Adjunctive Psychotherapy for Perinatal Bipolar Disorder

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.

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