Cognitive Enhancement Therapy for Psychosis and Alcoholism

Overseen By Candice E Crocker, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Nova Scotia Health Authority

Must be taking: Antipsychotics

Disqualifiers: Other substance use disorders

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how cognitive enhancement therapy (CET) can help reduce alcohol use in people experiencing early-phase psychosis. Researchers seek to determine if CET can improve recovery outcomes compared to the usual treatment, a brief educational session. Participants will include individuals who have dealt with a psychotic disorder, such as schizophrenia, for less than five years and who struggle with problematic alcohol use. The trial also examines how reducing alcohol use might impact everyday activities, like returning to work or school and rebuilding relationships, which are key to full recovery. This study focuses on people from Nova Scotia who are already receiving early intervention services for psychosis. As an unphased trial, it offers a unique opportunity to contribute to understanding how CET can enhance recovery in early psychosis.

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 prior data suggests that Cognitive Enhancement Therapy is safe for individuals with early phase psychosis and alcohol use disorder?

Research has shown that Cognitive Enhancement Therapy (CET) benefits people with schizophrenia. Results indicate that CET can improve thinking skills and social and work abilities, suggesting it is generally well-tolerated. Additionally, CET has shown promise in reducing alcohol use for those with long-term schizophrenia. However, some studies have not found significant differences in substance use when comparing CET to regular care, indicating that its effectiveness can vary.

While direct data on CET's side effects in humans is limited, its use in treating schizophrenia without major safety concerns provides some confidence in its safety for this new purpose. Participants in other studies have not reported significant safety issues. This suggests that CET may be safe for individuals with early-stage psychosis and alcohol use disorder, but discussing any concerns with a healthcare provider remains important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Cognitive Enhancement Therapy (CET) for psychosis and alcoholism because it offers a fresh approach by focusing on improving cognitive functions. Most standard treatments for these conditions, like antipsychotic medications and counseling, aim to manage symptoms or modify behavior. However, CET goes a step further by targeting cognitive deficits that often accompany psychosis and alcoholism, potentially leading to better overall functioning and quality of life. This approach not only seeks to reduce alcohol consumption but also enhances cognitive skills, which can be crucial for long-term recovery and relapse prevention.

What evidence suggests that Cognitive Enhancement Therapy might be an effective treatment for early phase psychosis and alcohol use disorder?

Research shows that Cognitive Enhancement Therapy (CET), which participants in this trial may receive, can help reduce alcohol use in people with psychosis. Studies have found significant improvements in thinking skills and social interactions for those who participate in CET. Evidence indicates that CET is particularly effective in reducing alcohol problems in patients with long-term schizophrenia. These findings suggest that CET could also help young people in the early stages of psychosis drink less and improve their chances of recovery. ^{1 3 6 7 8}

Who Is on the Research Team?

Philip G Tibbo, MD

Principal Investigator

Nova Scotia Health Authority

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

Presence of another substance use disorder other than nicotine dependence

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Enhancement Therapy (CET)

Trial Overview 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.

How Is the Trial Designed?

Group I: Cognitive enhancement therapy (CET) Experimental Treatment 1 Intervention

Cognitive enhancement therapy with an aim to reduce alcohol consumption

Group II: Treatment as Usual Active Control 1 Intervention

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials

302

Recruited

95,300+

Phil Tibbo

Lead Sponsor

Trials

1

Recruited

20+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Published Research Related to This Trial

In a 2-year trial involving 58 early-course schizophrenia patients, cognitive enhancement therapy (CET) led to significant improvements in both neurocognition, particularly executive functioning, and social cognition, specifically emotion management.

These cognitive improvements were found to mediate functional outcomes, suggesting that effective cognitive rehabilitation should address both social and non-social cognitive deficits to enhance overall functioning in individuals with schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanisms of functional improvement in a 2-year trial of cognitive enhancement therapy for early schizophrenia. Eack, SM., Pogue-Geile, MF., Greenwald, DP., et al.[2022]

Cognitive Enhancement Therapy (CET) showed sustained improvements in cognitive and social functioning one year after treatment in individuals with schizophrenia, based on a study of 121 participants.

Early improvements in processing speed were identified as a key factor mediating the long-term benefits of CET on social cognition and adjustment, suggesting that enhancing this cognitive aspect may be crucial for ongoing therapeutic effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Durability and mechanism of effects of cognitive enhancement therapy. Hogarty, GE., Greenwald, DP., Eack, SM.[2019]

A double-blind study involving 60 inpatients demonstrated that cranial electrotherapy stimulation (CES) is effective in treating brain dysfunction related to alcoholism and other chemical dependencies, with no observed placebo effect.

CES may serve as a valuable addition to rehabilitation programs for individuals with addiction, positively impacting cognitive areas not typically addressed by standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cranial electrotherapy stimulation treatment of cognitive brain dysfunction in chemical dependence. Schmitt, R., Capo, T., Frazier, H., et al.[2015]

Cranial electrotherapy stimulation (CES) significantly reduced anxiety symptoms in a study of 40 inpatient alcohol and/or polydrug users compared to sham treatment and routine controls, indicating its efficacy as a treatment option.

The study found no differences in treatment response based on age or type of substance abuse, and importantly, there was no placebo effect observed, suggesting that CES provides a genuine therapeutic benefit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cranial electrotherapy stimulation as a treatment for anxiety in chemically dependent persons. Schmitt, R., Capo, T., Boyd, E.[2019]

Cognitive Enhancement Therapy (CET) aims to improve social cognition in schizophrenia patients by using interactive software and group exercises, focusing on abstract thinking and social context understanding.

Preliminary observations suggest that CET effectively addresses cognitive deficits related to social interactions, potentially helping patients manage symptoms of schizophrenia more effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practice principles of cognitive enhancement therapy for schizophrenia. Hogarty, GE., Flesher, S.[2019]

Cranial electrotherapy stimulation (CES) was found to significantly improve brain dysfunction in alcoholic patients, particularly on two subscales of the Revised Beta Examination that are linked to brain health.

CES may reduce the recovery time for reversible brain dysfunctions in alcoholics from months or years to just weeks, suggesting it could be a valuable treatment option for enhancing recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Confirming evidence of an effective treatment for brain dysfunction in alcoholic patients. Smith, RB.[2019]

Cognitive Enhancement Therapy (CET) has been shown to provide lasting benefits in functional outcomes for patients with early course schizophrenia, as evidenced by a follow-up study of 58 patients one year after treatment.

Patients who received CET continued to show significant improvements compared to those who underwent Enriched Supportive Therapy (EST), indicating that cognitive rehabilitation can have a durable impact on managing schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-year durability of the effects of cognitive enhancement therapy on functional outcome in early schizophrenia. Eack, SM., Greenwald, DP., Hogarty, SS., et al.[2021]

A survey of 152 service members and veterans revealed that cranial electrotherapy stimulation (CES) led to clinical improvements of 25% or more in anxiety (66.7%), PTSD (62.5%), insomnia (65.3%), and depression (53.9%).

Participants overwhelmingly perceived CES as safe (99.0%), and those not on prescription medications found it more effective than when combined with medication, highlighting CES as a promising noninvasive treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Military service member and veteran self reports of efficacy of cranial electrotherapy stimulation for anxiety, posttraumatic stress disorder, insomnia, and depression. Kirsch, DL., Price, LR., Nichols, F., et al.[2015]

Cranial electrotherapy stimulation (CES) significantly reduced preoperative anxiety and injection pain from rocuronium in female patients undergoing thyroidectomy, based on a study of 50 participants.

Postoperative pain was also lower in the CES group at 1 and 4 hours after surgery, but CES did not influence stress hormone levels like ACTH, cortisol, or glucose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of cranial electrotherapy stimulation on preoperative anxiety, pain and endocrine response. Lee, SH., Kim, WY., Lee, CH., et al.[2018]

Cognitive enhancement therapy (CET) significantly improved overall cognition in patients with early-course schizophrenia over an 18-month period, as confirmed by a study involving 102 outpatients.

While CET showed promising effects on social cognition and attention, it did not significantly outperform enriched supportive therapy (EST) in improving social adjustment, although the benefits appeared to increase for those who completed the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Confirmatory Efficacy of Cognitive Enhancement Therapy for Early Schizophrenia: Results From a Multisite Randomized Trial. Wojtalik, JA., Mesholam-Gately, RI., Hogarty, SS., et al.[2023]

Cognitive Enhancement Therapy (CET) significantly improved negative symptoms in early course schizophrenia patients, with a medium effect size (d=0.61), particularly in areas like social withdrawal and affective flattening, compared to the control group.

Neurocognitive improvements during CET were linked to reductions in negative symptoms, suggesting that cognitive rehabilitation can be beneficial not only for cognitive deficits but also for negative symptoms in schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Negative symptom improvement during cognitive rehabilitation: results from a 2-year trial of Cognitive Enhancement Therapy. Eack, SM., Mesholam-Gately, RI., Greenwald, DP., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4308498/

Cognitive Enhancement Therapy in Substance Misusing ... Intent-to-treat efficacy analyses showed large and significant improvements in neurocognition (d = .86), social cognition (d = 1.13), and social adjustment (d = ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2772598725000285

Piloting of an Intervention to Reduce Problematic Alcohol ... The three participants in the TAU group also saw a decrease in alcohol use, with a 31% reduction in mean alcohol use scores between baseline and ...

3. cognitiveenhancementtherapy.com cognitiveenhancementtherapy.com/evidence/

evidence supporting the effectiveness of cet Patients receiving CET demonstrated significant and large improvements across the domains of Neurocognition, Processing Speed, Cognitive Style, and Social ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07056894

Effects of Action-Based Cognitive Remediation on ... Studies have found that some cognitive remediation therapies can help reduce alcohol use in chronic schizophrenia, but there is limited research targeting the ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4837677/

Patterns of Substance Use During Cognitive Enhancement ... This study provides the first evidence suggesting that cognitive enhancement therapy may be effective at reducing alcohol use problems in patients with ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02459210

Adaptation of Cognitive Enhancement Therapy for Persons ... Research on CET for individuals with schizophrenia has found that CET appears to have helped participants improve cognition and social and work functioning.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9434502/

Cognitive Enhancement Therapy vs social skills training in ... This study builds on prior research on psychosocial rehabilitation by comparing the effectiveness of two treatments demonstrated as efficacious in improving ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0376871625002091

Cognitive-behavioral interventions for co-occurring ... The current meta-analysis provides an overview of cognitive-behaviorally-based interventions (CBI) that treat co-occurring alcohol and other drug use (AOD)