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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Pennsylvania
-
Phila, Pennsylvania, Forente stater, 19102
- Drexel University
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Hamilton Rating Scale for depression
Tidsramme: 12 weeks
|
Measure of depression severity
|
12 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Global Assessment of functioning
Tidsramme: 12 weeks
|
Measure of functional status
|
12 weeks
|
|
Dyadic Adjustment Scale
Tidsramme: 12 weeks
|
Measure of dyadic adjustment of marital couple
|
12 weeks
|
|
Social Support Questionnaire
Tidsramme: 12 weeks
|
Measure of improvement in social support
|
12 weeks
|
|
Client Satisfaction Questionnaire
Tidsramme: 12 weeks
|
Measure of client satisfaction with midwife counseling
|
12 weeks
|
|
Edinburgh Postnatal Depression Scale
Tidsramme: 12 weeks
|
Measure of severity of postpartum depression
|
12 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Barbara E Posmontier, PHD, Drexel University
- Hovedetterforsker: Richard Neugebauer, PhD, Columbia University
- Hovedetterforsker: Rita Shaughnessy, PhD, MD, Drexel University
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 18981
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