Trial Outcomes & Findings for Multisite RCT of STEP-Home: A Transdiagnostic Skill-based Community Reintegration Workshop (NCT NCT03868930)
NCT ID: NCT03868930
Last Updated: 2025-10-30
Results Overview
A 16-item measure of post-deployment community reintegration in post-9/11 Veterans. Higher scores indicate greater reintegration and functional difficulties. Min: 0, Max: 64
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
221 participants
Primary outcome timeframe
Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
Results posted on
2025-10-30
Participant Flow
Participants were recruited from VA clinical services, community partners (e.g., schools, Vet Centers, Veteran organizations), advertisements on social media (e.g., Facebook, Instagram), and the Veterans Affairs/Department of Defense Identity Repository.
195 (138M/57F) post-9/11 U.S. military Veterans were randomized to either 12 sessions of SH or PCGT. Assessments were conducted at baseline, 12 and 24 weeks. Analyses were based on intention to treat.
Participant milestones
| Measure |
STEP-Home
The STEP-Home Arm involves a skills-based intervention focused on Emotional Regulation, Problem Solving, and Attention Training strategies.
STEP-Home: This group will meet for 2 hours a week for 12 weeks. The core skills of Emotional Regulation (ER) (45-minutes) and Problem Solving (PS) (45-minutes) are introduced and then integrated throughout all Veteran-specific content modules for practice and repetition for 12 weeks. Attention Training (AT) augments PS and ER core skills and is interspersed throughout group and individual sessions.
|
PCGT
The Present Center Group Therapy (PCGT) Arm involves a nonspecific, supportive intervention, focused on identifying and discussing current life stressors.
PCGT: The PCGT group will also meet for 2 hours a week for 12 weeks. It is a nonspecific and supportive intervention to control for the nonspecific benefits of the group experience (e.g., therapist contact, instillation of hope, expectation of improvement). It will focus on identifying and discussing current life stressors that contribute to reintegration difficulties, psychoeducation, and promotion of wellness and physical health.
|
|---|---|---|
|
Intervention & Post-Treatment Assessment
STARTED
|
100
|
95
|
|
Intervention & Post-Treatment Assessment
COMPLETED
|
53
|
57
|
|
Intervention & Post-Treatment Assessment
NOT COMPLETED
|
47
|
38
|
|
Follow-Up Assessment
STARTED
|
53
|
57
|
|
Follow-Up Assessment
COMPLETED
|
44
|
45
|
|
Follow-Up Assessment
NOT COMPLETED
|
9
|
12
|
Reasons for withdrawal
| Measure |
STEP-Home
The STEP-Home Arm involves a skills-based intervention focused on Emotional Regulation, Problem Solving, and Attention Training strategies.
STEP-Home: This group will meet for 2 hours a week for 12 weeks. The core skills of Emotional Regulation (ER) (45-minutes) and Problem Solving (PS) (45-minutes) are introduced and then integrated throughout all Veteran-specific content modules for practice and repetition for 12 weeks. Attention Training (AT) augments PS and ER core skills and is interspersed throughout group and individual sessions.
|
PCGT
The Present Center Group Therapy (PCGT) Arm involves a nonspecific, supportive intervention, focused on identifying and discussing current life stressors.
PCGT: The PCGT group will also meet for 2 hours a week for 12 weeks. It is a nonspecific and supportive intervention to control for the nonspecific benefits of the group experience (e.g., therapist contact, instillation of hope, expectation of improvement). It will focus on identifying and discussing current life stressors that contribute to reintegration difficulties, psychoeducation, and promotion of wellness and physical health.
|
|---|---|---|
|
Intervention & Post-Treatment Assessment
Lost to Follow-up
|
3
|
1
|
|
Intervention & Post-Treatment Assessment
Physician Decision
|
1
|
4
|
|
Intervention & Post-Treatment Assessment
Did not start treatment
|
18
|
16
|
|
Intervention & Post-Treatment Assessment
Withdrawal by Subject
|
25
|
17
|
|
Follow-Up Assessment
Lost to Follow-up
|
9
|
12
|
Baseline Characteristics
Participants with available baseline data.
Baseline characteristics by cohort
| Measure |
STEP-Home
n=93 Participants
The STEP-Home Arm involves a skills-based intervention focused on Emotional Regulation, Problem Solving, and Attention Training strategies.
STEP-Home: This group will meet for 2 hours a week for 12 weeks. The core skills of Emotional Regulation (ER) (45-minutes) and Problem Solving (PS) (45-minutes) are introduced and then integrated throughout all Veteran-specific content modules for practice and repetition for 12 weeks. Attention Training (AT) augments PS and ER core skills and is interspersed throughout group and individual sessions.
|
PCGT
n=91 Participants
The Present Center Group Therapy (PCGT) Arm involves a nonspecific, supportive intervention, focused on identifying and discussing current life stressors.
PCGT: The PCGT group will also meet for 2 hours a week for 12 weeks. It is a nonspecific and supportive intervention to control for the nonspecific benefits of the group experience (e.g., therapist contact, instillation of hope, expectation of improvement). It will focus on identifying and discussing current life stressors that contribute to reintegration difficulties, psychoeducation, and promotion of wellness and physical health.
|
Total
n=184 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Branch of Service
Navy
|
10 Participants
n=5 Participants • Participants with available baseline data.
|
12 Participants
n=7 Participants • Participants with available baseline data.
|
22 Participants
n=5 Participants • Participants with available baseline data.
|
|
Branch of Service
Air Force
|
5 Participants
n=5 Participants • Participants with available baseline data.
|
9 Participants
n=7 Participants • Participants with available baseline data.
|
14 Participants
n=5 Participants • Participants with available baseline data.
|
|
Branch of Service
Marines
|
11 Participants
n=5 Participants • Participants with available baseline data.
|
10 Participants
n=7 Participants • Participants with available baseline data.
|
21 Participants
n=5 Participants • Participants with available baseline data.
|
|
Branch of Service
Coast Guard
|
3 Participants
n=5 Participants • Participants with available baseline data.
|
0 Participants
n=7 Participants • Participants with available baseline data.
|
3 Participants
n=5 Participants • Participants with available baseline data.
|
|
Age, Continuous
|
38.2 Years
STANDARD_DEVIATION 10.3 • n=5 Participants • Participants with available baseline data
|
39.8 Years
STANDARD_DEVIATION 10.5 • n=7 Participants • Participants with available baseline data
|
39.1 Years
STANDARD_DEVIATION 10.4 • n=5 Participants • Participants with available baseline data
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
62 Participants
n=5 Participants • Categories are not mutually exclusive.
|
60 Participants
n=7 Participants • Categories are not mutually exclusive.
|
122 Participants
n=5 Participants • Categories are not mutually exclusive.
|
|
Race/Ethnicity, Customized
Black
|
19 Participants
n=5 Participants • Categories are not mutually exclusive.
|
21 Participants
n=7 Participants • Categories are not mutually exclusive.
|
40 Participants
n=5 Participants • Categories are not mutually exclusive.
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants • Categories are not mutually exclusive.
|
1 Participants
n=7 Participants • Categories are not mutually exclusive.
|
3 Participants
n=5 Participants • Categories are not mutually exclusive.
|
|
Race/Ethnicity, Customized
American Indian/Alaskan Native
|
4 Participants
n=5 Participants • Categories are not mutually exclusive.
|
4 Participants
n=7 Participants • Categories are not mutually exclusive.
|
8 Participants
n=5 Participants • Categories are not mutually exclusive.
|
|
Race/Ethnicity, Customized
Other
|
15 Participants
n=5 Participants • Categories are not mutually exclusive.
|
7 Participants
n=7 Participants • Categories are not mutually exclusive.
|
22 Participants
n=5 Participants • Categories are not mutually exclusive.
|
|
Race/Ethnicity, Customized
Hispanic
|
23 Participants
n=5 Participants • Categories are not mutually exclusive.
|
22 Participants
n=7 Participants • Categories are not mutually exclusive.
|
45 Participants
n=5 Participants • Categories are not mutually exclusive.
|
|
Branch of Service
Army
|
55 Participants
n=5 Participants • Participants with available baseline data.
|
43 Participants
n=7 Participants • Participants with available baseline data.
|
98 Participants
n=5 Participants • Participants with available baseline data.
|
|
Branch of Service
Missing Data
|
6 Participants
n=5 Participants • Participants with available baseline data.
|
9 Participants
n=7 Participants • Participants with available baseline data.
|
15 Participants
n=5 Participants • Participants with available baseline data.
|
|
Branch of Service
Multiple Branches
|
3 Participants
n=5 Participants • Participants with available baseline data.
|
8 Participants
n=7 Participants • Participants with available baseline data.
|
11 Participants
n=5 Participants • Participants with available baseline data.
|
PRIMARY outcome
Timeframe: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)Population: Number of participants analyzed indicates number of enrolled participants that completed survey questions at each time point
A 16-item measure of post-deployment community reintegration in post-9/11 Veterans. Higher scores indicate greater reintegration and functional difficulties. Min: 0, Max: 64
Outcome measures
| Measure |
STEP-Home
n=93 Participants
The STEP-Home Arm involves a skills-based intervention focused on Emotional Regulation, Problem Solving, and Attention Training strategies.
STEP-Home: This group will meet for 2 hours a week for 12 weeks. The core skills of Emotional Regulation (ER) (45-minutes) and Problem Solving (PS) (45-minutes) are introduced and then integrated throughout all Veteran-specific content modules for practice and repetition for 12 weeks. Attention Training (AT) augments PS and ER core skills and is interspersed throughout group and individual sessions.
|
PCGT
n=83 Participants
The Present Center Group Therapy (PCGT) Arm involves a nonspecific, supportive intervention, focused on identifying and discussing current life stressors.
PCGT: The PCGT group will also meet for 2 hours a week for 12 weeks. It is a nonspecific and supportive intervention to control for the nonspecific benefits of the group experience (e.g., therapist contact, instillation of hope, expectation of improvement). It will focus on identifying and discussing current life stressors that contribute to reintegration difficulties, psychoeducation, and promotion of wellness and physical health.
|
|---|---|---|
|
Military to Civilian Questionnaire
Baseline
|
33.8 score on a scale
Standard Deviation 13.2
|
34.7 score on a scale
Standard Deviation 11.5
|
|
Military to Civilian Questionnaire
Post-Intervention
|
25.5 score on a scale
Standard Deviation 15.3
|
27.1 score on a scale
Standard Deviation 11.2
|
|
Military to Civilian Questionnaire
Follow-Up
|
24.4 score on a scale
Standard Deviation 15.5
|
27.7 score on a scale
Standard Deviation 11
|
PRIMARY outcome
Timeframe: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)Population: Number of participants analyzed indicates number of enrolled participants that completed survey questions at each time point
A 36-item measure of readjustment in post-9/11 Veterans with six subscales (career challenges, social difficulties, intimate relationship problems, health concerns, concerns about deployment, and PTSD symptoms). Min and max scores for all the subscales, and the total score, are below. For all, lower scores are better. Total score is calculated by adding the value of all items in all subscales. Career: Min: 5, Max: 25 Health: Min: 5, Max: 25 Intimate Relationship: Min: 5, Max: 25 Social readjustment: Min: 7, Max: 35 Concerns about deployment: Min: 6, Max: 30 PTSD symptoms: Min: 8, Max: 40 TOTAL score: Min: 36, Max: 180
Outcome measures
| Measure |
STEP-Home
n=91 Participants
The STEP-Home Arm involves a skills-based intervention focused on Emotional Regulation, Problem Solving, and Attention Training strategies.
STEP-Home: This group will meet for 2 hours a week for 12 weeks. The core skills of Emotional Regulation (ER) (45-minutes) and Problem Solving (PS) (45-minutes) are introduced and then integrated throughout all Veteran-specific content modules for practice and repetition for 12 weeks. Attention Training (AT) augments PS and ER core skills and is interspersed throughout group and individual sessions.
|
PCGT
n=83 Participants
The Present Center Group Therapy (PCGT) Arm involves a nonspecific, supportive intervention, focused on identifying and discussing current life stressors.
PCGT: The PCGT group will also meet for 2 hours a week for 12 weeks. It is a nonspecific and supportive intervention to control for the nonspecific benefits of the group experience (e.g., therapist contact, instillation of hope, expectation of improvement). It will focus on identifying and discussing current life stressors that contribute to reintegration difficulties, psychoeducation, and promotion of wellness and physical health.
|
|---|---|---|
|
Post-deployment Readjustment Inventory (Change)
Baseline Health Concerns
|
17.0 score on a scale
Standard Deviation 5.7
|
18.0 score on a scale
Standard Deviation 4.7
|
|
Post-deployment Readjustment Inventory (Change)
Post-Treatment Intimate Relationship Problems
|
14.2 score on a scale
Standard Deviation 5.6
|
14.8 score on a scale
Standard Deviation 4.6
|
|
Post-deployment Readjustment Inventory (Change)
Baseline Total Score
|
117.1 score on a scale
Standard Deviation 32.6
|
121.0 score on a scale
Standard Deviation 26.9
|
|
Post-deployment Readjustment Inventory (Change)
Post-Treatment Total Score
|
107.8 score on a scale
Standard Deviation 35.8
|
116.2 score on a scale
Standard Deviation 27.4
|
|
Post-deployment Readjustment Inventory (Change)
Follow-Up Total Score
|
100.0 score on a scale
Standard Deviation 37.9
|
111.1 score on a scale
Standard Deviation 27.5
|
|
Post-deployment Readjustment Inventory (Change)
Baseline Career Challenges
|
15.5 score on a scale
Standard Deviation 5.7
|
16.6 score on a scale
Standard Deviation 4.5
|
|
Post-deployment Readjustment Inventory (Change)
Post-Treatment Career Challenges
|
13.9 score on a scale
Standard Deviation 5.2
|
15.5 score on a scale
Standard Deviation 4.7
|
|
Post-deployment Readjustment Inventory (Change)
Follow-Up Career Challenges
|
12.8 score on a scale
Standard Deviation 5.8
|
14.8 score on a scale
Standard Deviation 4.4
|
|
Post-deployment Readjustment Inventory (Change)
Post-Treatment Health Concerns
|
15.7 score on a scale
Standard Deviation 5.6
|
17.3 score on a scale
Standard Deviation 4.9
|
|
Post-deployment Readjustment Inventory (Change)
Follow-Up Health Concerns
|
14.4 score on a scale
Standard Deviation 5.7
|
17.4 score on a scale
Standard Deviation 5.0
|
|
Post-deployment Readjustment Inventory (Change)
Baseline Intimate Relationship Problems
|
15.3 score on a scale
Standard Deviation 5.6
|
16.0 score on a scale
Standard Deviation 5.1
|
|
Post-deployment Readjustment Inventory (Change)
Follow-Up Intimate Relationship Problems
|
13.3 score on a scale
Standard Deviation 5.6
|
13.8 score on a scale
Standard Deviation 4.5
|
|
Post-deployment Readjustment Inventory (Change)
Baseline Social Readjustment
|
23.5 score on a scale
Standard Deviation 7.3
|
24.5 score on a scale
Standard Deviation 5.9
|
|
Post-deployment Readjustment Inventory (Change)
Post-Treatment Social Readjustment
|
22.0 score on a scale
Standard Deviation 7.5
|
23.8 score on a scale
Standard Deviation 5.9
|
|
Post-deployment Readjustment Inventory (Change)
Follow-Up Social Readjustment
|
20.8 score on a scale
Standard Deviation 8.1
|
21.8 score on a scale
Standard Deviation 6.0
|
|
Post-deployment Readjustment Inventory (Change)
Baseline Concerns About Deployment
|
16.8 score on a scale
Standard Deviation 6.2
|
17.5 score on a scale
Standard Deviation 5.8
|
|
Post-deployment Readjustment Inventory (Change)
Post-Treatment Concerns About Deployment
|
15.8 score on a scale
Standard Deviation 6.4
|
16.6 score on a scale
Standard Deviation 5.3
|
|
Post-deployment Readjustment Inventory (Change)
Follow-Up Concerns About Deployment
|
14.5 score on a scale
Standard Deviation 6.2
|
15.6 score on a scale
Standard Deviation 5.5
|
|
Post-deployment Readjustment Inventory (Change)
Baseline PTSD Symptoms
|
28.3 score on a scale
Standard Deviation 8.3
|
30.0 score on a scale
Standard Deviation 6.6
|
|
Post-deployment Readjustment Inventory (Change)
Post-Treatment PTSD Symptoms
|
26.2 score on a scale
Standard Deviation 9.0
|
28.1 score on a scale
Standard Deviation 6.5
|
|
Post-deployment Readjustment Inventory (Change)
Follow-Up PTSD Symptoms
|
24.3 score on a scale
Standard Deviation 9.4
|
27.7 score on a scale
Standard Deviation 6.8
|
PRIMARY outcome
Timeframe: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)Population: Number of participants analyzed indicates number of enrolled participants that completed survey questions at each time point
A 57-item widely used measure to assess state anger, trait anger, and anger expression with three subscales (state anger, trait anger, and anger expression). Min and max scores for the subscales, and the total score, are below. For all, lower scores are better. How I Feel Right Now (State Anger): Min: 10, Max: 40, Calculated by summing 15 items in scale How I Generally Feel (Trait Anger): Min: 10, Max: 40, Calculated by summing 15 items in scale When Angry or Furious (Anger expression index): Min: 24, Max: 96, Calculated by summing anger control scores for each item (12 items) and subtracting that from sum of anger expression scores for each item (12 items)
Outcome measures
| Measure |
STEP-Home
n=90 Participants
The STEP-Home Arm involves a skills-based intervention focused on Emotional Regulation, Problem Solving, and Attention Training strategies.
STEP-Home: This group will meet for 2 hours a week for 12 weeks. The core skills of Emotional Regulation (ER) (45-minutes) and Problem Solving (PS) (45-minutes) are introduced and then integrated throughout all Veteran-specific content modules for practice and repetition for 12 weeks. Attention Training (AT) augments PS and ER core skills and is interspersed throughout group and individual sessions.
|
PCGT
n=83 Participants
The Present Center Group Therapy (PCGT) Arm involves a nonspecific, supportive intervention, focused on identifying and discussing current life stressors.
PCGT: The PCGT group will also meet for 2 hours a week for 12 weeks. It is a nonspecific and supportive intervention to control for the nonspecific benefits of the group experience (e.g., therapist contact, instillation of hope, expectation of improvement). It will focus on identifying and discussing current life stressors that contribute to reintegration difficulties, psychoeducation, and promotion of wellness and physical health.
|
|---|---|---|
|
State-Trait Anger Expression Inventory (STAXI-2) (Change)
Baseline State Anger
|
25.8 score on a scale
Standard Deviation 11.2
|
26.2 score on a scale
Standard Deviation 9.2
|
|
State-Trait Anger Expression Inventory (STAXI-2) (Change)
Baseline Trait Anger
|
21.9 score on a scale
Standard Deviation 6.7
|
21.6 score on a scale
Standard Deviation 6.2
|
|
State-Trait Anger Expression Inventory (STAXI-2) (Change)
Baseline Anger Index
|
43.1 score on a scale
Standard Deviation 14.4
|
42.0 score on a scale
Standard Deviation 12.9
|
|
State-Trait Anger Expression Inventory (STAXI-2) (Change)
Post-Treatment State Anger
|
22.8 score on a scale
Standard Deviation 9.0
|
21.4 score on a scale
Standard Deviation 7.3
|
|
State-Trait Anger Expression Inventory (STAXI-2) (Change)
Post-Treatment Trait Anger
|
19.9 score on a scale
Standard Deviation 7.1
|
20.6 score on a scale
Standard Deviation 7.0
|
|
State-Trait Anger Expression Inventory (STAXI-2) (Change)
Post-Treatment Anger Index
|
40.2 score on a scale
Standard Deviation 13.0
|
41.9 score on a scale
Standard Deviation 14.7
|
|
State-Trait Anger Expression Inventory (STAXI-2) (Change)
Follow-Up State Anger
|
21.7 score on a scale
Standard Deviation 10.0
|
21.9 score on a scale
Standard Deviation 7.3
|
|
State-Trait Anger Expression Inventory (STAXI-2) (Change)
Follow-Up Trait Anger
|
19.3 score on a scale
Standard Deviation 6.1
|
18.5 score on a scale
Standard Deviation 6.7
|
|
State-Trait Anger Expression Inventory (STAXI-2) (Change)
Follow-Up Anger Index
|
37.7 score on a scale
Standard Deviation 12.9
|
39.2 score on a scale
Standard Deviation 14.5
|
SECONDARY outcome
Timeframe: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)Population: Number of participants analyzed indicates number of enrolled participants that completed survey questions at each time point
Measure of everyday performance failures arising from brief failures of sustained attention. Min: 12, Max: 60 (lower scores are better)
Outcome measures
| Measure |
STEP-Home
n=55 Participants
The STEP-Home Arm involves a skills-based intervention focused on Emotional Regulation, Problem Solving, and Attention Training strategies.
STEP-Home: This group will meet for 2 hours a week for 12 weeks. The core skills of Emotional Regulation (ER) (45-minutes) and Problem Solving (PS) (45-minutes) are introduced and then integrated throughout all Veteran-specific content modules for practice and repetition for 12 weeks. Attention Training (AT) augments PS and ER core skills and is interspersed throughout group and individual sessions.
|
PCGT
n=56 Participants
The Present Center Group Therapy (PCGT) Arm involves a nonspecific, supportive intervention, focused on identifying and discussing current life stressors.
PCGT: The PCGT group will also meet for 2 hours a week for 12 weeks. It is a nonspecific and supportive intervention to control for the nonspecific benefits of the group experience (e.g., therapist contact, instillation of hope, expectation of improvement). It will focus on identifying and discussing current life stressors that contribute to reintegration difficulties, psychoeducation, and promotion of wellness and physical health.
|
|---|---|---|
|
Attention-Related Cognitive Errors Scale (ARCES) (Change)
Baseline
|
41.9 score on a scale
Standard Deviation 12.4
|
42.7 score on a scale
Standard Deviation 9.9
|
|
Attention-Related Cognitive Errors Scale (ARCES) (Change)
Post-Treatment
|
38.2 score on a scale
Standard Deviation 12.7
|
39.6 score on a scale
Standard Deviation 12.9
|
|
Attention-Related Cognitive Errors Scale (ARCES) (Change)
Follow-Up
|
37.7 score on a scale
Standard Deviation 14.1
|
39.0 score on a scale
Standard Deviation 11.7
|
SECONDARY outcome
Timeframe: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)Population: Number of participants analyzed indicates number of enrolled participants that completed survey questions at each time point
Measure of problem solving confidence, approach-avoidance style, and personal control. Min and max scores for all the subscales, and the total score, are below. For all, lower scores are better. Total score calculated by adding the scores of all items. Problem-Solving Confidence: Min: 11, Max: 66 Approach-Avoidance Style: Min: 16, Max: 96 Personal Control: Min: 5, Max: 30 TOTAL score: Min: 32, Max: 192
Outcome measures
| Measure |
STEP-Home
n=55 Participants
The STEP-Home Arm involves a skills-based intervention focused on Emotional Regulation, Problem Solving, and Attention Training strategies.
STEP-Home: This group will meet for 2 hours a week for 12 weeks. The core skills of Emotional Regulation (ER) (45-minutes) and Problem Solving (PS) (45-minutes) are introduced and then integrated throughout all Veteran-specific content modules for practice and repetition for 12 weeks. Attention Training (AT) augments PS and ER core skills and is interspersed throughout group and individual sessions.
|
PCGT
n=56 Participants
The Present Center Group Therapy (PCGT) Arm involves a nonspecific, supportive intervention, focused on identifying and discussing current life stressors.
PCGT: The PCGT group will also meet for 2 hours a week for 12 weeks. It is a nonspecific and supportive intervention to control for the nonspecific benefits of the group experience (e.g., therapist contact, instillation of hope, expectation of improvement). It will focus on identifying and discussing current life stressors that contribute to reintegration difficulties, psychoeducation, and promotion of wellness and physical health.
|
|---|---|---|
|
Problem Solving Inventory (PSI) (Change)
Post-Treatment Personal Control
|
18.4 score on a scale
Standard Deviation 4.8
|
18.6 score on a scale
Standard Deviation 5.6
|
|
Problem Solving Inventory (PSI) (Change)
Baseline Total Score
|
100.6 score on a scale
Standard Deviation 21.9
|
102.6 score on a scale
Standard Deviation 21.7
|
|
Problem Solving Inventory (PSI) (Change)
Post-Treatment Total Score
|
93.1 score on a scale
Standard Deviation 22.0
|
94.1 score on a scale
Standard Deviation 26.7
|
|
Problem Solving Inventory (PSI) (Change)
Follow-Up Total Score
|
94.3 score on a scale
Standard Deviation 24.0
|
95.3 score on a scale
Standard Deviation 24.2
|
|
Problem Solving Inventory (PSI) (Change)
Baseline Problem Solving
|
31.7 score on a scale
Standard Deviation 8.5
|
31.5 score on a scale
Standard Deviation 9.1
|
|
Problem Solving Inventory (PSI) (Change)
Post-Treatment Problem Solving
|
27.3 score on a scale
Standard Deviation 9.0
|
31.5 score on a scale
Standard Deviation 9.1
|
|
Problem Solving Inventory (PSI) (Change)
Follow-Up Problem Solving
|
28.2 score on a scale
Standard Deviation 10.6
|
28.8 score on a scale
Standard Deviation 9.6
|
|
Problem Solving Inventory (PSI) (Change)
Baseline Approach Avoidance
|
49.4 score on a scale
Standard Deviation 13.4
|
51.8 score on a scale
Standard Deviation 13.3
|
|
Problem Solving Inventory (PSI) (Change)
Post-Treatment Approach Avoidance
|
47.4 score on a scale
Standard Deviation 11.2
|
47.6 score on a scale
Standard Deviation 15.5
|
|
Problem Solving Inventory (PSI) (Change)
Follow-Up Approach Avoidance
|
47.2 score on a scale
Standard Deviation 11.7
|
47.6 score on a scale
Standard Deviation 14.2
|
|
Problem Solving Inventory (PSI) (Change)
Baseline Personal Control
|
20.3 score on a scale
Standard Deviation 5.6
|
21.2 score on a scale
Standard Deviation 4.8
|
|
Problem Solving Inventory (PSI) (Change)
Follow-Up Personal Control
|
19.0 score on a scale
Standard Deviation 5.0
|
19.0 score on a scale
Standard Deviation 4.4
|
SECONDARY outcome
Timeframe: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)Population: Number of participants analyzed indicates number of enrolled participants that completed survey questions at each time point
Measure to assess multiple aspects of emotion dysregulation. Min and max scores for all the subscales, and the total score, are below. For all, lower scores are better. Nonacceptance of emotional responses: Min: 6, Max: 30 Difficulty engaging in goal-directed behavior: Min: 6, Max: 25 Impulse control difficulties: Min: 6, Max: 30 Lack of emotional awareness: Min: 6, Max: 30 Limited access to emotion regulation strategies: Min: 8, Max: 40 Lack of emotional clarity: Min: 5, Max: 25 TOTAL score: Min: 36, Max: 180, Total score calculated by adding the scores of all items (reverse scoring awareness items).
Outcome measures
| Measure |
STEP-Home
n=55 Participants
The STEP-Home Arm involves a skills-based intervention focused on Emotional Regulation, Problem Solving, and Attention Training strategies.
STEP-Home: This group will meet for 2 hours a week for 12 weeks. The core skills of Emotional Regulation (ER) (45-minutes) and Problem Solving (PS) (45-minutes) are introduced and then integrated throughout all Veteran-specific content modules for practice and repetition for 12 weeks. Attention Training (AT) augments PS and ER core skills and is interspersed throughout group and individual sessions.
|
PCGT
n=56 Participants
The Present Center Group Therapy (PCGT) Arm involves a nonspecific, supportive intervention, focused on identifying and discussing current life stressors.
PCGT: The PCGT group will also meet for 2 hours a week for 12 weeks. It is a nonspecific and supportive intervention to control for the nonspecific benefits of the group experience (e.g., therapist contact, instillation of hope, expectation of improvement). It will focus on identifying and discussing current life stressors that contribute to reintegration difficulties, psychoeducation, and promotion of wellness and physical health.
|
|---|---|---|
|
Difficulties in Emotion Regulation Scale (DERS) (Change)
Baseline Non-Acceptance
|
16.1 score on a scale
Standard Deviation 7.4
|
18.0 score on a scale
Standard Deviation 6.5
|
|
Difficulties in Emotion Regulation Scale (DERS) (Change)
Follow-Up Goals
|
14.7 score on a scale
Standard Deviation 6.1
|
15.9 score on a scale
Standard Deviation 5.2
|
|
Difficulties in Emotion Regulation Scale (DERS) (Change)
Post-Treatment Clarity
|
12.0 score on a scale
Standard Deviation 5.1
|
13.4 score on a scale
Standard Deviation 4.0
|
|
Difficulties in Emotion Regulation Scale (DERS) (Change)
Baseline Total Score
|
104.2 score on a scale
Standard Deviation 26.0
|
106.9 score on a scale
Standard Deviation 24.3
|
|
Difficulties in Emotion Regulation Scale (DERS) (Change)
Post-Treatment Total Score
|
90.8 score on a scale
Standard Deviation 26.1
|
97.6 score on a scale
Standard Deviation 25.8
|
|
Difficulties in Emotion Regulation Scale (DERS) (Change)
Follow-Up Total Score
|
89.2 score on a scale
Standard Deviation 30.0
|
94.0 score on a scale
Standard Deviation 26.4
|
|
Difficulties in Emotion Regulation Scale (DERS) (Change)
Post-Treatment Non-Acceptance
|
15.0 score on a scale
Standard Deviation 6.6
|
16.2 score on a scale
Standard Deviation 5.9
|
|
Difficulties in Emotion Regulation Scale (DERS) (Change)
Follow-Up Non-Acceptance
|
14.7 score on a scale
Standard Deviation 7.4
|
16.1 score on a scale
Standard Deviation 7.4
|
|
Difficulties in Emotion Regulation Scale (DERS) (Change)
Baseline Goals
|
17.4 score on a scale
Standard Deviation 4.9
|
17.7 score on a scale
Standard Deviation 5.4
|
|
Difficulties in Emotion Regulation Scale (DERS) (Change)
Post-Treatment Goals
|
15.5 score on a scale
Standard Deviation 5.6
|
16.6 score on a scale
Standard Deviation 5.6
|
|
Difficulties in Emotion Regulation Scale (DERS) (Change)
Baseline Impulse
|
15.3 score on a scale
Standard Deviation 5.1
|
15.0 score on a scale
Standard Deviation 6.3
|
|
Difficulties in Emotion Regulation Scale (DERS) (Change)
Post-Treatment Impulse
|
13.1 score on a scale
Standard Deviation 4.4
|
13.5 score on a scale
Standard Deviation 5.7
|
|
Difficulties in Emotion Regulation Scale (DERS) (Change)
Follow-Up Impulse
|
12.2 score on a scale
Standard Deviation 5.0
|
12.5 score on a scale
Standard Deviation 4.8
|
|
Difficulties in Emotion Regulation Scale (DERS) (Change)
Baseline Awareness
|
17.2 score on a scale
Standard Deviation 5.6
|
19.0 score on a scale
Standard Deviation 4.9
|
|
Difficulties in Emotion Regulation Scale (DERS) (Change)
Post-Treatment Awareness
|
16.2 score on a scale
Standard Deviation 5.8
|
17.8 score on a scale
Standard Deviation 5.7
|
|
Difficulties in Emotion Regulation Scale (DERS) (Change)
Follow-Up Awareness
|
16.5 score on a scale
Standard Deviation 6.5
|
17.4 score on a scale
Standard Deviation 5.6
|
|
Difficulties in Emotion Regulation Scale (DERS) (Change)
Baseline Strategies
|
23.3 score on a scale
Standard Deviation 8.4
|
22.6 score on a scale
Standard Deviation 7.4
|
|
Difficulties in Emotion Regulation Scale (DERS) (Change)
Post-Treatment Strategies
|
19.0 score on a scale
Standard Deviation 8.0
|
20.2 score on a scale
Standard Deviation 7.4
|
|
Difficulties in Emotion Regulation Scale (DERS) (Change)
Follow-Up Strategies
|
19.0 score on a scale
Standard Deviation 8.5
|
19.5 score on a scale
Standard Deviation 7.4
|
|
Difficulties in Emotion Regulation Scale (DERS) (Change)
Baseline Clarity
|
13.7 score on a scale
Standard Deviation 4.7
|
14.8 score on a scale
Standard Deviation 3.5
|
|
Difficulties in Emotion Regulation Scale (DERS) (Change)
Follow-Up Clarity
|
12.1 score on a scale
Standard Deviation 4.7
|
13.0 score on a scale
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)Population: Number of participants analyzed indicates number of enrolled participants that completed survey questions at each time point
A 20-item measure of PTSD updated for DSM-5. Min: 0, Max: 80 (lower scores are better)
Outcome measures
| Measure |
STEP-Home
n=87 Participants
The STEP-Home Arm involves a skills-based intervention focused on Emotional Regulation, Problem Solving, and Attention Training strategies.
STEP-Home: This group will meet for 2 hours a week for 12 weeks. The core skills of Emotional Regulation (ER) (45-minutes) and Problem Solving (PS) (45-minutes) are introduced and then integrated throughout all Veteran-specific content modules for practice and repetition for 12 weeks. Attention Training (AT) augments PS and ER core skills and is interspersed throughout group and individual sessions.
|
PCGT
n=82 Participants
The Present Center Group Therapy (PCGT) Arm involves a nonspecific, supportive intervention, focused on identifying and discussing current life stressors.
PCGT: The PCGT group will also meet for 2 hours a week for 12 weeks. It is a nonspecific and supportive intervention to control for the nonspecific benefits of the group experience (e.g., therapist contact, instillation of hope, expectation of improvement). It will focus on identifying and discussing current life stressors that contribute to reintegration difficulties, psychoeducation, and promotion of wellness and physical health.
|
|---|---|---|
|
PTSD Checklist for DSM-5 (PCL-5) (Change)
Baseline
|
43.5 score on a scale
Standard Deviation 20.1
|
44.9 score on a scale
Standard Deviation 17.7
|
|
PTSD Checklist for DSM-5 (PCL-5) (Change)
Post-Intervention
|
36.3 score on a scale
Standard Deviation 20.7
|
39.6 score on a scale
Standard Deviation 19.4
|
|
PTSD Checklist for DSM-5 (PCL-5) (Change)
Follow-Up
|
34.9 score on a scale
Standard Deviation 21.6
|
41.0 score on a scale
Standard Deviation 20.6
|
SECONDARY outcome
Timeframe: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)Population: Number of participants analyzed indicates number of enrolled participants that completed survey questions at each time point
A 21-item measure of current depression, anxiety, and stress. Each subscale Min: 7, Max: 28 (lower scores are better)
Outcome measures
| Measure |
STEP-Home
n=86 Participants
The STEP-Home Arm involves a skills-based intervention focused on Emotional Regulation, Problem Solving, and Attention Training strategies.
STEP-Home: This group will meet for 2 hours a week for 12 weeks. The core skills of Emotional Regulation (ER) (45-minutes) and Problem Solving (PS) (45-minutes) are introduced and then integrated throughout all Veteran-specific content modules for practice and repetition for 12 weeks. Attention Training (AT) augments PS and ER core skills and is interspersed throughout group and individual sessions.
|
PCGT
n=82 Participants
The Present Center Group Therapy (PCGT) Arm involves a nonspecific, supportive intervention, focused on identifying and discussing current life stressors.
PCGT: The PCGT group will also meet for 2 hours a week for 12 weeks. It is a nonspecific and supportive intervention to control for the nonspecific benefits of the group experience (e.g., therapist contact, instillation of hope, expectation of improvement). It will focus on identifying and discussing current life stressors that contribute to reintegration difficulties, psychoeducation, and promotion of wellness and physical health.
|
|---|---|---|
|
Depression Anxiety and Stress Scale (DASS-21) (Change)
Post-Intervention Stress
|
17.1 score on a scale
Standard Deviation 11.6
|
18.9 score on a scale
Standard Deviation 9.4
|
|
Depression Anxiety and Stress Scale (DASS-21) (Change)
Follow-Up Anxiety
|
11.1 score on a scale
Standard Deviation 10.6
|
12.8 score on a scale
Standard Deviation 10.2
|
|
Depression Anxiety and Stress Scale (DASS-21) (Change)
Follow-Up Depression
|
12.7 score on a scale
Standard Deviation 11.4
|
16.3 score on a scale
Standard Deviation 10.0
|
|
Depression Anxiety and Stress Scale (DASS-21) (Change)
Follow-Up Stress
|
15.6 score on a scale
Standard Deviation 10.4
|
18.8 score on a scale
Standard Deviation 8.8
|
|
Depression Anxiety and Stress Scale (DASS-21) (Change)
Baseline Anxiety
|
15.4 score on a scale
Standard Deviation 11.6
|
14.6 score on a scale
Standard Deviation 10.0
|
|
Depression Anxiety and Stress Scale (DASS-21) (Change)
Baseline Depression
|
18.7 score on a scale
Standard Deviation 12.3
|
19.0 score on a scale
Standard Deviation 10.5
|
|
Depression Anxiety and Stress Scale (DASS-21) (Change)
Baseline Stress
|
20.7 score on a scale
Standard Deviation 10.9
|
20.9 score on a scale
Standard Deviation 9.0
|
|
Depression Anxiety and Stress Scale (DASS-21) (Change)
Post-Intervention Anxiety
|
12.7 score on a scale
Standard Deviation 11.2
|
12.8 score on a scale
Standard Deviation 9.6
|
|
Depression Anxiety and Stress Scale (DASS-21) (Change)
Post-Intervention Depression
|
16.0 score on a scale
Standard Deviation 13.1
|
15.7 score on a scale
Standard Deviation 10.6
|
SECONDARY outcome
Timeframe: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)Population: Number of participants analyzed indicates number of enrolled participants that completed survey questions at each time point
A 22-item measure of current post-concussive symptoms. Total score Min: 0, Max: 88 (lower scores are better), calculated by adding the scores of all of the subscales. Vestibular Min: 0, Max: 12 (3 items) Somatosensory Min: 0, Max: 20 (5 items) Affective Min: 0, Max: 24 (6 items) Cognitive Min: 0, Max: 32 (8 items)
Outcome measures
| Measure |
STEP-Home
n=87 Participants
The STEP-Home Arm involves a skills-based intervention focused on Emotional Regulation, Problem Solving, and Attention Training strategies.
STEP-Home: This group will meet for 2 hours a week for 12 weeks. The core skills of Emotional Regulation (ER) (45-minutes) and Problem Solving (PS) (45-minutes) are introduced and then integrated throughout all Veteran-specific content modules for practice and repetition for 12 weeks. Attention Training (AT) augments PS and ER core skills and is interspersed throughout group and individual sessions.
|
PCGT
n=82 Participants
The Present Center Group Therapy (PCGT) Arm involves a nonspecific, supportive intervention, focused on identifying and discussing current life stressors.
PCGT: The PCGT group will also meet for 2 hours a week for 12 weeks. It is a nonspecific and supportive intervention to control for the nonspecific benefits of the group experience (e.g., therapist contact, instillation of hope, expectation of improvement). It will focus on identifying and discussing current life stressors that contribute to reintegration difficulties, psychoeducation, and promotion of wellness and physical health.
|
|---|---|---|
|
Neurobehavioral Symptoms Inventory (NSI) (Change)
Baseline Total Score
|
39.2 score on a scale
Standard Deviation 19.7
|
39.0 score on a scale
Standard Deviation 16.7
|
|
Neurobehavioral Symptoms Inventory (NSI) (Change)
Post-Intervention Total Score
|
30.5 score on a scale
Standard Deviation 19.5
|
35.0 score on a scale
Standard Deviation 17.9
|
|
Neurobehavioral Symptoms Inventory (NSI) (Change)
Follow-Up Vestibular
|
2.7 score on a scale
Standard Deviation 2.9
|
4.2 score on a scale
Standard Deviation 3.2
|
|
Neurobehavioral Symptoms Inventory (NSI) (Change)
Post-Treatment Somatic
|
6.6 score on a scale
Standard Deviation 6.1
|
8.4 score on a scale
Standard Deviation 5.6
|
|
Neurobehavioral Symptoms Inventory (NSI) (Change)
Post-Treatment Cognitive
|
7.6 score on a scale
Standard Deviation 4.9
|
8.0 score on a scale
Standard Deviation 4.8
|
|
Neurobehavioral Symptoms Inventory (NSI) (Change)
Follow-Up Affective
|
9.4 score on a scale
Standard Deviation 6.1
|
12.2 score on a scale
Standard Deviation 5.7
|
|
Neurobehavioral Symptoms Inventory (NSI) (Change)
Baseline Vestibular
|
3.3 score on a scale
Standard Deviation 3.2
|
3.3 score on a scale
Standard Deviation 2.9
|
|
Neurobehavioral Symptoms Inventory (NSI) (Change)
Post-Treatment Vestibular
|
2.5 score on a scale
Standard Deviation 2.6
|
3.3 score on a scale
Standard Deviation 2.8
|
|
Neurobehavioral Symptoms Inventory (NSI) (Change)
Baseline Somatic
|
8.1 score on a scale
Standard Deviation 6.6
|
9.0 score on a scale
Standard Deviation 5.5
|
|
Neurobehavioral Symptoms Inventory (NSI) (Change)
Follow-Up Somatic
|
7.0 score on a scale
Standard Deviation 6.3
|
9.2 score on a scale
Standard Deviation 5.7
|
|
Neurobehavioral Symptoms Inventory (NSI) (Change)
Baseline Cognitive
|
9.0 score on a scale
Standard Deviation 4.0
|
9.4 score on a scale
Standard Deviation 4.2
|
|
Neurobehavioral Symptoms Inventory (NSI) (Change)
Follow-Up Cognitive
|
6.6 score on a scale
Standard Deviation 4.2
|
7.7 score on a scale
Standard Deviation 4.2
|
|
Neurobehavioral Symptoms Inventory (NSI) (Change)
Baseline Affective
|
14.2 score on a scale
Standard Deviation 6.3
|
13.4 score on a scale
Standard Deviation 5.3
|
|
Neurobehavioral Symptoms Inventory (NSI) (Change)
Post-Treatment Affective
|
11.5 score on a scale
Standard Deviation 6.8
|
12.3 score on a scale
Standard Deviation 5.6
|
|
Neurobehavioral Symptoms Inventory (NSI) (Change)
Follow-Up Total Score
|
27.9 score on a scale
Standard Deviation 19.1
|
36.3 score on a scale
Standard Deviation 17.4
|
SECONDARY outcome
Timeframe: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)Population: Number of participants analyzed indicates number of enrolled participants that completed survey questions at each time point
Measures functional states in six domains (understanding and communicating, getting around, self care, getting along with people, life activities (work/school), and participation in society). Possible raw min and max scores are below. For all subscales and total score, data is presented as a computed score in a range from 0-100. This is calculated by taking the raw score for each subscale and total score, dividing it by number of possible points for the relevant questions, and multiplying it by 100. Lower scores are better. Understanding and Communicating: Min: 0, Max: 24 Getting Around: Min: 0, Max: 20 Self Care: Min: 0, Max: 16 Getting Along with People: Min: 0, Max: 20 Life Activities: Min: 0, Max: 16 Work-School: Min: 0, Max: 16 Participation: Min: 0, Max: 32 Total Aggregate: Min: 0, Max: 144
Outcome measures
| Measure |
STEP-Home
n=86 Participants
The STEP-Home Arm involves a skills-based intervention focused on Emotional Regulation, Problem Solving, and Attention Training strategies.
STEP-Home: This group will meet for 2 hours a week for 12 weeks. The core skills of Emotional Regulation (ER) (45-minutes) and Problem Solving (PS) (45-minutes) are introduced and then integrated throughout all Veteran-specific content modules for practice and repetition for 12 weeks. Attention Training (AT) augments PS and ER core skills and is interspersed throughout group and individual sessions.
|
PCGT
n=82 Participants
The Present Center Group Therapy (PCGT) Arm involves a nonspecific, supportive intervention, focused on identifying and discussing current life stressors.
PCGT: The PCGT group will also meet for 2 hours a week for 12 weeks. It is a nonspecific and supportive intervention to control for the nonspecific benefits of the group experience (e.g., therapist contact, instillation of hope, expectation of improvement). It will focus on identifying and discussing current life stressors that contribute to reintegration difficulties, psychoeducation, and promotion of wellness and physical health.
|
|---|---|---|
|
World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change)
Follow-Up Communicating
|
31.3 score on a scale
Standard Deviation 22.8
|
36.0 score on a scale
Standard Deviation 20.6
|
|
World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change)
Baseline Total Score
|
39.2 score on a scale
Standard Deviation 20.7
|
38.3 score on a scale
Standard Deviation 18.1
|
|
World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change)
Post-Treatment Total Score
|
31.6 score on a scale
Standard Deviation 22.7
|
33.5 score on a scale
Standard Deviation 18.0
|
|
World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change)
Follow-Up Total Score
|
31.0 score on a scale
Standard Deviation 21.6
|
33.7 score on a scale
Standard Deviation 19.0
|
|
World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change)
Baseline Communicating
|
38.4 score on a scale
Standard Deviation 22.0
|
41.1 score on a scale
Standard Deviation 19.0
|
|
World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change)
Post-Treatment Communicating
|
35.3 score on a scale
Standard Deviation 24.6
|
36.5 score on a scale
Standard Deviation 21.6
|
|
World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change)
Baseline Getting Around
|
27.6 score on a scale
Standard Deviation 26.8
|
24.8 score on a scale
Standard Deviation 24.9
|
|
World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change)
Post-Treatment Getting Around
|
24.8 score on a scale
Standard Deviation 24.9
|
26.4 score on a scale
Standard Deviation 23.1
|
|
World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change)
Follow-Up Getting Around
|
24.9 score on a scale
Standard Deviation 25.1
|
27.8 score on a scale
Standard Deviation 25.0
|
|
World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change)
Baseline Self-Care
|
18.1 score on a scale
Standard Deviation 22.7
|
18.4 score on a scale
Standard Deviation 19.9
|
|
World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change)
Post-Treatment Self-Care
|
14.6 score on a scale
Standard Deviation 21.0
|
13.9 score on a scale
Standard Deviation 17.7
|
|
World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change)
Follow-Up Self-Care
|
13.8 score on a scale
Standard Deviation 17.6
|
14.7 score on a scale
Standard Deviation 18.9
|
|
World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change)
Baseline Getting Along
|
42.8 score on a scale
Standard Deviation 25.5
|
46.7 score on a scale
Standard Deviation 21.7
|
|
World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change)
Post-Treatment Getting Along
|
36.9 score on a scale
Standard Deviation 27.8
|
40.4 score on a scale
Standard Deviation 19.9
|
|
World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change)
Follow-Up Getting Along
|
34.4 score on a scale
Standard Deviation 27.3
|
41.0 score on a scale
Standard Deviation 22.6
|
|
World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change)
Baseline Work/Activity
|
39.8 score on a scale
Standard Deviation 26.2
|
44.2 score on a scale
Standard Deviation 24.4
|
|
World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change)
Post-Treatment Work/Activity
|
34.9 score on a scale
Standard Deviation 28.6
|
39.7 score on a scale
Standard Deviation 27.8
|
|
World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change)
Follow-Up Work/Activity
|
34.2 score on a scale
Standard Deviation 26.4
|
37.2 score on a scale
Standard Deviation 26.8
|
|
World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change)
Baseline Participation
|
41.4 score on a scale
Standard Deviation 26.7
|
42.4 score on a scale
Standard Deviation 19.8
|
|
World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change)
Post-Treatment Participation
|
35.9 score on a scale
Standard Deviation 26.6
|
36.4 score on a scale
Standard Deviation 21.3
|
|
World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change)
Follow-Up Participation
|
38.3 score on a scale
Standard Deviation 27.3
|
38.0 score on a scale
Standard Deviation 21.0
|
SECONDARY outcome
Timeframe: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)Population: Number of participants analyzed indicates number of enrolled participants that completed survey questions at each time point
A 5-item measure of satisfaction with life. Min: 5, Max: 35 (higher scores are better)
Outcome measures
| Measure |
STEP-Home
n=83 Participants
The STEP-Home Arm involves a skills-based intervention focused on Emotional Regulation, Problem Solving, and Attention Training strategies.
STEP-Home: This group will meet for 2 hours a week for 12 weeks. The core skills of Emotional Regulation (ER) (45-minutes) and Problem Solving (PS) (45-minutes) are introduced and then integrated throughout all Veteran-specific content modules for practice and repetition for 12 weeks. Attention Training (AT) augments PS and ER core skills and is interspersed throughout group and individual sessions.
|
PCGT
n=82 Participants
The Present Center Group Therapy (PCGT) Arm involves a nonspecific, supportive intervention, focused on identifying and discussing current life stressors.
PCGT: The PCGT group will also meet for 2 hours a week for 12 weeks. It is a nonspecific and supportive intervention to control for the nonspecific benefits of the group experience (e.g., therapist contact, instillation of hope, expectation of improvement). It will focus on identifying and discussing current life stressors that contribute to reintegration difficulties, psychoeducation, and promotion of wellness and physical health.
|
|---|---|---|
|
Satisfaction With Life Scale (SWLS) (Change)
Baseline
|
15.1 score on a scale
Standard Deviation 7.1
|
15.3 score on a scale
Standard Deviation 7.5
|
|
Satisfaction With Life Scale (SWLS) (Change)
Post-Treatment
|
18.0 score on a scale
Standard Deviation 7.6
|
16.6 score on a scale
Standard Deviation 7.7
|
|
Satisfaction With Life Scale (SWLS) (Change)
Follow-Up
|
17.8 score on a scale
Standard Deviation 8.9
|
17.7 score on a scale
Standard Deviation 7.8
|
SECONDARY outcome
Timeframe: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)Population: Number of participants analyzed indicates number of enrolled participants that completed survey questions at each time point
Assesses engagement in school, work, and life activities. Participants self reported engagement in each category at each time point. Categories are not mutually exclusive, but rather indicate how many participants endorsed participating in each category at each time point. A scale is not used in this measure.
Outcome measures
| Measure |
STEP-Home
n=84 Participants
The STEP-Home Arm involves a skills-based intervention focused on Emotional Regulation, Problem Solving, and Attention Training strategies.
STEP-Home: This group will meet for 2 hours a week for 12 weeks. The core skills of Emotional Regulation (ER) (45-minutes) and Problem Solving (PS) (45-minutes) are introduced and then integrated throughout all Veteran-specific content modules for practice and repetition for 12 weeks. Attention Training (AT) augments PS and ER core skills and is interspersed throughout group and individual sessions.
|
PCGT
n=82 Participants
The Present Center Group Therapy (PCGT) Arm involves a nonspecific, supportive intervention, focused on identifying and discussing current life stressors.
PCGT: The PCGT group will also meet for 2 hours a week for 12 weeks. It is a nonspecific and supportive intervention to control for the nonspecific benefits of the group experience (e.g., therapist contact, instillation of hope, expectation of improvement). It will focus on identifying and discussing current life stressors that contribute to reintegration difficulties, psychoeducation, and promotion of wellness and physical health.
|
|---|---|---|
|
Number of Participants Differing in Activity Engagement Over Time (Change)
Baseline Volunteer Activities
|
15 Participants
|
19 Participants
|
|
Number of Participants Differing in Activity Engagement Over Time (Change)
Post-Intervention Veteran-Oriented Programs
|
27 Participants
|
20 Participants
|
|
Number of Participants Differing in Activity Engagement Over Time (Change)
Baseline Work
|
42 Participants
|
37 Participants
|
|
Number of Participants Differing in Activity Engagement Over Time (Change)
Baseline School/Training Programs
|
18 Participants
|
26 Participants
|
|
Number of Participants Differing in Activity Engagement Over Time (Change)
Baseline Veteran-Oriented Programs
|
29 Participants
|
17 Participants
|
|
Number of Participants Differing in Activity Engagement Over Time (Change)
Baseline Community Activities
|
17 Participants
|
12 Participants
|
|
Number of Participants Differing in Activity Engagement Over Time (Change)
Baseline Socializing
|
50 Participants
|
46 Participants
|
|
Number of Participants Differing in Activity Engagement Over Time (Change)
Post-Intervention Work
|
22 Participants
|
20 Participants
|
|
Number of Participants Differing in Activity Engagement Over Time (Change)
Post-Intervention School/Training Programs
|
14 Participants
|
19 Participants
|
|
Number of Participants Differing in Activity Engagement Over Time (Change)
Post-Intervention Volunteer Activities
|
17 Participants
|
14 Participants
|
|
Number of Participants Differing in Activity Engagement Over Time (Change)
Post-Intervention Community Activities
|
12 Participants
|
13 Participants
|
|
Number of Participants Differing in Activity Engagement Over Time (Change)
Post-Intervention Socializing
|
34 Participants
|
37 Participants
|
|
Number of Participants Differing in Activity Engagement Over Time (Change)
Follow-Up Work
|
18 Participants
|
22 Participants
|
|
Number of Participants Differing in Activity Engagement Over Time (Change)
Follow-Up School/Training Programs
|
8 Participants
|
16 Participants
|
|
Number of Participants Differing in Activity Engagement Over Time (Change)
Follow-Up Volunteer Activities
|
11 Participants
|
11 Participants
|
|
Number of Participants Differing in Activity Engagement Over Time (Change)
Follow-Up Veteran-Oriented Programs
|
15 Participants
|
11 Participants
|
|
Number of Participants Differing in Activity Engagement Over Time (Change)
Follow-Up Community Activities
|
14 Participants
|
8 Participants
|
|
Number of Participants Differing in Activity Engagement Over Time (Change)
Follow-Up Socializing
|
26 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)Population: Number of participants analyzed indicates number of enrolled participants that completed survey questions at each time point
A measure of obstacles to employment in five areas (Personal/Financial, Emotional/Physical, Career Decision-Making and Planning, Job-Seeking Knowledge, and Training/Education). Min and max scores for all the subscales, and the total score, are below. For all, lower scores are better. Only total score analyzed, subscales not reported. Personal and Financial: Min: 10, Max: 40 Emotional and Physical: Min: 10, Max: 40 Career Decision-Making and Planning: Min: 10, Max: 40 Job-Seeking Knowledge: Min: 10, Max: 40 Training and Education: Min: 10, Max: 40 TOTAL score: Min: 50, Max: 200
Outcome measures
| Measure |
STEP-Home
n=84 Participants
The STEP-Home Arm involves a skills-based intervention focused on Emotional Regulation, Problem Solving, and Attention Training strategies.
STEP-Home: This group will meet for 2 hours a week for 12 weeks. The core skills of Emotional Regulation (ER) (45-minutes) and Problem Solving (PS) (45-minutes) are introduced and then integrated throughout all Veteran-specific content modules for practice and repetition for 12 weeks. Attention Training (AT) augments PS and ER core skills and is interspersed throughout group and individual sessions.
|
PCGT
n=81 Participants
The Present Center Group Therapy (PCGT) Arm involves a nonspecific, supportive intervention, focused on identifying and discussing current life stressors.
PCGT: The PCGT group will also meet for 2 hours a week for 12 weeks. It is a nonspecific and supportive intervention to control for the nonspecific benefits of the group experience (e.g., therapist contact, instillation of hope, expectation of improvement). It will focus on identifying and discussing current life stressors that contribute to reintegration difficulties, psychoeducation, and promotion of wellness and physical health.
|
|---|---|---|
|
Barriers to Employment Success Inventory (BESI) (Change)
Follow-Up Total Score
|
89.0 score on a scale
Standard Deviation 35.9
|
88.3 score on a scale
Standard Deviation 32.6
|
|
Barriers to Employment Success Inventory (BESI) (Change)
Baseline Total Score
|
103.5 score on a scale
Standard Deviation 33.9
|
101.8 score on a scale
Standard Deviation 32.9
|
|
Barriers to Employment Success Inventory (BESI) (Change)
Post-Treatment Total Score
|
90.7 score on a scale
Standard Deviation 33.9
|
96.3 score on a scale
Standard Deviation 32.1
|
SECONDARY outcome
Timeframe: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)Population: Number of participants analyzed indicates number of enrolled participants that completed survey questions at each time point
Change in average number of hours worked per month over time. Participants self-reported average number of hours worked in the month before STEP-Home (baseline), in each month of the intervention/PCGT (measured at post-treatment), and post-treatment monitoring (follow-up). A scale is not used in this measure. Each row indicates the number of participants that worked the indicated number of hours at each time point. Rows are mutually exclusive.
Outcome measures
| Measure |
STEP-Home
n=94 Participants
The STEP-Home Arm involves a skills-based intervention focused on Emotional Regulation, Problem Solving, and Attention Training strategies.
STEP-Home: This group will meet for 2 hours a week for 12 weeks. The core skills of Emotional Regulation (ER) (45-minutes) and Problem Solving (PS) (45-minutes) are introduced and then integrated throughout all Veteran-specific content modules for practice and repetition for 12 weeks. Attention Training (AT) augments PS and ER core skills and is interspersed throughout group and individual sessions.
|
PCGT
n=88 Participants
The Present Center Group Therapy (PCGT) Arm involves a nonspecific, supportive intervention, focused on identifying and discussing current life stressors.
PCGT: The PCGT group will also meet for 2 hours a week for 12 weeks. It is a nonspecific and supportive intervention to control for the nonspecific benefits of the group experience (e.g., therapist contact, instillation of hope, expectation of improvement). It will focus on identifying and discussing current life stressors that contribute to reintegration difficulties, psychoeducation, and promotion of wellness and physical health.
|
|---|---|---|
|
Number of Participants Differing in Average Number of Hours Worked (Change)
Baseline >40 hours/week
|
20 Participants
|
10 Participants
|
|
Number of Participants Differing in Average Number of Hours Worked (Change)
Post-Intervention 31-40 hours/week
|
5 Participants
|
6 Participants
|
|
Number of Participants Differing in Average Number of Hours Worked (Change)
Follow-Up 31-40 hours/week
|
5 Participants
|
8 Participants
|
|
Number of Participants Differing in Average Number of Hours Worked (Change)
Follow-Up >40 hours/week
|
9 Participants
|
5 Participants
|
|
Number of Participants Differing in Average Number of Hours Worked (Change)
Baseline <1 hour
|
53 Participants
|
55 Participants
|
|
Number of Participants Differing in Average Number of Hours Worked (Change)
Baseline 1-10 hours/week
|
4 Participants
|
4 Participants
|
|
Number of Participants Differing in Average Number of Hours Worked (Change)
Baseline 11-20 hours/week
|
3 Participants
|
6 Participants
|
|
Number of Participants Differing in Average Number of Hours Worked (Change)
Baseline 21-30 hours/week
|
5 Participants
|
3 Participants
|
|
Number of Participants Differing in Average Number of Hours Worked (Change)
Baseline 31-40 hours/week
|
9 Participants
|
10 Participants
|
|
Number of Participants Differing in Average Number of Hours Worked (Change)
Post-Intervention <1 hour/week
|
33 Participants
|
37 Participants
|
|
Number of Participants Differing in Average Number of Hours Worked (Change)
Post-Intervention 1-10 hours/week
|
0 Participants
|
3 Participants
|
|
Number of Participants Differing in Average Number of Hours Worked (Change)
Post-Intervention 11-20 hours/week
|
0 Participants
|
4 Participants
|
|
Number of Participants Differing in Average Number of Hours Worked (Change)
Post-Intervention 21-30 hours/week
|
2 Participants
|
2 Participants
|
|
Number of Participants Differing in Average Number of Hours Worked (Change)
Post-Intervention >40 hours/week
|
15 Participants
|
5 Participants
|
|
Number of Participants Differing in Average Number of Hours Worked (Change)
Follow-Up <1 hour/week
|
26 Participants
|
23 Participants
|
|
Number of Participants Differing in Average Number of Hours Worked (Change)
Follow-Up 1-10 hours/week
|
2 Participants
|
2 Participants
|
|
Number of Participants Differing in Average Number of Hours Worked (Change)
Follow-Up 11-20 hours/week
|
2 Participants
|
5 Participants
|
|
Number of Participants Differing in Average Number of Hours Worked (Change)
Follow-Up 21-30 hours/week
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)Population: Number of participants analyzed indicates number of enrolled participants that completed survey questions at each time point
Measures apathy, disinhibition, and executive dysfunction. Min and max possible scores for subscales and total score are below. For all, lower scores are better. Total score calculated by adding the scores of all items. Subscale scores calculated by adding the scores of the items in each subscale. Apathy Min: 14, Max: 70 Disinhibition Min: 15, Max: 75 Executive Dysfunction Min: 17, Max: 85 Total Score Min: 46, Max: 230
Outcome measures
| Measure |
STEP-Home
n=84 Participants
The STEP-Home Arm involves a skills-based intervention focused on Emotional Regulation, Problem Solving, and Attention Training strategies.
STEP-Home: This group will meet for 2 hours a week for 12 weeks. The core skills of Emotional Regulation (ER) (45-minutes) and Problem Solving (PS) (45-minutes) are introduced and then integrated throughout all Veteran-specific content modules for practice and repetition for 12 weeks. Attention Training (AT) augments PS and ER core skills and is interspersed throughout group and individual sessions.
|
PCGT
n=80 Participants
The Present Center Group Therapy (PCGT) Arm involves a nonspecific, supportive intervention, focused on identifying and discussing current life stressors.
PCGT: The PCGT group will also meet for 2 hours a week for 12 weeks. It is a nonspecific and supportive intervention to control for the nonspecific benefits of the group experience (e.g., therapist contact, instillation of hope, expectation of improvement). It will focus on identifying and discussing current life stressors that contribute to reintegration difficulties, psychoeducation, and promotion of wellness and physical health.
|
|---|---|---|
|
Frontal Systems Behavior Scale (FrSBe) (Change)
Baseline Total Score
|
124.8 score on a scale
Standard Deviation 25.9
|
124.9 score on a scale
Standard Deviation 25.8
|
|
Frontal Systems Behavior Scale (FrSBe) (Change)
Post-Treatment Total Score
|
111.8 score on a scale
Standard Deviation 25.6
|
111.9 score on a scale
Standard Deviation 25.0
|
|
Frontal Systems Behavior Scale (FrSBe) (Change)
Follow-Up Total Score
|
109.2 score on a scale
Standard Deviation 23.7
|
110.2 score on a scale
Standard Deviation 26.1
|
|
Frontal Systems Behavior Scale (FrSBe) (Change)
Baseline Apathy
|
41.1 score on a scale
Standard Deviation 9.8
|
43.2 score on a scale
Standard Deviation 9.4
|
|
Frontal Systems Behavior Scale (FrSBe) (Change)
Post-Treatment Apathy
|
36.2 score on a scale
Standard Deviation 9.8
|
38.3 score on a scale
Standard Deviation 10.2
|
|
Frontal Systems Behavior Scale (FrSBe) (Change)
Follow-Up Apathy
|
35.8 score on a scale
Standard Deviation 8.8
|
41.8 score on a scale
Standard Deviation 9.3
|
|
Frontal Systems Behavior Scale (FrSBe) (Change)
Baseline Disinhibition
|
37.6 score on a scale
Standard Deviation 10.4
|
37.0 score on a scale
Standard Deviation 8.4
|
|
Frontal Systems Behavior Scale (FrSBe) (Change)
Post-Treatment Disinhibition
|
33.2 score on a scale
Standard Deviation 9.6
|
31.8 score on a scale
Standard Deviation 9.6
|
|
Frontal Systems Behavior Scale (FrSBe) (Change)
Follow-Up Disinhibition
|
32.3 score on a scale
Standard Deviation 9.6
|
31.1 score on a scale
Standard Deviation 10.3
|
|
Frontal Systems Behavior Scale (FrSBe) (Change)
Baseline Executive Dysfunction
|
45.6 score on a scale
Standard Deviation 9.0
|
46.5 score on a scale
Standard Deviation 8.1
|
|
Frontal Systems Behavior Scale (FrSBe) (Change)
Post-Treatment Executive Dysfunction
|
42.4 score on a scale
Standard Deviation 8.7
|
41.8 score on a scale
Standard Deviation 9.3
|
|
Frontal Systems Behavior Scale (FrSBe) (Change)
Follow-Up Executive Dysfunction
|
41.1 score on a scale
Standard Deviation 7.8
|
41.8 score on a scale
Standard Deviation 9.3
|
Adverse Events
STEP-Home
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PCGT
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place