AzTrials
AzTrials

SchizophreniaNCT00810355

Cognitive Behavior Therapy and Work Outcome

A study testing Support Group, Cognitive Behavior Therapy and Cognitive Remediation in people with Schizophrenia, run by VA Office of Research and Development 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
Search all trials

Trial summary

This research studies the effects of Cognitive Behavior Therapy and Cognitive Remediation on work for persons with schizophrenia. Cognitive Behavior Therapy is a form of counseling that helps people to improve their mental health by changing the way they think about themselves and others. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Schizophrenia
What is being tested?
Support Group, Cognitive Behavior Therapy and Cognitive Remediation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
87 participants
Where
1 siteUnited States
Study dates
1 Oct 2009to 6 Aug 2015
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of schizophrenia spectrum disorder,
  • interest in vocational rehabilitation

Who cannot join

  • No changes in medication type or housing in the last 30 days,
  • mental retardation

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Richard L. Roudebush VA Medical Center, Indianapolis, IN

    Indianapolis, Indiana, 46202-2884

Other trials in United States

About this study

Official title: Effects of CBT and Cognitive Remediation on Work in Schizophrenia

This research studies the effects of Cognitive Behavior Therapy and Cognitive Remediation on work for persons with schizophrenia. Cognitive Behavior Therapy is a form of counseling that helps people to improve their mental health by changing the way they think about themselves and others. Cognitive Remediation is an exercise to improve the thinking process. The purpose of this study is to determine the extent to which Cognitive Remediation combined with Cognitive Behavior Therapy helps people who are working.

Read the detailed description

Objectives: The proposed grant seeks to compare the effects of a manualized form of Cognitive Behavior Therapy (CBT) combined with Cognitive Remediation (CR) with CBT alone and Support Services (SS) alone on vocational outcomes for persons with schizophrenia spectrum disorders. Key hypotheses are: I) Participants receiving CBT +CR will work more weeks and hours than participants receiving CBT alone or SS alone; II) Participants receiving CBT + CR condition will show better work performance than the CBT alone and SS alone conditions; III) Participants receiving CBT + CR will experience greater improvements in symptoms, dysfunctional beliefs and quality of life than the CBT alone or SS alone conditions Research Plan: One hundred twenty participants with Structured Clinical Interview for DSM-IV (SCID) confirmed diagnoses of schizophrenia or schizoaffective disorder will be recruited from the Roudebush VA Medical Center , surrounding mental health centers and the Marion VA Medical Center. Participants with these diagnoses will be eligible if they are sufficiently stable to sustain participant in rehabilitation, as defined by no hospitalizations, medication or housing changes in the last 30 days. Participants will be offered a 6 month paid job placement and randomly assigned to receive either CBT + CR, CBT only or SS only.

Methodology: Following informed consent, a baseline assessment will include an inventory of work, residential, substance abuse, legal, quality of life, psychiatric and service utilization history. Participants will be offered a 26-week job placement at the VA Medical center or within the community and randomly assigned to receive 6 months of either CBT +CR, CBT only or SS. Jobs will include entry-level positions supervised by regular job site supervisors. Participants in the SS condition will attend a weekly individual and support group offering unstructured support regarding work related problems they identify. Participants in the CBT group will attend weekly group and individual sessions employing a manualized CBT intervention to identify and correct dysfunctional cognitions related to work. Participants in the CBT + CR condition will attend meetings as indicated for CBT along with performing cognitive exercises on the computer, progressing at their own pace. Hours of work will be recorded weekly. Work performance will be measured biweekly. Symptoms and cognitions will be assessed every 2 months. Primary forms of data analyses will be multivariate repeated measure analyses of variance in which CBT +CR, CBT only and SS groups will be compared on vocational, symptom, and self-esteem variables.

Results: The investigators have recently demonstrated in separate randomized controlled trials that CBT and CR can be fully implemented in a VA setting and that each leads to better work outcomes in schizophrenia. Means and standard deviations of key outcomes have been determined and are used in the power analysis for this study.

Significance: The proposed research aims provide a scientifically sound exploration of the therapeutic value of productive activity in the rehabilitation of persons with schizophrenia and to determine the extent to which manualized CBT procedures when combined with CR may contribute to the success of this process. Results may provide exportable guidelines for augmenting work services with an appropriate psychological treatment. This information may lead to more effective rehabilitation programs as well as increases in productivity, functional independence and an enhanced quality of life for persons with schizophrenia. The study also fulfills the rehabilitation goal of maximum inclusion by providing CBT and CR services that may make it possible for some patients to function at work that otherwise could not.

Conditions
Schizophrenia
Being tested
Support Group, Cognitive Behavior Therapy, Cognitive Remediation
Keywords
Schizophrenia Spectrum Disorders, Cognitive Behavior Therapy, work
Medical subject headings
Schizophrenia

What participants receive

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

  • Support GroupBehavioural

    General support and problem solving for work activity

  • Cognitive Behavior TherapyBehavioural

    Individual and group therapy focused on identifying and correcting maladaptive beliefs about work

  • Cognitive RemediationBehavioural

    Computerized training to enhance cognitive functioning.

Study groups in NCT00810355
Study groupRoleWhat they receive
Arm 1Active comparatorSupport group
Receives: Behavioral: Support Group
Arm 2ExperimentalCognitive Behavior Therapy
Receives: Behavioral: Support Group; Behavioral: Cognitive Behavior Therapy
Arm 3ExperimentalCognitive Behavior Therapy and Cognitive Remediation
Receives: Behavioral: Support Group; Behavioral: Cognitive Behavior Therapy; Behavioral: Cognitive Remediation

What is being measured

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

  1. Work Quality

    Average work performance scored on the Work Behavior Inventory (WBI) by total average of the 5 subscales. Scores range from 1-5. Higher scores represent better work performance.

    Measured: 6 months

  2. Work Quantity

    Average number of hours worked per week. Higher numbers represent more hours worked, ranging from 0-40.

    Measured: 6 months

  3. Symptoms

    Symptoms (positive, negative, cognitive, hostility, and depression subscales) are rated on Positive and Negative Syndrome Scale (PANSS). These are averages of each subscale: positive (range 6-42), negative (range 8-56), cognitive (range 7-49), hostility (range 4-28), depression (range 4-28). Higher scores indicate more extreme /worse symptoms.

    Measured: 6 months

Timeline

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

  1. First posted18 Dec 2008 (estimated)
  2. Study start1 Oct 2009
  3. Primary completion6 Aug 2015
  4. Study completion6 Aug 2015

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
87 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00810355
Sponsor's protocol ID
D6629-R
Status last verified
Apr 2017
First submitted
16 Dec 2008
Last updated
23 May 2017
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Support Group, Cognitive Behavior Therapy and Cognitive Remediation in people with Schizophrenia, run by VA Office of Research and Development 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 2 inclusion and 2 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 23 May 2017. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Work Quality (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 23 May 2017; AzTrials last refreshed its copy on 29 Oct 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in