Behavioral Change in the Mother-Infant Dyad: Preventing Postpartum Depression

NCT01379781 | Completed Results DMC

• 1 other identifier: #6285
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

Postpartum depression (PPD) is undertreated and the consequences of this are substantial for women and children. Studies show that infant cry/fuss and sleep behavior are associated with PPD, and that parenting interventions can change infant behavior, yet these findings have never been applied to PPD. In this study, the investigators are teaching parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to women likely to develop PPD to see if the investigators can prevent the onset of this disorder.

Conditions

Postpartum Depression

Keywords

prevention; postpartum depression

Outcome Measures

Primary Outcomes (1)

• Hamilton Rating Scales of Depression

  * Assessing severity of depression; clinician rated * 24 questions * 13 items are scored on a 5 point scale ranging from 0=not present to 4=severe * 11 items are scored from 0-2 * A composite score is created by the sum of the scores from all items. Scores can range from 0-74 * 0-7: normal * 8-13: mild depression * 14-18: moderate depression * 19-23: severe depression * 24: very severe depression * Higher summed values indicate a greater severity of depression

  6 weeks postpartum

Study Arms (2)

Behavioral Intervention for PPD

EXPERIMENTAL

Behavioral Intervention for PPD delivered over 3 in-person sessions.

Behavioral: Behavioral Intervention for PPD

Treatment As Usual

NO INTERVENTION

Referred to Treatment in the Community.

Interventions

Behavioral Intervention for PPD BEHAVIORAL

We will select a sample of pregnant women at risk for PPD, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits.

Also known as: Preventative Behavioral Intervention for PPD.

Behavioral Intervention for PPD

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy, non-smoking pregnant women
• Ages 18-35
• Score of 28 or higher on the Predictive Index of Postnatal Depression
• Low to normal obstetric risk
• Before 34 weeks gestation

You may not qualify if:

• High Risk pregnancy
• Taking medications that affect the cardiovascular system (α blockers, β blockers, corticosteroids
• Chronic-use asthma medications (e.g. beta2-adrenoceptor agonists)
• Smoking during pregnancy
• Illicit drug/alcohol use during pregnancy
• Taking any psychotropic medications

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (1)

• Jones KA, Freijah I, Brennan SE, McKenzie JE, Bright TM, Fiolet R, Kamitsis I, Reid C, Davis E, Andrews S, Muzik M, Segal L, Herrman H, Chamberlain C. Interventions from pregnancy to two years after birth for parents experiencing complex post-traumatic stress disorder and/or with childhood experience of maltreatment. Cochrane Database Syst Rev. 2023 May 4;5(5):CD014874. doi: 10.1002/14651858.CD014874.pub2.

  PMID: 37146219 DERIVED

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Behavior Therapy; Tuberculin

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Antigens, Bacterial; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antigens; Biological Factors

Results Point of Contact

• Title: Catherine Monk, Ph.D., Assoc Professor
• Organization: Columbia University Medical Center

cem31@columbia.edu

(646) 774-8941

Study Officials

• Catherine E Monk, Ph.D.

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medical Psychology

Study Record Dates

• First Submitted: June 22, 2011
• First Posted: June 23, 2011
• Study Start: August 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2018
• Last Updated: July 3, 2024
• Results First Posted: August 10, 2015

Record last verified: 2024-06

Locations

US (1)