Adapted Cognitive/Affective Remediation for Cannabis Misuse in Schizophrenia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by University of Pittsburgh.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01292577
First received: January 27, 2011
Last updated: February 8, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Schizoaffective Disorder
Behavioral: CET/PT
Behavioral: Treatment as Usual
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adapted Cognitive/Affective Remediation for Cannabis Misuse in Schizophrenia

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Cognitive/Affective Functional Outcomes [ Time Frame: Baseline, 6-month, 12-month and 18 month ] [ Designated as safety issue: No ]
    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:
  • Substance Use Outcomes [ Time Frame: Baseline, 6-month, 12-month 18-month ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 50
Study Start Date: October 2010
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CET/PT
Behavioral Intervention: Participants will receive adapted Cognitive Enhancement Therapy/Personal Therapy.
Behavioral: CET/PT
CET/PT is an 18-month comprehensive small group approach for the remediation of cognitive deficit in schizophrenia consisting of individual sessions and 45 group training sessions in social cognition that are integrated with an affect regulation approach and 60 hours of computer assisted training in attention, memory, and problem solving skills.
Active Comparator: Treatment as Usual
Behavioral Intervention: Participants will receive treatment as usual.
Behavioral: Treatment as Usual
The usual care individuals with schizophrenia that misuse substances receive in the community for their conditions.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01292577

Contacts
Contact: Amber L. Bahorik, M.S.W. 412-864-3807 bahorikal@upmc.edu

Locations
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Amber L. Bahorik, M.S.W.    412-864-3807    bahorikal@upmc.edu   
Principal Investigator: Shaun M. Eack, Ph.D.         
Sub-Investigator: Susan S. Hogarty, M.S.N.         
Sub-Investigator: Deborah P Greenwald, Ph.D.         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Shaun M Eack, Ph.D. University of Pittsburgh
  More Information

Publications:
Responsible Party: Shaun M. Eack Ph.D., University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01292577     History of Changes
Other Study ID Numbers: 118404, R21DA30763
Study First Received: January 27, 2011
Last Updated: February 8, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Schizophrenia
Schizoaffective Disorder
Cannabis
Alcohol
Substance Misuse
Cognition
Psychosocial Treatment
Cognitive Enhancement Therapy
Personal Therapy
Treatment as Usual

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on September 30, 2014