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Improving Adherence to Cognitive Rehabilitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02481713
Recruitment Status : Recruiting
First Posted : June 25, 2015
Last Update Posted : December 20, 2018
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
Purpose of study is to evaluate impact of brief motivational interviewing vs. feedback on learning styles in improving attendance to cognitive training

Condition or disease Intervention/treatment Phase
Psychosis Behavioral: motivational interviewing Behavioral: learning style interviews Not Applicable

Detailed Description:
This study is evaluating whether motivational enhancement can improve outcomes of cognitive rehabilitation in Veterans with schizophrenia spectrum disorders. Approximately 120 individuals will be randomized to either a 2-session motivational interview (MI, experimental condition) or a 2-session assessment and feedback on learning styles (CI, active control), and will then be asked to participate in 4 months of cognitive rehabilitation. Booster MI or CI sessions will be administered monthly over the course of the cognitive rehabilitation. Primary outcome is number of cognitive rehabilitation sessions attended.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Enhancing Adherence to Cognitive Rehabilitation
Actual Study Start Date : December 1, 2015
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: MI condition
motivational interview condition
Behavioral: motivational interviewing
motivational interviewing

Sham Comparator: CI condition
learning style interview condition
Behavioral: learning style interviews
interview and feedback about learning style

Primary Outcome Measures :
  1. number of sessions attended [ Time Frame: end of four month training period ]
    number of cognitive training sessions attended

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • diagnosis of psychotic disorder
  • 18 years old or older

Exclusion Criteria:

  • meeting criteria for substance abuse/dependence in past 30 days
  • psychiatric hospitalization in past 30 days
  • change in psychiatric medications in past 30 days
  • severe auditory/visual impairment
  • evidence of developmental disability

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02481713

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Contact: Joanna Fiszdon, PhD (203) 932-5711 ext 2231

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United States, Connecticut
VA Connecticut Healthcare System West Haven Campus, West Haven, CT Recruiting
West Haven, Connecticut, United States, 06516
Contact: Joanna Fiszdon, PhD    203-932-5711 ext 2231   
Principal Investigator: Joanna Fiszdon, PhD         
Sponsors and Collaborators
VA Office of Research and Development
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Principal Investigator: Joanna Fiszdon, PhD VA Connecticut Healthcare System West Haven Campus, West Haven, CT

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Responsible Party: VA Office of Research and Development Identifier: NCT02481713     History of Changes
Other Study ID Numbers: D1790-R
First Posted: June 25, 2015    Key Record Dates
Last Update Posted: December 20, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:

Additional relevant MeSH terms:
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Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders