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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ANZCTR
Last refreshed on: 12 February 2018
Main ID:  ACTRN12618000198224
Date of registration: 07/02/2018
Prospective Registration: Yes
Primary sponsor: Complejo Hospitalario of Navarra
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
Date of first enrolment: 2/04/2018
Target sample size: 144
Recruitment status: Not yet recruiting
URL:  http://www.anzctr.org.au/ACTRN12618000198224.aspx
Study type:  Interventional
Study design:  Randomised controlled trial  Parallel
Phase:  Not Applicable
Countries of recruitment
Contacts
Key inclusion & exclusion criteria
Health Condition(s) or Problem(s) studied
Personality disorders
Intervention(s)
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.
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
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