Effect of Action-Based Cognitive Remediation in Patients With Bipolar Disorder
PRETEC-ABC
2 other identifiers
interventional
64
1 country
1
Brief Summary
PRETEC-ABC aims to assess the effect of a new form of cognitive remediation, Action-Based Cognitive Remediation (ABCR), in patients with bipolar disorder in remission on cognition, and to assess the neural assays for treatment effects with the purpose of identifying a neural biomarker for pro-cognitive effect. It is hypothesized (i) that ABCR vs. a control treatment has a beneficial effect on cognition in remitted patients with bipolar disorder remission. It is hypothesized (ii) that this treatment-associated improvement of cognition translates into better functional capacity at a six months follow-up assessment (secondary outcome). Finally, as an exploratory measure, it is hypothesized that ABCR will produce an early change in frontal activity and that this activity will correlate with ABCR-associated improvements in cognitive function.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2017
Typical duration for not_applicable
1 active site
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
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
September 15, 2017
CompletedFirst Posted
Study publicly available on registry
September 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 25, 2020
CompletedMarch 4, 2020
March 1, 2020
2.5 years
September 15, 2017
March 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cognitive composite score
A cognitive composite based on an average of the Rey Auditory Verbal Learning Test (RAVLT), Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Coding, verbal fluency with the letter "D", WAIS-III Letter-Number Sequencing, Trail Making Test B (TMT B) and Rapid Visual Information Processing (RVP) from Cambridge Cognition (CANTAB).
Change from baseline and week 11
Secondary Outcomes (2)
One Touch Stockings of Cambridge
Baseline, two weeks of treatment, week 11, and 6-months follow-up
Functional Assessment Short Test
Baseline, week 11, and 6-months follow-up
Other Outcomes (15)
Rey Auditory Verbal Learning Test
Baseline, two weeks of treatment, week 11, and 6-months follow-up
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Coding
Baseline, two weeks of treatment, week 11, and 6-months follow-up
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Digit Span
Baseline, two weeks of treatment, week 11, and 6-months follow-up
- +12 more other outcomes
Study Arms (2)
Action Based Cognitive Remediation
EXPERIMENTALUnstructured support group
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Fluent Danish skills and objective cognitive impairment (a total score below cutoff, or scores below cutoff on a minimum of two out of the five subtests (Verbal Learning Test - Immediate, Working Memory Test, Verbal Fluency Test, Verbal Learning Test - Delayed and Processing Speed Test) on the Screen for Cognitive Impairment in Psychiatry - Danish version (SCIP-D).
- Patients must meet the ICD-10 diagnosis of BD (type I and II) confirmed using the Schedules for Clinical Assessment in Neuropsychiatry (SCAN) interview.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mental Health Services, Capital Region of Denmark, Copenhagen University Hospital, Rigshospitalet
Copenhagen, 2100, Denmark
Related Publications (2)
Ott CV, Vinberg M, Kessing LV, Bowie CR, Forman JL, Miskowiak KW. Effect of Action-Based Cognitive Remediation on cognitive impairment in patients with remitted bipolar disorder: A randomized controlled trial. Bipolar Disord. 2021 Aug;23(5):487-499. doi: 10.1111/bdi.13021. Epub 2020 Oct 29.
PMID: 33053258DERIVEDOtt CV, Vinberg M, Bowie CR, Christensen EM, Knudsen GM, Kessing LV, Miskowiak KW. Effect of action-based cognitive remediation on cognition and neural activity in bipolar disorder: study protocol for a randomized controlled trial. Trials. 2018 Sep 12;19(1):487. doi: 10.1186/s13063-018-2860-8.
PMID: 30208971DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kamilla W Miskowiak, Dr
Mental Health Services, Capital Region of Denmark
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 15, 2017
First Posted
September 27, 2017
Study Start
January 1, 2017
Primary Completion
July 1, 2019
Study Completion
January 25, 2020
Last Updated
March 4, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share