Improving Adherence to Cognitive Rehabilitation

NCT ID: NCT02481713

Last Updated: 2021-11-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-01

Study Completion Date

2020-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Psychosis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

psychosis adherence motivation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MI condition

motivational interview condition

Group Type EXPERIMENTAL

motivational interviewing

Intervention Type BEHAVIORAL

motivational interviewing

CI condition

learning style interview condition

Group Type SHAM_COMPARATOR

learning style interviews

Intervention Type BEHAVIORAL

interview and feedback about learning style

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

motivational interviewing

motivational interviewing

Intervention Type BEHAVIORAL

learning style interviews

interview and feedback about learning style

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Joanna M. Fiszdon, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

West Haven, Connecticut, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

D1790-R

Identifier Type: -

Identifier Source: org_study_id