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Adjunctive Psychotherapy for Perinatal Bipolar Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Butler Hospital
Women and Infants Hospital of Rhode Island
The Miriam Hospital
Michigan State University
Information provided by (Responsible Party):
Lauren M. Weinstock, PhD, Brown University

Brief Summary:
Bipolar disorder (BD) is a serious, disabling, and highly recurrent illness. The perinatal period dramatically increases risk for mood episodes in women with BD, but pregnancy complicates pharmacologic treatment decisions and efficacy. This study will be the first to systematically develop and pilot test an adjunctive psychosocial intervention to assist in treatment of BD during the high-risk perinatal period.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Behavioral: Interpersonal and Social Rhythm Therapy Behavioral: Enhanced Treatment as Usual Not Applicable

Detailed Description:
The perinatal period appears to be especially destabilizing for women with bipolar disorder (BD), with prospective studies revealing mood episode morbidity in up to 70% of pregnant women with the disorder, and risk of postpartum mania in as high as 50% of cases. There are clear negative sequelae of BD for mothers and their offspring, including gross maternal impairment, substantial risk for suicide, high risk of postpartum psychosis, and adverse childbirth outcomes. Yet data concerning the clinical management of BD during the perinatal period are strikingly limited. Pharmacotherapy is complicated due to known teratogenic risks of certain medications, the lack of safety data for others, and difficult treatment decisions, including the decision to discontinue pharmacotherapy, that women and clinicians face in light of limited data. Prophylactic mood stabilization has been widely recommended, yet data suggest that even among women with BD treated with medication, there remains significant risk of mood episode morbidity in the perinatal period. Given the pernicious course of BD in the perinatal period, adjunctive interventions aimed at improving clinical outcomes are critically needed. Interpersonal and Social Rhythm Therapy (IPSRT) is an adjunctive psychosocial intervention that may serve this need, as it: (a) incorporates key elements of Interpersonal Psychotherapy (IPT), which has a strong evidence base for treatment of perinatal depression in unipolar samples, (b) includes a behavioral intervention to stabilize the circadian rhythm disruption that may place perinatal women at high risk for mood and psychotic symptoms, (c) has established efficacy for the treatment of BD in non-perinatal samples, and (d) carries the promise of potential clinical benefit without additional fetal exposure. Yet there are no published studies evaluating the efficacy of IPSRT, or any psychosocial intervention, as an adjunct to pharmacotherapy for BD in the perinatal period. Given its many potential benefits, the primary aim of this R34 Exploratory Research Proposal (PAR-12-279) is to adapt and pilot IPSRT for perinatal women with BD. The development phase of this study will result in a treatment manual, training manual, and fidelity scales which will be tested in an open trial of 12 pregnant women with BD, treated through the early postpartum. The pilot phase will examine feasibility and acceptability of the proposed recruitment methods, research design, intervention, and interventionist training program by randomizing 40 pregnant women with BD to enhanced treatment as usual (E-TAU) or E-TAU + IPSRT, delivered through the early postpartum. Primary outcomes will be mood and psychotic symptoms up to 16 weeks postpartum. Additional outcomes include medication adherence, maternal functioning, and birth outcomes (secondary), and increased social support and circadian and social rhythm stability (tertiary). This pilot study will lay the groundwork for a larger, stage II clinical trial (R01) to evaluate the efficacy of this intervention for improving clinical and functional outcomes among this high risk, understudied population during the vulnerable transition from pregnancy to the postpartum period.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

Secondary Outcome Measures :
  1. Brief Quality of Life Scale for Bipolar Disorder (QoL.BD) [ Time Frame: up to 16 weeks postpartum ]
  2. Barkin Index of Maternal Functioning [ Time Frame: up to 16 weeks postpartum ]
  3. Medication Recommendation Tracking Form (MRTF) [ Time Frame: up to 16 weeks postpartum ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • DSM-5 diagnosis of bipolar I or bipolar II disorder
  • at least moderately symptomatic (depression or manic symptoms) at time of study entry
  • currently pregnant, up to 28 weeks gestation

Exclusion Criteria:

  • presence of psychiatric symptoms severe enough to warrant inpatient hospitalization
  • current psychotic symptoms
  • active alcohol or substance use disorder
  • cognitive deficits that preclude full understanding of study materials
  • inability to understand English sufficiently well to understand consent or assessment instruments when read aloud
  • plans to relocate within 8 months

Information from the National Library of Medicine

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 identifier (NCT number): NCT02402738

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United States, Rhode Island
Butler Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Brown University
Butler Hospital
Women and Infants Hospital of Rhode Island
The Miriam Hospital
Michigan State University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Lauren M. Weinstock, PhD, Associate Professor (Research), Brown University Identifier: NCT02402738    
Other Study ID Numbers: 1R34MH102466-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 30, 2015    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders