Functional Remediation for Bipolar Disorder

NCT03403179 | Completed

• 1 other identifier: HUM00113668
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder

Keywords

Cognition; Cognitive Remediation; Mood Disorder; Functional Impairment; Psychosocial intervention

Outcome Measures

Primary Outcomes (3)

• 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.

  30 weeks

• Acceptability (Subject Satisfaction)

  Acceptability of the intervention will be measured by use of the Satisfaction with Therapy and Therapist Scale.

  30 weeks

• Acceptability (Subject completion)

  Measured by percentage of subjects who complete the intervention.

  30 weeks

Secondary Outcomes (1)

• Functional Impact

  30 weeks

Study Arms (1)

Receiving Psychosocial Intervention

EXPERIMENTAL

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.

Other: Functional Remediation

Interventions

Functional Remediation OTHER

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.

Receiving Psychosocial Intervention

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan Depression Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Bipolar Disorder; Mood Disorders

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mental Disorders

Study Officials

• Sagar Parikh, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Model Details: 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.

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: January 18, 2018
• Study Start: November 17, 2017
• Primary Completion: December 10, 2018
• Study Completion: December 20, 2018
• Last Updated: February 28, 2019

Record last verified: 2019-02

Locations

US (1)