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

5. desember 2017 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

48

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • California
      • Los Angeles, California, Forente stater, 90095-6968
        • University of California, Los Angeles

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 45 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Atferdsmessig: Saksbehandling og støttende psykoterapi
En individuell terapeut vil gi ukentlig saksbehandling og terapi rettet mot individuelle psykologiske problemer og daglige funksjonsbehov til pasienten
Atferdsmessig: Family psychoeducation
All immediate family members will be invited to family psychoeducation sessions.
Atferdsmessig: 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.
Andre navn:
  • kognitiv remediering
Atferdsmessig: 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.
Andre navn:
  • fysisk trening
Aktiv komparator: 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.
Atferdsmessig: Saksbehandling og støttende psykoterapi
En individuell terapeut vil gi ukentlig saksbehandling og terapi rettet mot individuelle psykologiske problemer og daglige funksjonsbehov til pasienten
Atferdsmessig: Family psychoeducation
All immediate family members will be invited to family psychoeducation sessions.
Atferdsmessig: 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.
Andre navn:
  • kognitiv remediering

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) overall composite score
Tidsramme: 6 months
The overall composite score from the MCCB is a summary of cognitive performance across seven domains.
6 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Brain-derived neurotrophic factor (BDNF)
Tidsramme: 6 months
BDNF is a principal growth factor known to mediate the effects of exercise in the brain.
6 months
Cardiorespiratory fitness
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 6 months
The Prosody Task involves identifying emotions in audio recordings of male and female actors portraying 5 emotions.
6 months
Global Functioning Scale
Tidsramme: 6 months
A 10-point rating scale to evaluate role and social functioning
6 months
Modified Social Adjustment Scale - Work Outcome
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 6 months
The Independent Living rating assesses daily living skills and extent of living independently based on a clinician interview.
6 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of California, Los Angeles

Samarbeidspartnere

National Institute of Mental Health (NIMH)

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. november 2013

Primær fullføring (Faktiske)

1. november 2016

Studiet fullført (Faktiske)

1. juli 2017

Datoer for studieregistrering

Først innsendt

19. november 2013

Først innsendt som oppfylte QC-kriteriene

16. oktober 2014

Først lagt ut (Anslag)

17. oktober 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

7. desember 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. desember 2017

Sist bekreftet

1. desember 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 1R34MH102529-01 (U.S. NIH-stipend/kontrakt)
  • R34MH102529 (U.S. NIH-stipend/kontrakt)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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