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SchizophreniaNCT02121106

Remote Cognitive Remediation

A study testing Cognitive Remediation in people with Schizophrenia and Bipolar Disorder With Psychosis, run by Queen's University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Cognitive Remediation
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteCanada
Study dates
Sep 2013to Sep 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Queen's University

    Kingston, Ontario, K7L 3N6

Other trials in Canada

About this study

Official title: Remote Cognitive Remediation for Psychosis

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.

Being tested
Cognitive Remediation, Sham Cognitive Remediation
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive RemediationBehavioural

  • Sham Cognitive RemediationBehavioural

Study groups in NCT02121106
Study groupRoleWhat they receive
Cognitive RemediationExperimentalParticipants in this group will receive active cognitive remediation.
Receives: Behavioral: Cognitive Remediation
Sham Cognitive RemediationSham comparatorParticipants 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.
Receives: Behavioral: Sham Cognitive Remediation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neurocognitive composite score

    Measured: 10 weeks: pre- to post-intervention

Secondary outcomes (1)
  1. Functional Capacity

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2014 (estimated)
  2. Study startSep 2013
  3. Primary completionSep 2016
  4. Study completionSep 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02121106
Sponsor's protocol ID
361958
Status last verified
Nov 2018
First submitted
17 Apr 2014
Last updated
14 Nov 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Remediation in people with Schizophrenia and Bipolar Disorder With Psychosis, run by Queen's University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neurocognitive composite score (time frame: 10 weeks: pre- to post-intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2018.

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Remote Cognitive Remediation (NCT02121106) | AzTrials