Remote Cognitive Remediation

Schizophrenia Clinical Trial

Official title:

Remote Cognitive Remediation for Psychosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02121106
• Other study ID #: 361958
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: September 2016

Study information

• Verified date: November 2018
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Bipolar Disorder With Psychosis
• Mental Disorders
• Psychotic Disorders
• Schizophrenia

Intervention

Behavioral:
• Cognitive Remediation

• Sham Cognitive Remediation

Locations

Country	Name	City	State
Canada	Queen's University	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Queen's University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurocognitive composite score		10 weeks: pre- to post-intervention
Secondary	Functional Capacity	Participants will complete computerized assessments of functional skills (e.g., using a bank machine, planning medication use, scheduling appointments).	10 weeks: at study entry (pre-treatment) and immediately following treatment (post-treatment)