- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01926613
Thinking Skills for Work in Severe Mental Illness (TSW)
20 augusti 2013 uppdaterad av: Dartmouth-Hitchcock Medical Center
Cognitive Rehabilitation and Supported Employment for Severe Mental Illness
The purpose of this study is help people with serious mental illness and receiving vocational rehabilitation get and keep the job they want by improving their thinking skills, such as attention and memory, using computer exercises and other strategies.
One half of the participants in the study will receive vocational rehabilitation and the exercises to improve thinking skills, and the other half will receive just vocational rehabilitation.
All participants will receive an assessment of symptoms and thinking skills at the beginning of the study and 6, 12, and 24 months later.
Work activity during the 24 months in the study will be collected.
It is expected that those participants who receive the practice of their thinking skills will be more likely to get and keep the job they want compared with people who do not receive this treatment.
Studieöversikt
Status
Avslutad
Intervention / Behandling
Detaljerad beskrivning
This randomized controlled trial is evaluating the effectiveness of a pilot-tested, manualized cognitive remediation intervention entitled the "Thinking Skills for Work Program" by comparing it to enhanced supported employment services in clients with severe mental illness (SMI) who are participants in high fidelity supported employment programs at the Greater Mental health Center of Manchester and Thresholds, Inc., Chicago, Il, but who have had difficulty getting or keeping jobs.
Participants are randomized to either the Thinking Skills for Work (cognitive remediation +supported employment; CT+SE) or enhanced supported employment (E-SE), with cognitive, symptom, and quality of life assessments performed at baseline, 3 months (following the completion of the computerized cognitive training component of the Thinking Skills for Work program), 12 months, and 24 months, and employment data gathered over the full 2-year period.
For the E-SE condition, supported employment services are enhanced by training provided to the employment specialists regarding to recognize cognitive problems related to work performance, and how employment specialists can teach clients coping strategies for managing these problems.
Primary analyses will focus on testing the hypotheses that the Thinking Skills for Work Program (CT+SE) leads to better cognitive functioning and better competitive work outcomes over the 2-year follow-up period compared to the E-SE program.
Studietyp
Interventionell
Inskrivning (Faktisk)
110
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Illinois
-
Chicago, Illinois, Förenta staterna, 60613
- Thresholds, Inc.
-
-
New Hampshire
-
Manchester, New Hampshire, Förenta staterna, 03103
- Mental Health Center of Greater Manchester
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Chronic mental disorder
- Minimum age 18
- Unemployed
- Wants employment
- Must be a recipient of services at one of two participating agencies
- Fluent in English
- Willing and legally able to provide informed consent to participate in study -Subjects with court appointed legal guardians will be included
Exclusion Criteria:
- History of neurological conditions that impair cognition
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Supported Employment Only
Supported employment is an evidence based practice designed to help people with serious mental illness obtain competitive work.
This vocational model adheres to the principles of zero inclusion, rapid job search, no prevocational training, attention to client preferences and integration with clinical services.
|
Supported Employment is an evidence based vocational rehabilitation program
|
|
Experimentell: Thinking Skills for Work
The Thinking Skills for Work Program includes 5 components delivered by a Cognitive Specialist who works collaboratively with the consumer's Employment Specialist: a) assessing the consumer's strengths and weaknesses in cognitive functioning, and analysis of the contribution of cognitive impairments and other factors to job losses and difficulties obtaining a job; b) teaching coping strategies for dealing with cognitive challenges associated with job search or maintaining a job; c) computer cognitive training involving cognitive exercises with a commercially available software program, which is designed to improve the broad range of cognitive skills through a combination of practice and strategy coaching by the Cognitive Specialist; d) job search planning; and e) job support consultation.
|
The Thinking Skills for Work includes assessment of cognitive strengths and weaknesses and their relationship with work history, computerized cognitive practice, compensatory strategy training, and integration of cognitive and supported employment services.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
AMOUNT OF EMPLOYMENT
Tidsram: 24 months
|
TOTAL HOURS OF COMPETITIVE EMPLOYMENT FROM BASELINE TO 24 MONTHS.
TOTAL WEEKS OF EMPLOYMENT FROM BASELINE TO 24 MONTHS.
TOTAL NUMBER OF JOBS HELD FROM BASELINE TO 24 MONTHS.
|
24 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
EXECUTIVE FUNCTIONING AND MEMORY
Tidsram: BASELINE, 6, 12, and 24 months
|
CHANGE FROM BASELINE IN EXECUTIVE FUNCTIONING AND MEMORY AT 6 MONTHS USING THE MATRICS COGNITIVE ASSESSMENT BATTERY.
CHANGE FROM BASELINE IN EXECUTIVE FUNCTIONING AND MEMORY AT 12 MONTHS USING THE MATRICS COGNITIVE ASSESSMENT BATTERY.. CHANGE FROM BASELINE IN EXECUTIVE FUNCTIONING AND MEMORY AT 24 MONTHS USING THE MATRICS COGNITIVE ASSESSMENT BATTERY.
|
BASELINE, 6, 12, and 24 months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: Susan R McGurk, Ph.D., Dartmouth-Hitchcock Medical Center
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 april 2006
Primärt slutförande (Faktisk)
1 oktober 2009
Avslutad studie (Faktisk)
1 oktober 2011
Studieregistreringsdatum
Först inskickad
19 augusti 2013
Först inskickad som uppfyllde QC-kriterierna
20 augusti 2013
Första postat (Uppskatta)
21 augusti 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
21 augusti 2013
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
20 augusti 2013
Senast verifierad
1 augusti 2013
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- MH077210
- 1R01MH077210-01 (U.S.S. NIH-anslag/kontrakt)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .