Clinical trial NCT01457235: The Effects of Cognitive Remediation on Cognitive Function in Remitted Bipolar Disorder - a Proof of Concept Study
Official title: The Effects of Cognitive Remediation on Cognitive Function in Remitted Bipolar Disorder - a Proof of Concept Study (REMEDI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Keywords: Bipolar disorder
Cognitive Remediation
Cognition
Cognitive function
Mood disorders
Affective disorders
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: TrygFonden, Denmark
name: Copenhagen University Hospital, Hvidovre
First posted: 2011-10-21
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cognitive remediation (CR) is a new psychological treatment, which aims to improve cognitive function and coping skills. Several studies have recently demonstrated that CR improves cognitive and occupational function in patients with schizophrenia and with depression (e.g. Wykes et al 2007, Elgamal et al 2007). However, it is unclear whether CR improves cognitive and socio-occupational function in individuals with bipolar disorder (BD) and, if so, what impact this might have on these people's abilities in terms of work, coping strategies, quality of life, and everyday safety.

The aim of the present PhD study is to investigate if CR has beneficial effects on cognitive and socio-occupational function in patients with previous mania and depression who experience persistent cognitive difficulties. Such effects would suggest implementation of CR in future treatment of bipolar disorder in order to facilitate the patients' ability to cope with the responsibilities related to work and everyday life. The hypotheses of the present study are that CR (in comparison to standard treatment) will 1) improve verbal learning and recall; and 2) improve sustained attention, executive function and psychosocial function.


Eligibility criteria: Inclusion Criteria:

* Bipolar disorder in complete or partial remission (Hamilton Depression Rating Scale score of max 14 and Young Mania Scale score of max 14)
* Subjective complaints of moderate to severe cognitive problems on the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) (Fava et al 2006) (score at least 4 on at least 2 domains)

Exclusion Criteria:

* Current ECT treatment
* Drug and/or alcohol abuse
* Schizophrenia
* Significant risk of suicide
* Use of benzodiazepines equivalent to more than 22,5 milligrams of Alopam

Primary outcomes:
measure: Enhance verbal learning and memory as reflected by increase in Rey Auditory Verbal Learning Test (RAVLT) total learning scores and recall
timeFrame: Baseline and weeks 12 and 26
Secondary outcomes:
measure: Improve sustained attention
timeFrame: Baseline and weeks 12 and 26
measure: Improve executive function
timeFrame: Baseline and weeks 12 and 26
measure: Increase psychosocial function
timeFrame: Baseline and weeks 12 and 26
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Psychiatric Centre Copenhagen, Rigshospitalet, Denmark
Study officials:
affiliation: Psychiatric Centre Copenhagen, Rigshospitalet, Denmark
name: Kamilla W Miskowiak, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Demant KM, Vinberg M, Kessing LV, Miskowiak KW. Effects of Short-Term Cognitive Remediation on Cognitive Dysfunction in Partially or Fully Remitted Individuals with Bipolar Disorder: Results of a Randomised Controlled Trial. PLoS One. 2015 Jun 12;10(6):e0127955. doi: 10.1371/journal.pone.0127955. eCollection 2015.
citation: Demant KM, Almer GM, Vinberg M, Kessing LV, Miskowiak KW. Effects of cognitive remediation on cognitive dysfunction in partially or fully remitted patients with bipolar disorder: study protocol for a randomized controlled trial. Trials. 2013 Nov 10;14:378. doi: 10.1186/1745-6215-14-378.