Adjunctive Psychotherapy for Perinatal Bipolar Disorder
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|ClinicalTrials.gov Identifier: NCT02402738|
Recruitment Status : Terminated (We chose to maximize this iterative treatment development study by terminating the pilot RCT in favor of enhancing an initial open trial (increased N 12 to 14))
First Posted : March 30, 2015
Last Update Posted : January 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder||Behavioral: Interpersonal and Social Rhythm Therapy Behavioral: Enhanced Treatment as Usual||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Adjunctive Psychotherapy for Perinatal Bipolar Disorder|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||March 2018|
|Actual Study Completion Date :||March 2018|
Experimental: Interpersonal and Social Rhythm Therapy
Participants may be randomized to receive up to 20 outpatient sessions of Interpersonal and Social Rhythm Therapy, provided as an adjunct to community treatment as usual. Intervention sessions begin during pregnancy and continue through 8 weeks postpartum.
Behavioral: Interpersonal and Social Rhythm Therapy
Active Comparator: Enhanced Treatment as Usual
Those randomized to the Enhanced Treatment as Usual arm will follow their usual treatment plans in the community, with enhanced monitoring of symptoms and functioning through regular study assessments. With a release of information, we will provide community clinicians with a monthly standardized report that summarizes level of symptom severity and risk, designed to aid in continuity of care.
Behavioral: Enhanced Treatment as Usual
- Longitudinal Interval Follow-Up Evaluation (LIFE) [ Time Frame: up to 16 weeks postpartum ]The LIFE is administered to calculate percent time symptomatic (with depression or mania symptoms) over the study period.
- Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) [ Time Frame: up to 16 weeks postpartum ]The QIDS-C is administered to assess change in severity of depressive symptoms over study period.
- Clinician-Administered Rating Scale for Mania (CARS-M) [ Time Frame: up to 16 weeks postpartum ]The CARS-M is administered to assess change in severity of manic and psychotic symptoms over study period.
- Brief Quality of Life Scale for Bipolar Disorder (QoL.BD) [ Time Frame: up to 16 weeks postpartum ]
- Barkin Index of Maternal Functioning [ Time Frame: up to 16 weeks postpartum ]
- Medication Recommendation Tracking Form (MRTF) [ Time Frame: up to 16 weeks postpartum ]
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): NCT02402738
|United States, Rhode Island|
|Providence, Rhode Island, United States, 02906|