Enhancing Cognitive Training Through Exercise After a First Schizophrenia Episode (CT&E)
5. prosince 2017 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
48
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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California
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Los Angeles, California, Spojené státy, 90095-6968
- University of California, Los Angeles
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 45 let (Dospělý)
Přijímá zdravé dobrovolníky
Ano
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
- a first episode of a psychotic illness that began within the past two years;
- a diagnosis by Diagnostic and Statistical Manual of Mental Disorders of schizophrenia, schizoaffective disorder, mainly depressed type, or schizophreniform disorder;
- between 18 and 45 years of age;
- 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
- residence within commuting distance of the Aftercare Research Program at the University of California, Los Angeles.
Exclusion Criteria:
- evidence of a known neurological disorder (e.g., epilepsy) or significant head injury;
- 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;
- mental retardation, i.e. premorbid intelligence quotient less than 70.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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.
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Individuální terapeut zajistí týdenní case management a terapii zaměřenou na individuální psychické problémy a každodenní potřeby fungování pacienta
All immediate family members will be invited to family psychoeducation sessions.
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.
Ostatní jména:
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.
Ostatní jména:
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Aktivní komparátor: 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.
|
Individuální terapeut zajistí týdenní case management a terapii zaměřenou na individuální psychické problémy a každodenní potřeby fungování pacienta
All immediate family members will be invited to family psychoeducation sessions.
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.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) overall composite score
Časové okno: 6 months
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The overall composite score from the MCCB is a summary of cognitive performance across seven domains.
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6 months
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Brain-derived neurotrophic factor (BDNF)
Časové okno: 6 months
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BDNF is a principal growth factor known to mediate the effects of exercise in the brain.
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6 months
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Cardiorespiratory fitness
Časové okno: 6 months
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Cardiorespiratory fitness, a secondary physical health outcome variable, will be measured using a ramped version of the traditional Bruce treadmill protocol.
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6 months
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University of California, San Diego (UCSD) Performance-Based Skills Assessment (UPSA)
Časové okno: 6 months
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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.
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6 months
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Facial Emotion Identification Test
Časové okno: 6 months
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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.
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6 months
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Prosody Task
Časové okno: 6 months
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The Prosody Task involves identifying emotions in audio recordings of male and female actors portraying 5 emotions.
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6 months
|
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Global Functioning Scale
Časové okno: 6 months
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A 10-point rating scale to evaluate role and social functioning
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6 months
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Modified Social Adjustment Scale - Work Outcome
Časové okno: 6 months
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A measure of the quantity and type of work at a job, school, or in the home
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6 months
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Independent Living Skills Survey
Časové okno: 6 months
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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
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6 months
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Quality of Life Scale
Časové okno: 6 months
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The Quality of Life scale135, a 53-item interview-based inventory, assesses a patient's subjective satisfaction in several key domains
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6 months
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Role Functioning Scale: Work Productivity, Social Relationships, Family Relationships
Časové okno: 6 months
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The Role Functioning Scale is a global clinician-rated measure of everyday functioning in several domains.
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6 months
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Independent Living rating from Role Functioning Scale
Časové okno: 6 months
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The Independent Living rating assesses daily living skills and extent of living independently based on a clinician interview.
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6 months
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Keith H Nuechterlein, Ph.D., University of California, Los Angeles
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
1. listopadu 2013
Primární dokončení (Aktuální)
1. listopadu 2016
Dokončení studie (Aktuální)
1. července 2017
Termíny zápisu do studia
První předloženo
19. listopadu 2013
První předloženo, které splnilo kritéria kontroly kvality
16. října 2014
První zveřejněno (Odhad)
17. října 2014
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
7. prosince 2017
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
5. prosince 2017
Naposledy ověřeno
1. prosince 2017
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 1R34MH102529-01 (Grant/smlouva NIH USA)
- R34MH102529 (Grant/smlouva NIH USA)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .