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Trial registered on ANZCTR


Registration number
ACTRN12617001348347p
Ethics application status
Submitted, not yet approved
Date submitted
13/09/2017
Date registered
25/09/2017
Date last updated
17/10/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Social rhythm therapy for treatment-resistant Bipolar Disorder
Scientific title
Effect of social rhythm therapy on mood symptoms for treatment-resistant Bipolar Disorder
Secondary ID [1] 292872 0
None
Universal Trial Number (UTN)
Trial acronym
SRT-TR
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Bipolar Disorder 304720 0
Condition category
Condition code
Mental Health 304029 304029 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Social rhythm therapy is an adaptation of Interpersonal and Social Rhythm Therapy. It is 12-session face-to-face and online course of Social Rhythm Therapy over 12-14 weeks. In most cases this will be completed over 12 weeks but in order to maintain a patient-centred approach we have built in the flexibility for an extension of two weeks if patients are unable to attend some sessions.
The goals of SRT are to improve sleep quality, monitor and assess social rhythmicity, regularise social rhythms in the context of promoting self-awareness of how BD is impacting on each person’s life. It is a structured therapy and 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). It will be delivered by psychotherapists with at least 6 years experience in the Psychological Medicine Clinical Research Unit, University of Otago, Christchurch. The intervention will be delivered as 1 x one hour session per week for 12 sessions.
The intervention is manualised and sessions will be audio-recorded and reviewed by a psychotherapy supervisor. Fidelity will be assessed using an adaptation of the fidelity scale developed by Frank et al 2005.
Intervention code [1] 299114 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303361 0
Mood symptoms measured using The Longitudinal Interval Follow-up Evaluation (LIFE) (Keller et al. 1987)
Timepoint [1] 303361 0
Baseline and 6 months from baseline.
Secondary outcome [1] 338742 0
Quality of life assessed using QoL-BD (Michalak and Murray 2010)
Timepoint [1] 338742 0
Baseline, following 12 session of SRT and 6 months from baseline
Secondary outcome [2] 338810 0
Social rhythm stability measured using social rhythm matrix (Frank 2005)
Timepoint [2] 338810 0
From baseline daily for two weeks; daily following during weeks 11 and 12 of SRT; and 6 months from baseline
Secondary outcome [3] 338811 0
Level of functioning using The Functioning Assessment Short Test (Rosa et al. 2007)
Timepoint [3] 338811 0
Baseline, following 12 sessions of SRT and 6 months from baseline

Eligibility
Key inclusion criteria
aged 18 years +; currently under community mental health service care; diagnosis of Bipolar I or Bipolar II; treatment resistant BD (have been in treatment with mental health services for two years during which time they have spent at least 4 months in each year in an episode of depression, mania, hypomania or mixed mood); must have been trialled on three mood stabilisers including a trial of Lithium; able to access internet.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
BD not primary diagnosis; unable to provide informed consent; unable to participate in a 12-week psychotherapy.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
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 will compare scores on LIFE (mood symptoms) generated at baseline (from the 6 months prior to baseline) and those generated 6 months post baseline (from the 6 months after baseline) using paired T-tests. Other comparisons will also be by simple paired t-tests in order to generate effect size differences to power a more definitive randomised controlled trial.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 9205 0
New Zealand
State/province [1] 9205 0

Funding & Sponsors
Funding source category [1] 297501 0
University
Name [1] 297501 0
University of Otago, Christchurch
Address [1] 297501 0
4 Oxford Tce
Christchurch
8011
Country [1] 297501 0
New Zealand
Primary sponsor type
University
Name
University of Otago, Christchurch
Address
4 Oxford Tce
Christchurch
8011
Country
New Zealand
Secondary sponsor category [1] 296508 0
None
Name [1] 296508 0
Address [1] 296508 0
Country [1] 296508 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 298601 0
HDEC
Ethics committee address [1] 298601 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 298601 0
New Zealand
Date submitted for ethics approval [1] 298601 0
10/10/2017
Approval date [1] 298601 0
Ethics approval number [1] 298601 0

Summary
Brief summary
While medication is considered the first line of treatment in BD, there is increasing evidence that the course of BD can be further modified by interventions targeted at the social and environmental context. Most people with BD are discharged within 4-6 months there is a sub-group who spend years on community mental health service caseloads because they do not respond to medication, may have a rapid cycling form of the disorder and/or do not recover from mood episodes. There are no formal adjunctive therapies available for BD in usual practice.
SRT is a clinical adaptation of Interpersonal and Social Rhythm Therapy (IPSRT) (Frank 2005). It is based on the stress-vulnerability model.
Design
This study is an open-label trial of SRT for patients under the care of community mental health services with treatment resistant BPD. The aim of the study is to examine whether SRT is effective in stabilizing social rhythms in patients with treatment resistant BD.
Participants
Twenty patients will be recruited from community mental health services for 12 weeks of SRT as an adjunct to their usual care. Participants will remain under the care of mental health services but will have weekly one-hour SRT sessions.
Primary hypothesis: Following 12 sessions of SRT and 6 months from baseline patients will demonstrate improved mood symptoms.
Secondary hypotheses: Following 12 weeks of SRT patients will have:
o Improvement in quality of life
o Improvement in social rhythm stability
o Improvement in level of functioning
Measurement:
• Mood symptoms will be measured using The Longitudinal Interval Follow-up Evaluation (LIFE) (Keller et al. 1987) at baseline and 6 months to determine the occurrence of episodes of hypomania, major depressive disorder or mania.
• Stability in social rhythms will be measured using the Social Rhythm Matrix (Monk et al. 1991). This is a daily self-report of social rhythm activities: sleep, eating, activities. Stability will be measured as < 45-minute discrepancy between the times of target and actual social rhythms. Stability is defined as a score indicating that all social rhythms have been occurring within a 45-minute window over the final 2 weeks of SRT.
• Quality of life will be measured using QoL-BD (Michalak and Murray 2010) a validated measure for those with BD.
• Level of functioning will be measured using The Functioning Assessment Short Test (Rosa et al. 2007).
Qualitative interviews
Qualitative interviews will be conducted at baseline exploring the participants’ experiences of BD and treatment, and their perceptions on what they need to recover.
The primary analysis will compare scores generated at baseline (from the 6 months prior to baseline) and those generated 6 months post baseline (from the 6 months after baseline) using paired T-tests. Other comparisons will also be by simple paired t-tests in order to generate effect size differences.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77622 0
Prof Richard Porter
Address 77622 0
Dept of Psychological Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch 8011
Country 77622 0
New Zealand
Phone 77622 0
+64 3 3720400
Fax 77622 0
Email 77622 0
richard.porter@otago.ac.nz
Contact person for public queries
Name 77623 0
Prof Professor Richard Porter
Address 77623 0
Dept of Psychological Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch 8011
Country 77623 0
New Zealand
Phone 77623 0
+64 3 3720400
Fax 77623 0
Email 77623 0
richard.porter@otago.ac.nz
Contact person for scientific queries
Name 77624 0
Prof Richard Porter
Address 77624 0
Dept of Psychological Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch 8011
Country 77624 0
New Zealand
Phone 77624 0
+64 3 3720400
Fax 77624 0
Email 77624 0
richard.porter@otago.ac.nz

No data has been provided for results reporting
Summary results
Not applicable