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Adapted Cognitive/Affective Remediation for Cannabis Misuse in Schizophrenia

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University of Pittsburgh

Status and phase

Completed
Phase 2
Phase 1

Conditions

Schizophrenia
Schizoaffective Disorder

Treatments

Behavioral: Treatment as Usual
Behavioral: CET/PT

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01292577
R21DA030763 (U.S. NIH Grant/Contract)
118404

Details and patient eligibility

About

This study will integrate and adapt a cognitive remediation (Cognitive Enhancement Therapy [CET]) and an affect regulation (Personal Therapy [PT]) intervention for 50 individuals with schizophrenia that misuse cannabis. Participants will be randomized to CET/PT plus treatment as usual (TAU) or TAU alone and treated for 18 months.

Full description

Schizophrenia is a severe and chronic mental illness that places significant burden on the individuals who suffer from it, their families, and society. One of the most vexing problems in the treatment of schizophrenia is the high rate of substance use comorbidity. The majority of schizophrenia patients experience substantial cognitive and affective impairments. Consistent deficits have been observed in the broad domains of neurocognition(e.g., attention, memory, and problem-solving), social cognition (e.g., perspective-taking, foresight, social cue recognition), and affect regulation, which are major contributors to functional impairment in the disorder. These cognitive and affective deficits may be exacerbated among schizophrenia patients that misuse substances and because these deficits are untreated by current pharmacotherapeutic strategies many turn to cannabis and other drugs to cope.

Cognitive Enhancement Therapy (CET) is a treatment that has proved effective in improving cognition in individuals with schizophrenia. Personal Therapy (PT) is a treatment designed to help individuals with the affective deficits that may lead to substance misuse for individuals with schizophrenia. This study will adapt and integrate CET and PT to test whether this intervention is better or more effective for treating substance misusing schizophrenia patients than the usual treatment received (Treatment as Usual or TAU).

Participation in this study will last 18 months. Eligible participants will be randomly assigned to receive either CET/PT or TAU. Participants that receive the CET/PT condition must be able to attend weekly treatment sessions in Pittsburgh, PA. All participants will complete cognitive, functional, and affective outcome measures at the beginning of the study, 6-months, 12-months, and at 18-months regardless of treatment assignment. Results from all outcome measures will be used to estimate the effectiveness of CET/PT for individuals that have schizophrenia and misuse substances.

Enrollment

33 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosis of schizophrenia or schizoaffective disorder confirmed by the Structured Clinical Interview for DSM-IV Disorders (SCID).
  • Cannabis severity scores of moderate or higher on the Addiction Severity Index (ASI).
  • present with significant cognitive disability based on the Cognitive Style and Social Cognition Eligibility Interview
  • Intelligence quotient (IQ) greater than 80
  • Ability to read and speak fluent English
  • Ability to attend weekly treatment sessions in Pittsburgh, PA.

Exclusion criteria

  • Organic Brain Syndrome
  • English Language below a sixth grade level
  • Persistent suicidal or homicidal behavior
  • comorbid medical disorders producing cognitive impairment
  • receipt of substance abuse pharmacotherapies (e.g., naltrexone)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

33 participants in 2 patient groups

CET/PT
Experimental group
Description:
Behavioral Intervention: Participants will receive adapted Cognitive Enhancement Therapy/Personal Therapy.
Treatment:
Behavioral: CET/PT
Treatment as Usual
Active Comparator group
Description:
Behavioral Intervention: Participants will receive treatment as usual.
Treatment:
Behavioral: Treatment as Usual

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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