Trial Outcomes & Findings for Acceptance and Commitment Therapy (ACT) for OEF/OIF Veterans (NCT NCT01253044)
NCT ID: NCT01253044
Last Updated: 2015-10-19
Results Overview
To determine if receiving ACT, as compared to PCT, is associated with reduced distress as measured by the BSI-18 General Symptom Index (GSI) at the end of treatment. The BSI-18 GSI summarizes a respondent's overall level of distress. The score used in a normatively based T-score (range 1-100) calculated from the sum of responses. Higher scores are indicative of greater distress.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
160 participants
Primary outcome timeframe
Baseline and week 12
Results posted on
2015-10-19
Participant Flow
Participant milestones
| Measure |
Acceptance and Commitment Therapy
Acceptance and Commitment Therapy: Acceptance and Commitment Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
|
Present Centered Therapy
Present Centered Therapy: Present Centered Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
|
|---|---|---|
|
Overall Study
STARTED
|
80
|
80
|
|
Overall Study
COMPLETED
|
42
|
51
|
|
Overall Study
NOT COMPLETED
|
38
|
29
|
Reasons for withdrawal
| Measure |
Acceptance and Commitment Therapy
Acceptance and Commitment Therapy: Acceptance and Commitment Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
|
Present Centered Therapy
Present Centered Therapy: Present Centered Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
38
|
29
|
Baseline Characteristics
Acceptance and Commitment Therapy (ACT) for OEF/OIF Veterans
Baseline characteristics by cohort
| Measure |
Acceptance and Commitment Therapy
n=80 Participants
Acceptance and Commitment Therapy: Acceptance and Commitment Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
|
Present Centered Therapy
n=80 Participants
Present Centered Therapy: Present Centered Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.5 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
34.0 years
STANDARD_DEVIATION 8.1 • n=7 Participants
|
34.2 years
STANDARD_DEVIATION 8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
70 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
60 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and week 12To determine if receiving ACT, as compared to PCT, is associated with reduced distress as measured by the BSI-18 General Symptom Index (GSI) at the end of treatment. The BSI-18 GSI summarizes a respondent's overall level of distress. The score used in a normatively based T-score (range 1-100) calculated from the sum of responses. Higher scores are indicative of greater distress.
Outcome measures
| Measure |
Acceptance and Commitment Therapy
n=80 Participants
Acceptance and Commitment Therapy: Acceptance and Commitment Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
|
Present Centered Therapy
n=80 Participants
Present Centered Therapy: Present Centered Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
|
|---|---|---|
|
Brief Symptom Inventory 18 (BSI-18)
Baseline
|
73.3 T-score
Standard Deviation 8.3
|
74.0 T-score
Standard Deviation 7.7
|
|
Brief Symptom Inventory 18 (BSI-18)
Post-treatment
|
65.0 T-score
Standard Deviation 13.1
|
66.8 T-score
Standard Deviation 10.4
|
SECONDARY outcome
Timeframe: Baseline and week 12To determine if receiving ACT, as compared to PCT, is associated with reduced functional impairment at the end of treatment. The score used is an average (range 0-10) of completed items, with higher scores indicating greater disability.
Outcome measures
| Measure |
Acceptance and Commitment Therapy
n=80 Participants
Acceptance and Commitment Therapy: Acceptance and Commitment Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
|
Present Centered Therapy
n=80 Participants
Present Centered Therapy: Present Centered Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
|
|---|---|---|
|
Sheehan Disability Inventory
Baseline
|
6.7 units on a scale
Standard Deviation 2.0
|
6.4 units on a scale
Standard Deviation 1.9
|
|
Sheehan Disability Inventory
Post-treatment
|
4.9 units on a scale
Standard Deviation 2.4
|
5.3 units on a scale
Standard Deviation 2.2
|
Adverse Events
Acceptance and Commitment Therapy
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Present Centered Therapy
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Acceptance and Commitment Therapy
n=80 participants at risk
Acceptance and Commitment Therapy: Acceptance and Commitment Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
|
Present Centered Therapy
n=80 participants at risk
Present Centered Therapy: Present Centered Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
|
|---|---|---|
|
Surgical and medical procedures
Nephrectomy
|
0.00%
0/80 • 12 weeks
|
1.2%
1/80 • Number of events 1 • 12 weeks
|
|
Psychiatric disorders
Alcohol poisoning
|
1.2%
1/80 • Number of events 1 • 12 weeks
|
0.00%
0/80 • 12 weeks
|
|
Psychiatric disorders
Suicidality
|
0.00%
0/80 • 12 weeks
|
1.2%
1/80 • Number of events 1 • 12 weeks
|
|
Psychiatric disorders
Agitated altercation
|
0.00%
0/80 • 12 weeks
|
1.2%
1/80 • Number of events 1 • 12 weeks
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place