Bipolar DisorderNCT02402738
Adjunctive Psychotherapy for Perinatal Bipolar Disorder
A study testing Interpersonal and Social Rhythm Therapy and Enhanced Treatment as Usual in people with Bipolar Disorder, run by Brown University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Interpersonal and Social Rhythm Therapy and Enhanced Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Bipolar Disorder
- Being tested
- Interpersonal and Social Rhythm Therapy, Enhanced Treatment as Usual
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interpersonal and Social Rhythm TherapyBehavioural
Enhanced Treatment as UsualBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Enhanced Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Longitudinal Interval Follow-Up Evaluation (LIFE)
The LIFE is administered to calculate percent time symptomatic (with depression or mania symptoms) over the study period.
Measured: 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.
Measured: 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.
Measured: up to 16 weeks postpartum
Secondary outcomes (3)
Brief Quality of Life Scale for Bipolar Disorder (QoL.BD)
Measured: up to 16 weeks postpartum
Barkin Index of Maternal Functioning
Measured: up to 16 weeks postpartum
Medication Recommendation Tracking Form (MRTF)
Measured: up to 16 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2015 (estimated)
- Study startApr 2014
- Primary completionMar 2018
- Study completionMar 2018
Why it stopped: 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)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- Butler Hospital, Women and Infants Hospital of Rhode Island, The Miriam Hospital, Michigan State University
- Responsible party
- Principal investigator, Lauren M. Weinstock, PhD, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02402738
- Sponsor's protocol ID
- 1R34MH102466-01A1
- Status last verified
- Jan 2019
- First submitted
- 20 Mar 2015
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30803997
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Psychotherapy for Perinatal Bipolar Disorder
- ClinicalTrials.gov ID
- NCT02402738
- Acronym / sponsor ID
- 1R34MH102466-01A1
- Conditions
- Bipolar Disorder
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 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)
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- Butler Hospital, Women and Infants Hospital of Rhode Island, The Miriam Hospital, Michigan State University
- Study start
- Apr 2014
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 30 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interpersonal and Social Rhythm Therapy | Experimental | Behavioral: Interpersonal and Social Rhythm TherapyParticipants 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. |
| Enhanced Treatment as Usual | Active comparator | Behavioral: Enhanced Treatment as UsualThose 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interpersonal and Social Rhythm Therapy | Behavioural | Interpersonal and Social Rhythm Therapy |
| Enhanced Treatment as Usual | Behavioural | Enhanced Treatment as Usual |
Primary outcome
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.
3 secondary outcomes
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
Results and safety
The study was stopped early (reason given: 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)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
- Derived from this study: PubMed 30803997Johansen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interpersonal and Social Rhythm Therapy and Enhanced Treatment as Usual in people with Bipolar Disorder, run by Brown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Longitudinal Interval Follow-Up Evaluation (LIFE) (time frame: up to 16 weeks postpartum). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02402738, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2019.