Adapted Cognitive/Affective Remediation for Cannabis Misuse in Schizophrenia

Phase 1

Completed

• Conditions: Schizophrenia; Schizoaffective Disorder
• Interventions: Behavioral: CET/PT; Behavioral: Treatment as Usual

• Registration Number: NCT01292577
• Lead Sponsor: University of Pittsburgh

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2011-01-27
• Study First Submitted QC: 2011-02-08
• Study First Posted: 2011-02-09
• Primary Completion: 2014-05
• Study Completion: 2014-09
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-10
• Last Update Posted: 2020-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Cognitive/Affective Functional Outcomes	Baseline, 6-month, 12-month and 18 month	This research seeks to determine whether cannabis misusing schizophrenia patients assigned to CET/PT show better cognitive/affective functional outcomes compared to patients assigned to TAU. The degree of change from baseline to 6-, 12-, and 18-months will be examined in accordance with the following cognitive/affective measures: NIMH-MATRICS battery (Green et al., 2004),the Wisconsin Cart Sorting Test (Heaton et al., 2003), and the Mayer-Salovey-Caruso Emotional Intelligence Test (Mayer, Salovey, Caruso \& Sitarenios, 2003).

Secondary Outcome Measures

Name	Time	Method
Substance Use Outcomes	Baseline, 6-month, 12-month 18-month	This research seeks to determine whether cannabis misusing schizophrenia patients assigned to CET/PT show reduced substance usage rates compared to patients assigned to TAU. The degree of change in substance use from baseline to 6-, 12- and 18-month time points will be examined in accordance with the following measures for patients receiving either intervention assignment: the Timeline Follow-Back Method (Sobell, Maisto \& Sobell, 1995) and the Addiction Severity Index (McLellan et al., 1980).

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States