An interventional study of Mindfulness for Bipolar and Psychoeducation for Bipolar in Bipolar Disorder, Currently in Remission, sponsored by Swinburne University of Technology. Completed at 1 site in Australia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-12-01.
Sponsored by Swinburne University of Technology · Not applicable, Interventional, and Other
The aim of this study is to improve outcomes in people with bipolar disorder (BD) by comparing two new online interventions specifically designed to improve quality of life amongst people who have had multiple (10 or more) episodes of BD.
People who have had significant experience with bipolar disorder (defined here as 10 or more episodes) may not benefit from existing psychosocial interventions targeting symptoms and relapse, and may be better served by interventions targeting quality of life (QoL). Our international team of researchers, clinicians and consumers has developed two different online interventions, both of which there is reason to believe will be useful. Both interventions are brief, with 4 weeks of new online content released weekly, plus one additional week of application. This 5-week 'active phase' is supported by email contact with a personal online coach. The remainder of the 6 months of participant involvement in the trial includes continued access to the website (without coaching support) and follow-up assessments. Both arms are equivalent in using cutting-edge internet technologies and design features to help people engage with the therapeutic content and generalise it into their real lives. The websites have been developed following best-practice principles of persuasive system design, and rely heavily on consumer videos, social engagement through discussion boards, personalised feedback, and intuitive content structure to maximise engagement.
Australia's NHMRC has funded a 4-year project (2016-2019) to develop and compare the effectiveness of the two websites in terms of a range of outcomes, primarily QoL. The randomized controlled trial (RCT) will definitively assess the QoL benefits of two websites for late stage Bipolar Disorder. The RCT has been designed to optimise various aims: minimise risk of bias to support definitive scientific findings (internal validity), support ready dissemination should outcomes be positive (external validity, end-user involvement), and to optimally manage the risks inherent in the population being studied. We expect to find definitive evidence of the comparative QoL benefits of the two interventions, and insights about secondary outcomes including self-rated state anxiety, self-rated depression, and clinician-rated depression. A number of clinical and functional secondary outcomes will also be explored, as will hypothesised mediators and baseline moderators of QoL outcomes. Economic analysis based on cost-consequence analysis, and a range of process evaluations will also be conducted.
A total of 300 participants will be block randomised to provide power to identify a small-moderate treatment effect on QoL. Participants will be blinded as to the experimental intervention. The study uses a single-site (internet-based) design, with advertising occurring primarily online, but also through traditional methods via clinical networks of the researchers in Australia, United Kingdom (UK), Canada and the US. Major assessment time points are baseline, post-treatment (primary endpoint), 3 months post-baseline and 6 months post-baseline. Participants will be remunerated for assessments, which include both online questionnaires and a (blinded) semi-structured clinical interview by phone.
A multi-layered risk-management approach has been developed based on our experience with online interventions for bipolar disorder and psychosis. First and foremost, we explain to participants that their participation does not replace usual care, and no emergency assistance is available through the website (a link to the international site unsuicide is provided). This devolving of responsibility to the participant is reinforced by the inclusion criterion of being under the care of a medical practitioner and having access to local emergency services. Second, both intervention sites contain general information about the potential risks (e.g., generating distress) of the interventions, as well as specific alerts to the potential challenges of particular exercises. Third, a comprehensive 'red flag decision tree' has been developed to guide the team's response to any risk issues arising (see Table 2). Finally, any adverse events arising will be reviewed weekly in the trial executive committee.
1,601 studies on the registry are indexed under Bipolar Disorder; 254 are open to participants now.
This study's enrollment of 302 is above the median of 64 across 1,223 interventional studies indexed under Bipolar Disorder.
Browse Bipolar Disorder studies →Swinburne University of Technology is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
To ensure ready translation, minimally restrictive inclusion and exclusion criteria will be set.
Inclusion Criteria:
Exclusion criteria:
Introduction to, and training in the skills of mindfulness, self-compassion, and values-oriented action, and how these can be applied to managing symptoms of bipolar disorder.
Behavioral: Mindfulness for Bipolar
Information about bipolar disorder and the patient's role in managing the condition, including identifying triggers, and responding to early warning signs of episodes, and developing a healthy lifestyle
Behavioral: Psychoeducation for Bipolar
Brief online self-management program with email coaching support
Brief online self-management program with email coaching support
Change in Brief QoL.BD
Self-report measure to assess quality of life.
Time frame: Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Change in Montgomery-Asberg Depression Scale (MADRS)
A clinician-rated scale to assess depression symptoms.
Time frame: Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Change in Young Mania Rating Scale (YMRS)
A clinician-rated scale to assess manic symptoms.
Time frame: Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Change in Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR)
A self-report measure of depression.
Time frame: Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Change in Depression Anxiety Stress Scale (DASS-21, Anxiety and Stress Scales only)
A self-report measure of anxiety and stress symptoms.
Time frame: Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Change in Functional Assessment Staging Test (FAST)
A clinician-rated scale to assess functioning across 6 different domains.
Time frame: Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Change in Pittsburgh Sleep Quality Index (PSQI)
A self-report measure of sleep quality.
Time frame: Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Change in Sleep, Circadian Rhythms and Mood questionnaire (SCRAM)
A self-report measure to assess overlap between sleep, circadian rhythms and mood.
Time frame: Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Occurrence of intervention-related relapse
Using the Time to Intervention for Mood Episode (TIME) and a modified version of the MINI International Neuropsychiatric Interview (MINI) to determine treatment-related relapse events.
Time frame: Immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Change in Resource Use Questionnaire
A self-report measure of health service use.
Time frame: Baseline, 3 and 6 months.
Change in Assessment of Quality of Life 8dimension (AQol8d)
A self-report measure of quality of life.
Time frame: Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Change in Five Facet Mindfulness Questionnaire (FMQ)
A self-report measure of mindfulness.
Time frame: Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Change in Self-Compassion Scale (SCS)
A self-report measure of self-compassion.
Time frame: Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Change in Difficulties in Emotion Regulation Scale-16 Item (DERS-16)
A self-report measure to assess multiple aspects of emotion dysregulation.
Time frame: Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Change in Ruminative Responses Scale (section of the Response Styles Questionnaire)
A self-report measure of tendency to ruminate.
Time frame: Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Change in Responses to Positive Affect scale (RPA)
A self-report measure to assess rumination and dampening.
Time frame: Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Change in Non-attachment to Ego Scale
A self-report measure to assess non-attachment to self.
Time frame: Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Change in Depressive Experience Questionnaire Self-Criticism Six-Item Scale (DEQ-SC6)
A self-report measure to assess self-criticism.
Time frame: Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Change in the Short revised almost perfect scale (SAPS)
A self-report measure to assess perfectionism.
Time frame: Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Change in adherence to medication.
Self-reported adherence to medication.
Time frame: Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
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Swinburne University of Technology