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Cognitive Remediation in Youth at Risk of Serious Mental Illness

30 marzo 2017 aggiornato da: Danijela Piskulic, University of Calgary

Pilot Study of Cognitive Remediation and Motivational Interviewing on Cognition and Functioning in Young People at Risk of Serious Mental Illness

The primary aim of the project is to test the effectiveness of a cognitive remediation treatment (CRT) program, My Brain Solutions (MBS), in addition to motivational interviewing (MI) in improving cognition and functional outcome of individuals at risk of SMI. An active control treatment consisting of CRT alone will be used. Hypotheses: 1. Both study groups will have improvement in cognition at the end of treatment; 2. CRT+MI group will have increased treatment adherence and superior improvements in cognition at the end of treatment and 12 months post baseline compared to the CRT only group; Secondary Hypothesis: 3. Improved cognition will be associated with improved functional outcome.

Panoramica dello studio

Descrizione dettagliata

Individuals identified to be at clinical high risk of psychosis (CHR) of psychosis already evidence cognitive deficits, which increase around the time of conversion. Much less is known about individuals that may be at risk of other serious mental disorders (SMI). However, early reports are suggesting that young people at risk of SMI who are deemed to have "attenuated syndromes" according to the clinical staging model of mental health disorders already evidence cognitive deficits. Therefore, cognition is an excellent treatment target. Furthermore, there is clear evidence, in both established psychiatric disorders such as schizophrenia, depression and bipolar disorder, and in CHR samples, that deficits in cognition are associated to poor functional outcome. Thus, treatments targeting cognition may consequently improve functional outcome. This is a pilot project to determine feasibility and sample size for a large randomized controlled trial of cognitive remediation therapy (CRT) in people at risk of SMI with CIHR and AIHS funding targets. The primary aim of the project is to test the effectiveness of a novel computerized CRT program in improving cognition in youth at risk of SMI following the addition of a counseling intervention, MI, to improve adherence to CRT. One group will receive CRT and the other CRT plus MI. Hypotheses: 1. Both study groups will have improvement in cognition at the end of treatment; 2. CRT+MI group will have increased treatment adherence and superior improvements in cognition at the end of treatment and 12 months post baseline compared to the CRT only group; Secondary Hypothesis: 3. Improved cognition will be associated with improved functional outcome. This is a longitudinal, single blind, controlled pilot trial of CRT in persons at risk of SMI. Twenty-eight participants will be recruited from the Adolescent Mental Health: Canadian Psychiatric Risk and Outcome Study (PROCAN) study at the Calgary site led by Dr. J. Addington. Participants in the PROCAN project who meet operationally defined criteria as being at risk of SMI by meeting attenuated syndromes criteria will be included. Participants will be randomized to either the CRT condition consisting of a novel program called My Brain Fitness (MBS) and motivational interviewing (MI) or a control condition consisting of CRT alone, and will receive training that will be administered over a period of 10 weeks. Assessments will occur at baseline, post treatment (3 months) and at 12 months after baseline. Half of all participants will receive individual 1 hr MI once every 2 weeks for the duration of the cognitive remediation component of the study. The study clinicians who are master level psychologists, will deliver MI ensuring engagement of study participants. Time spent in therapy will be monitored and recorded. All of the data necessary for this study will be collected as part of the PROCAN assessment at baseline and 12 months. The one exception is that we will do an assessment of cognitive function, clinical symptoms and functional outcome at 10 weeks or immediately post treatment, which will take approximately 2.5 hours.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

12

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • University of Calgary

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 14 anni a 25 anni (Bambino, Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Male and female participants aged 14-25 years with subthreshold mood and psychotic symptoms.

Exclusion Criteria:

  • (i) meet criteria for current or lifetime Axis I bipolar or psychotic disorder (other Axis I disorders will not be exclusionary as they may be precursors to mood or psychotic disorders);
  • (ii) IQ < 70;
  • (iii) past or current history of a significant central nervous system disorder or serious medical disorder; and
  • (iv) current pharmacological treatment that would be considered as an adequate trial of treatment for a SMI.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: cognitive remediation treatment and MI
Cognitive remediation treatment consisting of a novel computerized training called My Brain Solutions (MBS) and motivational interviewing, a client-centered, directive method for enhancing intrinsic motivation to change.
Cognitive remediation treatment consisting of a novel computerized training called My Brain Solutions (MBS)
Altri nomi:
  • My Brain Solutions
A client-centered, directive method for enhancing intrinsic motivation to change.
Altri nomi:
  • MI
Comparatore attivo: cognitive remediation treatment
Cognitive remediation treatment consisting of a novel computerized training called My Brain Solutions (MBS)
Cognitive remediation treatment consisting of a novel computerized training called My Brain Solutions (MBS)
Altri nomi:
  • My Brain Solutions

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Cognitive function assessment pre- and post-CRT in youth at risk of SMI using WebNeuro computerized cognitive battery
Lasso di tempo: one year
A web-based battery for assessing general and emotional cognition, completed at any computer using mouse and keyboard. The assessment has been validated against traditional paper-and-pencil tests and with established reliability, cross-cultural consistency and norms.
one year

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Social functioning assessment pre- and post-CRT in youth at risk of SMI using Global Functioning: Social (GFS) scale.
Lasso di tempo: one year
GFS consists of 10 items that are used to provide a rating of current social functioning. Scores range between 1 and 10, with 10 indicating superior functioning and 1 representing severe dysfunction.
one year
Social functioning assessment pre- and post-CRT in youth at risk of SMI using Global Functioning: Role (GFR) scale.
Lasso di tempo: one year
GFR consists of 10 items that are used to provide a rating of current role or occupational functioning. Scores range between 1 and 10, with 10 indicating superior functioning and 1 representing severe dysfunction.
one year
Functional capacity assessment pre- and post-CRT in youth at risk of SMI using Social Skills Performance Assessment (SSPA).
Lasso di tempo: one year
The SSPA is focused on both verbal and nonverbal social skills that are needed to succeed in two different social interaction tasks. Higher scores on the SSPA indicate better social skills.
one year

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Danijela Piskulic, PhD, University of Calgary

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 febbraio 2016

Completamento primario (Effettivo)

1 marzo 2017

Completamento dello studio (Effettivo)

1 marzo 2017

Date di iscrizione allo studio

Primo inviato

16 ottobre 2015

Primo inviato che soddisfa i criteri di controllo qualità

19 ottobre 2015

Primo Inserito (Stima)

21 ottobre 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 aprile 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 marzo 2017

Ultimo verificato

1 marzo 2017

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • UCalgary-MAT

Piano per i dati dei singoli partecipanti (IPD)

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INDECISO

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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