NCT02402738

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 30, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

January 16, 2019

Status Verified

January 1, 2019

Enrollment Period

3.9 years

First QC Date

March 20, 2015

Last Update Submit

January 14, 2019

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (3)

  • Longitudinal Interval Follow-Up Evaluation (LIFE)

    The LIFE is administered to calculate percent time symptomatic (with depression or mania symptoms) over the study period.

    up to 16 weeks postpartum

  • Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C)

    The QIDS-C is administered to assess change in severity of depressive symptoms over study period.

    up to 16 weeks postpartum

  • Clinician-Administered Rating Scale for Mania (CARS-M)

    The CARS-M is administered to assess change in severity of manic and psychotic symptoms over study period.

    up to 16 weeks postpartum

Secondary Outcomes (3)

  • Brief Quality of Life Scale for Bipolar Disorder (QoL.BD)

    up to 16 weeks postpartum

  • Barkin Index of Maternal Functioning

    up to 16 weeks postpartum

  • Medication Recommendation Tracking Form (MRTF)

    up to 16 weeks postpartum

Study Arms (2)

Interpersonal and Social Rhythm Therapy

EXPERIMENTAL

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

Enhanced Treatment as Usual

ACTIVE COMPARATOR

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

Interventions

Interpersonal and Social Rhythm TherapyBEHAVIORAL
Interpersonal and Social Rhythm Therapy
Enhanced Treatment as UsualBEHAVIORAL
Enhanced Treatment as Usual

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

Related Publications (1)

  • 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.

    PMID: 30803997DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor (Research)

Study Record Dates

First Submitted

March 20, 2015

First Posted

March 30, 2015

Study Start

April 1, 2014

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

January 16, 2019

Record last verified: 2019-01

Locations

US(1)