Effectiveness of Group Interpersonal Psychotherapy in Treating Women With Prenatal Depression

NCT00633178 | Completed DMC

• 2 other identifiers: R34MH072838, #4914R34MH072838
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the effectiveness of group interpersonal psychotherapy for preventing postpartum depression in pregnant women with depression and for improving healthy outcomes in their babies.

Conditions

Depression

Keywords

Prenatal Depression; Postpartum Depression; Fetal Development; Interpersonal Therapy

Outcome Measures

Primary Outcomes (2)

• Improved prenatal mood

  Hamilton Scales for Depression Score

  Measured during the prenatal period (pregnant participants enroll at 23/24 weeks gestation and are assessed through 40 weeks of gestations)

• Postpartum depression

  Hamilton Scales for Depression Score

  Measured during the postpartum period (pregnant participants enroll at 23/24 weeks gestation and are assessed through 40 weeks of gestations)

Study Arms (3)

Group Interpersonal Therapy (IPT)

EXPERIMENTAL

Participants will receive group interpersonal therapy.

Behavioral: Group interpersonal therapy (IPT)

Treatment as Usual (ETAU)

ACTIVE COMPARATOR

Participants will receive psychiatric treatment as usual.

Behavioral: Treatment as usual (TAU)

No Treatment

NO INTERVENTION

Participants are healthy and will receive no treatment.

Interventions

Group interpersonal therapy (IPT) BEHAVIORAL

Group IPT will include weekly treatment sessions with a psychiatrist for 12 weeks. The sessions will focus on overcoming relationship problems associated with depression. The first two and last sessions will be alone with the psychiatrist and the remaining sessions will be with a group of five to eight other pregnant women.

Group Interpersonal Therapy (IPT)

Treatment as usual (TAU) BEHAVIORAL

TAU will include referrals to outpatient treatment, which may include cognitive behavioral psychotherapy, insight-oriented psychotherapy, and/or antidepressant medication. TAU participants receiving psychotherapy will attend 12 weekly treatment sessions comparable to the IPT group sessions; treatment for TAU participants receiving medication for their depression may last longer than 12 weeks.

Treatment as Usual (ETAU)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Score of at least 10 on the Edinburgh Postnatal Depression Scale (EPDS)

You may not qualify if:

• Multi-fetal pregnancy
• Taking medications that affect the cardiovascular system (e.g., doxazosin)
• History of suicide attempt or current suicidal ideation
• Psychotic features
• Life-time history of bipolar disorder
• Current eating disorder
• Currently diagnosed with any of the following: obsessive compulsive disorder, major depression with melancholic features, severe major depression, panic disorder, organic brain syndrome, mental retardation, antisocial personality disorder, borderline personality disorder, or presence of three or more schizotypal features
• Smokes cigarettes
• Substance dependence or abuse
• Complicated pregnancy or delivery
• Premature delivery
• Neonate medical/developmental problems
• Taking a psychotropic medication at the time of the initial phone contact with study investigators

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Depression; Depression, Postpartum

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

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

Study Officials

• Catherine Monk, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2008
• First Posted: March 11, 2008
• Study Start: January 1, 2005
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: July 1, 2021

Record last verified: 2011-12

Locations

US (1)