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Cognitive Behavior Therapy and Work Outcome

Effects of CBT and Cognitive Remediation on Work in Schizophrenia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00810355
Enrollment
87
Registered
2008-12-18
Start date
2009-10-01
Completion date
2015-08-06
Last updated
2017-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

Schizophrenia Spectrum Disorders, Cognitive Behavior Therapy, work

Brief 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. 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.

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.

Interventions

BEHAVIORALSupport Group

General support and problem solving for work activity

BEHAVIORALCognitive Behavior Therapy

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

BEHAVIORALCognitive Remediation

Computerized training to enhance cognitive functioning.

Sponsors

Indiana University School of Medicine
CollaboratorOTHER
VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Work Quality6 monthsAverage 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.
Work Quantity6 monthsAverage number of hours worked per week. Higher numbers represent more hours worked, ranging from 0-40.
Symptoms6 monthsSymptoms (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.

Countries

United States

Participant flow

Recruitment details

12 subjects consented, but failed to complete intake procedures for randomization. This is why the final results total enrollment number differs from the protocol enrollment number.

Participants by arm

ArmCount
Support Group
Support group Support Group: General support and problem solving for work activity
25
Cognitive Behavior Therapy
Cognitive Behavior Therapy Support Group: General support and problem solving for work activity Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work
25
Cognitive Behavior Therapy and Cognitive Remediation
Cognitive Behavior Therapy and Cognitive Remediation Support Group: General support and problem solving for work activity Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work Cognitive Remediation: Computerized training to enhance cognitive functioning.
25
Total75

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyLost to Follow-up131711
Overall StudyWithdrawal by Subject100

Baseline characteristics

CharacteristicSupport GroupCognitive Behavior TherapyCognitive Behavior Therapy and Cognitive RemediationTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
2 Participants0 Participants0 Participants2 Participants
Age, Categorical
Between 18 and 65 years
23 Participants25 Participants25 Participants73 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
15 Participants14 Participants15 Participants44 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants1 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
10 Participants11 Participants9 Participants30 Participants
Region of Enrollment
United States
25 participants25 participants25 participants75 participants
Sex: Female, Male
Female
1 Participants2 Participants1 Participants4 Participants
Sex: Female, Male
Male
24 Participants23 Participants24 Participants71 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
0 / 250 / 250 / 25
serious
Total, serious adverse events
1 / 250 / 251 / 25

Outcome results

Primary

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.

Time frame: 6 months

ArmMeasureGroupValue (MEAN)Dispersion
Support GroupSymptomsaverage hostility symptoms8.24 scores on a scaleStandard Deviation 2.79
Support GroupSymptomsaverage cognitive symptoms18.44 scores on a scaleStandard Deviation 3.85
Support GroupSymptomsaverage positive symptoms17.79 scores on a scaleStandard Deviation 5.03
Support GroupSymptomsaverage negative symptoms20.97 scores on a scaleStandard Deviation 4.74
Support GroupSymptomsaverage depression symptoms11.62 scores on a scaleStandard Deviation 2.95
Cognitive Behavior TherapySymptomsaverage cognitive symptoms16.91 scores on a scaleStandard Deviation 3.37
Cognitive Behavior TherapySymptomsaverage positive symptoms17.11 scores on a scaleStandard Deviation 4.48
Cognitive Behavior TherapySymptomsaverage negative symptoms20.61 scores on a scaleStandard Deviation 4.84
Cognitive Behavior TherapySymptomsaverage hostility symptoms7.09 scores on a scaleStandard Deviation 2.28
Cognitive Behavior TherapySymptomsaverage depression symptoms11.86 scores on a scaleStandard Deviation 3.72
Cognitive Behavior Therapy and Cognitive RemediationSymptomsaverage depression symptoms11.66 scores on a scaleStandard Deviation 3.6
Cognitive Behavior Therapy and Cognitive RemediationSymptomsaverage hostility symptoms7.17 scores on a scaleStandard Deviation 2.54
Cognitive Behavior Therapy and Cognitive RemediationSymptomsaverage positive symptoms15.85 scores on a scaleStandard Deviation 5.13
Cognitive Behavior Therapy and Cognitive RemediationSymptomsaverage cognitive symptoms16.46 scores on a scaleStandard Deviation 3.04
Cognitive Behavior Therapy and Cognitive RemediationSymptomsaverage negative symptoms19.42 scores on a scaleStandard Deviation 4.32
Primary

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.

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
Support GroupWork Quality3.01 scores on a scaleStandard Deviation 0.33
Cognitive Behavior TherapyWork Quality3.23 scores on a scaleStandard Deviation 0.35
Cognitive Behavior Therapy and Cognitive RemediationWork Quality3.33 scores on a scaleStandard Deviation 0.38
Primary

Work Quantity

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

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
Support GroupWork Quantity14.79 hours worked per weekStandard Deviation 7.77
Cognitive Behavior TherapyWork Quantity15.04 hours worked per weekStandard Deviation 6.56
Cognitive Behavior Therapy and Cognitive RemediationWork Quantity17.73 hours worked per weekStandard Deviation 6

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026