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Evaluating the effectiveness of Imagery Focussed therapy in patients suffering from bipolar disorder: An exploratory trial

Evaluating the effectiveness of Imagery Focussed therapy in patients suffering from bipolar disorder: An exploratory trial - Imagery focussed therapy in bipolar disorder

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON48929
Enrollment
60
Registered
2018-08-07
Start date
2018-10-08
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

manic depression

Interventions

Both groups (ImCT and TAU) consult a psychiatrist and receive advice and guidance on medication, which is monitored and adjusted conform guidelines (NICE) throughout this study. Description of ImCT

Sponsors

Department of Clinical Psychological Sciences
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Aged 18-68 * Sufficient Dutch language ability to permit the assessment to be completed. * Diagnosis of bipolar disorder (I or II or NOS) according to DSM-5 (clinicians assessment). * Willing to complete daily and weekly monitoring throughout the duration of the study. * Successful completion of the daily monitoring in the 4 weeks active run-in phase. * Willing to be randomised to either ImCT or psychoeducation/TAU condition * Can commit to attending 10 consecutive weekly sessions either ImCT of psychoeducation/TAU.

Exclusion criteria

Exclusion criteria: * Learning difficulties, organic brain disease or severe neurological impairment. * Current severe substance or alcohol misuse (clinicians assessment). * Current manic episode as diagnosed by DSM-5 * Current active psychotic symptoms * Presence of active suicidal risk as indicated by a score of 2 or more on item 12 of the QIDS (Rush et al., 2003) (i.e. frequent thought and/or plans to end their life) confirmed by convergent clinical opinion. * Taking part in concurrent treatment studies investigating pharmacological or psychological treatment for Bipolar Disorder. * participated in either CBT or psychoeducation within the year previous to start of this study

Design outcomes

Primary

MeasureTime frame
* 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 -5 = severe depression, admission required due to severe dysfunction, to 0 = stable mood, to + 5 = severe mania, admission required due to severe dysfunction). Daily measurements are calculated during a 4-week baseline, during the invention and until follow up at 16 weeks and are compared between the ImCT- and psychoeducation/TAU group.

Secondary

MeasureTime frame
* Level of depression: using the Quick Inventory of Depressive Symptoms (QIDS-SR, Rush et al., 2003) measured weekly, pre- and post intervention and at 8 and 16 weeks follow-up in both groups (ImCT and psychoeducation/TAU). * Level of mania: using the Altman Self-Rating Mania Scale (ASRM-NL: Altman et al., 1997), measured weekly, pre- and post intervention and at 8 and 16 weeks follow-up in both groups (ImCT and psychoeducation/TAU). * Level of anxiety: using the Beck Anxiety Inventory (BAI, Osman, et al., 1993) measured weekly, pre- and post interventions and at 8 and 16 weeks follow up in both groups (ImCT and psychoeducation/TAU). * Level of daily anxiety: participants rate their anxiety daily on a 11 point likert scale. (0= no anxiety, to 11 = severe anxiety). Both daily ratings (mood and anxiety) use a secure email application called Research Manager. Daily measurements are calculated during a 4-week baseline, during the invention and until follow up at 16 weeks and are compared between the ImCT- and psychoeducation/TAU group. Moderators: * Target imagery: weekly measures recorded on a VAS rating scale of problematic target imagery in the ImCT group. * General Imagery (frequency of imagery, quality of imagery and appraisals of imagery): measured pre- and post intervention with 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 bipolar disorders, patients suffering from unipolar depression and imagery prone students without a present disorder.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)