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Trial registered on ANZCTR
Registration number
ACTRN12618000198224p
Ethics application status
Not yet submitted
Date submitted
27/01/2018
Date registered
7/02/2018
Date last updated
8/02/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
Effectiveness of Interpersonal Metacognitive Therapy in group (MIT-G) for Personality Disorders
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Scientific title
Effectiveness of Metacognitive Interpersonal Therapy in group (MIT-G) for Personality Disorders
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Secondary ID [1]
293890
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None
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Universal Trial Number (UTN)
U1111-1208-6135
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Trial acronym
MIT-G/Trial
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Personality disorders
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Condition category
Condition code
Mental Health
305445
305445
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0
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Psychosis and personality disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The experimental condition will receive 16 group sessions based on Metacognitive Interpersonal Therapy (MIT-G) plus treatment as usual (TAU). TAU will consist of consultations on medications and supportive counselling, and it will be not affected by the trial protocol. The MIT-G involves 16 weekly group-sessions lasting approximately 120 minutes each addresses to (i) improve metacognition, in particular the abilities to making sense of the mental states both of the self and of others and to use knowledge about mental states to deal with suffering, (ii) to modified maladaptive interpersonal schemas, and (iii) to improve in emotional regulation.
Throughout the MIT-G sessions, patients will be guided to revise their maladaptive constructions of self and others and to develop richer, more flexible and healthier perspectives on themselves and others which whom they interact with. Interpersonal episodes form the foundation of group session content. In line with other metacognitively oriented psychotherapies, patients will be encouraged to consider psychological reaction chains, including the relationships between external triggers, thoughts, feelings, and behaviours. These procedures are designed to facilitate metacognitive skill growth, increasing the patient’s awareness of their emotions and internal reaction chains. Interpersonal episodes will be used to develop a joint formulation of maladaptive interpersonal schemas. This forms the basis of between session exercises, designed to interrupt schema-driven cycles.
The MIT-G groups will be composed of 5 to 10 participants in order to be large enough to be stimulating and produce an atmosphere of cooperativeness among group members, but not too large as to be chaotic or marginalizing for more introverted participants. Trial therapists will be Clinical Psychologists or Psychiatrists versed in group therapy with personality disorders. Therapists will also receive a specific three-day MIT-G training to ensure that treatments are consistently delivered by therapist who are confident with the MIT-G approach.
After sixteen sessions of treatment or 16-week waitlist period, the assessment will be repeated (post-treatment). Follow-up assessment will take place six months after completion of the MIT-G intervention.
The attendance to group sessions will be counted in an attendance list. The minimal exposure to MIT-G treatment protocol for post-test analysis will be considered to be eight or more sessions. Finally, in order to favor adherence to treatment, participants will receive text-message reminders.
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Intervention code [1]
300158
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Treatment: Other
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Comparator / control treatment
The control group will involve a waiting list control group receiving TAU alone. Waitlist participants will not receive MIT-G during a 16-week waitlist period, but will receive the treatment immediately following the sixteen week waiting period.
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Control group
Active
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Outcomes
Primary outcome [1]
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Symptom Checklist-90-Revised (SCL-90-R)
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Assessment method [1]
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Timepoint [1]
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Baseline (0 weeks), post-treatment (after 16 weeks in the wait-list control group) and 6-month follow-up (primary timepoint)
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Primary outcome [2]
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Social Functioning Scale (SFS)
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Assessment method [2]
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Timepoint [2]
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Baseline (0 weeks), post-treatment (after 16 weeks in the wait-list control group) and 6-month follow-up (primary timepoint)
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Primary outcome [3]
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Beck Hopelessness Scale (BHS)
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Assessment method [3]
304585
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Timepoint [3]
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Baseline (0 weeks), post-treatment (after 16 weeks in the wait-list control group) and 6-month follow-up (primary timepoint)
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Secondary outcome [1]
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Beck Suicide Ideation Scale (BSS)
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Assessment method [1]
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Timepoint [1]
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Baseline (0 weeks), post-treatment (after 16 weeks in the wait-list control group) and 6-month follow-up
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Secondary outcome [2]
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Barratt Impulsiveness Scale-11 (BIS-11)
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Assessment method [2]
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Timepoint [2]
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Baseline (0 weeks), post-treatment (after 16 weeks in the wait-list control group) and 6-month follow-up
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Secondary outcome [3]
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Beck Depression Inventory-II (BDI-II)
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Assessment method [3]
342460
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Timepoint [3]
342460
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Baseline (0 weeks), post-treatment (after 16 weeks in the wait-list control group) and 6-month follow-up
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Secondary outcome [4]
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Clinical Outcomes in Routine Evaluation (CORE-OM)
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Assessment method [4]
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Timepoint [4]
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In addition to use this instrument at baseline, post-treatment (after 16 weeks in the wait-list control group) and 6-month follow-up assessments, CORE-OM will also be used to monitor inter-session progress of participants at the end of each MIT-G group session (or TAU sessions in the wait-list control group).
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Secondary outcome [5]
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Indiana Psychiatric Illness Interview (IPII)
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Assessment method [5]
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Timepoint [5]
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Baseline (0 weeks), post-treatment (after 16 weeks in the wait-list control group) and 6-month follow-up
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Secondary outcome [6]
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Metacognition Assessment Scale (MAS-A)
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Assessment method [6]
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Timepoint [6]
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Baseline (0 weeks), post-treatment (after 16 weeks in the wait-list control group) and 6-month follow-up
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Secondary outcome [7]
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Interpersonal Reactivity Index (IRI)
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Assessment method [7]
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Timepoint [7]
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Baseline (0 weeks), post-treatment (after 16 weeks in the wait-list control group) and 6-month follow-up
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Secondary outcome [8]
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MIT-G acceptance and subjective impact. These variables will be assessed using an anonymous self-report scale to evaluate the therapy’s enjoyableness, usefulness and effect on daily functioning using a 5-point scale.
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Assessment method [8]
342465
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Timepoint [8]
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Only in the experimental condition, at the end of group therapy sessions 4, 8, 12 and 16
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Secondary outcome [9]
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Group Climate Questionnaire-S (GCQ-S).
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Assessment method [9]
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Timepoint [9]
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Only in the experimental condition, at the end of group therapy sessions 4, 8, 12 and 16
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Eligibility
Key inclusion criteria
Diagnosis of Personality Disorder, according to DSM-IV-TR criteria.
Being able to give informed consent.
No change in medication in the past month.
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Diagnosis with full or sub-threshold antisocial PD.
High rate of substance use (defined as drinking or engaging in drug use to the point of intoxication, three or more times per week);
High risk of suicide (defined as the presence of a current plan and/or intent to commit suicide), severe depression and/or bipolar disorder;
Psychosis in schizophrenia spectrum;
Impaired intellectual functioning, operationally defined as Wechsler Adult Intelligence Scale–IV Full-Scale IQ scores below 70;
Major neurological illness;
Insufficient ability in speaking and understanding the common language of the group therapy conductors and participants;
Did not have the capacity to consent to research participation.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The personal data of the interested participants will be coded and out of these coded data random selection will be chosen by research assistants to prevent selection bias.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Statistical analyses will be based on the intention-to-treat principle. Linear mixed (covariance pattern) with unstructured covariance matrices will be fitted using SAS PROC MIXED to allow for correlation between post-treatment and follow-up measure of the same variable. Otherwise identified as marginal models, this approach is equivalent to fitting models with random intercepts that vary at the level of study participants. Maximum likelihood estimation procedures ensure that inferences will remain unbiased under the missing at random assumption. Analyses will be adjusted for baseline response. Time and treatment-by-time interaction terms will be retained in all models and group differences estimated at each post-randomization time point. Residual diagnostics will be conducted to check violation of normality assumptions. Post-treatment and follow-up effect sizes based on adjusted treatment means will be computed using Cohen’s d along with 95% confidence intervals. The same approach will be adopted for the primary and secondary outcomes. Self-rated “utility” and social functioning calculations will be performed on five sessions taken at regular intervals, using the Friedman test for non-parametric repeated measures.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
2/04/2018
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Actual
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Date of last participant enrolment
Anticipated
2/04/2020
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Actual
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Date of last data collection
Anticipated
2/10/2020
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Actual
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Sample size
Target
144
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment postcode(s) [1]
18692
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4059 - Kelvin Grove
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Recruitment outside Australia
Country [1]
9527
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Spain
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State/province [1]
9527
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Navarra
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Country [2]
9528
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United Kingdom
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State/province [2]
9528
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Edinburgh
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Country [3]
9529
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Norway
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State/province [3]
9529
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Akershus
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Country [4]
9530
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Italy
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State/province [4]
9530
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Rome
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Funding & Sponsors
Funding source category [1]
298513
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Charities/Societies/Foundations
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Name [1]
298513
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Fundación Instituto de Investigación Sanitaria de Navarra (IdiSNA)
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Address [1]
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Complejo Hospitalario of Navarra
C/Irunlarrea 3
PC: 31008 Pamplona
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Country [1]
298513
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Spain
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Primary sponsor type
Hospital
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Name
Complejo Hospitalario of Navarra
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Address
Complejo Hospitalario of Navarra
Adult Mental Health Unit-CSM Ermitagaña,
C/Ermitagaña 20,
PC: 31008 Pamplona
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Country
Spain
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Secondary sponsor category [1]
297660
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None
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Name [1]
297660
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Address [1]
297660
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Country [1]
297660
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
299491
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Ethics committee address [1]
299491
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Ethics committee country [1]
299491
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Spain
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Date submitted for ethics approval [1]
299491
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20/02/2018
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Approval date [1]
299491
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Ethics approval number [1]
299491
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Summary
Brief summary
The present study aims to measure the effectiveness of a group, manual-based therapy (Metacognitive Interpersonal Therapy in group, MIT-G) at improving interpersonal functioning and psychological symptoms in patients with personality disorders (PDs). It is also intended to examine whether this approach yields gains in one core mechanism of change, which is metacognition and if these gains in metacognitive abilities are correlated with improvements in interpersonal functioning and psychological symptoms. Methods/Design: MIT-G will be evaluated in an international and multicentre randomized controlled trial. Several therapists in mental health institutions of Spain, Norway, Australia, Italy and United Kingdom will participate in this trial. Patients will be randomly assigned to either MIT-G plus treatment as usual (TAU) or a waiting list control group plus TAU. Discussion: If MIT-G proven effective, it can be a useful addition to the care for PDs patients. The design brings along some methodological difficulties, these issues are addressed in the discussion of this paper.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Felix Inchausti
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Address
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Adult Mental Health Unit-CSM Ermitagaña
Complejo Hospitalario of Navarra
Ermitagaña 20
31008 Pamplona
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Country
80594
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Spain
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Phone
80594
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+34 948 19 83 50
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Fax
80594
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Email
80594
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[email protected]
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Contact person for public queries
Name
80595
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Giancarlo Dimaggio
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Address
80595
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Centro di Terapia Metacognitiva Interpersonale
Piazza dei Martiri di Belfiore, 4
00195 Roma
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Country
80595
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Italy
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Phone
80595
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+39 06 323 04 91
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Fax
80595
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Email
80595
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[email protected]
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Contact person for scientific queries
Name
80596
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Raffaele Popolo
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Address
80596
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Centro di Terapia Metacognitiva Interpersonale
Piazza dei Martiri di Belfiore, 4
00195 Roma
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Country
80596
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Italy
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Phone
80596
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+39 06 323 04 91
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Fax
80596
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Email
80596
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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