Recruiting

Alcohol Intervention

Sponsor:

Nova Scotia Health Authority

Code:

NCT05365347

Conditions

Psychosis

Alcohol Use Disorder

Eligibility Criteria

Sex: All

Age: 16 - 35

Healthy Volunteers: Not accepted

Interventions

Cognitive Enhancement Therapy (CET)

Study Details

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

Study ID

NCT05365347

Start date

Dec 1, 2022

Status verified date

Feb, 2024

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 35

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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))

Exclusion Criteria:

  • presence of another substance use disorder other than nicotine dependence

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Treatment as Usual

experimental: Cognitive enhancement therapy (CET)

Cognitive enhancement therapy with an aim to reduce alcohol consumption

Interventions

Cognitive Enhancement Therapy (CET)

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.

Primary outcome measure

  • Alcohol consumption (mL per day) [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Locations

Nova Scotia Health Authority

Recruiting

Halifax, Nova Scotia, Canada, B3S0H6

More Information

Sponsor

Nova Scotia Health Authority

Last update posted

Aug 23, 2024

Last verified

Feb, 2024

Keywords

  • Early Phase Psychosis
  • Alcohol Use Disorder
  • Cognitive Enhancement Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nova Scotia Health Authority on 2024-08-23.