Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| TrygFonden, Denmark | INDUSTRY |
| Copenhagen University Hospital, Hvidovre | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Group | Active Comparator | This group receives cognitive remediation in groups (each group consisting of 6-8 subjects) |
|
| Waiting List | No Intervention | Patients randomized to the waiting list group continues standard treatment and will be offered a course of cognitive remediation upon completion of participation provided that they still meet the inclusion criteria. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Remediation | Other | All subjects will complete an MR brain scan, blood test, saliva test, and a neuropsychological battery of manual and computerised tests at baseline, at week 12 (end of active treatment) and week 26 (follow-up). Subjects randomly allocated to an active group will participate in a 12-week group-based cognitive remediation programme once a week for two hours. The waiting list group continues treatment as usual. |
| Measure | Description | Time Frame |
|---|---|---|
| Enhance verbal learning and memory as reflected by increase in Rey Auditory Verbal Learning Test (RAVLT) total learning scores and recall | We expect a clinically relevant difference in the change between groups to be at least 4 points on RAVLT total scores. | Baseline and weeks 12 and 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Improve sustained attention | Increase total scores of sustained attention measured with the Rapid Visual Information Processing (RVP) test from baseline to post treatment (week 12) | Baseline and weeks 12 and 26 |
| Improve executive function |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kamilla W Miskowiak, Dr | Psychiatric Centre Copenhagen, Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Psychiatric Centre Copenhagen, Rigshospitalet, Denmark | Copenhagen | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26070195 | Derived | 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. | |
| 24206639 | Derived |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D019964 | Mood Disorders |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000072466 | Cognitive Remediation |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Increase total scores of executive function measured with the Trail Making Test (TMT) part B from baseline to post treatment (week 12)
| Baseline and weeks 12 and 26 |
| Increase psychosocial function | Increase psychosocial function measured with Functional Assessment Short Test (FAST) total scores from baseline to post treatment (week 12) | Baseline and weeks 12 and 26 |
| 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. |