NCT01550913

Brief Summary

This study will evaluate the effectiveness of Sober Network Interpersonal Psychotherapy (IPT) in treating women with depression and comorbid substance abuse.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2011

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 12, 2012

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 30, 2016

Status Verified

March 1, 2016

Enrollment Period

4.4 years

First QC Date

March 5, 2012

Last Update Submit

March 29, 2016

Conditions

Perinatal Depression, Substance Use

Keywords

Substance useperinatal depressionpregnant

Outcome Measures

Primary Outcomes (3)

  • Change from baseline in heavy drinking/drug using days at 3 months

    Using the Timeline Followback, participants will report their daily use in the time period between each interview (intake, 6 weeks, 12 weeks, 18-20 weeks and 3 months post treatment). The number of heavy drinking/drug using days reported at intake will be compared to the number reported at the followup assessments.

    up to 3 months post-treatment

  • Change from baseline in depressive symptoms at 18-20 weeks

    The total score of the Hamilton Rating Scale for Depression from intake will be compared to the total score at the 18-20 week assessment to show a reduction in the depressive symptoms.

    baseline and 18-20 weeks

  • Change from baseline in depressive symptoms at 3 months

    The total score of the Hamilton Rating Scale for Depression from intake will be compared to the total score at the 3 month followup assessment to show a reduction in the depressive symptoms.

    baseline and 3 months post-treatment

Secondary Outcomes (1)

  • Change from baseline in Sober and social support at 3 months

    up to 3 months post-treatment

Study Arms (2)

Sober Network IPT

EXPERIMENTAL

Participants are assigned to Sober Network Interpersonal Psychotherapy (IPT)

Behavioral: Sober Network Interpersonal Psychotherapy (IPT)

Treatment as Usual

OTHER

Participants are assigned to have Treatment as Usual

Other: Treatment as Usual

Interventions

Sober Network Interpersonal Psychotherapy (IPT)BEHAVIORAL

IPT will be administered in 16 group 90-minute sessions over 18-20 weeks and 3 individual sessions (at the beginning, middle and end of treatment). These sessions will focus on improving your relationships with others, building sober relationships, setting goals, and increasing coping skills.

Sober Network IPT
Treatment as UsualOTHER

Women in the treatment as usual condition will either be referred to appropriate treatment in the community or continue their current substance use treatment.

Treatment as Usual

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • pregnant or has delivered in the past year
  • reports the use of an illegal drug and/or consumption of 4 or more drinks on one occasion within the last 6 months; if postpartum, report the use of an illegal drug and/or consumption of 4 or more drinks on one occasion or 7 or more drinks in a week within the last 6 months; if pregnant, report the use of an illegal drug within the last 6 months and/or the consumption of 2 or more drinks in one month while pregnant, along with a history of consumption of 4 or more drinks on one occasion or 7 or more drinks in a week within 3 months pre-pregnancy
  • meets DSM-IV criteria of current Major Depressive Disorder (MDD) by Structured Clinical Interview for the DSM-IV(SCID) interview;
  • has a 17-item Hamilton Rating Scale for Depression (HRSD) score \> 16, indicating moderate to severe depression;
  • is between 18 and 50 years old; and
  • is able to speak and read English sufficiently to be able to complete the study procedures

You may not qualify if:

  • meets lifetime criteria for:
  • bipolar disorder
  • a primary psychotic disorder
  • anorexia nervosa
  • bulimia nervosa
  • has started an SUD or MDD medication dose within the 8 weeks prior to enrollment
  • is imminently suicidal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women and Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Caron Zlotnick, PhD

    Women and Infants Hospital of Rhode Island

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Behavioral Medicine Research

Study Record Dates

First Submitted

March 5, 2012

First Posted

March 12, 2012

Study Start

July 1, 2011

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

March 30, 2016

Record last verified: 2016-03

Locations

US(1)