RCT of a Web-based Intervention to Improve Quality of Life in Late Stage Bipolar Disorder (ORBIT)

Bipolar Disorder, Currently in Remission Clinical Trial

— ORBIT  

Official title:

Web-based Intervention With Email Support to Improve Quality of Life in Late Stage Bipolar Disorder (ORBIT): Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03197974
• Other study ID #: ORBIT
• Secondary ID: APP1102097
• Status: Completed
• Phase: N/A
• Start date: September 14, 2017
• Est. completion date: May 29, 2019

Study information

• Verified date: November 2020
• Source: Swinburne University of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: May 29, 2019
• Est. primary completion date: May 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

To ensure ready translation, minimally restrictive inclusion and exclusion criteria will be set.

Inclusion Criteria:

• diagnosis of BD from a mental health professional

• diagnosis of BD (BD I, BD II or Other Specified Bipolar and Related Disorder) confirmed by semi-structured interview using DSM-5 (Diagnostic and statistical manual of mental disorders-5) criteria, excluding criteria that mania/hypomania require abnormalities of activity/energy.

• must have experienced 10 or more episodes of mania, hypomania or depression

• must be under the care of and able to provide phone/mail contact details for a nominated medical practitioner

• must have local access to emergency services

• must have sufficient understanding of written and spoken English

• must have ready daily access to the internet and adequate internet literacy

• aged between 18 - 65 years

Exclusion criteria:

• currently experiencing an episode of depression or hypo/mania

• currently psychotic or actively suicidal

Related Conditions & MeSH terms

• Bipolar Disorder
• Bipolar Disorder, Currently in Remission

Intervention

Behavioral:
• Mindfulness for Bipolar
Brief online self-management program with email coaching support
• Psychoeducation for Bipolar
Brief online self-management program with email coaching support

Locations

Country	Name	City	State
Australia	Swinburne University of Technology	Hawthorn	Victoria

Sponsors (7)

Lead Sponsor	Collaborator
Swinburne University of Technology	Australian National University, Deakin University, Lancaster University, National Health and Medical Research Council, Australia, University of British Columbia, University of California, Berkeley

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Resource Use Questionnaire	A self-report measure of health service use.	Baseline, 3 and 6 months.
Other	Change in Assessment of Quality of Life 8dimension (AQol8d)	A self-report measure of quality of life.	Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Other	Change in Five Facet Mindfulness Questionnaire (FMQ)	A self-report measure of mindfulness.	Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Other	Change in Self-Compassion Scale (SCS)	A self-report measure of self-compassion.	Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Other	Change in Difficulties in Emotion Regulation Scale-16 Item (DERS-16)	A self-report measure to assess multiple aspects of emotion dysregulation.	Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Other	Change in Ruminative Responses Scale (section of the Response Styles Questionnaire)	A self-report measure of tendency to ruminate.	Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Other	Change in Responses to Positive Affect scale (RPA)	A self-report measure to assess rumination and dampening.	Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Other	Change in Non-attachment to Ego Scale	A self-report measure to assess non-attachment to self.	Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Other	Change in Depressive Experience Questionnaire Self-Criticism Six-Item Scale (DEQ-SC6)	A self-report measure to assess self-criticism.	Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Other	Change in the Short revised almost perfect scale (SAPS)	A self-report measure to assess perfectionism.	Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Other	Change in adherence to medication.	Self-reported adherence to medication.	Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Primary	Change in Brief QoL.BD	Self-report measure to assess quality of life.	Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Secondary	Change in Montgomery-Asberg Depression Scale (MADRS)	A clinician-rated scale to assess depression symptoms.	Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Secondary	Change in Young Mania Rating Scale (YMRS)	A clinician-rated scale to assess manic symptoms.	Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Secondary	Change in Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR)	A self-report measure of depression.	Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Secondary	Change in Depression Anxiety Stress Scale (DASS-21, Anxiety and Stress Scales only)	A self-report measure of anxiety and stress symptoms.	Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Secondary	Change in Functional Assessment Staging Test (FAST)	A clinician-rated scale to assess functioning across 6 different domains.	Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Secondary	Change in Pittsburgh Sleep Quality Index (PSQI)	A self-report measure of sleep quality.	Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Secondary	Change in Sleep, Circadian Rhythms and Mood questionnaire (SCRAM)	A self-report measure to assess overlap between sleep, circadian rhythms and mood.	Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Secondary	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.	Immediately post-intervention (post the 5 week active phase), 3 and 6 months.