Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001157864
Ethics application status
Approved
Date submitted
1/07/2021
Date registered
27/08/2021
Date last updated
15/02/2023
Date data sharing statement initially provided
27/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Intensive Rhythm Stabilisation for Bipolar Disorder
Scientific title
Effect of Social Rhythm and Bright Light Therapy on symptom burden in treatment resistant bipolar disorder
Secondary ID [1] 304581 0
HRC Ref ID#: 19/654
Universal Trial Number (UTN)
U1111-1224-5666
Trial acronym
IRS study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bipolar Disorder 322480 0
Condition category
Condition code
Mental Health 320117 320117 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will recieve both Social rhythm therapy and Bright Light Therapy.
SRT: Social Rhythm Therapy - a structured therapy delivered weekly over 12 weeks based on a stress-diathesis model of disruption to circadian rhythms focusing on stabilisation of the social rhythms that underpin circadian rhythms. SRT incorporates two generic psychotherapy components (promotion of self-awareness and articulation of the experience of BD symptoms) and one specific component (promotion of social rhythm regularity). A range of strategies for addressing disruption to the sleep/wake cycle is utilised, including setting a regular wake time, avoiding blue light in the evening, incorporating wind down activities into sleep preparation, ensuring the stability of key social rhythms (e.g. daily activities and eating), daily scheduling of work and recreational activities, discouraging naps during daylight hours, utilising stimulus control strategies for use of the bedroom, and exposure to morning bright light and dim evening light. This therapy, in contrast to other evidence-based psychotherapies for BD, is relatively short and easily trained, so it may be more practical and likely to be adopted in routine practice.

In the current study, SRT will be provided by trained therapists in an individual format. Each session will be one hour and will occur weekly for 12 weeks. According to a manualised protocol (developed with the University of Pittsburgh) and supervised by an experienced therapist, therapy will be delivered according to a manualised protocol (developed with the University of Pittsburgh). All sessions will be audio-taped and 10% will be randomly selected and rated to ensure adherence to therapy protocols.

Bright Light: Bright Light Therapy (BLT) patients will be provided with a lightbox (Daylight Simulator “Day-Light” Classic Model) to deliver 30 minutes of bright light at approximately 10,000 lux, for 12 weeks. Exposure will occur daily at midday, with the exact schedule being determined by a predictive algorithm based on Morningness-Eveningness Questionnaire scores. Treatment adherence will be monitored by daily logs of device treatment times completed by patients and reviewed at each therapy session.
Intervention code [1] 320933 0
Treatment: Other
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327995 0
Change in Mania and Depressive symptoms as measured by the Longitudinal Interval Follow-up Examination (LIFE)
Timepoint [1] 327995 0
Assessed at study entry and again at 6 months after study entry
Secondary outcome [1] 397184 0
Change in Social rhythm stability, as measured using the Social Rhythm Matrix
Timepoint [1] 397184 0
Measured at baseline and 12 weeks after study entry
Secondary outcome [2] 397185 0
Change in Cognitive functioning, as reflected by a cognitive composite score, which averages scores across the four cognitive domains: 1) verbal learning and memory, 2) visuospatial learning and memory, 3) executive functioning, and 4) psychomotor speed.
Timepoint [2] 397185 0
Measured at baseline and 12 weeks after study entry
Secondary outcome [3] 397186 0
Change in General functioning, as measured with the Functional Analysis Screening Tool (FAST)
Timepoint [3] 397186 0
Measured at baseline and 12 weeks after study entry
Secondary outcome [4] 397187 0
Change in Quality of life, as measured using the Quality of Life in Bipolar Disorder (QoL.BD) questionnaire
Timepoint [4] 397187 0
Measured at baseline and 12 weeks after study entry
Secondary outcome [5] 397188 0
Change in Current mood symptom severity, as measured with the Quick Inventory of Depressive Symptomatology (QIDS) and Young Mania Rating Scale (YMRS)
Timepoint [5] 397188 0
Measure at baseline and 12 weeks after study entry
Secondary outcome [6] 397189 0
Change in Biological rhythms (sleep/social, activity, and feeding patterns), as measured with the Biological Rhythms Interview for Assessment in Neuropsychiatry (BRIAN)
Timepoint [6] 397189 0
Measure at baseline and 12 weeks after study entry
Secondary outcome [7] 397195 0
Change in longer-term symptom burden (duration and severity of mood and mania symptoms), as measured by the LIFE
Timepoint [7] 397195 0
Measured at baseline and 12 months after study entry

Eligibility
Key inclusion criteria
(i) aged over 18 years, (ii) currently under community mental health service care, (iii) diagnosis of Bipolar I or Bipolar II Disorder, and (iv) treatment-resistance, defined as being in treatment with mental health services for at least 9 months and with no planned discharge within the coming six months.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) BD not the primary diagnosis, (ii) unable to provide informed consent, (iii) unable to participate in 12-week psychotherapy, and (iv) unable to undergo bright light exposure (e.g., retinal disease, light sensitivity).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not necessary as is open label
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not necessary as is open label
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary analysis in this study will compare LIFE scores generated at baseline (6 months prior to baseline) and those generated 6 months after baseline. One of the main reasons for conducting this open-label, pilot study is to examine the variability in outcome measures, particularly mood symptoms (LIFE), to enable a power calculation for a larger-scale study. In our previous study (Inder et al., 2015), mean change in the LIFE between the 6 months prior to baseline and the first 6 months of therapy was 0.7 with a SD of 1.3 (i.e., an effect size of 0.54). These figures may be different in this group, and with this intervention, and a primary aim is to determine this in order to be able to power an RCT of this treatment.

Mean change and standard deviations will also be generated for key secondary outcomes (e.g., cognitive function) in order to determine suitable power for a planned RCT.

The relationship between measures (for example change in sleep and change in cognition) will be examined.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/09/2021
Actual
20/10/2021
Date of last participant enrolment
Anticipated
11/07/2023
Actual
Date of last data collection
Anticipated
11/07/2024
Actual
Sample size
Target
20
Accrual to date
8
Final
Recruitment outside Australia
Country [1] 23824 0
New Zealand
State/province [1] 23824 0
Christchurch

Funding & Sponsors
Funding source category [1] 308946 0
Government body
Name [1] 308946 0
Health Research Council of New Zealand
Country [1] 308946 0
New Zealand
Primary sponsor type
University
Name
University of Otago, Christchurch
Address
Department of Psychological Medicine
University of Otago, Christchurch
4 Oxford Terrace
Christchurch
Country
New Zealand
Secondary sponsor category [1] 309923 0
None
Name [1] 309923 0
Address [1] 309923 0
Country [1] 309923 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308832 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 308832 0
Ethics committee country [1] 308832 0
New Zealand
Date submitted for ethics approval [1] 308832 0
28/05/2021
Approval date [1] 308832 0
10/06/2021
Ethics approval number [1] 308832 0
18/NTB/238/AM02

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112054 0
Prof Richard Porter
Address 112054 0
Dept Psychological Medicine
University of Otago, Christchurch 8011
PO Box 4345
Country 112054 0
New Zealand
Phone 112054 0
+64 03 3720402
Fax 112054 0
Email 112054 0
[email protected]
Contact person for public queries
Name 112055 0
Katie Douglas
Address 112055 0
Dept Psychological Medicine
University of Otago, Christchurch 8011
PO Box 4345
Country 112055 0
New Zealand
Phone 112055 0
+64 03 3720400
Fax 112055 0
Email 112055 0
[email protected]
Contact person for scientific queries
Name 112056 0
Kaite Douglas
Address 112056 0
Dept Psychological Medicine
University of Otago, Christchurch 8011
PO Box 4345
Country 112056 0
New Zealand
Phone 112056 0
+64 03 3720400
Fax 112056 0
Email 112056 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This was not part of the protocol


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.