Back to resultsFunctional Remediation for Bipolar Disorder
Primary Purpose
Bipolar Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Functional Remediation
Sponsored by
About this trial
This is an interventional other trial for Bipolar Disorder focused on measuring Cognition, Cognitive Remediation, Mood Disorder, Functional Impairment, Psychosocial intervention
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
Sites / Locations
- University of Michigan Depression Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Receiving Psychosocial Intervention
Arm Description
Functional Remediation: The functional remediation program consists of 21 weekly sessions, each lasting 90 min. This intervention addresses neurocognitive issues such as attention, memory and executive functions, but it focuses even more on enhancing functioning in daily routine. The content of the intervention is based on ecological tasks to be performed in two settings, in the clinic as well as at home. Participants will be trained with exercises for memory, attention, problem solving and reasoning, multitasking and organization in order to improve their functional outcome. Most of the techniques are based on paper-and-pencil tasks and group activities.
Outcomes
Primary Outcome Measures
Feasibility
Feasibility will be determined by a composite of ability to recruit and deliver the treatment intervention to both cohorts of participants, with adequate delivery of the intervention as measured by completion of the manual's objectives.
Acceptability (Subject Satisfaction)
Acceptability of the intervention will be measured by use of the Satisfaction with Therapy and Therapist Scale.
Acceptability (Subject completion)
Measured by percentage of subjects who complete the intervention.
Secondary Outcome Measures
Functional Impact
The Functioning Assessment Short Test (FAST) is an interviewer-administered scale for disability due to psychiatric illness, used both pre-and post-completion. The instrument has 24 items capturing 6 domains of functioning: (1) Autonomy (2) Occupational Functioning (3) Cognitive Functioning (4) Financial Issues (5) Relationships (6) Leisure Time. Scores above 11 identify at least mild functional impairment. Impact of the intervention on change in FAST score will be examined.
Full Information
NCT ID
NCT03403179
First Posted
January 11, 2018
Last Updated
February 27, 2019
Sponsor
University of Michigan
1. Study Identification
Unique Protocol Identification Number
NCT03403179
Brief Title
Functional Remediation for Bipolar Disorder
Official Title
A Pilot Study of Functional Remediation for Bipolar Disorder: Feasibility and Preliminary Efficacy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
November 17, 2017 (Actual)
Primary Completion Date
December 10, 2018 (Actual)
Study Completion Date
December 20, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
Cognition, Cognitive Remediation, Mood Disorder, Functional Impairment, Psychosocial intervention
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Receiving Psychosocial Intervention
Arm Type
Experimental
Arm Description
Functional Remediation: The functional remediation program consists of 21 weekly sessions, each lasting 90 min. This intervention addresses neurocognitive issues such as attention, memory and executive functions, but it focuses even more on enhancing functioning in daily routine. The content of the intervention is based on ecological tasks to be performed in two settings, in the clinic as well as at home. Participants will be trained with exercises for memory, attention, problem solving and reasoning, multitasking and organization in order to improve their functional outcome. Most of the techniques are based on paper-and-pencil tasks and group activities.
Intervention Type
Other
Intervention Name(s)
Functional Remediation
Intervention Description
Functional Remediation: The functional remediation program consists of 21 weekly sessions, each lasting 90 min. This intervention addresses neurocognitive issues such as attention, memory and executive functions, but it focuses even more on enhancing functioning in daily routine. The content of the intervention is based on ecological tasks to be performed in two settings, in the clinic as well as at home. Participants will be trained with exercises for memory, attention, problem solving and reasoning, multitasking and organization in order to improve their functional outcome. Most of the techniques are based on paper-and-pencil tasks and group activities.
Primary Outcome Measure Information:
Title
Feasibility
Description
Feasibility will be determined by a composite of ability to recruit and deliver the treatment intervention to both cohorts of participants, with adequate delivery of the intervention as measured by completion of the manual's objectives.
Time Frame
30 weeks
Title
Acceptability (Subject Satisfaction)
Description
Acceptability of the intervention will be measured by use of the Satisfaction with Therapy and Therapist Scale.
Time Frame
30 weeks
Title
Acceptability (Subject completion)
Description
Measured by percentage of subjects who complete the intervention.
Time Frame
30 weeks
Secondary Outcome Measure Information:
Title
Functional Impact
Description
The Functioning Assessment Short Test (FAST) is an interviewer-administered scale for disability due to psychiatric illness, used both pre-and post-completion. The instrument has 24 items capturing 6 domains of functioning: (1) Autonomy (2) Occupational Functioning (3) Cognitive Functioning (4) Financial Issues (5) Relationships (6) Leisure Time. Scores above 11 identify at least mild functional impairment. Impact of the intervention on change in FAST score will be examined.
Time Frame
30 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sagar Parikh, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Depression Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Functional Remediation for Bipolar Disorder
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