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SchizophreniaPhase 1/2NCT01292577

Adapted Cognitive/Affective Remediation for Cannabis Misuse in Schizophrenia

A Phase 1/2 study testing CET/PT and Treatment as Usual in people with Schizophrenia and Schizoaffective Disorder, run by University of Pittsburgh at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Schizophrenia, Schizoaffective Disorder
What is being tested?
CET/PT and Treatment as Usual
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteUnited States
Study dates
Sep 2010to Sep 2014
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

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.

Read the 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.

Being tested
CET/PT, Treatment as Usual
Keywords
Schizophrenia, Schizoaffective Disorder, Cannabis, Alcohol, Substance Misuse, Cognition, Psychosocial Treatment, Cognitive Enhancement Therapy, Personal Therapy, Treatment as Usual
Medical subject headings
Schizophrenia, Psychotic Disorders, Marijuana Abuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CET/PTBehavioural

    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.

  • Treatment as UsualBehavioural

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

Study groups in NCT01292577
Study groupRoleWhat they receive
CET/PTExperimentalBehavioral Intervention: Participants will receive adapted Cognitive Enhancement Therapy/Personal Therapy.
Receives: Behavioral: CET/PT
Treatment as UsualActive comparatorBehavioral Intervention: Participants will receive treatment as usual.
Receives: Behavioral: Treatment as Usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

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

Secondary outcomes (1)

  1. 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).

    Measured: Baseline, 6-month, 12-month 18-month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2011 (estimated)
  2. Study startSep 2010
  3. Primary completionMay 2014
  4. Study completionSep 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01292577
Sponsor's protocol ID
118404
Other IDs
R21DA030763
Status last verified
Apr 2020
First submitted
27 Jan 2011
Last updated
13 Apr 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 20860867

  • 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.

    PubMed 20472402

  • 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.

    PubMed 20439824

  • 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.

    PubMed 15351765

  • 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.

    PubMed 27089154

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CET/PT and Treatment as Usual in people with Schizophrenia and Schizoaffective Disorder, run by University of Pittsburgh at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cognitive/Affective Functional Outcomes (time frame: Baseline, 6-month, 12-month and 18 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01292577, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2020.

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