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Remote Cognitive Remediation

Primary Purpose

Schizophrenia, Bipolar Disorder With Psychosis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cognitive Remediation
Sham Cognitive Remediation
Sponsored by
Queen's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Psychotic Disorder (e.g., schizophrenia, schizoaffective, bipolar disorder with psychotic features)

Exclusion Criteria:

  • Current substance abuse or dependence
  • Physical or sensory issues that preclude completion of assessments or treatment

Sites / Locations

  • Queen's University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Cognitive Remediation

Sham Cognitive Remediation

Arm Description

Participants in this group will receive active cognitive remediation.

Participants in this group will receive a sham comparison, which is a computerized exposure to the same exercises as the active intervention, but with cognitively complex elements removed and no titration of the difficulty of tasks.

Outcomes

Primary Outcome Measures

Neurocognitive composite score

Secondary Outcome Measures

Functional Capacity
Participants will complete computerized assessments of functional skills (e.g., using a bank machine, planning medication use, scheduling appointments).

Full Information

First Posted
April 17, 2014
Last Updated
November 12, 2018
Sponsor
Queen's University
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1. Study Identification

Unique Protocol Identification Number
NCT02121106
Brief Title
Remote Cognitive Remediation
Official Title
Remote Cognitive Remediation for Psychosis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
With medication, many individuals with psychosis experience a remission from hallucinations and delusions, the most salient aspects of the disorders. However, alleviation of these symptoms is not associated with recovery of everyday functioning in important areas like working, socializing, maintaining the household, and recreational pursuits. The reason these difficulties with functioning persist is that psychotic disorders are associated with considerable difficulties with cognitive functions such as attention, memory, and planning. Cognitive impairments persist even when the delusions and hallucinations are treated, and in fact account for most of the persistent impairments in functioning. Recently, psychological treatments called Cognitive Remediation have been developed and tested in research settings, where techniques that train the brain to process information more efficiently result in very large improvements in cognition. However, there are two major hurdles remaining as investigators attempt to determine how this treatment can graduate from research laboratories to become a widespread clinical treatment. First, cognitive remediation in research settings is very intensive: it requires frequent visits with specialized therapists who deliver the treatment to groups of patients. This makes it quite difficult for people with psychosis, who might not have the financial means or motivation to travel and who might be experiencing symptoms that make it unlikely that they will attend groups, to participate fully if the traditional research techniques were directly transported to a clinical setting. The second hurdle is that even though cognitive remediation improves cognition, it does not always transfer to everyday behavior changes. Investigators recently found that this transfer to functioning is more meaningful and durable when using additional techniques that teach people skills such as being aware of your own thinking and to use multiple, flexible problem solving strategies. The goal of this project is to address these limitations by testing a new development in the treatment: delivering cognitive remediation to participants in their homes, with cognitive exercises and therapist support provided online. The techniques are the same as successful in-session cognitive remediation, but those with psychosis can engage in the intervention at home and therapists will be able to service more individuals with online discussion forums and video demonstrations. The more people engage in cognitive remediation, the better the outcomes. This is particularly true for receiving a consistent dose of exercise, rather than in longer, once per week sessions typical of traditional psychotherapies. The online component of this program provides patients with the ability to engage in a higher and more consistent rate of exercises and skill development, and we will explore whether the amount and continuity of engagement is associated with larger and broader improvements.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Bipolar Disorder With Psychosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Remediation
Arm Type
Experimental
Arm Description
Participants in this group will receive active cognitive remediation.
Arm Title
Sham Cognitive Remediation
Arm Type
Sham Comparator
Arm Description
Participants in this group will receive a sham comparison, which is a computerized exposure to the same exercises as the active intervention, but with cognitively complex elements removed and no titration of the difficulty of tasks.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Remediation
Intervention Type
Behavioral
Intervention Name(s)
Sham Cognitive Remediation
Primary Outcome Measure Information:
Title
Neurocognitive composite score
Time Frame
10 weeks: pre- to post-intervention
Secondary Outcome Measure Information:
Title
Functional Capacity
Description
Participants will complete computerized assessments of functional skills (e.g., using a bank machine, planning medication use, scheduling appointments).
Time Frame
10 weeks: at study entry (pre-treatment) and immediately following treatment (post-treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Psychotic Disorder (e.g., schizophrenia, schizoaffective, bipolar disorder with psychotic features) Exclusion Criteria: Current substance abuse or dependence Physical or sensory issues that preclude completion of assessments or treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher R Bowie, Ph.D.
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen's University
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 3N6
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Remote Cognitive Remediation

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