Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03266679




Registration number
NCT03266679
Ethics application status
Date submitted
13/08/2017
Date registered
30/08/2017

Titles & IDs
Public title
Psychological Factors In The Treatment Of Bipolar Mood Disorders
Scientific title
Bipolar Mood Disorders: A Recovery-Oriented Intervention Approach Addressing Deficits In Metacognitive Capacities
Secondary ID [1] 0 0
Ethics Approval No: 1700000591
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metacognitive Capacities 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Other mental health disorders
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Metacognitive Reflection and Insight Therapy - Adapted

Other: Patients receiving metacognition-based intervention - Case-Series Design - all participants receive the intervention - metacognition-based therapy (adapted version of Metacognitive Reflection and Insight Therapy developed by Lysaker \& Klion) - weekly for a period of 12 months. No control/comparison group.


Other interventions: Metacognitive Reflection and Insight Therapy - Adapted
The intervention involves the following elements: setting an agenda, developing a therapeutic relationship, therapist transparency and insertion of therapist's mind, analysis of narrative episodes, problem definition, stimulating self-reflection and understanding of others, stimulating mastery, reflecting on therapeutic relationship, and client assessment of outcomes.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The Indiana Psychiatric Illness Interview (IPII)
Timepoint [1] 0 0
IPII + MAS-A (see below) combined take approximately 45- 60 minutes
Primary outcome [2] 0 0
The Metacognition Assessment Scale - Abbreviated (MAS-A)
Timepoint [2] 0 0
IPII + MAS-A combined take approximately 45-60 minutes
Primary outcome [3] 0 0
The Narrative Coherence Rating Scale (NCRS)
Timepoint [3] 0 0
10-15 minutes
Secondary outcome [1] 0 0
Treatment Outcome Package (TOP)
Timepoint [1] 0 0
15-20 minutes
Secondary outcome [2] 0 0
The Hamilton Depression Rating Scale (HDRS)
Timepoint [2] 0 0
10 minutes
Secondary outcome [3] 0 0
The Young Mania Rating Scale (YMRS)
Timepoint [3] 0 0
10 minutes
Secondary outcome [4] 0 0
The Sheehan Disability Scale (SDS)
Timepoint [4] 0 0
1-2 minutes
Secondary outcome [5] 0 0
The 36-Item Short Form Healthy Survey (SF-36)
Timepoint [5] 0 0
5-10 minutes
Secondary outcome [6] 0 0
The Inventory of Interpersonal Difficulties (IIP-32)
Timepoint [6] 0 0
5 minutes

Eligibility
Key inclusion criteria
* Diagnosed with a Bipolar Affective (mood) Disorder
* Medication has not been changed for at least the past one month
* No hospitalisations in the past month
* Able to provide informed consent
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Diagnosed with an Intellectual Disability
* Diagnosed with Schizoaffective Disorder
* High risk of suicide; defined as current, daily suicidal ideation, or the presence of a current plan and intent to commit suicide

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/07/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2019
Sample size
Target
Accrual to date
Final
4
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Queensland University of Technology - Brisbane
Recruitment hospital [2] 0 0
Metro South Addiction & Mental Health Services - Brisbane
Recruitment postcode(s) [1] 0 0
4059 - Brisbane
Recruitment postcode(s) [2] 0 0
4102 - Brisbane

Funding & Sponsors
Primary sponsor type
Other
Name
Queensland University of Technology
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Metro South Health Addiction & Mental Health Services
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Priyanka Komandur
Address 0 0
Queensland University of Technology
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03266679