Clinical trial NCT03266679: Psychological Factors In The Treatment Of Bipolar Mood Disorders
Official title: Bipolar Mood Disorders: A Recovery-Oriented Intervention Approach Addressing Deficits In Metacognitive Capacities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metacognitive Capacities
Keywords: bipolar disorder
metacognition
reflective functioning
metacognition-based intervention
sense of self
insight
Lead sponsor: Queensland University of Technology
Sponsor class: OTHER
Collaborators: name: Metro South Health Addiction & Mental Health Services
First posted: 2017-08-30
Enrollment: 4
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Case-Series Design
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

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

Primary outcomes:
measure: The Indiana Psychiatric Illness Interview (IPII)
timeFrame: IPII + MAS-A (see below) combined take approximately 45- 60 minutes
measure: The Metacognition Assessment Scale - Abbreviated (MAS-A)
timeFrame: IPII + MAS-A combined take approximately 45-60 minutes
measure: The Narrative Coherence Rating Scale (NCRS)
timeFrame: 10-15 minutes
Secondary outcomes:
measure: Treatment Outcome Package (TOP)
timeFrame: 15-20 minutes
measure: The Hamilton Depression Rating Scale (HDRS)
timeFrame: 10 minutes
measure: The Young Mania Rating Scale (YMRS)
timeFrame: 10 minutes
measure: The Sheehan Disability Scale (SDS)
timeFrame: 1-2 minutes
measure: The 36-Item Short Form Healthy Survey (SF-36)
timeFrame: 5-10 minutes
measure: The Inventory of Interpersonal Difficulties (IIP-32)
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: Queensland University of Technology
state: Queensland
city: Brisbane
country: Australia
facility: Metro South Addiction & Mental Health Services
state: Queensland
Study officials:
affiliation: Queensland University of Technology
name: Priyanka Komandur
role: PRINCIPAL_INVESTIGATOR
References: