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Remote Cognitive Remediation

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ClinicalTrials.gov Identifier: NCT02121106
Recruitment Status : Completed
First Posted : April 23, 2014
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Christopher Bowie, Queen's University

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.


Condition or disease Intervention/treatment Phase
Schizophrenia Bipolar Disorder With Psychosis Behavioral: Cognitive Remediation Behavioral: Sham Cognitive Remediation Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Remote Cognitive Remediation for Psychosis
Study Start Date : September 2013
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cognitive Remediation
Participants in this group will receive active cognitive remediation.
Behavioral: Cognitive Remediation
Sham Comparator: Sham 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.
Behavioral: Sham Cognitive Remediation



Primary Outcome Measures :
  1. Neurocognitive composite score [ Time Frame: 10 weeks: pre- to post-intervention ]

Secondary Outcome Measures :
  1. Functional Capacity [ Time Frame: 10 weeks: at study entry (pre-treatment) and immediately following treatment (post-treatment) ]
    Participants will complete computerized assessments of functional skills (e.g., using a bank machine, planning medication use, scheduling appointments).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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 ClinicalTrials.gov identifier (NCT number): NCT02121106


Locations
Canada, Ontario
Queen's University
Kingston, Ontario, Canada, K7L 3N6
Sponsors and Collaborators
Queen's University
Investigators
Principal Investigator: Christopher R Bowie, Ph.D. Queen's University

Responsible Party: Dr. Christopher Bowie, Associate Professor, Queen's University
ClinicalTrials.gov Identifier: NCT02121106     History of Changes
Other Study ID Numbers: 361958
First Posted: April 23, 2014    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018

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