Psychological Factors In The Treatment Of Bipolar Mood Disorders

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 evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03266679
Recruitment Status : Recruiting
First Posted : August 30, 2017
Last Update Posted : August 30, 2017
Metro South Health Addiction & Mental Health Services
Information provided by (Responsible Party):
Priyanka Komandur, Queensland University of Technology

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.

Condition or disease Intervention/treatment Phase
Metacognitive Capacities Other: Metacognitive Reflection and Insight Therapy - Adapted Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Case-Series Design
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bipolar Mood Disorders: A Recovery-Oriented Intervention Approach Addressing Deficits In Metacognitive Capacities
Actual Study Start Date : July 26, 2017
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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: 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.

Primary Outcome Measures :
  1. The Indiana Psychiatric Illness Interview (IPII) [ Time Frame: IPII + MAS-A (see below) combined take approximately 45- 60 minutes ]
    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.

  2. The Metacognition Assessment Scale - Abbreviated (MAS-A) [ Time Frame: IPII + MAS-A combined take approximately 45-60 minutes ]
    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

  3. The Narrative Coherence Rating Scale (NCRS) [ Time Frame: 10-15 minutes ]
    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).

Secondary Outcome Measures :
  1. Treatment Outcome Package (TOP) [ Time Frame: 15-20 minutes ]
    The TOP is a multidimensional outcome measure designed to track behavioural health treatment progress and outcomes. The TOP has three age-specific versions (child, adolescent, adult). The adult TOP clinical scales consist of 58 items assessing 12 symptom and functional domains: work functioning, sexual functioning, social conflict, depression, panic (somatic anxiety), psychosis, suicidal ideation, violence, mania, sleep, substance abuse, and quality of life. Items (e.g., "Felt down or depressed" "Felt on top of the world") can be summed across the domains to form a global symptom severity score. When using raw (non-standardised) scores, higher TOP total scores indicate healthier functioning. The TOP clinical scales and total score have demonstrated adequate internal consistency reliability and test-retest reliability, and convergent, discriminant, and criterion validity (Kraus, Seligman, & Jordan, 2005).

  2. The Hamilton Depression Rating Scale (HDRS) [ Time Frame: 10 minutes ]
    The HDRS is a 17-item, clinician-rated scale that will be used to assess the severity of, and change in, depressive symptoms in participants over the past week. Items (e.g., Feelings of Guilt) are rated on scales of varying grades of severity (e.g., 0 = absent, 4 = incapacitating). The HDRS item scores can be summed to obtain a total score (ranging from 0 to 52), where higher scores indicate greater depression severity. The HDRS has demonstrated adequate reliability (internal, interrater, and retest) and validity (convergent, discriminant, and predictive; Bagby, Ryder, Schuller, Marshall, 2004).

  3. The Young Mania Rating Scale (YMRS) [ Time Frame: 10 minutes ]
    The YMRS is an 11-item, clinician-rated scale that will be used to assess symptoms of mania over the past week. There are four items (Irritability, Speech, Thought Content, and Disruptive/Aggressive Behaviour) that are rated on a 0 to 8 scale, while the remaining items are rated on a 0 to 4 scale. All rating scales have explicitly described grades of severity. The YMRS scores can be summed to obtain a total score (ranging from 0 to 60), where higher scores indicate greater severity of the symptom. The YMRS has demonstrated adequate internal consistency and test-retest reliability, as well as convergent and divergent validity (Young et al., 1978).

  4. The Sheehan Disability Scale (SDS) [ Time Frame: 1-2 minutes ]
    The SDS is a 5-item, self-reported questionnaire used to measure the extent to which an individual's disability due to an illness or health problem has interfered with: (1) work/school; (2) social life/leisure activities (3) and family life/home responsibilities (each area is considered a subscale of the questionnaire) in the past week. The first three items (e.g.,"The symptoms have disrupted your work/school work") are rated on a Likert-type scale (0 = not at all, 10 = extremely). Each subscale can be scored separately or combined into a total score (sum of non-missing responses) ranging from 0 to 30, where higher scores indicate significant functional impairment.

  5. The 36-Item Short Form Healthy Survey (SF-36) [ Time Frame: 5-10 minutes ]
    The SF-36 is a 36-item scale used to measure an individual's QoL. The scale taps into varying health concepts, with eight subscales: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. Items (e.g., "How much bodily pain have you had in the past 4 weeks?") are rated on Likert-type scales of varying ranges (between 1-2 and 1-6). Items in the same scale are averaged together to form eight scale scores (average is based on questions that received a response, missing data is excluded). Items are scored such that higher scores indicate a more favourable health state (Ware Jr & Sherbourne, 1992).

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03266679

Contact: Priyanka Komandur 0449939632
Contact: Robert Schweitzer (07) 3138 4617

Australia, Queensland
Queensland University of Technology Recruiting
Brisbane, Queensland, Australia, 4059
Contact: Priyanka Komandur    0449939632   
Contact: Robert Schweitzer    (07) 3138 4617   
Metro South Addiction & Mental Health Services Recruiting
Brisbane, Queensland, Australia, 4102
Contact: Priyanka Komandur    0449939632   
Contact: Nathan Pasieczny    (07) 33171020   
Sub-Investigator: Nathan Pasieczny         
Sub-Investigator: Bronwyn Wright         
Sponsors and Collaborators
Queensland University of Technology
Metro South Health Addiction & Mental Health Services
Principal Investigator: Priyanka Komandur Queensland University of Technology

Responsible Party: Priyanka Komandur, PhD Student/Clinical Psychology Registrar, Queensland University of Technology Identifier: NCT03266679     History of Changes
Other Study ID Numbers: Ethics Approval No: 1700000591
First Posted: August 30, 2017    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Priyanka Komandur, Queensland University of Technology:
bipolar disorder
reflective functioning
metacognition-based intervention
sense of self

Additional relevant MeSH terms:
Mood Disorders
Bipolar Disorder
Mental Disorders
Bipolar and Related Disorders