- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02582528
Cognitive Remediation in Youth at Risk of Serious Mental Illness
30. marts 2017 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
12
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Alberta
-
Calgary, Alberta, Canada, T2N 4Z6
- University of Calgary
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
14 år til 25 år (Barn, Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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)
Andre navne:
A client-centered, directive method for enhancing intrinsic motivation to change.
Andre navne:
|
|
Aktiv komparator: 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)
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Cognitive function assessment pre- and post-CRT in youth at risk of SMI using WebNeuro computerized cognitive battery
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Social functioning assessment pre- and post-CRT in youth at risk of SMI using Global Functioning: Social (GFS) scale.
Tidsramme: 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.
Tidsramme: 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).
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Danijela Piskulic, PhD, University of Calgary
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. februar 2016
Primær færdiggørelse (Faktiske)
1. marts 2017
Studieafslutning (Faktiske)
1. marts 2017
Datoer for studieregistrering
Først indsendt
16. oktober 2015
Først indsendt, der opfyldte QC-kriterier
19. oktober 2015
Først opslået (Skøn)
21. oktober 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. april 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. marts 2017
Sidst verificeret
1. marts 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- UCalgary-MAT
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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