Psychological Factors In The Treatment Of Bipolar Mood Disorders

NCT ID: NCT03266679

Last Updated: 2021-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-26
• Study Completion Date: 2019-07-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Metacognitive Reflection and Insight Therapy - Adapted

Intervention Type: 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.

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 Type: OTHER

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Metro South Health Addiction & Mental Health Services

UNKNOWN

Sponsor Role: collaborator

Queensland University of Technology

OTHER

Sponsor Role: lead

Responsible Party

Priyanka Komandur

PhD Student/Clinical Psychology Registrar

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Priyanka Komandur

Role: PRINCIPAL_INVESTIGATOR

Queensland University of Technology

Locations

Queensland University of Technology

Brisbane, Queensland, Australia

Metro South Addiction & Mental Health Services

Brisbane, Queensland, Australia

Countries

Australia

Other Identifiers

Ethics Approval No: 1700000591

Identifier Type: -

Identifier Source: org_study_id