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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
Date last updated
14/09/2021

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
The aim of this study is to trial an intervention targeting potential deficits in an individual's ability to form, and reflect upon, ideas about themselves and others (known as metacognitive capacities), specifically in relation to individuals diagnosed with a bipolar mood disorder (BMD).

The proposed research will adopt a mixed qualitative and quantitative design. Participants will be recruited through hospital outpatient groups (i.e., Metro South Addiction \& Mental Health Services Woolloongabba Community Health Centre \& Beenleigh Community Health Centre in Brisbane, Queensland), and, as necessary, local non government organisations (NGOs), psychiatrists, general practitioners, online support networks (SANE Australia, Black Dog Institute), community mental health services(such as MINDNET), and/or social media groups (Facebook, Twitter) supporting people who meet criteria for a BMD. The research will then use clinical interviews and quantitative (survey) methods to: (1) confirm diagnosis of participants; and (2) confirm deficits in metacognitive capacities of participants. Following this, the research will then involve the implementation of an adapted intervention across a course of 12 months, aimed at improving the metacognitive capacities of participants with a diagnosis of a BMD.

The research will provide an enriched understanding of a dimension of people with BMDs that has not been previously explored. The research will help with gaining an understanding of the metacognitive processes of people with BMDs, and inform more targeted psychological interventions.
Trial website
https://clinicaltrials.gov/study/NCT03266679
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03266679