Trial Outcomes & Findings for Cognitive Behavior Therapy and Work Outcome (NCT NCT00810355)
NCT ID: NCT00810355
Last Updated: 2017-05-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
87 participants
Primary outcome timeframe
6 months
Results posted on
2017-05-23
Participant Flow
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.
Participant milestones
| Measure |
Support Group
Support Group: General support and problem solving for work activity
|
Cognitive Behavior Therapy
Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
25
|
|
Overall Study
COMPLETED
|
11
|
8
|
14
|
|
Overall Study
NOT COMPLETED
|
14
|
17
|
11
|
Reasons for withdrawal
| Measure |
Support Group
Support Group: General support and problem solving for work activity
|
Cognitive Behavior Therapy
Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work
|
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.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
13
|
17
|
11
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
Baseline Characteristics
Cognitive Behavior Therapy and Work Outcome
Baseline characteristics by cohort
| Measure |
Support Group
n=25 Participants
Support group
Support Group: General support and problem solving for work activity
|
Cognitive Behavior Therapy
n=25 Participants
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
|
Cognitive Behavior Therapy and Cognitive Remediation
n=25 Participants
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.
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
25 participants
n=7 Participants
|
25 participants
n=5 Participants
|
75 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 6 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.
Outcome measures
| Measure |
Support Group
n=25 Participants
Support group
Support Group: General support and problem solving for work activity
|
Cognitive Behavior Therapy
n=25 Participants
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
|
Cognitive Behavior Therapy and Cognitive Remediation
n=25 Participants
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.
|
|---|---|---|---|
|
Work Quality
|
3.01 scores on a scale
Standard Deviation 0.33
|
3.23 scores on a scale
Standard Deviation .35
|
3.33 scores on a scale
Standard Deviation .38
|
PRIMARY outcome
Timeframe: 6 monthsAverage number of hours worked per week. Higher numbers represent more hours worked, ranging from 0-40.
Outcome measures
| Measure |
Support Group
n=25 Participants
Support group
Support Group: General support and problem solving for work activity
|
Cognitive Behavior Therapy
n=25 Participants
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
|
Cognitive Behavior Therapy and Cognitive Remediation
n=25 Participants
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.
|
|---|---|---|---|
|
Work Quantity
|
14.79 hours worked per week
Standard Deviation 7.77
|
15.04 hours worked per week
Standard Deviation 6.56
|
17.73 hours worked per week
Standard Deviation 6.00
|
PRIMARY outcome
Timeframe: 6 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.
Outcome measures
| Measure |
Support Group
n=25 Participants
Support group
Support Group: General support and problem solving for work activity
|
Cognitive Behavior Therapy
n=25 Participants
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
|
Cognitive Behavior Therapy and Cognitive Remediation
n=25 Participants
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.
|
|---|---|---|---|
|
Symptoms
average positive symptoms
|
17.79 scores on a scale
Standard Deviation 5.03
|
17.11 scores on a scale
Standard Deviation 4.48
|
15.85 scores on a scale
Standard Deviation 5.13
|
|
Symptoms
average negative symptoms
|
20.97 scores on a scale
Standard Deviation 4.74
|
20.61 scores on a scale
Standard Deviation 4.84
|
19.42 scores on a scale
Standard Deviation 4.32
|
|
Symptoms
average cognitive symptoms
|
18.44 scores on a scale
Standard Deviation 3.85
|
16.91 scores on a scale
Standard Deviation 3.37
|
16.46 scores on a scale
Standard Deviation 3.04
|
|
Symptoms
average hostility symptoms
|
8.24 scores on a scale
Standard Deviation 2.79
|
7.09 scores on a scale
Standard Deviation 2.28
|
7.17 scores on a scale
Standard Deviation 2.54
|
|
Symptoms
average depression symptoms
|
11.62 scores on a scale
Standard Deviation 2.95
|
11.86 scores on a scale
Standard Deviation 3.72
|
11.66 scores on a scale
Standard Deviation 3.60
|
Adverse Events
Support Group
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Cognitive Behavior Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cognitive Behavior Therapy and Cognitive Remediation
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Support Group
n=25 participants at risk
Support group
Support Group: General support and problem solving for work activity
|
Cognitive Behavior Therapy
n=25 participants at risk
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
|
Cognitive Behavior Therapy and Cognitive Remediation
n=25 participants at risk
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.
|
|---|---|---|---|
|
Psychiatric disorders
psychiatric hospitalization
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Paul Lysaker
Richard L. Roudebush VA Medical Center
Phone: 317-988-2546
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place