Trial Outcomes & Findings for The Use of Skills Training to Augment Compensated Work Therapy (CWT)/VI for Veterans With SMI (NCT NCT00272168)

Results Overview

Data collected included from participants: 1) hours scheduled to work per week and 2) weekly wages earned.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

88 participants

Primary outcome timeframe

Post Treatment (approximately 3 months after completion of the baseline assessment)

Results posted on

2016-06-17

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 1: MPROVE The Maryland Program for Vocational Effectiveness (MPROVE) Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)	Arm 2: Control Supportive Treatment for Serious Mental Illness (control) Supportive Treatment for Serious Mental Illness (SMI): Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members.
Overall Study STARTED	47	41
Overall Study COMPLETED	37	31
Overall Study NOT COMPLETED	10	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Use of Skills Training to Augment Compensated Work Therapy (CWT)/VI for Veterans With SMI

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1: MPROVE n=47 Participants The Maryland Program for Vocational Effectiveness (MPROVE) Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)	Arm 2: Control n=41 Participants Supportive Treatment for SMI (control) Supportive Treatment for SMI: Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members.	Total n=88 Participants Total of all reporting groups
Age, Continuous	51.47 years STANDARD_DEVIATION 6.29 • n=5 Participants	51.51 years STANDARD_DEVIATION 6.07 • n=7 Participants	51.49 years STANDARD_DEVIATION 6.15 • n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants	34 Participants n=7 Participants	73 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Region of Enrollment United States	47 participants n=5 Participants	41 participants n=7 Participants	88 participants n=5 Participants

PRIMARY outcome

Timeframe: Post Treatment (approximately 3 months after completion of the baseline assessment)

Data collected included from participants: 1) hours scheduled to work per week and 2) weekly wages earned.

Outcome measures

Outcome measures
Measure	Arm 1: MPROVE n=37 Participants The Maryland Program for Vocational Effectiveness (MPROVE) Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)	Arm 2: Control n=31 Participants Supportive Treatment for SMI (control) Supportive Treatment for SMI: Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members.
Employment Status	26.2 Hours worked per week Standard Deviation 12.39	24.83 Hours worked per week Standard Deviation 9.43

PRIMARY outcome

Timeframe: Post Treatment

This measure is completed with participants' supervisors and assesses current work behavior and vocational function. The WBI yields six scores related to fundamental work requirements: social skills, cooperativeness, work habits, work quality personal presentation, and a general score of overall work performance. Each of these is rated between 1-5: 1. Consistently an area Needing Improvement 2. Occasionally an area Needing Improvement 3. Performance Adequate in this area 4. Occasionally an area of Superior Performance 5. Consistently an area of Superior Performance. The global impression of work behavior (overall rating of work functioning using the same 1-5 scale) was used for the purpose of reporting results for this study.

Outcome measures

Outcome measures
Measure	Arm 1: MPROVE n=37 Participants The Maryland Program for Vocational Effectiveness (MPROVE) Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)	Arm 2: Control n=31 Participants Supportive Treatment for SMI (control) Supportive Treatment for SMI: Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members.
Work Performance (Work Behavior Inventory)	2.37 rating on a scale Standard Deviation 0.76	2.37 rating on a scale Standard Deviation 0.74

PRIMARY outcome

Timeframe: Post Treatment

This was assessed using the Maryland Assessment of Social Competence (MASC), which assesses participants social problem solving skill abilities in both work-related and non-work related situations. Using three scenes, the participant is rated on the following scale for each scene. Overall score is then averaged to arrive at a final score. 1. Very Poor 2. Poor 3. Neither good nor poor 4. Somewhat good 5. Very good

Outcome measures

Outcome measures
Measure	Arm 1: MPROVE n=37 Participants The Maryland Program for Vocational Effectiveness (MPROVE) Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)	Arm 2: Control n=31 Participants Supportive Treatment for SMI (control) Supportive Treatment for SMI: Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members.
Social Functioning	3.69 units on a scale Standard Deviation 1.2	3.56 units on a scale Standard Deviation 1.31

PRIMARY outcome

Timeframe: Post Treatment (approximately 3 months after completion of the baseline assessment)

Data collected included from participants: weekly wages earned

Outcome measures

Outcome measures
Measure	Arm 1: MPROVE n=37 Participants The Maryland Program for Vocational Effectiveness (MPROVE) Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)	Arm 2: Control n=31 Participants Supportive Treatment for SMI (control) Supportive Treatment for SMI: Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members.
Employment Status	143.08 dollars/week Standard Deviation 186.76	72.07 dollars/week Standard Deviation 79.81

SECONDARY outcome

Timeframe: Post Treatment

Cognitive insight was assessed using the Beck Cognitive Insight Scale, a 15-item questionnaire developed to evaluate patients' self-reflectiveness and their overconfidence in their interpretations of their experiences. Participant responses to each of these items were as follows: 1. Do not agree at all 2. Agree slightly 3. Agree a lot 4. Agree completely Total score for the self-certainty scale could range from 6 to 24. Total score for the self-reflectiveness scale could range from 9 to 36. Total score for the composite score was calculated by subtracting the summed score for the self-certainty scale from the summed score of the self-reflectiveness scale and could range from 3 to 12, lower composite scores are an indicator of lower psychiatric functioning.

Outcome measures

Outcome measures
Measure	Arm 1: MPROVE n=37 Participants The Maryland Program for Vocational Effectiveness (MPROVE) Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)	Arm 2: Control n=31 Participants Supportive Treatment for SMI (control) Supportive Treatment for SMI: Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members.
Cognitive Insight	9.56 units on a scale Standard Deviation 5.32	7.29 units on a scale Standard Deviation 5.79

SECONDARY outcome

Timeframe: Post-Treatment

Psychiatric Symptoms were assessed using the Brief Psychiatric Rating Scale (BPRS), a widely used instrument for assessing the positive, negative, and affective symptoms of individuals who have mental illnesses. The BPRS consists of 20 symptom constructs scored from 1 (not present) to 7 (extremely severe). BPRS total score could range from 0 (not present) to 140 (extremely severe).

Outcome measures

Outcome measures
Measure	Arm 1: MPROVE n=47 Participants The Maryland Program for Vocational Effectiveness (MPROVE) Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)	Arm 2: Control n=41 Participants Supportive Treatment for SMI (control) Supportive Treatment for SMI: Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members.
Psychiatric Symptoms	36.25 scores on a scale Standard Deviation 8.69	38.71 scores on a scale Standard Deviation 10.63

Adverse Events

Arm 1: MPROVE

Serious events: 13 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2: Control

Serious events: 9 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm 1: MPROVE n=47 participants at risk The Maryland Program for Vocational Effectiveness (MPROVE) Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)	Arm 2: Control n=41 participants at risk Supportive Treatment for SMI (control) Supportive Treatment for SMI: Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members.
General disorders Medical Hospitalization	14.9% 7/47 • Duration of participants involvement in the study, which was approximately 12 months.	4.9% 2/41 • Duration of participants involvement in the study, which was approximately 12 months.
Psychiatric disorders Psychiatric Hospitalization	12.8% 6/47 • Duration of participants involvement in the study, which was approximately 12 months.	17.1% 7/41 • Duration of participants involvement in the study, which was approximately 12 months.

Other adverse events

Adverse event data not reported

Additional Information

Wendy Tenhula, Ph.D.

VA Central Office

Phone: 202-461-4167

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place