NCT02766361

Brief Summary

The study consists of a clinical trial comparing a new structured group intervention, denominated "Cognitive-Behavioral Rehabilitation", to treatment as usual (TAU) for bipolar patients. The new approach is a combination of cognitive behavioral strategies and cognitive rehabilitation exercises, consisting of twelve weekly group sessions of 90 minutes each. To be included in the study, patients must be diagnosed with bipolar disorder, type I or II, be 18 to 55 years old, in full or partial remission and have an IQ of at least 80. A comprehensive neuropsychological battery, followed by mood, social functioning and quality of life assessments will occur in three moments: pre and post-intervention and after 12 months.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2016

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 9, 2016

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

May 26, 2022

Status Verified

May 1, 2022

Enrollment Period

4.7 years

First QC Date

May 2, 2016

Last Update Submit

May 19, 2022

Conditions

Bipolar Disorder

Keywords

Bipolar disorderPsychotherapyCognitive rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Interval to first mood episode

    Survival data

    6 months after the beginning of intervention group

Secondary Outcomes (15)

  • Change in Quality of life scores score WHOQOL

    3, 6 and 12 months after the beginning of intervention group

  • Change in Functionality Scale for Bipolar disorder (FAST)

    3, 6 and 12 months after the beginning of intervention group

  • Change in Barratt Impulsivity scale (BIS)

    3, 6 and 12 months after the beginning of intervention group

  • Change in Brian Sleep Scale

    3, 6 and 12 months after the beginning of intervention group

  • Change in Social skills scale (IHS)

    3, 6 and 12 months after the beginning of intervention group

  • +10 more secondary outcomes

Other Outcomes (2)

  • Change in YMRS

    3, 6 and 12 months after the beginning of intervention group

  • Change in MADRS

    3, 6 and 12 months after the beginning of intervention group

Study Arms (2)

Cognitive Behavioral Rehabilitation

EXPERIMENTAL

12 sessions of new intervention of cognitive behavior therapy and cognitive rehabilitation

Behavioral: Cognitive Behavioral Rehabilitation

Treatment as Usual

ACTIVE COMPARATOR

standard out-patient treatment offered in our clinic, which involves psychopharmacological mood stabilization and regular contacts with mental health nurses.

Other: Treatment as Usual

Interventions

Cognitive Behavioral RehabilitationBEHAVIORAL

12 weekly sessions of Combined intervention lasting 90 minutes

Also known as: Combined intervention of CBT and Cognitive Rehabilitation
Cognitive Behavioral Rehabilitation
Treatment as UsualOTHER

standard out-patient treatment offered in our clinic, which involves psychopharmacological mood stabilization and regular contacts with mental health nurses.

Treatment as Usual

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • IQ higher than 80
  • Bipolar I or II diagnoses
  • Being literate

You may not qualify if:

  • substance or alcohol abuse in the last 6 months,
  • current suicide risk,
  • organic mental disorders
  • scores higher than 12, in the Montgomery-Åsberg Depression Rating Scale (MADRS) or the Young Mania Rating Scale (YMRS) at the beginning of the interventions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bipolar Disorder Program (PROMAN), Department of Psychiatry

São Paulo, 05372100, Brazil

Location

Related Publications (1)

  • Gomes BC, Rocca CC, Belizario GO, Lafer B. Cognitive-behavioral rehabilitation vs. treatment as usual for bipolar patients: study protocol for a randomized controlled trial. Trials. 2017 Mar 28;18(1):142. doi: 10.1186/s13063-017-1896-5.

    PMID: 28351410DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Cognitive TrainingTherapeutics

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Beny Lafer, Professor

    University of São Paulo Medical School, São Paulo, Brazil

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

May 2, 2016

First Posted

May 9, 2016

Study Start

March 1, 2016

Primary Completion

November 1, 2020

Study Completion

December 1, 2023

Last Updated

May 26, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will share

Locations

BR(1)