NCT01292577

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for phase_1 schizophrenia

Timeline
Completed

Started Sep 2010

Longer than P75 for phase_1 schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2011

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 9, 2011

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

April 13, 2020

Status Verified

April 1, 2020

Enrollment Period

3.7 years

First QC Date

January 27, 2011

Last Update Submit

April 10, 2020

Conditions

SchizophreniaSchizoaffective Disorder

Keywords

SchizophreniaSchizoaffective DisorderCannabisAlcoholSubstance MisuseCognitionPsychosocial TreatmentCognitive Enhancement TherapyPersonal TherapyTreatment as Usual

Outcome Measures

Primary Outcomes (1)

  • 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).

    Baseline, 6-month, 12-month and 18 month

Secondary Outcomes (1)

  • Substance Use Outcomes

    Baseline, 6-month, 12-month 18-month

Study Arms (2)

CET/PT

EXPERIMENTAL

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

Behavioral: CET/PT

Treatment as Usual

ACTIVE COMPARATOR

Behavioral Intervention: Participants will receive treatment as usual.

Behavioral: Treatment as Usual

Interventions

CET/PTBEHAVIORAL

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.

CET/PT
Treatment as UsualBEHAVIORAL

The usual care individuals with schizophrenia that misuse substances receive in the community for their conditions.

Treatment as Usual

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (5)

  • 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.

    PMID: 20860867BACKGROUND

  • 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.

    PMID: 20472402BACKGROUND

  • 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.

    PMID: 20439824BACKGROUND

  • 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.

    PMID: 15351765BACKGROUND

  • 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.

    PMID: 27089154DERIVED

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersMarijuana Abuse

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersSubstance-Related DisordersChemically-Induced Disorders

Study Officials

  • Shaun M Eack, Ph.D.

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Social Work and Psychiatry

Study Record Dates

First Submitted

January 27, 2011

First Posted

February 9, 2011

Study Start

September 1, 2010

Primary Completion

May 1, 2014

Study Completion

September 1, 2014

Last Updated

April 13, 2020

Record last verified: 2020-04

Locations

US(1)