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NCT05358457 | Not yet recruiting | Psychosis


Pilot Study to Evaluate the Effectiveness of Online Familiar Metacognitive Training (MCTf)
Sponsor:

Fundació Sant Joan de Déu

Brief Summary:

The objective of this study is to adapt and evaluate the efficacy of Familiar Metacognitive Training (MCTf) in mothers and adolescent children in a group context with the main purpose of improving family relationships, cognitive awareness and symptoms of women with psychosis and the knowledge of the disease by the children. Secondary objectives: to evaluate the improvement in metacognition and social cognition, symptoms, protective factors and self-perception of stigma.

Condition or disease

Psychosis

Mother-Child Relations

Intervention/treatment

Familiar Metacognitive Training

Phase

Not Applicable

Detailed Description:

This is a randomized clinical trial will be carried out in which a group of mothers with psychosis and their adolescent children (between 12 and 18 years old) will receive the MCTf online and the other group will receive the treatment as usual. In total, 48 mothers and their children will be recruited from a total of 11 adult mental health care centers. Mothers will be evaluated with cognitive insight scales, other metacognitive and social cognition scales, symptoms, family and social functioning, protective factors (self-steem, resilience, and coping strategies) and self-perceived stigma. The adolescent children will be evaluated with symptoms, metacognition and social cognition, family and social functioning, knowledge of the mother´s illness and protective factors scales. The will be assessed at 2 times: baseline and post-therapy. The Metacognitive training is a group psychological intervention that has demonstrated its efficacy in improve symptoms, insight, metacognition and cognition in people with psychosis. Our hypothesis is that MCTf will be help the adolescents to better understand their mother´s thoughts and their understanding of metacognition and, consequently, to decrease anxiety and depressive symptoms.Furthermore, the investigators expect an increase in familiar and social functioning, as well as in protective factors such as: self-steem, resilience and coping strategies.

Study Type : Interventional
Estimated Enrollment : 48 participants
Masking: Single
Masking Description: The evaluator will be blind to the group that ows the patients included
Primary Purpose: Treatment
Official Title: Pilot Study to Evaluate the Effectiveness of Online Familiar Metacognitive Training (MCTf) in Mothers With Psychosis and Their Adolescent Children
Actual Study Start Date : September 2022
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025
Arm Intervention/treatment

Experimental: Online Familiar Metacognitive Training

Metacognitive training for psychosis. The MCTf consists of 11 therapeutic units developed during weekly sessions lasting 45 and 60 minutes. Each unit contains abundant therapeutic material that includes psychoeducational information, exercises and case examples.The group will be composed of 3-4 mothers with psychosis and her adolescent children and two therapists. The application of the intervention will be by a secure videoconfering method.

No Intervention: Control group

The control group will be receive treatment as usual (TAU).

Ages Eligible for Study:
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Presence of one of the following diagnoses according to DSM-V criteria: schizophrenia, unspecific psychotic disorder, schizoaffective disorder, delusional disorder, brief psychotic disorder, schizophreniform disorder.
  • Mother of one o more adolescent (12-18 years old).
  • Psychopatological stability in the previous 3 months.(without medication changes).
Exclusion Criteria
  • Head injury or intellectual disabillity (premorbid IQ <=70)
  • Present scores on the PANSS >= hostility, lack of cooperation or suspiciousness, to guarantee a good relationship in the group.
  • Patients with substance dependence disorder.
  • Inclusion/exclusion criteria of adolescents are: 1.age between 12 and 18 yerars old, 2. interested in the group. Exclusion criteria: Head injury or intellectual disabillity (premorbid IQ <=70).

Pilot Study to Evaluate the Effectiveness of Online Familiar Metacognitive Training (MCTf)

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Pilot Study to Evaluate the Effectiveness of Online Familiar Metacognitive Training (MCTf)

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