Improving Adherence to Cognitive Rehabilitation
Primary Purpose
Psychosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
motivational interviewing
learning style interviews
Sponsored by
About this trial
This is an interventional treatment trial for Psychosis focused on measuring psychosis, adherence, motivation
Eligibility Criteria
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
Sites / Locations
- VA Connecticut Healthcare System West Haven Campus, West Haven, CT
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
MI condition
CI condition
Arm Description
motivational interview condition
learning style interview condition
Outcomes
Primary Outcome Measures
Number of Sessions Attended
number of cognitive training sessions attended
Number of Sessions Attended
number of sessions attended among patients who attended at least 1 session
Secondary Outcome Measures
Full Information
NCT ID
NCT02481713
First Posted
June 22, 2015
Last Updated
October 5, 2021
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT02481713
Brief Title
Improving Adherence to Cognitive Rehabilitation
Official Title
Enhancing Adherence to Cognitive Rehabilitation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2015 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
Purpose of study is to evaluate impact of brief motivational interviewing vs. feedback on learning styles in improving attendance to cognitive training
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis
Keywords
psychosis, adherence, motivation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
114 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MI condition
Arm Type
Experimental
Arm Description
motivational interview condition
Arm Title
CI condition
Arm Type
Sham Comparator
Arm Description
learning style interview condition
Intervention Type
Behavioral
Intervention Name(s)
motivational interviewing
Intervention Description
motivational interviewing
Intervention Type
Behavioral
Intervention Name(s)
learning style interviews
Intervention Description
interview and feedback about learning style
Primary Outcome Measure Information:
Title
Number of Sessions Attended
Description
number of cognitive training sessions attended
Time Frame
end of four month training period
Title
Number of Sessions Attended
Description
number of sessions attended among patients who attended at least 1 session
Time Frame
end of 4 month training period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanna M. Fiszdon, PhD
Organizational Affiliation
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
Data will be available once primary and secondary study aims have been published.
IPD Sharing Access Criteria
Completely de-identified data will be made available to other investigators, with written request and IRB approval, ideally under a data use agreement.
Learn more about this trial
Improving Adherence to Cognitive Rehabilitation
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