Piloting of an Intervention to Reduce Problematic Alcohol Use in Early Phase Psychosis Patients

NCT05365347 | Recruiting

• 1 other identifier: 46877
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Psychosis; Alcohol Use Disorder

Keywords

Early Phase Psychosis; Alcohol Use Disorder; Cognitive Enhancement Therapy

Outcome Measures

Primary Outcomes (1)

• Alcohol consumption (mL per day)

  To determine if youth and emerging adults with early phase psychosis and problematic alcohol use (score of 8 or higher on the AUDIT) will reduce alcohol consumption after treatment with a cognitive enhancement therapy intervention. Changes in alcohol consumption will be measured (mL per day).

  6 months

Secondary Outcomes (3)

• Feasibility of a shortened intervention

  6 months

• Possible role of gender in alcohol consumption

  6 months

• Engagement based on gender

  6 months

Study Arms (2)

Treatment as Usual

NO INTERVENTION

Cognitive enhancement therapy (CET)

EXPERIMENTAL

Cognitive enhancement therapy with an aim to reduce alcohol consumption

Behavioral: Cognitive Enhancement Therapy (CET)

Interventions

Cognitive Enhancement Therapy (CET) BEHAVIORAL

Cognitive enhancement therapy is an evidence based intervention for schizophrenia focused on improving the cognitive domains of memory, attention span and learning ability. It has shown efficacy in reducing substance use as an indirect outcome but this will be the focus of this intervention.

Cognitive enhancement therapy (CET)

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• This study will enroll individuals 16-35 years of age from Early Intervention Services for Psychosis in Nova Scotia
• less than 5 years of psychotic illness.
• Individuals will have a psychotic spectrum diagnosis (primary psychotic disorder) that will include schizophrenia, schizoaffective disorder, and unspecified schizophrenia spectrum disorder.
• have problematic alcohol use (score of 8 or higher on the World Health Organization Alcohol Use Disorders Identification Test (WHO-AUDIT))

You may not qualify if:

• presence of another substance use disorder other than nicotine dependence

Sponsors & Collaborators

• Nova Scotia Health Authority: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Nova Scotia Health Authority

Halifax, Nova Scotia, B3S0H6, Canada

RECRUITING

MeSH Terms

Conditions

Psychotic Disorders; Alcoholism

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Officials

• Philip G Tibbo, MD

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Candice E Crocker, PhD

CONTACT

902-473-3755; Candice.Crocker@nshealth.ca

Philip G Tibbo, MD

CONTACT

902-473-1678; psychosis.research@nshealth.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The psychometrist assessing participant outcomes will not be aware of the participants allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 24 participants who will be randomized to either treatment as usual in an Early Intervention for Psychosis Service (EIS) with 1 hour of psychoeducation or EIS plus cognitive enhancement therapy for alcohol misuse.

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 9, 2022
• Study Start: December 1, 2022
• Primary Completion: June 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: August 23, 2024

Record last verified: 2024-02

Locations

CA (1)