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

Primary Purpose

Distress, Anxiety, Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acceptance and Commitment Therapy
Present Centered Therapy
Sponsored by
Veterans Medical Research Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distress focused on measuring OEF/OIF, Veterans, Psychotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Previous deployment to OEF or OIF
  • Current distress and impairment [at least one Diagnostic and Statistical Manual version IV (DSM-IV) anxiety or depressive disorder as determined by the Mini International Neuropsychiatric Interview (MINI) or post-concussive symptoms (PCS) as determined by a positive traumatic brain injury (TBI) screen with a score of 25 or greater on the Rivermead with distress or impairment related to PCS].
  • Capable of giving informed consent.

Exclusion Criteria:

  • Cognitive impairment that would interfere with treatment. Potential participants will be excluded if they screen positive for more than mild cognitive impairment on the Montreal Cognitive Assessment (MoCA; excluded if score < 26).
  • Severe psychopathology (psychosis, bipolar illness, urgent suicidality or self-injurious behavior) or untreated substance dependence in the past month.
  • Anticipated change in pharmacologic intervention. Patients may stay on their current medications during the study but will be asked to refrain from beginning or altering medication use during the study to the extent possible.
  • Other psychotherapy focusing on the same target symptoms. Patients may attend self-help groups or treatment for other types of problems (e.g., couples counseling) but not other treatment for the same presenting problems.
  • Anticipated deployment or other circumstance that would interfere with completion of all study procedures.

Sites / Locations

  • VA San Diego Healthcare System
  • Walter Reed National Military Medical Center
  • Togus VA Medical Center
  • Durham VA Medical Center
  • Cincinnati VA Medical Center
  • VA Puget Sound Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Acceptance and Commitment Therapy

Present Centered Therapy

Arm Description

12 weeks of individually delivered Acceptance and Commitment Therapy

12 weeks of individually delivered Present Centered Therapy

Outcomes

Primary Outcome Measures

Brief Symptom Inventory 18 (BSI-18)
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.

Secondary Outcome Measures

Sheehan Disability Inventory
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.

Full Information

First Posted
December 1, 2010
Last Updated
September 18, 2015
Sponsor
Veterans Medical Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01253044
Brief Title
Acceptance and Commitment Therapy (ACT) for OEF/OIF Veterans
Official Title
Initial Randomized Controlled Trial of Acceptance and Commitment Therapy (ACT) for Distress and Impairment in OEF/OIF Veterans
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Veterans Medical Research Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This trial compares two psychotherapies, Acceptance and Commitment Therapy (ACT) and Present Centered Therapy (PCT), for veterans of the conflicts in Iraq and Afghanistan. We hypothesize that ACT will be more effective than PCT at reducing emotional distress and improving functioning. We further hypothesize that both interventions will be highly acceptable to participants.
Detailed Description
The proposed study is a randomized controlled trial (RCT) of Acceptance and Commitment Therapy (ACT) as compared to a control psychotherapy, Present Centered Therapy (PCT), for individuals with distress and impairment who deployed as part of Operation Enduring Freedom and/or Operation Iraqi Freedom (OEF/OIF). ACT was selected for study because it has a number of advantages for this population. It is not tied to any particular symptom constellation, so it can be applied to a variety of presenting concerns (Hayes, Luoma, et al., 2006; Öst, 2008, Powers et al., 2009), resulting in reduced training burden for clinicians and less need for applying sequential treatments to address co-morbidities. ACT has good face validity (i.e., "it makes sense") and conveys a compelling message to young Service Members and Veterans. ACT asks individuals to move forward in accordance with one's values regardless of limitations rather than struggling against those limitations. ACT appears to be acceptable to patients (mean attrition of 15.4% in 13 RCTs (Öst, 2008). ACT is being widely disseminated without adequate evidence of its effectiveness for this important population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distress, Anxiety, Depression, Postconcussive Symptoms
Keywords
OEF/OIF, Veterans, Psychotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acceptance and Commitment Therapy
Arm Type
Experimental
Arm Description
12 weeks of individually delivered Acceptance and Commitment Therapy
Arm Title
Present Centered Therapy
Arm Type
Active Comparator
Arm Description
12 weeks of individually delivered Present Centered Therapy
Intervention Type
Behavioral
Intervention Name(s)
Acceptance and Commitment Therapy
Other Intervention Name(s)
ACT
Intervention Description
Acceptance and Commitment Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
Intervention Type
Behavioral
Intervention Name(s)
Present Centered Therapy
Other Intervention Name(s)
PCT
Intervention Description
Present Centered Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
Primary Outcome Measure Information:
Title
Brief Symptom Inventory 18 (BSI-18)
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
Secondary Outcome Measure Information:
Title
Sheehan Disability Inventory
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Previous deployment to OEF or OIF Current distress and impairment [at least one Diagnostic and Statistical Manual version IV (DSM-IV) anxiety or depressive disorder as determined by the Mini International Neuropsychiatric Interview (MINI) or post-concussive symptoms (PCS) as determined by a positive traumatic brain injury (TBI) screen with a score of 25 or greater on the Rivermead with distress or impairment related to PCS]. Capable of giving informed consent. Exclusion Criteria: Cognitive impairment that would interfere with treatment. Potential participants will be excluded if they screen positive for more than mild cognitive impairment on the Montreal Cognitive Assessment (MoCA; excluded if score < 26). Severe psychopathology (psychosis, bipolar illness, urgent suicidality or self-injurious behavior) or untreated substance dependence in the past month. Anticipated change in pharmacologic intervention. Patients may stay on their current medications during the study but will be asked to refrain from beginning or altering medication use during the study to the extent possible. Other psychotherapy focusing on the same target symptoms. Patients may attend self-help groups or treatment for other types of problems (e.g., couples counseling) but not other treatment for the same presenting problems. Anticipated deployment or other circumstance that would interfere with completion of all study procedures.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ariel J Lang, PhD
Organizational Affiliation
University California San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA San Diego Healthcare System
City
La Jolla
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
Walter Reed National Military Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20889
Country
United States
Facility Name
Togus VA Medical Center
City
Augusta
State/Province
Maine
ZIP/Postal Code
04330
Country
United States
Facility Name
Durham VA Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Cincinnati VA Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
VA Puget Sound Health System
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28060206
Citation
Bomyea J, Lang AJ, Schnurr PP. TBI and Treatment Response in a Randomized Trial of Acceptance and Commitment Therapy. J Head Trauma Rehabil. 2017 Sep/Oct;32(5):E35-E43. doi: 10.1097/HTR.0000000000000278.
Results Reference
derived

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

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