NCT02481713

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 25, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

November 4, 2021

Completed
Last Updated

November 4, 2021

Status Verified

October 1, 2021

Enrollment Period

4.8 years

First QC Date

June 22, 2015

Results QC Date

September 7, 2021

Last Update Submit

October 5, 2021

Conditions

Keywords

psychosisadherencemotivation

Outcome Measures

Primary Outcomes (2)

  • Number of Sessions Attended

    number of cognitive training sessions attended

    end of four month training period

  • Number of Sessions Attended

    number of sessions attended among patients who attended at least 1 session

    end of 4 month training period

Study Arms (2)

MI condition

EXPERIMENTAL

motivational interview condition

Behavioral: motivational interviewing

CI condition

SHAM COMPARATOR

learning style interview condition

Behavioral: learning style interviews

Interventions

motivational interviewing

MI condition

interview and feedback about learning style

CI condition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of psychotic disorder
  • years old or older

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Results Point of Contact

Title
Joanna Fiszdon, PhD
Organization
VA Connecticut Healthcare System

Study Officials

  • Joanna M. Fiszdon, PhD

    VA Connecticut Healthcare System West Haven Campus, West Haven, CT

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2015

First Posted

June 25, 2015

Study Start

December 1, 2015

Primary Completion

September 30, 2020

Study Completion

September 30, 2020

Last Updated

November 4, 2021

Results First Posted

November 4, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Data will be available once primary and secondary study aims have been published.
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.

Locations