Postpartum DepressionNCT02057627
Mother-Infant Intervention for Postpartum Depression and Associated Mother-Infant Relationship Dysfunction
A study testing Perinatal Dyadic Psychotherapy in people with Postpartum Depression, run by Spaulding Rehabilitation Hospital at 1 site in United States.
Trial summary
Maternal depression and mother-infant relationship dysfunction have reciprocal effects on each other. An integrated approach addressing both problems simultaneously may improve outcomes. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Postpartum Depression
- What is being tested?
- Perinatal Dyadic Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Jul 2012
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- First-time, English-speaking mothers of healthy singleton newborns
- Positive screen (> 10) on Edinburgh Postnatal Depression Scale
Who cannot join
- Suicidal ideation
- Currently receiving depression treatment
- Meets criteria for bipolar disorder and/or lifetime or current psychotic disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
MGH Insiitute of Health Professions
Boston, Massachusetts, 02129
About this study
Official title: Dyadic Intervention for Women at Risk for Postpartum Depression and Their Infants
Maternal depression and mother-infant relationship dysfunction have reciprocal effects on each other. An integrated approach addressing both problems simultaneously may improve outcomes. Perinatal Dyadic Psychotherapy (PDP) was developed to prevent/decrease postpartum depression and facilitate optimal mother-infant relationships. The purpose of this pilot study is to determine the feasibility, acceptability, and preliminary efficacy of PDP. Depressed first-time mothers (meeting diagnostic criteria for depression and/or with high depression symptom levels) and their 6-week-old infants will be randomized to receive either the PDP intervention or a control condition. The PDP intervention consists of 8 home-based, nurse-delivered mother-infant sessions consisting of (a) a supportive, relationship-based, mother-infant psychotherapeutic component, and (b) a developmentally based infant-oriented component focused on promoting positive mother-infant interactions. Control mothers will receive usual care plus depression monitoring by phone. Data will be collected at baseline, post-intervention, and 3 month follow-up. Assessments included maternal depression (diagnosis and severity), maternal anxiety (diagnosis and severity), parenting stress, and mother-infant interaction.
- Conditions
- Postpartum Depression
- Being tested
- Perinatal Dyadic Psychotherapy, Placebo Comparator
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perinatal Dyadic PsychotherapyBehavioural
8-session mother-infant psychotherapy (Perinatal Dyadic Psychotherapy) delivered by nurse-interventionists in participant's homes over 3 months
Placebo ComparatorBehavioural
Standard care plus depression monitoring by phone
| Study group | Role | What they receive |
|---|---|---|
| Perinatal Dyadic Psychotherapy | Experimental | The Perinatal Dyadic Psychotherapy intervention consists of 8 home-based, nurse-delivered mother-infant sessions consisting of (a) a supportive, relationship-based, mother-infant psychotherapeutic component, and (b) a developmentally based infant-oriented component focused on promoting positive mother-infant interactions. The 8 sessions take place over three months with weekly 4 sessions (weeks 1 through 4) followed by 4 every other week sessions (weeks 5 through 8) Receives: Behavioral: Perinatal Dyadic Psychotherapy |
| Standard care plus depression monitoring | Placebo comparator | Standard care plus depression monitoring by phone on a schedule comparable to the intervention groups' home visits. Eight phone calls will take place over three months with weekly 4 calls (weeks 1 through 4) followed by 4 every other week calls (weeks 5 through 8). Phone monitoring will include administration of the Edinburgh Postnatal Depression Scale. Receives: Behavioral: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline on maternal depression diagnosis immediately following the 3 month intervention and at 3 months post-intervention as measured by the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID)
Measured: baseline, 3 months (post-intervention) and 6 months (follow-up)
Change from baseline in maternal depressive symptom scores immediately following the 3 month intervention and at 3 months post-intervention as measured by the Edinburgh Postnatal Depression Scale
Measured: baseline, 3 months (post-intervention) and 6 months (follow-up)
Mother-infant interaction (videotaped and coded) immediately following the 3 month intervention and at 3 months post-intervention
Measured: 3 months (post-intervention) and 6 months (follow-up)
Secondary outcomes (3)
Change from baseline in maternal anxiety diagnosis immediately following the 3 month intervention and at 3 months post-intervention per Structured Clinical Interview for DSM-IV Axis I Disorders (SCID)
Measured: baseline, 3 months (post-intervention) and 6 months (follow-up)
Maternal parenting stress immediately following the 3 month intervention and at 3 months post-intervention as measured by the Parenting Stress Index - Short Form (PSI-SF)
Measured: 3 months (post-intervention) and 6 months (follow-up)
Change from baseline in maternal anxiety symptom level immediately following the 3 month intervention and at 3 months post-intervention as measured by the State-Trait Anxiety Inventory - State (STAI-State)
Measured: baseline, 3 months (post-intervention), 6 months (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2014 (estimated)
- Study startJun 2010
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Responsible party
- Principal investigator, Janice H. Goodman, Spaulding Rehabilitation Hospital
- Investigators
- Janice H Goodman, PhD, Principal investigator, MGH Institute of Health Professions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02057627
- Sponsor's protocol ID
- 1R21HD065156-01
- Status last verified
- Apr 2016
- First submitted
- 5 Feb 2014
- Last updated
- 20 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Goodman JH, Guarino AJ, Prager JE. Perinatal dyadic psychotherapy: design, implementation, and acceptability. J Fam Nurs. 2013 Aug;19(3):295-323. doi: 10.1177/1074840713484822. Epub 2013 Apr 5.
PubMed 23562990
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dyadic Intervention for Women at Risk for Postpartum Depression and Their Infants
- ClinicalTrials.gov ID
- NCT02057627
- Acronym / sponsor ID
- 1R21HD065156-01
- Conditions
- Postpartum Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Spaulding Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Study start
- Jun 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 7 Feb 2014 (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.
Maternal depression and mother-infant relationship dysfunction have reciprocal effects on each other. An integrated approach addressing both problems simultaneously may improve outcomes. Perinatal Dyadic Psychotherapy (PDP) was developed to prevent/decrease postpartum depression and facilitate optimal mother-infant relationships. The purpose of this pilot study is to determine the feasibility, acceptability, and preliminary efficacy of PDP. Depressed first-time mothers (meeting diagnostic criteria for depression and/or with high depression symptom levels) and their 6-week-old infants will be randomized to receive either the PDP intervention or a control condition. The PDP intervention consists of 8 home-based, nurse-delivered mother-infant sessions consisting of (a) a supportive, relationship-based, mother-infant psychotherapeutic component, and (b) a developmentally based infant-oriented component focused on promoting positive mother-infant interactions. Control mothers will receive usual care plus depression monitoring by phone. Data will be collected at baseline, post-intervention, and 3 month follow-up. Assessments included maternal depression (diagnosis and severity), maternal anxiety (diagnosis and severity), parenting stress, and mother-infant interaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perinatal Dyadic Psychotherapy | Experimental | Behavioral: Perinatal Dyadic PsychotherapyThe Perinatal Dyadic Psychotherapy intervention consists of 8 home-based, nurse-delivered mother-infant sessions consisting of (a) a supportive, relationship-based, mother-infant psychotherapeutic component, and (b) a developmentally based infant-oriented component focused on promoting positive mother-infant interactions. The 8 sessions take place over three months with weekly 4 sessions (weeks 1 through 4) followed by 4 every other week sessions (weeks 5 through 8) |
| Standard care plus depression monitoring | Placebo comparator | Behavioral: Placebo ComparatorStandard care plus depression monitoring by phone on a schedule comparable to the intervention groups' home visits. Eight phone calls will take place over three months with weekly 4 calls (weeks 1 through 4) followed by 4 every other week calls (weeks 5 through 8). Phone monitoring will include administration of the Edinburgh Postnatal Depression Scale. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- First-time, English-speaking mothers of healthy singleton newborns
- Positive screen (> 10) on Edinburgh Postnatal Depression Scale
Key exclusion criteria (3 listed)
- Suicidal ideation
- Currently receiving depression treatment
- Meets criteria for bipolar disorder and/or lifetime or current psychotic disorder
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 |
|---|---|---|
| Perinatal Dyadic Psychotherapy8-session mother-infant psychotherapy (Perinatal Dyadic Psychotherapy) delivered by nurse-interventionists in participant's homes over 3 months | Behavioural | Perinatal Dyadic Psychotherapy |
| Placebo ComparatorStandard care plus depression monitoring by phone | Behavioural | Standard care plus depression monitoring |
Primary outcome
Change from baseline on maternal depression diagnosis immediately following the 3 month intervention and at 3 months post-intervention as measured by the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID)
Time frame: baseline, 3 months (post-intervention) and 6 months (follow-up)
Change from baseline in maternal depressive symptom scores immediately following the 3 month intervention and at 3 months post-intervention as measured by the Edinburgh Postnatal Depression Scale
Time frame: baseline, 3 months (post-intervention) and 6 months (follow-up)
Mother-infant interaction (videotaped and coded) immediately following the 3 month intervention and at 3 months post-intervention
Time frame: 3 months (post-intervention) and 6 months (follow-up)
3 secondary outcomes
Change from baseline in maternal anxiety diagnosis immediately following the 3 month intervention and at 3 months post-intervention per Structured Clinical Interview for DSM-IV Axis I Disorders (SCID)
Time frame: baseline, 3 months (post-intervention) and 6 months (follow-up)
Maternal parenting stress immediately following the 3 month intervention and at 3 months post-intervention as measured by the Parenting Stress Index - Short Form (PSI-SF)
Time frame: 3 months (post-intervention) and 6 months (follow-up)
Change from baseline in maternal anxiety symptom level immediately following the 3 month intervention and at 3 months post-intervention as measured by the State-Trait Anxiety Inventory - State (STAI-State)
Time frame: baseline, 3 months (post-intervention), 6 months (follow-up)
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 20 Apr 2016.
- Results publication: PubMed 23562990Goodman JH, Guarino AJ, Prager JE. Perinatal dyadic psychotherapy: design, implementation, and acceptability. J Fam Nurs. 2013 Aug;19(3):295-323. doi: 10.1177/1074840713484822. Epub 2013 Apr 5.
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.
Janice H Goodman, PhD principal investigator
MGH Institute of Health Professions
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perinatal Dyadic Psychotherapy in people with Postpartum Depression, run by Spaulding Rehabilitation Hospital 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 2 inclusion and 3 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 20 Apr 2016. 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. Some participants in this study may receive a placebo. 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?
Change from baseline on maternal depression diagnosis immediately following the 3 month intervention and at 3 months post-intervention as measured by the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID) (time frame: baseline, 3 months (post-intervention) and 6 months (follow-up)). The study lists 3 primary outcomes in all. 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 NCT02057627, which also lists 1 linked publication.
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 20 Apr 2016.