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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03266679




Registration number
NCT03266679
Ethics application status
Date submitted
13/08/2017
Date registered
30/08/2017
Date last updated
14/09/2021

Titles & IDs
Public title
Psychological Factors In The Treatment Of Bipolar Mood Disorders
Scientific title
Bipolar Mood Disorders: A Recovery-Oriented Intervention Approach Addressing Deficits In Metacognitive Capacities
Secondary ID [1] 0 0
Ethics Approval No: 1700000591
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metacognitive Capacities 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Other mental health disorders
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Metacognitive Reflection and Insight Therapy - Adapted

Other: 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 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 code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The Indiana Psychiatric Illness Interview (IPII)
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
IPII + MAS-A (see below) combined take approximately 45- 60 minutes
Primary outcome [2] 0 0
The Metacognition Assessment Scale - Abbreviated (MAS-A)
Assessment method [2] 0 0
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
Timepoint [2] 0 0
IPII + MAS-A combined take approximately 45-60 minutes
Primary outcome [3] 0 0
The Narrative Coherence Rating Scale (NCRS)
Assessment method [3] 0 0
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).
Timepoint [3] 0 0
10-15 minutes
Secondary outcome [1] 0 0
Treatment Outcome Package (TOP)
Assessment method [1] 0 0
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).
Timepoint [1] 0 0
15-20 minutes
Secondary outcome [2] 0 0
The Hamilton Depression Rating Scale (HDRS)
Assessment method [2] 0 0
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).
Timepoint [2] 0 0
10 minutes
Secondary outcome [3] 0 0
The Young Mania Rating Scale (YMRS)
Assessment method [3] 0 0
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).
Timepoint [3] 0 0
10 minutes
Secondary outcome [4] 0 0
The Sheehan Disability Scale (SDS)
Assessment method [4] 0 0
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.
Timepoint [4] 0 0
1-2 minutes
Secondary outcome [5] 0 0
The 36-Item Short Form Healthy Survey (SF-36)
Assessment method [5] 0 0
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).
Timepoint [5] 0 0
5-10 minutes
Secondary outcome [6] 0 0
The Inventory of Interpersonal Difficulties (IIP-32)
Assessment method [6] 0 0
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).
Timepoint [6] 0 0
5 minutes

Eligibility
Key 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
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/07/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2019
Sample size
Target
Accrual to date
Final
4
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Queensland University of Technology - Brisbane
Recruitment hospital [2] 0 0
Metro South Addiction & Mental Health Services - Brisbane
Recruitment postcode(s) [1] 0 0
4059 - Brisbane
Recruitment postcode(s) [2] 0 0
4102 - Brisbane

Funding & Sponsors
Primary sponsor type
Other
Name
Queensland University of Technology
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Metro South Health Addiction & Mental Health Services
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Priyanka Komandur
Address 0 0
Queensland University of Technology
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT03266679