia Pty LtdAvslutadAmyotrofisk lateral sklerosAustralien
-
Clene NanomedicineUniversity of Texas Southwestern Medical CenterRekryteringMultipel sklerosFörenta staterna
-
Clene NanomedicineUniversity of Texas Southwestern Medical CenterAvslutadParkinsons sjukdomFörenta staterna
-
Clene NanomedicineMassachusetts General HospitalTillgängligt
-
Clene NanomedicineUniversity of Texas Southwestern Medical CenterIndragenAmyotrofisk lateral sklerosFörenta staterna
-
Clene NanomedicineTillgängligtAmyotrofisk lateral sklerosFörenta staterna
-
Merit E. Cudkowicz, MDClene NanomedicineAvslutad
-
University of OregonAvslutad