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

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. ^{1 2 3 4 5}

Is 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. ^{6 7 8 9 10}

How 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. ^{1 2 3 4 11}

Research Team

Philip G Tibbo, MD

Principal Investigator

Nova Scotia Health Authority

Eligibility 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.

Exclusion Criteria

Presence of another substance use disorder other than nicotine dependence

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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) 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]

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 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) 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]

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]

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) 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Durability and mechanism of effects of cognitive enhancement therapy. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Confirmatory Efficacy of Cognitive Enhancement Therapy for Early Schizophrenia: Results From a Multisite Randomized Trial. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Mechanisms of functional improvement in a 2-year trial of cognitive enhancement therapy for early schizophrenia. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Practice principles of cognitive enhancement therapy for schizophrenia. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

One-year durability of the effects of cognitive enhancement therapy on functional outcome in early schizophrenia. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Cranial electrotherapy stimulation treatment of cognitive brain dysfunction in chemical dependence. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

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

8. United States 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. [2015]

9. England pubmed.ncbi.nlm.nih.gov

Effects of cranial electrotherapy stimulation on preoperative anxiety, pain and endocrine response. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Cranial electrotherapy stimulation as a treatment for anxiety in chemically dependent persons. [2019]

11. Ireland pubmed.ncbi.nlm.nih.gov

Negative symptom improvement during cognitive rehabilitation: results from a 2-year trial of Cognitive Enhancement Therapy. [2021]