Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000722695
Ethics application status
Approved
Date submitted
19/09/2005
Date registered
9/11/2005
Date last updated
9/11/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised clinical trial of interpersonal social rhythms psychotherapy in young people with bipolar disorder.
Scientific title
A randomised clinical trial of interpersonal social rhythms therapy with non-specific supportive clinical management in the treatment of young people with bipolar disorder to reduce the cummulative burden of depressive symptomatology over the period from 6 to 18 months after starting treatment.
Universal Trial Number (UTN)
Trial acronym
PBS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bipolar disorder 873 0
Condition category
Condition code
Neurological 941 941 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Interpersonal social rhythms psychotherapy (IPSRT).
Duration: 18 months.
Intervention code [1] 650 0
None
Comparator / control treatment
Non-specific Supportive Clinical Management (NSCM).
Duration: 18 months.
Control group
Active

Outcomes
Primary outcome [1] 1236 0
To evaluate the hypothesis that Interpersonal Social Rhythms Psychotherapy (IPSRT) is superior to a "control" psychological intervention (non-specific supportive clinical management (NSCM), in improving the medium term (6-18 month) outcome of young people with bipolar disaffective disorder, who are also receiving psychopharmacological treatment.
Timepoint [1] 1236 0
Analysis will be completed following the 18 month treatment protocol.
Primary outcome [2] 1237 0
Primary outcome is decreased cumulative burden of depressive symptoms.
Timepoint [2] 1237 0
Analysis will be completed following the 18 month treatment protocol.
Secondary outcome [1] 2254 0
1. Improved social functioning
Timepoint [1] 2254 0
Analysis will be completed following the 18 month treatment protocol.
Secondary outcome [2] 2255 0
2. Decreased manic/hypomanic cumulative burden.
Timepoint [2] 2255 0
Analysis will be completed following the 18 month treatment protocol.

Eligibility
Key inclusion criteria
(a) able and willing to sign informed consent for the research protocol. Patients may be on any medication, or combination of medication when they enter the study.
Minimum age
15 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) schizophrenia or schizoaffective disorder; (b) severe alcohol or drug dependence as a principal diagnosis; (c) low probability of remaining in contact with treating clinicians.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated permutated block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/10/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 234 0
New Zealand
State/province [1] 234 0

Funding & Sponsors
Funding source category [1] 1039 0
Government body
Name [1] 1039 0
Health Research Council of New Zealand
Country [1] 1039 0
New Zealand
Primary sponsor type
Government body
Name
Health Research Council of New Zealand
Address
Country
New Zealand
Secondary sponsor category [1] 901 0
None
Name [1] 901 0
N/A
Address [1] 901 0
Country [1] 901 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2339 0
Christchurch
Ethics committee address [1] 2339 0
Ethics committee country [1] 2339 0
New Zealand
Date submitted for ethics approval [1] 2339 0
Approval date [1] 2339 0
Ethics approval number [1] 2339 0

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

Contacts
Principal investigator
Name 35478 0
Address 35478 0
Country 35478 0
Phone 35478 0
Fax 35478 0
Email 35478 0
Contact person for public queries
Name 9839 0
Professor Peter Joyce
Address 9839 0
Department of Psychological Medicine
Christchurch School of Medicine & Health Sciences
PO Box 4345
Christchurch 8001
Country 9839 0
New Zealand
Phone 9839 0
+64 3 3720400
Fax 9839 0
+64 3 3720407
Email 9839 0
[email protected]
Contact person for scientific queries
Name 767 0
Professor Peter Joyce
Address 767 0
Department of Psychological Medicine
Christchurch School of Medicine & Health Sciences
PO Box 4345
Christchurch 8001
Country 767 0
New Zealand
Phone 767 0
+64 3 3720400
Fax 767 0
+64 3 3720407
Email 767 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseRandomized, controlled trial of Interpersonal and Social Rhythm Therapy for young people with bipolar disorder.2015https://dx.doi.org/10.1111/bdi.12273
EmbaseNovel insights into irritability: The relationship between subjective experience, age and mood.2021https://dx.doi.org/10.1192/bjo.2021.1033
EmbaseImprovement in cognitive function in young people with bipolar disorder: Results from participants in an 18-month randomised controlled trial of adjunctive psychotherapy.2020https://dx.doi.org/10.1177/0004867419887794
EmbaseDomain-Based Functional Improvements in Bipolar Disorder After Interpersonal and Social Rhythm Therapy.2022https://dx.doi.org/10.3389/fpsyt.2022.767629
EmbaseRelationship between baseline cognition and 18-month treatment response in bipolar disorder.2022https://dx.doi.org/10.1016/j.jad.2022.08.112
N.B. These documents automatically identified may not have been verified by the study sponsor.