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Acceptance and Commitment Therapy (ACT) for OEF/OIF Veterans

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ClinicalTrials.gov Identifier: NCT01253044
Recruitment Status : Completed
First Posted : December 3, 2010
Results First Posted : October 19, 2015
Last Update Posted : October 19, 2015
Sponsor:
Information provided by (Responsible Party):
Ariel Lang, PhD, Veterans Medical Research Foundation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Distress
Anxiety
Depression
Postconcussive Symptoms
Interventions Behavioral: Acceptance and Commitment Therapy
Behavioral: Present Centered Therapy
Enrollment 160
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Acceptance and Commitment Therapy Present Centered Therapy
Hide Arm/Group Description 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, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
Period Title: Overall Study
Started 80 80
Completed 42 51
Not Completed 38 29
Reason Not Completed
Lost to Follow-up             38             29
Arm/Group Title Acceptance and Commitment Therapy Present Centered Therapy Total
Hide Arm/Group Description 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, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed). Total of all reporting groups
Overall Number of Baseline Participants 80 80 160
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 80 participants 80 participants 160 participants
34.5  (7.9) 34.0  (8.1) 34.2  (8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 80 participants 160 participants
Female
15
  18.8%
17
  21.3%
32
  20.0%
Male
65
  81.3%
63
  78.8%
128
  80.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 80 participants 160 participants
Hispanic or Latino
9
  11.3%
12
  15.0%
21
  13.1%
Not Hispanic or Latino
70
  87.5%
65
  81.3%
135
  84.4%
Unknown or Not Reported
1
   1.3%
3
   3.8%
4
   2.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 80 participants 160 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
3
   3.8%
3
   3.8%
6
   3.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
8
  10.0%
10
  12.5%
18
  11.3%
White
60
  75.0%
60
  75.0%
120
  75.0%
More than one race
8
  10.0%
5
   6.3%
13
   8.1%
Unknown or Not Reported
1
   1.3%
2
   2.5%
3
   1.9%
1.Primary Outcome
Title Brief Symptom Inventory 18 (BSI-18)
Hide Description 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.
Time Frame Baseline and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acceptance and Commitment Therapy Present Centered Therapy
Hide Arm/Group Description:
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, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
Overall Number of Participants Analyzed 80 80
Mean (Standard Deviation)
Unit of Measure: T-score
Baseline 73.3  (8.3) 74.0  (7.7)
Post-treatment 65.0  (13.1) 66.8  (10.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Acceptance and Commitment Therapy, Present Centered Therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .912
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
2.Secondary Outcome
Title Sheehan Disability Inventory
Hide Description To 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.
Time Frame Baseline and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acceptance and Commitment Therapy Present Centered Therapy
Hide Arm/Group Description:
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, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
Overall Number of Participants Analyzed 80 80
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 6.7  (2.0) 6.4  (1.9)
Post-treatment 4.9  (2.4) 5.3  (2.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Acceptance and Commitment Therapy, Present Centered Therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .273
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Time Frame 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Acceptance and Commitment Therapy Present Centered Therapy
Hide Arm/Group Description 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, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
All-Cause Mortality
Acceptance and Commitment Therapy Present Centered Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Acceptance and Commitment Therapy Present Centered Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/80 (1.25%)      3/80 (3.75%)    
Psychiatric disorders     
Alcohol poisoning *  1/80 (1.25%)  1 0/80 (0.00%)  0
Suicidality *  0/80 (0.00%)  0 1/80 (1.25%)  1
Agitated altercation *  0/80 (0.00%)  0 1/80 (1.25%)  1
Surgical and medical procedures     
Nephrectomy *  0/80 (0.00%)  0 1/80 (1.25%)  1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Acceptance and Commitment Therapy Present Centered Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/80 (0.00%)      0/80 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Ariel Lang
Organization: VA San Diego Healthcare System and UCSD
Phone: 858-246-0631
Responsible Party: Ariel Lang, PhD, Veterans Medical Research Foundation
ClinicalTrials.gov Identifier: NCT01253044     History of Changes
Other Study ID Numbers: W81XWH-08-2-0159
First Submitted: December 1, 2010
First Posted: December 3, 2010
Results First Submitted: June 30, 2015
Results First Posted: October 19, 2015
Last Update Posted: October 19, 2015