Remote Cognitive Remediation

NCT02121106 | Completed

• 1 other identifier: 361958
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Bipolar Disorder With Psychosis

Outcome Measures

Primary Outcomes (1)

• Neurocognitive composite score

  10 weeks: pre- to post-intervention

Secondary Outcomes (1)

• Functional Capacity

  10 weeks: at study entry (pre-treatment) and immediately following treatment (post-treatment)

Study Arms (2)

Cognitive Remediation

EXPERIMENTAL

Participants in this group will receive active cognitive remediation.

Behavioral: Cognitive Remediation

Sham Cognitive Remediation

SHAM COMPARATOR

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

Interventions

Cognitive Remediation BEHAVIORAL

Cognitive Remediation

Sham Cognitive Remediation BEHAVIORAL

Sham Cognitive Remediation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Queen's University: lead

Study Sites (1)

Queen's University

Kingston, Ontario, K7L 3N6, Canada

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Cognitive Remediation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Christopher R Bowie, Ph.D.

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 17, 2014
• First Posted: April 23, 2014
• Study Start: September 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: November 14, 2018

Record last verified: 2018-11

Locations

CA (1)