Clinical trial NCT01292577: Adapted Cognitive/Affective Remediation for Cannabis Misuse in Schizophrenia
Official title: Adapted Cognitive/Affective Remediation for Cannabis Misuse in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: Schizophrenia
Schizoaffective Disorder
Cannabis
Alcohol
Substance Misuse
Cognition
Psychosocial Treatment
Cognitive Enhancement Therapy
Personal Therapy
Treatment as Usual
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2011-02-09
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Cognitive/Affective Functional Outcomes
timeFrame: Baseline, 6-month, 12-month and 18 month
Secondary outcomes:
measure: Substance Use Outcomes
timeFrame: Baseline, 6-month, 12-month 18-month
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Shaun M Eack, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.