Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

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

5. Dezember 2017 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

48

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • California
      • Los Angeles, California, Vereinigte Staaten, 90095-6968
        • University of California, Los Angeles

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 45 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Verhalten: Fallmanagement und unterstützende Psychotherapie
Ein individueller Therapeut bietet wöchentlich Fallmanagement und Therapie an, die auf die individuellen psychologischen Probleme und alltäglichen Funktionsbedürfnisse des Patienten abzielt
Verhalten: Family psychoeducation
All immediate family members will be invited to family psychoeducation sessions.
Verhalten: 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.
Andere Namen:
  • kognitive Abhilfe
Verhalten: 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.
Andere Namen:
  • körperliche übung
Aktiver 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.
Verhalten: Fallmanagement und unterstützende Psychotherapie
Ein individueller Therapeut bietet wöchentlich Fallmanagement und Therapie an, die auf die individuellen psychologischen Probleme und alltäglichen Funktionsbedürfnisse des Patienten abzielt
Verhalten: Family psychoeducation
All immediate family members will be invited to family psychoeducation sessions.
Verhalten: 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.
Andere Namen:
  • kognitive Abhilfe

Was misst die Studie?

Primäre Ergebnismessungen

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

Sekundäre Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of California, Los Angeles

Mitarbeiter

National Institute of Mental Health (NIMH)

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. November 2013

Primärer Abschluss (Tatsächlich)

1. November 2016

Studienabschluss (Tatsächlich)

1. Juli 2017

Studienanmeldedaten

Zuerst eingereicht

19. November 2013

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

16. Oktober 2014

Zuerst gepostet (Schätzen)

17. Oktober 2014

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

7. Dezember 2017

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

5. Dezember 2017

Zuletzt verifiziert

1. Dezember 2017

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 1R34MH102529-01 (US NIH Stipendium/Vertrag)
  • R34MH102529 (US NIH Stipendium/Vertrag)

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Abonnieren