Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Other |
General Imagery (frequency of imagery, quality of imagery and appraisals of imagery): |
This measured using a 42-item online Imagery Survey recently validated in a student sample, and presently used in an on-going current study comparing imagery aspects between patients suffering from BD, patients suffering from unipolar depression and imagery prone students without a present disorder. This is further assessed using the Mental Imagery and Coping with Bipolar Disorder Questionnaire (MICQ-BD) is a 14 item self-report instrument assessing patient's response to mental imagery on a five-point Likert scale, ranging from "not at all" to "a lot". In a pilot study Holmes (2016) calculated the internal conconsistency (alpha = .70) of this measure to be satisfactory (DiSimplicio et al., 2016). |
administered at T0, after 4 weeks baseline at T1, after the end of intervention (12 weeks in the ImCT condition, and 6 weeks in the psychoeducation condition) T2, 8 weeks after the end of intervention T3, and after 16 weeks follow up -T4. |
|
| Other |
Ratings of target imagery (moderator) |
Changes in target imagery are measured in order to test if reductions in moodvariablity compared to baseline (i.e. the primary objective) are mediated by reductions in levels of problematic imagery during treatment. The Visual Analogue Scales of Imagery Characteristics (VAS Imagery) have been tailored to BD population rating on a scale 0-9, for example such as: "How real / vivid / absorbing / preoccupying / compelling have your image(s) been over the past week'"; "To which extent could you understand the role that the image(s) play in your mood instability?"; "To which extent could you find positive / helpful way of using the image(s)?". Target imagery is measured weekly throughout the duration of the study in the imCT group. |
Measured weekly throughout the study for 32 weeks in the ImCT condition and 26 weeks in the psychoeducation condition |
|
| Other |
General Imagery |
Changes in general imagery are measured using the Mental Imagery and Coping with Bipolar Disorder Questionnaire (MICQ-BD) is a 14 item self-report instrument assessing patient's response to mental imagery on a five-point Likert scale, ranging from "not at all" to "a lot". In a pilot study Holmes (2016) calculated the internal conconsistency (alpha = .70) of this measure to be satisfactory (DiSimplicio et al., 2016). |
administered at T0, after 4 weeks baseline at T1, after the end of intervention (12 weeks in the ImCT condition, and 6 weeks in the psychoeducation condition) T2, 8 weeks after the end of intervention T3, and after 16 weeks follow up -T4. |
|
| Primary |
Change from baseline Mood variability to follow up at 16 weeks after end of intervention |
Mood variability is measured using the Affect Lability Score Short Version (ALS-18; Oliver & Simons, 2004). The ALS-18 is a self-report scale measuring lability in affect and consists of 18 items. Ratings are made on a 4-point scale with a maximum score of 72. Scores range from A= very characteristic of me (4 points), to D= very uncharacteristic of me (1 point). |
The ALS-18 is administered at T0, after 4 weeks baseline at T1, after the end of intervention (12 weeks in the ImCT condition, and 6 weeks in the psychoeducation condition) T2, 8 weeks after the end of intervention T3, and after 16 weeks follow up -T4. |
|
| Secondary |
Change from baseline Level of depression to follow up at to follow up at 16 weeks |
- Level of depression, using the Quick Inventory of Depressive Symptoms (QIDS-SR) (Rush et al., 2003). The QIDS-SR is a 16-item self-report rating scale in which the nine DSM 5 symptoms of major depression are incorporated. Answers are rated on a four-point Likert scale (0-3). |
measured weekly throughout the duration of the study in both groups (32 weeks imCT and 26 weeks psychoeducation/TAU). |
|
| Secondary |
Change from baseline level of mania to follow up at 16 weeks |
- Level of mania, using the Altman Self-Rating Mania Scale (ASRM-NL) (Altman, Hedekker, & Peterson, 1997). The ASRM-NL is a 5 item self-report instrument to measure severity of mania symptoms. Answers are rated on a 5-point Likert scale, where higher scores indicate higher levels of mania. Total score ranges from 0 to 20, with a cut off score of 5 or more indicating relapse into mania. |
measured weekly throughout the duration of the study in both groups ( 32 weeks imCT and 26 weekspsychoeducation/TAU). |
|
| Secondary |
Change from baseline level of anxiety to follow up at 16 weeks |
- Level of anxiety, using the Beck Anxiety Inventory (BAI) (Osman, Barrios, Aukes, Osman, & Markway, 1993). The BAI is a 21-item self-report questionnaire used for measuring the severity of anxiety. Answers are rated on a 4-point Likert scale (0-3). Total scores range from o to 63, where scores of 22 or more indicate moderate anxiety, 36 or more concerning levels of anxiety. |
measured both daily and weekly throughout the duration of the study in both groups (32 weeks imCT and 26 weeks psychoeducation/TAU) |
|
| Secondary |
Change from baseline level of hopelessness to follow up at 16 weeks follow up |
participants rate their hopelessness using the Beck Hopelessness Scale (Beck, Brown, & Steer, 1997), The BHS is a 20 item self-report scale measuring three aspects of hopelessness: feelings about the future, motivation and expectations. The BHS demonstrates good internal consistency (alpha = .93) and has high reliability in psychiatric samples (Beck et al., 1997) |
measured at baseline (T0), after 4 weeks pre-intervention (T1), post-intervention after 6 weeks in the psychoeduc condition and 12 weeks in the ImCT condition (T2) and at follow up at 8 weeks (T3) and at 16 weeks (T4). |
|
| Secondary |
Change from baseline level of general functioning and coping to follow up at 16 weeks |
Participants rate their level of functioning using the Longitudinal Interval Follow up Evaluation - Range of Impaired Functioning Tool (Leon, et al., 1999). This is a brief scale for people suffering from affective disorders, measuring four different functional areas (employment, interpersonal relations, satisfaction and recreation) on a 5 point Likert scale (low rating imply higher functioning). |
Participants rate their level of functioning at baseline (T0), after 4 weeks pre-intervention (T1), post-intervention12 weeks in the ImCT condition and 6 weeks in the psychoeducation condition (T2) and at follow up at 8 weeks (T3) and at 16 weeks (T4). |
|
| Secondary |
Change from baseline level of mood variability to follow up at 16 weeks |
Mood variability, using daily measurements of both mania and depression with the National Institute of Mental Health Life Chart Methodology (NIMH-LCM) Prospective Self-Rating (Denicoff et al., 2000; Leverich and Post, 1998). Participants rate their mood (both mania and depression) on a 11-point likert scale, ranging from -4 (severe depression, admission required due to severe dysfunction) to 0 (stable mood) to +4 (severe mania, admission required due to severe dysfunction). |
Daily measurements throughout the duration of the study, 32 weeks for the participants in the ImCT condition and 26 weeks for the participants in the psychoeducation condition |
|
| Secondary |
Change from baseline level of anxiety to follow up at 16 weeks |
Anxiety is measured on a VAS scale indicating no anxiety (1) to severe anxiety (4). |
Daily measurements throughout the duration of the study, 32 weeks for the participants in the ImCT condition and 26 weeks for the participants in the psychoeducation condition |
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