Sober Network IPT for Perinatal Women With Comorbid Substance Use and Depression
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|ClinicalTrials.gov Identifier: NCT01550913|
Recruitment Status : Completed
First Posted : March 12, 2012
Last Update Posted : March 30, 2016
|Condition or disease||Intervention/treatment||Phase|
|Perinatal Depression, Substance Use||Behavioral: Sober Network Interpersonal Psychotherapy (IPT) Other: Treatment as Usual||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||59 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Sober Network IPT for Perinatal Women With Comorbid Substance Use and Depression|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
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.
- Change from baseline in heavy drinking/drug using days at 3 months [ Time Frame: up to 3 months post-treatment ]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 ]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 ]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.
- Change from baseline in Sober and social support at 3 months [ Time Frame: up to 3 months post-treatment ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01550913
|United States, Rhode Island|
|Women and Infants Hospital of Rhode Island|
|Providence, Rhode Island, United States, 02905|
|Principal Investigator:||Caron Zlotnick, PhD||Women and Infants Hospital of Rhode Island|