Cognitive Enhancement Therapy for Psychosis and Alcoholism
Recruiting in Palo Alto (17 mi)
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Nova Scotia Health Authority
Must be taking: Antipsychotics
Disqualifiers: Other substance use disorders
No Placebo Group
Trial Summary
What is the purpose of this trial?A focus of research for youth and Emerging Adults with early phase psychosis (EPP) has been cannabis use. However, this focus has led to overlooking the possible negative influence of another legal recreational drug, alcohol. Previous studies our research group has done have demonstrated that over use of alcohol reduces the effectiveness of early intervention in psychosis treatment services. These treatment services are wrap around services that address medical, and social needs of young people with psychosis. Individuals with alcohol use disorder and EPP have fewer positive symptoms such as hallucinations which are the aspects of psychotic disorders that respond most readily to medication but have greater levels of depressive symptoms. Biologically, we can see the negative impact of alcohol on brain structure in our MRI studies. Our aim presented in this grant is to pilot a psychosocial intervention using cognitive enhancement therapy to reduce alcohol consumption in individuals with early phase psychosis. This intervention has shown promise in reducing alcohol use in individuals with long standing schizophrenia and compare it to treatment as usual which involves brief (1 session) psychoeducation. The investigators hope to reduce substance use in young people in the early stages of a psychotic disorder and improve their odds of a full recovery. In addition to measuring symptoms and hospitalizations, this trial will measure what are called social determinants of health such as return to school or work and resumption of relationships. These variables have not been measured previously in alcohol use interventions in this population but in our experience are the best indicators of long term recovery from psychosis. The symptoms will generally improve with antipsychotic drug treatment but reach a threshold after 6 months in most individuals who engage with our 5 year program. Further functional and social recovery seem to be the best determinants of a full return to health in this population.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It focuses on reducing alcohol use in individuals with early phase psychosis.
What data supports the effectiveness of the treatment Cognitive Enhancement Therapy (CET) for psychosis and alcoholism?
Research shows that Cognitive Enhancement Therapy (CET) is effective in improving cognitive and social functioning in patients with early schizophrenia, with benefits lasting up to a year after treatment. This suggests that CET could potentially help with cognitive and social challenges in other conditions like psychosis and alcoholism.
12345Is Cognitive Enhancement Therapy (CET) safe for humans?
Cranial electrotherapy stimulation (CES), which is related to CET, has been reported as safe in various studies for conditions like anxiety, PTSD, insomnia, and depression, with a high percentage of users perceiving it as safe.
678910How is Cognitive Enhancement Therapy (CET) different from other treatments for psychosis and alcoholism?
Cognitive Enhancement Therapy (CET) is unique because it focuses on improving both neurocognitive and social-cognitive skills through interactive software and group exercises, which helps patients with schizophrenia improve their social functioning and cognitive abilities. Unlike other treatments, CET specifically targets social cognitive deficits, such as understanding social contexts and taking others' perspectives, which are often challenging for individuals with schizophrenia.
123411Eligibility Criteria
This trial is for young people aged 16-35 in Nova Scotia who are in the early stages of a psychotic illness (like schizophrenia) and have issues with drinking too much alcohol, as shown by scoring 8 or higher on a specific WHO test.Inclusion Criteria
Individuals with a psychotic spectrum diagnosis including schizophrenia, schizoaffective disorder, and unspecified schizophrenia spectrum disorder
Problematic alcohol use (score of 8 or higher on the World Health Organization Alcohol Use Disorders Identification Test (WHO-AUDIT))
I have had a psychotic illness for less than 5 years.
+1 more
Exclusion Criteria
Presence of another substance use disorder other than nicotine dependence
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants are randomized to either cognitive enhancement therapy (CET) or treatment as usual (TAU). CET involves bi-weekly sessions over a six-month period.
6 months
Bi-weekly sessions
Follow-up
Participants are monitored for changes in alcohol consumption and engagement with the intervention.
4 weeks
Participant Groups
The study tests Cognitive Enhancement Therapy to see if it helps reduce alcohol use among those with early phase psychosis. It will be compared to standard care, which includes just one session about the dangers of alcohol.
2Treatment groups
Experimental Treatment
Active Control
Group I: Cognitive enhancement therapy (CET)Experimental Treatment1 Intervention
Cognitive enhancement therapy with an aim to reduce alcohol consumption
Group II: Treatment as UsualActive Control1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Nova Scotia Health AuthorityHalifax, Canada
Loading ...
Who Is Running the Clinical Trial?
Nova Scotia Health AuthorityLead Sponsor
Phil TibboLead Sponsor
Canadian Institutes of Health Research (CIHR)Collaborator
References
Durability and mechanism of effects of cognitive enhancement therapy. [2019]This study sought to determine whether previously reported effects of cognitive enhancement therapy (CET) are maintained one year after treatment. CET is a developmental, small-group approach to the remediation of neurocognitive and social-cognitive deficits among persons with schizophrenia. A mechanism of action that might explain the effects of CET was also sought.
Confirmatory Efficacy of Cognitive Enhancement Therapy for Early Schizophrenia: Results From a Multisite Randomized Trial. [2023]Cognitive enhancement therapy (CET) is an 18-month comprehensive cognitive remediation intervention designed to improve cognition and functioning among patients with schizophrenia. The current study sought to confirm previously observed benefits of CET on cognitive and behavioral outcomes in the early course of the condition in a large multisite trial.
Mechanisms of functional improvement in a 2-year trial of cognitive enhancement therapy for early schizophrenia. [2022]Cognitive rehabilitation has emerged as an effective treatment for addressing cognitive impairments and functional disability in schizophrenia; however, the degree to which changes in various social and non-social cognitive processes translate into improved functioning during treatment remains unclear. This research sought to identify the neurocognitive and social-cognitive mechanisms of functional improvement during a 2-year trial of cognitive enhancement therapy (CET) for early-course schizophrenia.
Practice principles of cognitive enhancement therapy for schizophrenia. [2019]Cognitive Enhancement Therapy (CET) is a developmental approach to the rehabilitation of schizophrenia patients that attempts to facilitate an abstracting and "gistful" social cognition as a compensatory alternative to the more demanding and controlled cognitive strategies that often characterize schizophrenia as well as much of its treatment. Selected cognitive processes that developmentally underlie the capacity to acquire adult social cognition have been operationalized in the form of relevant interactive software and social group exercises. Treatment methods address the impairments, disabilities, and social handicaps associated with cognitive styles that appear to underlie the positive, negative, and disorganized symptom domains of schizophrenia. Style-related failures in secondary rather than primary socialization, particularly social cognitive deficits in context appraisal and perspective taking, are targeted goals. Illustrative examples of the techniques used to address social and nonsocial cognitive deficits are provided, together with encouraging preliminary observations regarding the efficacy of CET.
One-year durability of the effects of cognitive enhancement therapy on functional outcome in early schizophrenia. [2021]Cognitive rehabilitation is an effective intervention for addressing cognitive impairments in patients with schizophrenia. Previous research has shown that the early application of Cognitive Enhancement Therapy (CET) can improve neurocognitive and social-cognitive deficits in the early course of the disorder, and ultimately reduce the substantial functional disability that these patients experience. However, the lasting effects of CET on functional outcome in early course schizophrenia patients remain unknown. In this study, 58 patients in the early course of schizophrenia or schizoaffective disorder treated with 2 years of either CET or an Enriched Supportive Therapy (EST) control were followed-up 1 year after the completion of treatment to examine the durability of CET effects on functional outcome. At one-year post-treatment, a high (72%) retention rate was observed in both treatments. Results from intent-to-treat analyses employing linear mixed-effects models indicated that CET effects on functional outcome were broadly maintained one-year post-treatment, and that patients receiving CET continued to demonstrate highly significant differential functional benefits compared to patients treated with EST. These findings support the durability of CET effects on functional outcome in the early course of schizophrenia, and point to the potential of cognitive rehabilitation to have a lasting impact on the early trajectory of the disorder.
Cranial electrotherapy stimulation treatment of cognitive brain dysfunction in chemical dependence. [2015]Several studies have shown that cranial electrotherapy stimulation (CES) is useful in treating brain dysfunction associated with alcoholism. A double-blind study replicated the latest of these findings in 60 inpatients and extended them by treating individuals with alcoholism and other chemical dependencies. Treatment effects were assessed on three subscales of the WAIS that are clinical indicators of organic brain syndrome. No placebo effect was found. CES appears to be a valuable adjunct to rehabilitation programs for addicted persons and can effect changes in areas not addressed by other treatment modalities.
Confirming evidence of an effective treatment for brain dysfunction in alcoholic patients. [2019]In earlier studies we found that cranial electrotherapy stimulation (CES) was associated with significant improvement in several areas of brain dysfunction commonly found in alcoholic persons. In this study we compared the effects of CES among treatment and control groups on each of the six subscales of the Revised Beta Examination (Lindner, R. M., and Curvitz, M. Revised Beta Examination, Psychological Corp., New York, 1957) and found CES related to significant improvement on the two subscales which are below the norms in alcoholic patients and which have been correlated with other measures of brain dysfunction. It is concluded that CES can be an important therapeutic strategy in reducing to weeks the time required for recovery of several reversible brain dysfunctions in alcoholic persons which usually require months or years of abstinence.
Military service member and veteran self reports of efficacy of cranial electrotherapy stimulation for anxiety, posttraumatic stress disorder, insomnia, and depression. [2015]Cranial electrotherapy stimulation (CES) is being prescribed for service members and veterans for the treatment of anxiety, posttraumatic stress disorder (PTSD), insomnia and depression. The purpose of this study was to examine service members' and veterans' perceptions of the effectiveness and safety of CES treatment. Service members and veterans (N=1,514) who had obtained a CES device through the Department of Defense or Veterans Affairs Medical Center from 2006-2011 were invited to participate in the web based survey via email. One hundred fifty-two participants returned questionnaires. Data were analyzed using descriptive statistics. Participants reported clinical improvement of 25% or more from using CES for anxiety (66.7%), PTSD (62.5%), insomnia (65.3%) and depression (53.9%). The majority of these participants reported clinical improvement of 50% or more. Respondents also perceived CES to be safe (99.0%). Those individuals who were not taking any prescription medication rated CES more effective than the combined CES and prescription medication group. CES provides service members and veterans with a safe, noninvasive, nondrug, easy to use treatment for anxiety, PTSD, insomnia, and depression that can be used in the clinical setting or self-directed at home.
Effects of cranial electrotherapy stimulation on preoperative anxiety, pain and endocrine response. [2018]Cranial electrotherapy stimulation (CES) is used as a treatment for depression and anxiety, and as an adjunctive intervention for pain management. This prospective study investigated whether CES could decrease preoperative anxiety, the injection pain of rocuronium, postoperative pain and stress hormone levels.
Cranial electrotherapy stimulation as a treatment for anxiety in chemically dependent persons. [2019]Cranial electrotherapy stimulation (CES) is reported to be an effective treatment for anxiety, a major presenting symptom among chemically dependent patients. In this study, 40 inpatient alcohol and/or polydrug users were given CES or sham CES in a double blind design. An additional 20 patients served as normal hospital routine controls. Dependent measures of anxiety were the Profile of Mood States, the Institute for Personality and Ability Testing Anxiety Scale, and the State/Trait Anxiety Index. CES-treated patients showed significantly greater improvement on all anxiety measures than did either control group. There were no differences in response between older and younger patients, or between the primarily drug or alcohol abusers. No placebo effect was found on any of our measures. It is concluded tht CES is a clinically significant addition to the treatment regimen for this patient population.
Negative symptom improvement during cognitive rehabilitation: results from a 2-year trial of Cognitive Enhancement Therapy. [2021]Cognitive rehabilitation has shown beneficial effects on cognition in patients with schizophrenia, which may also help to improve negative symptoms due to overlapping pathophysiology between these two domains. To better understand the possible relationship between these areas, we conducted an exploratory analysis of the effects of Cognitive Enhancement Therapy (CET) on negative symptoms. Early course schizophrenia outpatients (n=58) were randomized to 2 years of CET or an Enriched Supportive Therapy (EST) control condition. Results revealed significant and medium-sized (d=0.61) differential improvements favoring CET in overall negative symptoms, particularly social withdrawal, affective flattening, and motor retardation. Neurocognitive improvement was associated with reduced negative symptoms in CET, but not EST patients. No relationships were observed between improvements in emotion processing aspects of social cognition, as measured by the Mayer-Salovey-Caruso Emotional Intelligence Test, and negative symptoms. CET represents an effective cognitive rehabilitation intervention for schizophrenia that may also have benefits to negative symptoms. Future studies specifically designed to examine negative symptoms during the course of cognitive rehabilitation are needed.