Trial Outcomes & Findings for 1/2 A Multi-site Systems Intervention for Unemployed Persons With Social Anxiety (NCT NCT02633267)

Last Updated: 2022-09-21

Results Overview

Measure of social anxiety and avoidance. This first set of questions asks how anxious or fearful an individual feels in the situation. Ratings range from 0-3(0=none, 1=mild, 2=moderate, 3=severe). The second set of questions asks how often an individual would avoid the situation. Ratings range from 0-3(0=never, 1=occasionally, 2=often, 3=usually). Sums of each subscale(fear/anxiety and avoidance) are added together to create the total score. The severity scale for this measure is 0-54=subclinical, 55-64=moderate, 65-79=marked, 80-94=severe, 95-144(maximum score)=very severe.

Recruitment status

COMPLETED

Study phase

Target enrollment

250 participants

Primary outcome timeframe

Mean scores across all timepoints: baseline, post treatment, 3 month, 6 month and 12 month follow up.

Results posted on

2022-09-21

Participant Flow

Participant milestones

Participant milestones
Measure	Usual Vocational Services + CBT This is the experimental intervention - Usual vocational services at a vocational services center plus additional cognitive behavioral therapy at vocational service center. Vocational Services as usual plus Cognitive Behavioral Therapy (CBT): Teaches thought restructuring and exposure therapy to socially anxious job seekers delivered by vocational service professionals Usual Vocational Services: Vocational services delivered by vocational professionals at vocational service center (e.g., resume assistance, job leads)	Usual Vocational Services This is the care as usual intervention - Vocational services as usually delivered to service seeking clients Usual Vocational Services: Vocational services delivered by vocational professionals at vocational service center (e.g., resume assistance, job leads)
Overall Study STARTED	120	130
Overall Study COMPLETED	89	91
Overall Study NOT COMPLETED	31	39

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

1/2 A Multi-site Systems Intervention for Unemployed Persons With Social Anxiety

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Usual Vocational Services + CBT n=120 Participants This is the experimental intervention - Usual vocational services at a vocational services center plus additional cognitive behavioral therapy at vocational service center. Vocational Services as usual plus Cognitive Behavioral Therapy (CBT): Teaches thought restructuring and exposure therapy to socially anxious job seekers delivered by vocational service professionals Usual Vocational Services: Vocational services delivered by vocational professionals at vocational service center (e.g., resume assistance, job leads)	Usual Vocational Services n=130 Participants This is the care as usual intervention - Vocational services as usually delivered to service seeking clients Usual Vocational Services: Vocational services delivered by vocational professionals at vocational service center (e.g., resume assistance, job leads)	Total n=250 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
Age, Categorical Between 18 and 65 years	120 Participants n=5 Participants	130 Participants n=7 Participants	250 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	46.25 years STANDARD_DEVIATION 10.84 • n=5 Participants	43 years STANDARD_DEVIATION 10.99 • n=7 Participants	44.63 years STANDARD_DEVIATION 10.92 • n=5 Participants
Sex/Gender, Customized Sex/Gender, Customized · Female	73 Participants n=5 Participants	75 Participants n=7 Participants	148 Participants n=5 Participants
Sex/Gender, Customized Sex/Gender, Customized · Male	44 Participants n=5 Participants	54 Participants n=7 Participants	98 Participants n=5 Participants
Sex/Gender, Customized Sex/Gender, Customized · Identify in another way	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Asian American	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	47 Participants n=5 Participants	55 Participants n=7 Participants	102 Participants n=5 Participants
Race/Ethnicity, Customized White	38 Participants n=5 Participants	51 Participants n=7 Participants	89 Participants n=5 Participants
Race/Ethnicity, Customized More than one race	16 Participants n=5 Participants	7 Participants n=7 Participants	23 Participants n=5 Participants
Race/Ethnicity, Customized I identify in another way	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Race/Ethnicity, Customized Unknown or not reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	120 participants n=5 Participants	130 participants n=7 Participants	250 participants n=5 Participants

PRIMARY outcome

Timeframe: Mean scores across all timepoints: baseline, post treatment, 3 month, 6 month and 12 month follow up.

Outcome measures

Outcome measures
Measure	Usual Vocational Services + CBT n=120 Participants This is the experimental intervention - Usual vocational services at a vocational services center plus additional cognitive behavioral therapy at vocational service center. Vocational Services as usual plus Cognitive Behavioral Therapy (CBT): Teaches thought restructuring and exposure therapy to socially anxious job seekers delivered by vocational service professionals Usual Vocational Services: Vocational services delivered by vocational professionals at vocational service center (e.g., resume assistance, job leads)	Usual Vocational Services n=130 Participants This is the care as usual intervention - Vocational services as usually delivered to service seeking clients Usual Vocational Services: Vocational services delivered by vocational professionals at vocational service center (e.g., resume assistance, job leads)
Liebowitz Social Anxiety Scale Baseline	81.05 score on a scale Standard Deviation 2.47	82.74 score on a scale Standard Deviation 2.34
Liebowitz Social Anxiety Scale Post	64.11 score on a scale Standard Deviation 3.24	73.05 score on a scale Standard Deviation 3.02
Liebowitz Social Anxiety Scale 3 months	57.78 score on a scale Standard Deviation 3.94	65.82 score on a scale Standard Deviation 3.85
Liebowitz Social Anxiety Scale 6 months	50.13 score on a scale Standard Deviation 3.79	58.77 score on a scale Standard Deviation 3.65
Liebowitz Social Anxiety Scale 12 months	40.97 score on a scale Standard Deviation 3.74	46.58 score on a scale Standard Deviation 3.78

SECONDARY outcome

Timeframe: Mean scores across all timepoints(baseline, post treatment, 3 month, 6 month and 12 month follow up).

Rating scale for depression. Participants are asked how often they have been bothered by specific symptoms within the last two weeks. They are asked about 8 different symptoms on a rating scale from 0-3(0=not at all, 1=several days, 2=more than half the days, 3=nearly everyday). Participants are asked how difficult problems made for them "do work, take care of things at home, and get along with others." This item is rated from 0-3(0=not difficult at all, 1=somewhat difficult, 2=very difficult, 3=extremely difficult). The final score is the total of all eight responses. Ranges include 0-4= minimal depression, 5-9=mild depression, 10-14 moderate depression, 15-19 moderately severe depression, 20-24\*=severe depression. Note: The study switched from using the PHQ-9 to the PHQ-8 midway throughout.

Outcome measures

Outcome measures
Measure	Usual Vocational Services + CBT n=120 Participants This is the experimental intervention - Usual vocational services at a vocational services center plus additional cognitive behavioral therapy at vocational service center. Vocational Services as usual plus Cognitive Behavioral Therapy (CBT): Teaches thought restructuring and exposure therapy to socially anxious job seekers delivered by vocational service professionals Usual Vocational Services: Vocational services delivered by vocational professionals at vocational service center (e.g., resume assistance, job leads)	Usual Vocational Services n=130 Participants This is the care as usual intervention - Vocational services as usually delivered to service seeking clients Usual Vocational Services: Vocational services delivered by vocational professionals at vocational service center (e.g., resume assistance, job leads)
Patient Health Questionnaire Baseline	10.99 score on a scale Standard Deviation 6.27	11.52 score on a scale Standard Deviation 7.01
Patient Health Questionnaire Post treatment	7.79 score on a scale Standard Deviation 6.07	9.26 score on a scale Standard Deviation 6.72
Patient Health Questionnaire 3 month follow up	7.70 score on a scale Standard Deviation 6.97	8.17 score on a scale Standard Deviation 6.61
Patient Health Questionnaire 6 month follow up	7.15 score on a scale Standard Deviation 6.25	7.44 score on a scale Standard Deviation 6.75
Patient Health Questionnaire 12 month follow up	6.78 score on a scale Standard Deviation 6.13	6.30 score on a scale Standard Deviation 6.06

SECONDARY outcome

Timeframe: Mean scores across all timepoints(3 month, 6 month and 12 month follow up), to show change across time.

How many hours per week worked during follow up period. Participants were asked to report weekly work hours starting at 3 month follow up.

Outcome measures

Outcome measures
Measure	Usual Vocational Services + CBT n=120 Participants This is the experimental intervention - Usual vocational services at a vocational services center plus additional cognitive behavioral therapy at vocational service center. Vocational Services as usual plus Cognitive Behavioral Therapy (CBT): Teaches thought restructuring and exposure therapy to socially anxious job seekers delivered by vocational service professionals Usual Vocational Services: Vocational services delivered by vocational professionals at vocational service center (e.g., resume assistance, job leads)	Usual Vocational Services n=130 Participants This is the care as usual intervention - Vocational services as usually delivered to service seeking clients Usual Vocational Services: Vocational services delivered by vocational professionals at vocational service center (e.g., resume assistance, job leads)
Hours Worked Per Week 3 month follow up	14.2 hours per week Standard Deviation 1.5	15.39 hours per week Standard Deviation 1.37
Hours Worked Per Week 6 month follow up	16.57 hours per week Standard Deviation 1.67	17.94 hours per week Standard Deviation 1.46
Hours Worked Per Week 12 month follow up	18.92 hours per week Standard Deviation 1.98	20.44 hours per week Standard Deviation 1.74

Adverse Events

Usual Vocational Services + CBT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Vocational Services

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Joseph Himle

University of Michigan

Phone: (734) 615-0611

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place