Depressive Disorder, MajorNCT01744041

Mommy-Baby Treatment for Perinatal Depression

A study testing Dyadic Interpersonal Psychotherapy and Enhanced Treatment as Usual in people with Depressive Disorder, Major and Postpartum Depression, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Depressive Disorder, Major, Postpartum Depression
What is being tested?: Dyadic Interpersonal Psychotherapy and Enhanced Treatment as Usual
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: 1 siteUnited States
Study dates: Nov 2012to 31 Jan 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Pregnant women
18 years and older
between 12 and 30 weeks gestation
Score greater than or equal to 13 on Edinburgh Depression Scale
Structured Clinical Interview (SCID-IV) diagnosis of Major Depressive Disorder, dysthymia, or Depressive Disorder, Not otherwise Specified
English Speaking

Who cannot join

Substance abuse or dependence in past 3 months
Active suicidal or homicidal ideation
Bipolar disorder, psychotic disorder
unstable medical condition or other medical/obstetrical complication
Evidence of severe intimate partner violence
Ongoing psychosocial or pharmacotherapy for depression

Trial locations and contacts

1 site in 1 country.

United States1 site

Washington University School of Medicine
St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Perinatal Depression: Dyadic-IPT to Improve Health of Mother and Baby

Perinatal depression is a major public health problem, affecting 15% of women during pregnancy through the postpartum period, with adverse consequences for the mother, the fetus, the infant, and the family. Despite increasing evidence of the importance of this critical risk interval, little research has investigated the effects of depression treatment during pregnancy on infant outcomes. The purpose of this study is to test the feasibility, acceptability, and effectiveness of a new intervention, Interpersonal psychotherapy for the mother-infant dyad (IPT-Dyad). This intervention begins during pregnancy and continues with the mother and infant until one year postpartum. The investigators hypothesize that IPT-Dyad will be better than treatment as usual in reducing depressive symptoms, improving psychosocial functioning,increasing parenting self-efficacy, improving infant emotional development, and enhancing mother-infant relationship quality.

Conditions: Depressive Disorder, Major, Postpartum Depression
Being tested: Dyadic Interpersonal Psychotherapy, Enhanced Treatment as Usual
Keywords: depression, pregnancy, postpartum, psychotherapy
Medical subject headings: Depressive Disorder, Major, Depression, Postpartum, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dyadic Interpersonal PsychotherapyBehavioural
This intervention consists of a brief psychotherapeutic intervention, Interpersonal Psychotherapy, during pregnancy. Interpersonal Psychotherapy focuses on improving social relationships and interpersonal communication to improve mood. The postpartum phase also utilizes developmentally appropriate strategies to improve the mother-infant relationship.
Enhanced Treatment as UsualOther
This intervention consists of personalized referrals to specialty mental health providers, spiritual counselors, or other needed social services. It includes some non-specific supportive techniques delivered primarily via telephone.

Study groups in NCT01744041
Study group	Role	What they receive
Dyadic Interpersonal Psychotherapy	Experimental	Brief Interpersonal Psychotherapy during pregnancy followed by dyadic mother-infant psychotherapy for one year postpartum Receives: Behavioral: Dyadic Interpersonal Psychotherapy
Enhanced Treatment as Usual	Active comparator	Personalized referral to community resources for depression treatment Receives: Other: Enhanced Treatment as Usual

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Edinburgh Depression Scale From Baseline
Edinburgh Postnatal Depression Scale, a 10-item scale of depression severity, scores range from 0 to 30 with higher scores indicating worse outcome.
Measured: Change from baseline at End of pregnancy (between 37-39 weeks gestation); change from baseline at 3 months postpartum; change from baseline at 6 months postpartum; change from baseline at 9 months postpartum; change from baseline at 12 months postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 201231 Jan 2017

First posted6 Dec 2012 (estimated)
Study startNov 2012
Primary completion31 Jan 2017
Study completion31 Jan 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
More trials run by Washington University School of MedicineThe sponsor's other registered studies.
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: None (open label)
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01744041
Sponsor's protocol ID: 201203136
Other IDs: K23MH090245
Status last verified: Dec 2021
First submitted: 27 Nov 2012
Last updated: 11 Jan 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Lenze SN, Rodgers J, Luby J. A pilot, exploratory report on dyadic interpersonal psychotherapy for perinatal depression. Arch Womens Ment Health. 2015 Jun;18(3):485-91. doi: 10.1007/s00737-015-0503-6. Epub 2015 Jan 22.
PubMed 25604869
Lenze SN, Potts MA. Brief Interpersonal Psychotherapy for depression during pregnancy in a low-income population: A randomized controlled trial. J Affect Disord. 2017 Mar 1;210:151-157. doi: 10.1016/j.jad.2016.12.029. Epub 2016 Dec 20.
PubMed 28038377
Lenze SN, Potts MA, Rodgers J, Luby J. Lessons learned from a pilot randomized controlled trial of dyadic interpersonal psychotherapy for perinatal depression in a low-income population. J Affect Disord. 2020 Jun 15;271:286-292. doi: 10.1016/j.jad.2020.03.084. Epub 2020 Apr 15.
PubMed 32479328

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Perinatal Depression: Dyadic-IPT to Improve Health of Mother and Baby
ClinicalTrials.gov ID: NCT01744041
Acronym / sponsor ID: 201203136
Conditions: Depressive Disorder, Major, Postpartum Depression
Keywords: depression, pregnancy, postpartum, psychotherapy
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: Nov 2012
Primary completion: 31 Jan 2017 (actual)
Study completion: 31 Jan 2017 (actual)
First posted: 6 Dec 2012 (estimated)
Results: Posted 11 Jan 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Dyadic Interpersonal Psychotherapy	Experimental	Behavioral: Dyadic Interpersonal PsychotherapyBrief Interpersonal Psychotherapy during pregnancy followed by dyadic mother-infant psychotherapy for one year postpartum
Enhanced Treatment as Usual	Active comparator	Other: Enhanced Treatment as UsualPersonalized referral to community resources for depression treatment

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Pregnant women
18 years and older
between 12 and 30 weeks gestation
Score greater than or equal to 13 on Edinburgh Depression Scale
Structured Clinical Interview (SCID-IV) diagnosis of Major Depressive Disorder, dysthymia, or Depressive Disorder, Not otherwise Specified

Key exclusion criteria (6 listed)

Substance abuse or dependence in past 3 months
Active suicidal or homicidal ideation
Bipolar disorder, psychotic disorder
unstable medical condition or other medical/obstetrical complication
Evidence of severe intimate partner violence

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
Dyadic Interpersonal PsychotherapyThis intervention consists of a brief psychotherapeutic intervention, Interpersonal Psychotherapy, during pregnancy. Interpersonal Psychotherapy focuses on improving social relationships and interpersonal communication to improve mood. The postpartum phase also utilizes developmentally appropriate strategies to improve the mother-infant relationship.	Behavioural	Dyadic Interpersonal Psychotherapy
Enhanced Treatment as UsualThis intervention consists of personalized referrals to specialty mental health providers, spiritual counselors, or other needed social services. It includes some non-specific supportive techniques delivered primarily via telephone.	Other	Enhanced Treatment as Usual

Primary outcome

Change in Edinburgh Depression Scale From Baseline
Time frame: Change from baseline at End of pregnancy (between 37-39 weeks gestation); change from baseline at 3 months postpartum; change from baseline at 6 months postpartum; change from baseline at 9 months postpartum; change from baseline at 12 months postpartum
Edinburgh Postnatal Depression Scale, a 10-item scale of depression severity, scores range from 0 to 30 with higher scores indicating worse outcome.

Results and safety

Results posted to the registry on 11 Jan 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dyadic Interpersonal Psychotherapy	21	15
Enhanced Treatment as Usual	21	13

Primary outcome: Change in Edinburgh Depression Scale From Baseline

Time frame: Change from baseline at End of pregnancy (between 37-39 weeks gestation); change from baseline at 3 months postpartum; change from baseline at 6 months postpartum; change from baseline at 9 months postpartum; change from baseline at 12 months postpartum. Mean (Standard Deviation). Unit: units on a scale

Measure	Dyadic Interpersonal Psychotherapy n = 21	Enhanced Treatment as Usual n = 21
Baseline Score	17.81 (3.71)	17.9 (4.6)
37-39 week gestation score	12.04 (1.22)	11.41 (1.72)
3-month postpartum score	11.0 (6.1)	10.3 (6.8)
6-month postpartum score	9.5 (2.9)	9.4 (5.8)
9-month postpartum score	10.6 (5.9)	9.4 (4.7)
12-month postpartum score	10.8 (4.0)	8.8 (4.9)

Population analysed: Data shown are for the participants who completed study questionnaires at that time-point. Due to participant drop-out, this number may be less than the overall number of participants analyzed.

Adverse events

Time frame: Baseline to 12 months postpartum, ranging from 14 to 40 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dyadic Interpersonal Psychotherapy	0 of 21 (0%)	0 of 21 (0%)	0 of 21
Enhanced Treatment as Usual	0 of 21 (0%)	0 of 21 (0%)	0 of 21

Limitations and caveats (from the sponsor): This is a small pilot study designed to assess feasibility and not efficacy of this intervention. The primary outcome measure was a self-report scale that may not reflect unbiased outcomes. There was a substantial drop-out rate in each study arm.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 25604869Lenze SN, Rodgers J, Luby J. A pilot, exploratory report on dyadic interpersonal psychotherapy for perinatal depression. Arch Womens Ment Health. 2015 Jun;18(3):485-91. doi: 10.1007/s00737-015-0503-6. Epub 2015 Jan 22.
Results publication: PubMed 28038377Lenze SN, Potts MA. Brief Interpersonal Psychotherapy for depression during pregnancy in a low-income population: A randomized controlled trial. J Affect Disord. 2017 Mar 1;210:151-157. doi: 10.1016/j.jad.2016.12.029. Epub 2016 Dec 20.
Derived from this study: PubMed 32479328Lenze SN, Potts MA, Rodgers J, Luby J. Lessons learned from a pilot randomized controlled trial of dyadic interpersonal psychotherapy for perinatal depression in a low-income population. J Affect Disord. 2020 Jun 15;271:286-292. doi: 10.1016/j.jad.2020.03.084. Epub 2020 Apr 15.

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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.

Shannon Lenze, Ph.D. principal investigator

Washington Univeristy

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 6 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 11 Jan 2022. 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?

Yes. Results are posted in the registry (first posted 11 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Edinburgh Depression Scale From Baseline (time frame: Change from baseline at End of pregnancy (between 37-39 weeks gestation); change from baseline at 3 months postpartum; change from baseline at 6 months postpartum; change from baseline at 9 months postpartum; change from baseline at 12 months postpartum). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01744041, which also lists 3 linked publications.

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 11 Jan 2022.