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Completed

NCT Number: NCT03403179

Functional Remediation for Bipolar Disorder

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.

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Depression Center

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Feasibility

    Time frame: 30 weeks

    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.

  2. Acceptability (Subject Satisfaction)

    Time frame: 30 weeks

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

  3. Acceptability (Subject completion)

    Time frame: 30 weeks

    Measured by percentage of subjects who complete the intervention.

Secondary outcomes

  1. Functional Impact

    Time frame: 30 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

A Pilot Study of Functional Remediation for Bipolar Disorder: Feasibility and Preliminary Efficacy

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 18, 2018
Registry last updated
Feb 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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