Psychological Factors In The Treatment Of Bipolar Mood Disorders

NCT03266679 | Completed

• 1 other identifier: Ethics Approval No: 1700000591
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

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.

Conditions

Metacognitive Capacities

Keywords

bipolar disorder; metacognition; reflective functioning; metacognition-based intervention; sense of self; insight

Outcome Measures

Primary Outcomes (3)

• The Indiana Psychiatric Illness Interview (IPII)

  The IPII is a semi-structured interview that will be used to assess how participants understand their experience with mental illness (i.e., to elicit and assess an illness narrative). The interview is conceptually divided into five sections. First, rapport is established and participants are asked to tell the story of their lives, beginning with their earliest memory. Second, participants are asked if they think they have a mental illness and, if so, whether or not this condition has affected different facets of their life. Third, participants are asked if and how their condition controls their life and, alternately, how they control their condition. Fourth, they are asked how their condition affects, and is affected by others. Finally, participants are asked about their expectations for the future. The narratives of self and illness are then qualitatively analysed (form and quality rather than content) and then quantitatively rated.

  IPII + MAS-A (see below) combined take approximately 45- 60 minutes

• The Metacognition Assessment Scale - Abbreviated (MAS-A)

  The MAS-A is an observer rating scale that will be used to assess metacognitive capacity. The MAS-A can be used either in a structured interview format or during a therapy session. The measure presumes that metacognition is comprised of multiple related but semi-independent functions. The MAS-A provides an overall measure of metacognitive capacity, as well as four subscale measures. The four subscales are: 1) Self-reflectivity or Understanding of One's Own Mind - the ability of a person to think about his or her own mental states; 2) Understanding Others' Minds - the ability to think about the mental states of others; 3) Decentration - the ability to see other's mental states with motivations and hypotheses independent from their own); and, 4) Mastery - the ability to use

  IPII + MAS-A combined take approximately 45-60 minutes

• The Narrative Coherence Rating Scale (NCRS)

  The NCRS is a six item, 18-point rating scale developed to assess narrative coherence of illness narratives elicited from the IPII. The six items are: 1) "Logical connections" among the narrative of past psychiatric illnesses; 2) "Logical connections" among the narrative of psychiatric illnesses in the present; 3) "Richness of historical detail" among the narrative of past psychiatric illnesses; 4) "Richness of historical detail" among the narrative of psychiatric illnesses in the present; 5) "Plausibility" among the narrative of psychiatric illnesses in the past; and 6) "Plausibility" among the narrative of psychiatric illnesses in the present. A trained rater reviews an IPII transcript and rates according to scoring anchors (Lysaker et al., 2002).

  10-15 minutes

Secondary Outcomes (6)

• Treatment Outcome Package (TOP)

  15-20 minutes

• The Hamilton Depression Rating Scale (HDRS)

  10 minutes

• The Young Mania Rating Scale (YMRS)

  10 minutes

• The Sheehan Disability Scale (SDS)

  1-2 minutes

• The 36-Item Short Form Healthy Survey (SF-36)

  5-10 minutes

Study Arms (1)

Patients receiving metacognition-based intervention

OTHER

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: Metacognitive Reflection and Insight Therapy - Adapted

Interventions

Metacognitive Reflection and Insight Therapy - Adapted OTHER

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.

Patients receiving metacognition-based intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queensland University of Technology: lead
• Metro South Health Addiction & Mental Health Services: collaborator

Study Sites (2)

Queensland University of Technology

Brisbane, Queensland, 4059, Australia

Location

Metro South Addiction & Mental Health Services

Brisbane, Queensland, 4102, Australia

Location

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• Priyanka Komandur

  Queensland University of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student/Clinical Psychology Registrar

Model Details: Case-Series Design

Study Record Dates

• First Submitted: August 13, 2017
• First Posted: August 30, 2017
• Study Start: July 26, 2017
• Primary Completion: May 1, 2019
• Study Completion: July 1, 2019
• Last Updated: September 14, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)