DistressNCT01253044
Acceptance and Commitment Therapy (ACT) for OEF/OIF Veterans
A study testing Acceptance and Commitment Therapy and Present Centered Therapy in people with Distress and Anxiety, run by Veterans Medical Research Foundation at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distress, Anxiety, Depression
- What is being tested?
- Acceptance and Commitment Therapy and Present Centered Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 6 sitesUnited States
- Study dates
- Nov 2010to Aug 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Togus VA Medical Center
Augusta, Maine, 04330
Cincinnati VA Medical Center
Cincinnati, Ohio, 45220
Durham VA Medical Center
Durham, North Carolina, 27705
VA San Diego Healthcare System
La Jolla, California, 92161
VA Puget Sound Health System
Seattle, Washington, 98108
Walter Reed National Military Medical Center
Washington D.C., District of Columbia, 20889
About this study
Official title: Initial Randomized Controlled Trial of Acceptance and Commitment Therapy (ACT) for Distress and Impairment in OEF/OIF Veterans
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.
Read the 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.
- Conditions
- Distress, Anxiety, Depression, Postconcussive Symptoms
- Being tested
- Acceptance and Commitment Therapy, Present Centered Therapy
- Keywords
- OEF/OIF, Veterans, Psychotherapy
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment TherapyBehavioural
Also called ACT
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 TherapyBehavioural
Also called PCT
Present Centered Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
| Study group | Role | What they receive |
|---|---|---|
| Acceptance and Commitment Therapy | Experimental | 12 weeks of individually delivered Acceptance and Commitment Therapy Receives: Behavioral: Acceptance and Commitment Therapy |
| Present Centered Therapy | Active comparator | 12 weeks of individually delivered Present Centered Therapy Receives: Behavioral: Present Centered Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and week 12
Secondary outcomes (1)
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.
Measured: Baseline and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Veterans Medical Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ariel Lang, PhD, Veterans Medical Research Foundation
- Investigators
- Ariel J Lang, PhD, Principal investigator, University California San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01253044
- Sponsor's protocol ID
- W81XWH-08-2-0159
- Status last verified
- Sep 2015
- First submitted
- 1 Dec 2010
- Last updated
- 19 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 28060206
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Randomized Controlled Trial of Acceptance and Commitment Therapy (ACT) for Distress and Impairment in OEF/OIF Veterans
- ClinicalTrials.gov ID
- NCT01253044
- Acronym / sponsor ID
- W81XWH-08-2-0159
- Conditions
- Distress, Anxiety, Depression, Postconcussive Symptoms
- Keywords
- OEF/OIF, Veterans, Psychotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Veterans Medical Research FoundationUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 3 Dec 2010 (estimated)
- Results
- Posted 19 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acceptance and Commitment Therapy | Experimental | Behavioral: Acceptance and Commitment Therapy12 weeks of individually delivered Acceptance and Commitment Therapy |
| Present Centered Therapy | Active comparator | Behavioral: Present Centered Therapy12 weeks of individually delivered Present Centered Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and Commitment TherapyAlso: ACTAcceptance and Commitment Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed). | Behavioural | Acceptance and Commitment Therapy |
| Present Centered TherapyAlso: PCTPresent Centered Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed). | Behavioural | Present Centered Therapy |
Primary outcome
Brief Symptom Inventory 18 (BSI-18)
Time frame: Baseline and week 12
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.
1 secondary outcome
Sheehan Disability Inventory
Time frame: Baseline and week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28060206Bomyea 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ariel J Lang, PhD principal investigator
University California San Diego
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy and Present Centered Therapy in people with Distress and Anxiety, run by Veterans Medical Research Foundation at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Symptom Inventory 18 (BSI-18) (time frame: Baseline and week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01253044, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2015.