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Adapted Cognitive/Affective Remediation for Cannabis Misuse in Schizophrenia

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CET/PT
Treatment as Usual
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Schizoaffective Disorder, Cannabis, Alcohol, Substance Misuse, Cognition, Psychosocial Treatment, Cognitive Enhancement Therapy, Personal Therapy, Treatment as Usual

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept 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)

Sites / Locations

  • University of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CET/PT

Treatment as Usual

Arm Description

Behavioral Intervention: Participants will receive adapted Cognitive Enhancement Therapy/Personal Therapy.

Behavioral Intervention: Participants will receive treatment as usual.

Outcomes

Primary Outcome Measures

Cognitive/Affective Functional Outcomes
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
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).

Full Information

First Posted
January 27, 2011
Last Updated
April 10, 2020
Sponsor
University of Pittsburgh
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01292577
Brief Title
Adapted Cognitive/Affective Remediation for Cannabis Misuse in Schizophrenia
Official Title
Adapted Cognitive/Affective Remediation for Cannabis Misuse in Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder
Keywords
Schizophrenia, Schizoaffective Disorder, Cannabis, Alcohol, Substance Misuse, Cognition, Psychosocial Treatment, Cognitive Enhancement Therapy, Personal Therapy, Treatment as Usual

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CET/PT
Arm Type
Experimental
Arm Description
Behavioral Intervention: Participants will receive adapted Cognitive Enhancement Therapy/Personal Therapy.
Arm Title
Treatment as Usual
Arm Type
Active Comparator
Arm Description
Behavioral Intervention: Participants will receive treatment as usual.
Intervention Type
Behavioral
Intervention Name(s)
CET/PT
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual
Intervention Description
The usual care individuals with schizophrenia that misuse substances receive in the community for their conditions.
Primary Outcome Measure Information:
Title
Cognitive/Affective Functional Outcomes
Description
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).
Time Frame
Baseline, 6-month, 12-month and 18 month
Secondary Outcome Measure Information:
Title
Substance Use Outcomes
Description
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).
Time Frame
Baseline, 6-month, 12-month 18-month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaun M Eack, Ph.D.
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20860867
Citation
Eack SM, Pogue-Geile MF, Greenwald DP, Hogarty SS, Keshavan MS. Mechanisms of functional improvement in a 2-year trial of cognitive enhancement therapy for early schizophrenia. Psychol Med. 2011 Jun;41(6):1253-61. doi: 10.1017/S0033291710001765. Epub 2010 Sep 22.
Results Reference
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PubMed Identifier
20472402
Citation
Eack SM, Greenwald DP, Hogarty SS, Keshavan MS. One-year durability of the effects of cognitive enhancement therapy on functional outcome in early schizophrenia. Schizophr Res. 2010 Jul;120(1-3):210-6. doi: 10.1016/j.schres.2010.03.042. Epub 2010 May 15.
Results Reference
background
PubMed Identifier
20439824
Citation
Eack SM, Hogarty GE, Cho RY, Prasad KM, Greenwald DP, Hogarty SS, Keshavan MS. Neuroprotective effects of cognitive enhancement therapy against gray matter loss in early schizophrenia: results from a 2-year randomized controlled trial. Arch Gen Psychiatry. 2010 Jul;67(7):674-82. doi: 10.1001/archgenpsychiatry.2010.63. Epub 2010 May 3.
Results Reference
background
PubMed Identifier
15351765
Citation
Hogarty GE, Flesher S, Ulrich R, Carter M, Greenwald D, Pogue-Geile M, Kechavan M, Cooley S, DiBarry AL, Garrett A, Parepally H, Zoretich R. Cognitive enhancement therapy for schizophrenia: effects of a 2-year randomized trial on cognition and behavior. Arch Gen Psychiatry. 2004 Sep;61(9):866-76. doi: 10.1001/archpsyc.61.9.866.
Results Reference
background
PubMed Identifier
27089154
Citation
Eack SM, Hogarty SS, Bangalore SS, Keshavan MS, Cornelius JR. Patterns of Substance Use During Cognitive Enhancement Therapy: An 18-Month Randomized Feasibility Study. J Dual Diagn. 2016;12(1):74-82. doi: 10.1080/15504263.2016.1145778.
Results Reference
derived

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Adapted Cognitive/Affective Remediation for Cannabis Misuse in Schizophrenia

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