## Protocol Section
### Identification Module
**NCT ID:** NCT03403179

**Brief Title:** Functional Remediation for Bipolar Disorder

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

#### Organization Study ID Info
**ID:** HUM00113668
#### Organization
**Class:** OTHER
**Full Name:** University of Michigan
### Status Module
#### Completion Date
**Date:** 2018-12-20

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-02-28

**Type:** ACTUAL

**Last Update Submit Date:** 2019-02-27

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2018-12-10

**Type:** ACTUAL

#### Start Date
**Date:** 2017-11-17

**Type:** ACTUAL

**Status Verified Date:** 2019-02

#### Study First Post Date
**Date:** 2018-01-18
**Type:** ACTUAL
**Study First Submit Date:** 2018-01-11
**Study First Submit QC Date:** 2018-01-11
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Michigan

#### Responsible Party

**Investigator Affiliation:** University of Michigan

**Investigator Full Name:** Sagar Parikh

**Investigator Title:** Professor of Psychiatry

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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 Module

**Conditions:**

- Bipolar Disorder

**Keywords:**

- Cognition

- Cognitive Remediation

- Mood Disorder

- Functional Impairment

- Psychosocial intervention

### Design Module

#### Design Info

**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.

##### Masking Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 30

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**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 Names:**

- Other: Functional Remediation

**Label:** Receiving Psychosocial Intervention

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Receiving Psychosocial 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.

**Name:** Functional Remediation

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**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.

**Measure:** Feasibility

**Time Frame:** 30 weeks

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

**Measure:** Acceptability (Subject Satisfaction)

**Time Frame:** 30 weeks

**Description:** Measured by percentage of subjects who complete the intervention.

**Measure:** Acceptability (Subject completion)

**Time Frame:** 30 weeks

#### Secondary Outcomes

**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.

**Measure:** Functional Impact

**Time Frame:** 30 weeks

### Eligibility Module

**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

**Maximum Age:** 55 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Ann Arbor

**Country:** United States

**Facility:** University of Michigan Depression Center

**State:** Michigan

**Zip:** 48109

#### Overall Officials

**Official 1:**

**Affiliation:** University of Michigan

**Name:** Sagar Parikh, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000068105

- Term: Bipolar and Related Disorders

- ID: D000019964

- Term: Mood Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M4996

- Name: Bipolar Disorder

- Relevance: HIGH

- As Found: Bipolar Disorder

- ID: M21835

- Name: Mood Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M226

- Name: Bipolar and Related Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001714

- Term: Bipolar Disorder

### Misc Info Module

- Version Holder: 2024-05-24
