Postpartum DepressionNCT01935375
Multidisciplinary Model of Nurse Midwife
A study testing CNM Interpersonal Psychotherapy and Treatment as Usual in people with Postpartum Depression, run by Drexel University at 1 site in United States.
Trial summary
HYPOTHESES: The hypotheses are that: 1. nurse midwives will be able to safely deliver interpersonal psychotherapy by telephone to women with postpartum depression 2. women receiving interpersonal psychotherapy will have less symptoms of postpartum depression, better functioning, better bonding with their babies, and… Read more about this study
- Who is it for?
- Ages 16 to 45 years, women only
- Conditions the study is for
- Postpartum Depression
- What is being tested?
- CNM Interpersonal Psychotherapy and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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
- Conditions
- Postpartum Depression
- Being tested
- CNM Interpersonal Psychotherapy, Treatment as Usual
- Keywords
- Postpartum Depression, Nurse Midwife, Interpersonal Psychotherapy
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CNM Interpersonal PsychotherapyBehavioural
Eight Weekly 50 minute sessions CNM Interpersonal Psychotherapy
Treatment as UsualBehavioural
Treatment as Usual is psychotherapy provided by a mental health provider
| Study group | Role | What they receive |
|---|---|---|
| CNM Interpersonal Psychotherapy | Experimental | CNM Interpersonal psychotherapy Receives: Behavioral: CNM Interpersonal Psychotherapy |
| Treatment as Usual | Active comparator | Treatment as Usual is psychotherapy with a mental health provider Receives: Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Rating Scale for depression
Measure of depression severity
Measured: 12 weeks
Secondary outcomes (5)
Global Assessment of functioning
Measure of functional status
Measured: 12 weeks
Dyadic Adjustment Scale
Measure of dyadic adjustment of marital couple
Measured: 12 weeks
Social Support Questionnaire
Measure of improvement in social support
Measured: 12 weeks
Client Satisfaction Questionnaire
Measure of client satisfaction with midwife counseling
Measured: 12 weeks
Edinburgh Postnatal Depression Scale
Measure of severity of postpartum depression
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2013 (estimated)
- Study startJul 2010
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara Posmontier, Drexel University
- Investigators
- Barbara E Posmontier, PHD, Principal investigator, Drexel UniversityRichard Neugebauer, PhD, Principal investigator, Columbia UniversityScott Stuart, MD, Principal investigator, University of IowaRita Shaughnessy, PhD, MD, Principal investigator, Drexel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01935375
- Sponsor's protocol ID
- 18981
- Status last verified
- Aug 2015
- First submitted
- 24 May 2010
- Last updated
- 7 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidisciplinary Model of Nurse Midwife Psychotherapy for Postpartum Depression
- ClinicalTrials.gov ID
- NCT01935375
- Acronym / sponsor ID
- 18981
- Conditions
- Postpartum Depression
- Keywords
- Postpartum Depression, Nurse Midwife, Interpersonal Psychotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 5 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CNM Interpersonal Psychotherapy | Experimental | Behavioral: CNM Interpersonal PsychotherapyCNM Interpersonal psychotherapy |
| Treatment as Usual | Active comparator | Behavioral: Treatment as UsualTreatment as Usual is psychotherapy with a mental health provider |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 6 to 24 weeks postpartum
- 16 years and older
- English-speaking
- Have access to a telephone
- Consents to enter the trial
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CNM Interpersonal PsychotherapyEight Weekly 50 minute sessions CNM Interpersonal Psychotherapy | Behavioural | CNM Interpersonal Psychotherapy |
| Treatment as UsualTreatment as Usual is psychotherapy provided by a mental health provider | Behavioural | Treatment as Usual |
Primary outcome
Hamilton Rating Scale for depression
Time frame: 12 weeks
Measure of depression severity
5 secondary outcomes
Global Assessment of functioning
Time frame: 12 weeks
Dyadic Adjustment Scale
Time frame: 12 weeks
Social Support Questionnaire
Time frame: 12 weeks
Client Satisfaction Questionnaire
Time frame: 12 weeks
Edinburgh Postnatal Depression Scale
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2015.
Related trials for Postpartum Depression
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Recruiting
Restoring Emotional Needs With Exogenous Ketones for Women With Postpartum Depression
Postpartum Depression (PPD)
Recruiting
Treatment With Repetitive Transcranial Magnetic Stimulation in Peripartal Depression
Depression During Pregnancy, Postpartum Depression (PPD)
Enrolling by invitation
Intervention to Reduce HIV Related Stigma Among Pregnant and Postpartum Women
HIV, HIV - Human Immunodeficiency Virus
RecruitingEarly Phase 1
A Web-based Intervention Program for Postpartum Depression
Postpartum Depression (PPD), Web-based Intervention
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara E Posmontier, PHD principal investigator
Drexel University
Richard Neugebauer, PhD principal investigator
Columbia University
Scott Stuart, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CNM Interpersonal Psychotherapy and Treatment as Usual in people with Postpartum Depression, run by Drexel University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Rating Scale for depression (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2015.