Clinical trial NCT03403179: Functional Remediation for Bipolar Disorder
Official title: A Pilot Study of Functional Remediation for Bipolar Disorder: Feasibility and Preliminary Efficacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Keywords: Cognition
Cognitive Remediation
Mood Disorder
Functional Impairment
Psychosocial intervention
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2018-01-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study is a single center, open-label, outpatient clinical trial with no randomization or blinding. The Barcelona Functional Remediation for Bipolar Disorder (FR) Program will be tested over a 21-week period using 30 participants split into two equal cohorts. The study will evaluate the feasibility and preliminary efficacy of the intervention.
Primary purpose: OTHER

Brief summary: Bipolar Disorder is a major mood disorder with periodic mood episodes that may be very distressing, both to the individual and to others. When ill, the person is at particular risk for disruptions to social and occupational functioning, physical health, and even premature death. When not in an episode, individuals with BD may still be feeling well but have ongoing neurobiological processes, as well as the psychological sequelae from illness episodes, that can lead to subtle neurocognitive impairment that impedes overall functioning. This study is a test of an existing, published intervention that ameliorates deficits in functioning in euthymic bipolar individuals.


Eligibility criteria: Inclusion Criteria:

* diagnosis of bipolar I or II disorder (BD), as determined by a structured diagnostic interview
* at least three months of clinical remission (euthymia or minimal symptoms), based on the phone screen assessing mood episodes in the prior three months
* score greater than 11 on a measure of everyday functioning (FAST; described in measures section) indicating at least mild impairment
* use of a standard bipolar mood-stabilizing medication at the same, adequate dose (according to CANMAT treatment guidelines) for at least 3 months prior to screening, with ability to continue that dose during the study.

Exclusion Criteria:

* history of neurological illness or injury (e.g., stroke, brain tumor)
* documented intellectual disability
* inability to provide written informed consent
* substance dependence within last 3 months or substance abuse in last 30 days
* inability to complete the six-month intervention
* received ECT in the past 12 months

Primary outcomes:
measure: Feasibility
timeFrame: 30 weeks
measure: Acceptability (Subject Satisfaction)
timeFrame: 30 weeks
measure: Acceptability (Subject completion)
timeFrame: 30 weeks
Secondary outcomes:
measure: Functional Impact
timeFrame: 30 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Depression Center
state: Michigan
Study officials:
affiliation: University of Michigan
name: Sagar Parikh, MD
role: PRINCIPAL_INVESTIGATOR
References: