Adjunctive Psychotherapy for Perinatal Bipolar Disorder

• ClinicalTrials.gov Identifier: NCT02402738
• Recruitment Status: Terminated
• First Posted: March 30, 2015
• Last Update Posted: January 16, 2019
• Sponsor: Brown University
• Collaborators: 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

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Johansen SL, Robakis TK, Williams KE, Rasgon NL. Management of perinatal depression with non-drug interventions. BMJ. 2019 Feb 25;364:l322. doi: 10.1136/bmj.l322. Review.

• Responsible Party: Lauren M. Weinstock, PhD, Associate Professor (Research), Brown University
• ClinicalTrials.gov Identifier: NCT02402738
• Other Study ID Numbers: 1R34MH102466-01A1 ( U.S. NIH Grant/Contract )
• First Posted: March 30, 2015
• Last Update Posted: January 16, 2019
• Last Verified: January 2019

Additional relevant MeSH terms:

Bipolar Disorder; Bipolar and Related Disorders; Mental Disorders