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

NCT ID: NCT01253044

Last Updated: 2015-10-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2013-08-31

Brief Summary

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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

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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.

Conditions

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Distress Anxiety Depression Postconcussive Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Acceptance and Commitment Therapy

12 weeks of individually delivered Acceptance and Commitment Therapy

Group Type EXPERIMENTAL

Acceptance and Commitment Therapy

Intervention Type BEHAVIORAL

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

12 weeks of individually delivered Present Centered Therapy

Group Type ACTIVE_COMPARATOR

Present Centered Therapy

Intervention Type BEHAVIORAL

Present Centered Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).

Interventions

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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).

Intervention Type BEHAVIORAL

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).

Intervention Type BEHAVIORAL

Other Intervention Names

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ACT PCT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Veterans Medical Research Foundation

OTHER

Sponsor Role lead

Responsible Party

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Ariel Lang, PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ariel J Lang, PhD

Role: PRINCIPAL_INVESTIGATOR

University California San Diego

Locations

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VA San Diego Healthcare System

La Jolla, California, United States

Site Status

Walter Reed National Military Medical Center

Washington D.C., District of Columbia, United States

Site Status

Togus VA Medical Center

Augusta, Maine, United States

Site Status

Durham VA Medical Center

Durham, North Carolina, United States

Site Status

Cincinnati VA Medical Center

Cincinnati, Ohio, United States

Site Status

VA Puget Sound Health System

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 28060206 (View on PubMed)

Other Identifiers

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W81XWH-08-2-0159

Identifier Type: -

Identifier Source: org_study_id

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