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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sagar Parikh, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Depression Center | Ann Arbor | Michigan | 48109 | United States |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D019964 | Mood Disorders |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D001523 | Mental Disorders |
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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.
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| 30 weeks |