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Enhancing Cognitive Training Through Exercise After a First Schizophrenia Episode (CT&E)

5 dicembre 2017 aggiornato da: Keith Nuechterlein, Ph.D., University of California, Los Angeles
This is a randomized controlled 6-month trial of the efficacy of a novel intervention combining neuroplasticity-based cognitive training with aerobic exercise, compared to the same systematic cognitive training alone. The primary treatment targets are overall cognitive deficit level and independent living skills. The investigators hypothesize that combining neuroplasticity-based computerized cognitive training and neurotrophin-enhancing physical exercise will produce large cognitive and functional improvements, even relative to cognitive training alone. Adding aerobic exercise to a cognitive training program will have the additional benefit of helping to ameliorate medication side effects, reduce the risk for developing metabolic syndrome, and help to prevent the deterioration in physical health that usually follows the onset of schizophrenia and its pharmacologic treatment. The investigators target the period shortly after a first episode of schizophrenia to maximize the generalization of cognitive improvement to functional outcome, before chronic disability is established.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

The Cognitive Training and Exercise intervention involves 24 weeks of systematic computerized cognitive training, 4 hours per week, plus aerobic exercise, four 30 minute sessions per week. The first 12 weeks involves neurocognitive training, using auditory training exercises from Posit Science Brain HQ. The second 12 weeks involves social cognitive training, using the Posit Science SocialVille modules. Aerobic exercise occurs as two 30-minute sessions at the clinic and two at home weekly. Intensity of aerobic exercise is tailored to maintain an individualized target heart rate zone and is monitored by a heart rate recorder. A weekly one-hour Bridging Skills Group with other members of the treatment condition is designed to aid generalization of training to everyday life situations.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

48

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

  • Stati Uniti
    • California
      • Los Angeles, California, Stati Uniti, 90095-6968
        • University of California, Los Angeles

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 18 anni a 45 anni (Adulto)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  1. a first episode of a psychotic illness that began within the past two years;
  2. a diagnosis by Diagnostic and Statistical Manual of Mental Disorders of schizophrenia, schizoaffective disorder, mainly depressed type, or schizophreniform disorder;
  3. between 18 and 45 years of age;
  4. sufficient acculturation and fluency in the English language to avoid invalidating research measures of thought, language, and speech disorder or of verbal cognitive abilities; and
  5. residence within commuting distance of the Aftercare Research Program at the University of California, Los Angeles.

Exclusion Criteria:

  1. evidence of a known neurological disorder (e.g., epilepsy) or significant head injury;
  2. evidence of alcohol or substance use disorder within the six months prior to the first episode and evidence that substance abuse triggered the psychotic episode or makes the schizophrenia diagnosis ambiguous;
  3. mental retardation, i.e. premorbid intelligence quotient less than 70.

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 Training and Exercise
24 weeks of systematic computerized cognitive training, 4 hours per week, plus aerobic exercise, four 30 minute sessions per week. The first 12 weeks involves neurocognitive training, using auditory training exercises from Posit Science Brain HQ. The 2nd 12 weeks involves social cognitive training, using the Posit Science SocialVille modules. Aerobic exercise occurs as two 30-minute sessions at the clinic and two at home weekly. Intensity of aerobic exercise is tailored to maintain an individualized target heart rate zone and is monitored by a heart rate recorder. A weekly one-hour Bridging Skills Group is designed to aid generalization of training to everyday life situations. All members receive individual case management and supportive psychotherapy, and family psychoeducation.
Comportamentale: Gestione del caso e psicoterapia di supporto
Un terapista individuale fornirà una gestione settimanale del caso e una terapia mirata ai problemi psicologici individuali e alle esigenze di funzionamento quotidiano del paziente
Comportamentale: Family psychoeducation
All immediate family members will be invited to family psychoeducation sessions.
Comportamentale: Cognitive training
The Cognitive Training and Exercise intervention involves 24 weeks of systematic computerized cognitive training, 4 hours per week, plus aerobic exercise, four 30 minute sessions per week. The first 12 weeks involves neurocognitive training, using auditory training exercises from Posit Science Brain HQ. The second 12 weeks involves social cognitive training, using the Posit Science SocialVille modules. A weekly one-hour Bridging Skills Group with other members of the treatment condition is designed to aid generalization of training to everyday life situations.
Altri nomi:
  • riparazione cognitiva
Comportamentale: Aerobic exercise
Aerobic exercise occurs as two 30-minute sessions at the clinic and two at home weekly. Intensity of aerobic exercise is tailored to maintain an individualized target heart rate zone and is monitored by a heart rate recorder.
Altri nomi:
  • esercizio fisico
Comparatore attivo: Cognitive Training
24 weeks of systematic computerized cognitive training, 4 hours per week, plus aerobic exercise, four 30 minute sessions per week. The first 12 weeks involves neurocognitive training, using auditory training exercises from Posit Science Brain HQ. The 2nd 12 weeks involves social cognitive training, using the Posit Science SocialVille modules. A weekly one-hour Bridging Skills Group is designed to aid generalization of training to everyday life situations. All members receive individual case management and supportive psychotherapy, and family psychoeducation.
Comportamentale: Gestione del caso e psicoterapia di supporto
Un terapista individuale fornirà una gestione settimanale del caso e una terapia mirata ai problemi psicologici individuali e alle esigenze di funzionamento quotidiano del paziente
Comportamentale: Family psychoeducation
All immediate family members will be invited to family psychoeducation sessions.
Comportamentale: Cognitive training
The Cognitive Training and Exercise intervention involves 24 weeks of systematic computerized cognitive training, 4 hours per week, plus aerobic exercise, four 30 minute sessions per week. The first 12 weeks involves neurocognitive training, using auditory training exercises from Posit Science Brain HQ. The second 12 weeks involves social cognitive training, using the Posit Science SocialVille modules. A weekly one-hour Bridging Skills Group with other members of the treatment condition is designed to aid generalization of training to everyday life situations.
Altri nomi:
  • riparazione cognitiva

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) overall composite score
Lasso di tempo: 6 months
The overall composite score from the MCCB is a summary of cognitive performance across seven domains.
6 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Brain-derived neurotrophic factor (BDNF)
Lasso di tempo: 6 months
BDNF is a principal growth factor known to mediate the effects of exercise in the brain.
6 months
Cardiorespiratory fitness
Lasso di tempo: 6 months
Cardiorespiratory fitness, a secondary physical health outcome variable, will be measured using a ramped version of the traditional Bruce treadmill protocol.
6 months
University of California, San Diego (UCSD) Performance-Based Skills Assessment (UPSA)
Lasso di tempo: 6 months
The UCSD Performance-Based Skills Assessment (UPSA)assesses five all-purpose skills that are important for functioning in the community: general organization, finance, social/communications, transportation, and household chores.
6 months
Facial Emotion Identification Test
Lasso di tempo: 6 months
The Facial Emotion Identification Test involves choice of emotions in facial expressions of 6 different emotions (happy, sad, angry, afraid, surprised, disgusted) plus neutral expressions.
6 months
Prosody Task
Lasso di tempo: 6 months
The Prosody Task involves identifying emotions in audio recordings of male and female actors portraying 5 emotions.
6 months
Global Functioning Scale
Lasso di tempo: 6 months
A 10-point rating scale to evaluate role and social functioning
6 months
Modified Social Adjustment Scale - Work Outcome
Lasso di tempo: 6 months
A measure of the quantity and type of work at a job, school, or in the home
6 months
Independent Living Skills Survey
Lasso di tempo: 6 months
The Independent Living Skills Survey is a 76-item measure based on patient interview, which provides a more detailed assessment of 11 daily living skill domains
6 months
Quality of Life Scale
Lasso di tempo: 6 months
The Quality of Life scale135, a 53-item interview-based inventory, assesses a patient's subjective satisfaction in several key domains
6 months
Role Functioning Scale: Work Productivity, Social Relationships, Family Relationships
Lasso di tempo: 6 months
The Role Functioning Scale is a global clinician-rated measure of everyday functioning in several domains.
6 months
Independent Living rating from Role Functioning Scale
Lasso di tempo: 6 months
The Independent Living rating assesses daily living skills and extent of living independently based on a clinician interview.
6 months

Collaboratori e investigatori

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

Sponsor

University of California, Los Angeles

Collaboratori

National Institute of Mental Health (NIMH)

Investigatori

  • Investigatore principale: Keith H Nuechterlein, Ph.D., University of California, Los Angeles

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 (Effettivo)

1 novembre 2013

Completamento primario (Effettivo)

1 novembre 2016

Completamento dello studio (Effettivo)

1 luglio 2017

Date di iscrizione allo studio

Primo inviato

19 novembre 2013

Primo inviato che soddisfa i criteri di controllo qualità

16 ottobre 2014

Primo Inserito (Stima)

17 ottobre 2014

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

7 dicembre 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 dicembre 2017

Ultimo verificato

1 dicembre 2017

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 1R34MH102529-01 (Sovvenzione/contratto NIH degli Stati Uniti)
  • R34MH102529 (Sovvenzione/contratto NIH degli Stati Uniti)

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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