Bipolar disorder, type I and type II
Conditions
Interventions
The experimental treatment will consist of a 12-week cognitive remediation program focussed on enhancing executive functioning. There will be weekly sessions of 2 hours and the treatment will take pla
Sponsors
None
Eligibility
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: Participants need to be of adult age (18-65 years old), diagnosed with a bipolar I of bipolar II disorder, and need to be stable for 3 months. At the moment of inclusion stability of symptomatology is assessed by a score of 43 (1 SD above mean).
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: An IQ < 80 as assessed by the Dutch Adult Reading Test (DART; Schmand and Van Harskamp, 1992), neurological problems, acquired brain injury, electric convulsive therapy in the past 12 months, substance abuse in the past 3 months, psychotic disorder, autism spectrum disorder, attention deficit disorder, rapid cycling, and neurocognitive disturbances due to severe posttraumatic stress disorder.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Goal Attainment Scale (GAS): A 5-point scale for individual assessment of outcome, originally introduced by T.J. Kiresuk and R.E. Sherman in 1968. In rehabilitation this is an important measure of outcome; strong evidence has been found for the reliability, validity and sensitivity of goal attainment scaling (Hurn et al., 2006). SMART goals (Specific, Measurable, Achievable, Relevant, Time-bound) will be formulated. The scale runs from -2 to +2: 0 is the SMART formulated goal; -2 and -1 is scored when outcome is below the goal; +1 and +2 is scored when outcome is above the goal. Participants will fill in the scale weekly on a smartphone app, which will take about 2 minutes. This scale is used to investigate whether participants improve in personal goals with regard to their functioning in daily life by means of the cognitive remediation intervention. Happiness single item scale: This scale is used to assess general wellbeing. The question is asked: “Do you feel happy in general?” The participant answers on a 11-point score (0-10). This single item scale by A.M. Abdel-Khalek (2006) shows good concurrent, convergent and divergent validity. Participants will fill in the scale weekly on a smartphone app, which will take about 1 minute. This scale is used to investigate whether the general wellbeing of participants improves by means of the cognitive remediation intervention. To account for the covariate sleep in the weekly measures of goals and general wellbeing, participants also will be asked to give an indication of hours slept the previous night on the smartphone app. | — |
Secondary
| Measure | Time frame |
|---|---|
| Quick Inventory of Depressive Symptomatology (QIDS-SR: Rush et al., 2003): A questionnaire that consist of 16 questions by which to assess the severity of the nine diagnostic symptom criteria of depression used in the DSM. Internal consistency was high and total scores were highly correlated with IDS-SR30 (.96) total scores (Rush et al., 2003). It takes about 5 minutes to complete this questionnaire. This scale will be used as a descriptive measure. It will also be used as a covariate and an exploratory measure, to examine if the cognitive remediation improves symptomatology. Altman Self-Rating Mania Scale (ASRM-NL; Altman et al., 1997): A 5-item self-rating questionnaire, used to measure the presence and/or severity of manic symptoms. The questionnaire has a significant correlation with the Young Mania Rating Scale (YMRS). Specificity is 85.5, sensitivity is 87.3. Questions are scored on a Likert scale from 0-4 (Altman et al., 1997; Renes, J.W. and Kupka, R.W., 2009). It takes about 3 minutes to complete this questionnaire. This scale will be used as a descriptive measure. It will also be used as a covariate and an exploratory measure, to examine if the cognitive remediation improves symptomatology. Cognitive Failure Questionnaire (CFQ; Broadbent et al., 1982; Merckelbach et al., 1996; Ponds, van Boxtel & Jolles, 2006): A commonly used questionnaire that is used to assess the level of subjective cognitive complaints. The scale consists of 25 items measuring the occurrence of cognitive problems in everyday life; items are scored on a 5-point scale. Higher scores indicate more frequent cognitive failures. The scale is validated in Dutch, internal consistency is acceptable to good, and test-retest reliability is high. A cut-off score of >43 is used to indicate problems in everyday life, which is 1 SD above mean. Time to administer is about 5-10 minutes. The CFQ is used as an exploratory measure to examine if cognitive functioning in daily life improves by means of | — |
Contacts
Public ContactMeike Smit
GGZ Delfland
Outcome results
None listed