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Sober Network IPT for Perinatal Women With Comorbid Substance Use and Depression

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Caron Zlotnick, Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier:
NCT01550913
First received: March 5, 2012
Last updated: March 29, 2016
Last verified: March 2016
  Purpose
This study will evaluate the effectiveness of Sober Network Interpersonal Psychotherapy (IPT) in treating women with depression and comorbid substance abuse.

Condition Intervention Phase
Perinatal Depression, Substance Use
Behavioral: Sober Network Interpersonal Psychotherapy (IPT)
Other: Treatment as Usual
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Sober Network IPT for Perinatal Women With Comorbid Substance Use and Depression

Resource links provided by NLM:


Further study details as provided by Women and Infants Hospital of Rhode Island:

Primary Outcome Measures:
  • Change from baseline in heavy drinking/drug using days at 3 months [ Time Frame: up to 3 months post-treatment ] [ Designated as safety issue: No ]
    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.

  • Change from baseline in depressive symptoms at 18-20 weeks [ Time Frame: baseline and 18-20 weeks ] [ Designated as safety issue: No ]
    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.

  • Change from baseline in depressive symptoms at 3 months [ Time Frame: baseline and 3 months post-treatment ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change from baseline in Sober and social support at 3 months [ Time Frame: up to 3 months post-treatment ] [ Designated as safety issue: No ]
    Using the total score of the Multidimensional Scale of Perceived Social Support (MSPSS) reported at the intake and at the 3 month followup the improvement in social and sober support will be determined.


Enrollment: 59
Study Start Date: July 2011
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sober Network IPT
Participants are assigned to Sober Network Interpersonal Psychotherapy (IPT)
Behavioral: Sober Network Interpersonal Psychotherapy (IPT)
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.
Treatment as Usual
Participants are assigned to have Treatment as Usual
Other: Treatment as Usual
Women in the treatment as usual condition will either be referred to appropriate treatment in the community or continue their current substance use treatment.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. pregnant or has delivered in the past year
  2. 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
  3. meets DSM-IV criteria of current Major Depressive Disorder (MDD) by Structured Clinical Interview for the DSM-IV(SCID) interview;
  4. has a 17-item Hamilton Rating Scale for Depression (HRSD) score > 16, indicating moderate to severe depression;
  5. is between 18 and 50 years old; and
  6. is able to speak and read English sufficiently to be able to complete the study procedures

Exclusion Criteria:

  1. meets lifetime criteria for:

    • bipolar disorder
    • a primary psychotic disorder
    • anorexia nervosa
    • bulimia nervosa
  2. has started an SUD or MDD medication dose within the 8 weeks prior to enrollment
  3. is imminently suicidal
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01550913

Locations
United States, Rhode Island
Women and Infants Hospital of Rhode Island
Providence, Rhode Island, United States, 02905
Sponsors and Collaborators
Women and Infants Hospital of Rhode Island
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Caron Zlotnick, PhD Women and Infants Hospital of Rhode Island
  More Information

Responsible Party: Caron Zlotnick, Director of Behavioral Medicine Research, Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier: NCT01550913     History of Changes
Other Study ID Numbers: R34DA030428-01A1 
Study First Received: March 5, 2012
Last Updated: March 29, 2016
Health Authority: United States: Federal Government

Keywords provided by Women and Infants Hospital of Rhode Island:
Substance use
perinatal depression
pregnant

Additional relevant MeSH terms:
Depression
Depressive Disorder
Asphyxia Neonatorum
Behavioral Symptoms
Mood Disorders
Mental Disorders
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on December 08, 2016