Metacognitive CapacitiesNCT03266679
Psychological Factors In The Treatment Of Bipolar Mood Disorders
A study testing Metacognitive Reflection and Insight Therapy - Adapted in people with Metacognitive Capacities, run by Queensland University of Technology at 2 sites in Australia.
Trial 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). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Metacognitive Capacities
- What is being tested?
- Metacognitive Reflection and Insight Therapy - Adapted
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesAustralia
- Study dates
- 26 Jul 2017to 1 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Queensland University of Technology
Brisbane, Queensland, 4059
Metro South Addiction & Mental Health Services
Brisbane, Queensland, 4102
About this study
Official title: Bipolar Mood Disorders: A Recovery-Oriented Intervention Approach Addressing Deficits In Metacognitive Capacities
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
- Being tested
- Metacognitive Reflection and Insight Therapy - Adapted
- Keywords
- bipolar disorder, metacognition, reflective functioning, metacognition-based intervention, sense of self, insight
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metacognitive Reflection and Insight Therapy - AdaptedOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Metacognitive Reflection and Insight Therapy - Adapted |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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).
Measured: 10-15 minutes
Secondary outcomes (6)
Treatment Outcome Package (TOP)
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).
Measured: 15-20 minutes
The Hamilton Depression Rating Scale (HDRS)
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).
Measured: 10 minutes
The Young Mania Rating Scale (YMRS)
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).
Measured: 10 minutes
The Sheehan Disability Scale (SDS)
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.
Measured: 1-2 minutes
The 36-Item Short Form Healthy Survey (SF-36)
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).
Measured: 5-10 minutes
The Inventory of Interpersonal Difficulties (IIP-32)
The IIP-32 is a 32-item self-report questionnaire used to measure the severity of a wide range of difficulties experienced in interpersonal relationships. It is a shortened version of the 127-item IIP (Horowitz, Rosenberg, Baer, Ureno, \& Villasenor, 1998) The scale comprises eight subscales: hard to be sociable, hard to be assertive, too aggressive, too open, too caring, hard to be supportive, hard to be involved, and too dependent. Items (e.g., "I open up to people too much") are rated on a 5-point Likert-type scale ranging from 0 (not at all) to 4 (extremely), where higher scores indicate greater severity of difficulties experienced. Correlations between the mean item score on the IIP and the IIP-32 were .94 and .96, respectively, at pre- and post-treatment administrations in an efficacy study of time-limited treatment for depression (Barkham, Hardy, \& Startup, 1996).
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start26 Jul 2017
- Primary completion1 May 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metacognitive CapacitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Case-Series Design
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queensland University of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Metro South Health Addiction & Mental Health Services
- Responsible party
- Principal investigator, Priyanka Komandur, Queensland University of Technology
- Investigators
- Priyanka Komandur, Principal investigator, Queensland University of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03266679
- Sponsor's protocol ID
- Ethics Approval No: 1700000591
- Status last verified
- Sep 2021
- First submitted
- 13 Aug 2017
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bipolar Mood Disorders: A Recovery-Oriented Intervention Approach Addressing Deficits In Metacognitive Capacities
- ClinicalTrials.gov ID
- NCT03266679
- Acronym / sponsor ID
- Ethics Approval No: 1700000591
- Conditions
- Metacognitive Capacities
- Keywords
- bipolar disorder, metacognition, reflective functioning, metacognition-based intervention, sense of self, insight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Queensland University of TechnologyUniversity, hospital or other
- Collaborators
- Metro South Health Addiction & Mental Health Services
- Study start
- 26 Jul 2017 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 30 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Case-Series Design
| Arm | Type | Receives |
|---|---|---|
| Patients receiving metacognition-based intervention | Other | Other: Metacognitive Reflection and Insight Therapy - AdaptedCase-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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metacognitive Reflection and Insight Therapy - AdaptedThe 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. | Other | Patients receiving metacognition-based intervention |
Primary outcome
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.
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
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).
6 secondary outcomes
Treatment Outcome Package (TOP)
Time frame: 15-20 minutes
The Hamilton Depression Rating Scale (HDRS)
Time frame: 10 minutes
The Young Mania Rating Scale (YMRS)
Time frame: 10 minutes
The Sheehan Disability Scale (SDS)
Time frame: 1-2 minutes
The 36-Item Short Form Healthy Survey (SF-36)
Time frame: 5-10 minutes
The Inventory of Interpersonal Difficulties (IIP-32)
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Priyanka Komandur principal investigator
Queensland University of Technology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metacognitive Reflection and Insight Therapy - Adapted in people with Metacognitive Capacities, run by Queensland University of Technology at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Indiana Psychiatric Illness Interview (IPII) (time frame: IPII + MAS-A (see below) combined take approximately 45- 60 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2021.