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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
Scientific title
Effectiveness of Metacognitive Interpersonal Therapy in group (MIT-G) for Personality Disorders
Secondary ID [1] 293890 0
None
Universal Trial Number (UTN)
U1111-1208-6135
Trial acronym
MIT-G/Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Personality disorders 306358 0
Condition category
Condition code
Mental Health 305445 305445 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 300158 0
Treatment: Other
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.
Control group
Active

Outcomes
Primary outcome [1] 304581 0
Symptom Checklist-90-Revised (SCL-90-R)
Timepoint [1] 304581 0
Baseline (0 weeks), post-treatment (after 16 weeks in the wait-list control group) and 6-month follow-up (primary timepoint)
Primary outcome [2] 304584 0
Social Functioning Scale (SFS)
Timepoint [2] 304584 0
Baseline (0 weeks), post-treatment (after 16 weeks in the wait-list control group) and 6-month follow-up (primary timepoint)
Primary outcome [3] 304585 0
Beck Hopelessness Scale (BHS)
Timepoint [3] 304585 0
Baseline (0 weeks), post-treatment (after 16 weeks in the wait-list control group) and 6-month follow-up (primary timepoint)
Secondary outcome [1] 342458 0
Beck Suicide Ideation Scale (BSS)
Timepoint [1] 342458 0
Baseline (0 weeks), post-treatment (after 16 weeks in the wait-list control group) and 6-month follow-up
Secondary outcome [2] 342459 0
Barratt Impulsiveness Scale-11 (BIS-11)
Timepoint [2] 342459 0
Baseline (0 weeks), post-treatment (after 16 weeks in the wait-list control group) and 6-month follow-up
Secondary outcome [3] 342460 0
Beck Depression Inventory-II (BDI-II)
Timepoint [3] 342460 0
Baseline (0 weeks), post-treatment (after 16 weeks in the wait-list control group) and 6-month follow-up
Secondary outcome [4] 342461 0
Clinical Outcomes in Routine Evaluation (CORE-OM)
Timepoint [4] 342461 0
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).
Secondary outcome [5] 342462 0
Indiana Psychiatric Illness Interview (IPII)
Timepoint [5] 342462 0
Baseline (0 weeks), post-treatment (after 16 weeks in the wait-list control group) and 6-month follow-up
Secondary outcome [6] 342463 0
Metacognition Assessment Scale (MAS-A)
Timepoint [6] 342463 0
Baseline (0 weeks), post-treatment (after 16 weeks in the wait-list control group) and 6-month follow-up
Secondary outcome [7] 342464 0
Interpersonal Reactivity Index (IRI)
Timepoint [7] 342464 0
Baseline (0 weeks), post-treatment (after 16 weeks in the wait-list control group) and 6-month follow-up
Secondary outcome [8] 342465 0
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.
Timepoint [8] 342465 0
Only in the experimental condition, at the end of group therapy sessions 4, 8, 12 and 16
Secondary outcome [9] 342466 0
Group Climate Questionnaire-S (GCQ-S).
Timepoint [9] 342466 0
Only in the experimental condition, at the end of group therapy sessions 4, 8, 12 and 16

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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/04/2018
Actual
Date of last participant enrolment
Anticipated
2/04/2020
Actual
Date of last data collection
Anticipated
2/10/2020
Actual
Sample size
Target
144
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 18692 0
4059 - Kelvin Grove
Recruitment outside Australia
Country [1] 9527 0
Spain
State/province [1] 9527 0
Navarra
Country [2] 9528 0
United Kingdom
State/province [2] 9528 0
Edinburgh
Country [3] 9529 0
Norway
State/province [3] 9529 0
Akershus
Country [4] 9530 0
Italy
State/province [4] 9530 0
Rome

Funding & Sponsors
Funding source category [1] 298513 0
Charities/Societies/Foundations
Name [1] 298513 0
Fundación Instituto de Investigación Sanitaria de Navarra (IdiSNA)
Country [1] 298513 0
Spain
Primary sponsor type
Hospital
Name
Complejo Hospitalario of Navarra
Address
Complejo Hospitalario of Navarra
Adult Mental Health Unit-CSM Ermitagaña,
C/Ermitagaña 20,
PC: 31008 Pamplona
Country
Spain
Secondary sponsor category [1] 297660 0
None
Name [1] 297660 0
Address [1] 297660 0
Country [1] 297660 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 299491 0
Ethics committee address [1] 299491 0
Ethics committee country [1] 299491 0
Spain
Date submitted for ethics approval [1] 299491 0
20/02/2018
Approval date [1] 299491 0
Ethics approval number [1] 299491 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80594 0
Dr Felix Inchausti
Address 80594 0
Adult Mental Health Unit-CSM Ermitagaña
Complejo Hospitalario of Navarra
Ermitagaña 20
31008 Pamplona
Country 80594 0
Spain
Phone 80594 0
+34 948 19 83 50
Fax 80594 0
Email 80594 0
finchausti@unav.es
Contact person for public queries
Name 80595 0
Giancarlo Dimaggio
Address 80595 0
Centro di Terapia Metacognitiva Interpersonale
Piazza dei Martiri di Belfiore, 4
00195 Roma
Country 80595 0
Italy
Phone 80595 0
+39 06 323 04 91
Fax 80595 0
Email 80595 0
gdimaje@gmail.com
Contact person for scientific queries
Name 80596 0
Raffaele Popolo
Address 80596 0
Centro di Terapia Metacognitiva Interpersonale
Piazza dei Martiri di Belfiore, 4
00195 Roma
Country 80596 0
Italy
Phone 80596 0
+39 06 323 04 91
Fax 80596 0
Email 80596 0
popoloraffaele@gmail.com

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
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Documents added automatically
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