PTSDMPTSDNCT01228539
Breaking the Cycle IV: Military PTSD (MPTSD) Treatment Study
A study testing TARGET (Trauma Affect Regulation) and Prolonged Exposure in people with PTSD and Anger, run by UConn Health at 1 site in United States.
Trial summary
The study will compare the efficacy of Trauma Affect Regulation: Guide for Education and Therapy (TARGET) vs. the best validated psychotherapy for adults with posttraumatic stress disorder (PTSD), Prolonged Exposure (PE). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- PTSD, Anger, Aggression
- What is being tested?
- TARGET (Trauma Affect Regulation) and Prolonged Exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be a returning OEF/OIF military personnel or veteran
- have experienced PTSD for the past month
- have experienced anger and at least one act of aggression in the last month
- be mentally able to provide a valid consent
Who cannot join
- currently be danger of suicide
- currently abusing alcohol or other substances
- been in an inpatient psychiatric or addiction treatment program in the past month
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Connecticut Health Center
Farmington, Connecticut, 06030-1410
About this study
The study will compare the efficacy of Trauma Affect Regulation: Guide for Education and Therapy (TARGET) vs. the best validated psychotherapy for adults with posttraumatic stress disorder (PTSD), Prolonged Exposure (PE). Male military personnel and veterans suffering with PTSD and problems with anger after returning from military service in Afghanistan (Operation Emerging Freedom, OEF) and/or Iraq (Operation Iraqi Freedom, OIF) will be participants. The goal is to determine if a present-centered psychotherapy that teaches skills for emotion regulation and does not require re-telling of traumatic memories is as efficacious as the trauma memory-focused PE psychotherapy.
Read the detailed description
The study is based on a theoretical and clinical model that involves a series of associated risks that are set in motion by exposure to military-related traumatic stressors in Iraq or Afghanistan. Trauma exposure places personnel at risk for PTSD, which in turn increases their risk of problems with anger and hostility, emotion dysregulation and experiential avoidance, and ultimately with alcohol abuse and aggression. The two types of treatments being compared, TARGET (Trauma Affect Regulation: Guide for Education and Therapy) and PE (Prolonged Exposure), are both designed to directly reduce PTSD severity by reducing emotion dysregulation (TARGET) and experiential avoidance (PE), and therefore are hypothesized to reduce the risk and severity of alcohol abuse and aggression- and thereby to reduce associated legal and societal costs.
- Conditions
- PTSD, Anger, Aggression
- Being tested
- TARGET (Trauma Affect Regulation), Prolonged Exposure
- Keywords
- PTSD, Anger, Aggression, Military
- Medical subject headings
- Stress Disorders, Post-Traumatic, Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TARGET (Trauma Affect Regulation)Behavioural
Also called TARGET
TARGET teaches a skill sequence for affect regulation and social/interpersonal information processing.
Prolonged ExposureBehavioural
Cognitive behavior therapy with trauma memory exposure
| Study group | Role | What they receive |
|---|---|---|
| TARGET | Experimental | Affect regulation psychotherapy for PTSD Receives: Behavioral: TARGET (Trauma Affect Regulation) |
| Prolonged Exposure | Active comparator | Cognitive behavioral therapy for PTSD with trauma memory exposure Receives: Behavioral: Prolonged Exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of PTSD symptoms
Clinician Administered PTSD Scale Ordinal Scores Posttraumatic Cognitions Inventory Trauma Memory Questionnaire Interpretation of PTSD Symptoms Scale
Measured: Post-therapy
Secondary outcomes (2)
Anger/aggression problems
State-Trait Anger Expression Inventory Brief Symptom Inventory
Measured: Post-therapy
Emotion Regulation
Negative Mood Regulation scale Difficulty with Emotion Regulation Scale Acceptance and Action Questionnaire
Measured: Post-therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2010 (estimated)
- Study startJan 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania
- Responsible party
- Principal investigator, Julian Ford, UConn Health
- Investigators
- Julian Ford, Ph.D., Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01228539
- Sponsor's protocol ID
- MPTSD-10-118-2
- Other IDs
- DOJ-2009-D1BX0299
- Acronym
- MPTSD
- Status last verified
- May 2013
- First submitted
- 22 Sep 2010
- Last updated
- 13 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breaking the Cycle IV: Military PTSD (MPTSD) Treatment Study
- ClinicalTrials.gov ID
- NCT01228539
- Acronym / sponsor ID
- MPTSD / MPTSD-10-118-2
- Conditions
- PTSD, Anger, Aggression
- Keywords
- PTSD, Anger, Aggression, Military
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- University of Pennsylvania
- Study start
- Jan 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 26 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will compare the efficacy of Trauma Affect Regulation: Guide for Education and Therapy (TARGET) vs. the best validated psychotherapy for adults with posttraumatic stress disorder (PTSD), Prolonged Exposure (PE). Male military personnel and veterans suffering with PTSD and problems with anger after returning from military service in Afghanistan (Operation Emerging Freedom, OEF) and/or Iraq (Operation Iraqi Freedom, OIF) will be participants. The goal is to determine if a present-centered psychotherapy that teaches skills for emotion regulation and does not require re-telling of traumatic memories is as efficacious as the trauma memory-focused PE psychotherapy.
Detailed description
The study is based on a theoretical and clinical model that involves a series of associated risks that are set in motion by exposure to military-related traumatic stressors in Iraq or Afghanistan. Trauma exposure places personnel at risk for PTSD, which in turn increases their risk of problems with anger and hostility, emotion dysregulation and experiential avoidance, and ultimately with alcohol abuse and aggression. The two types of treatments being compared, TARGET (Trauma Affect Regulation: Guide for Education and Therapy) and PE (Prolonged Exposure), are both designed to directly reduce PTSD severity by reducing emotion dysregulation (TARGET) and experiential avoidance (PE), and therefore are hypothesized to reduce the risk and severity of alcohol abuse and aggression- and thereby to reduce associated legal and societal costs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TARGET | Experimental | Behavioral: TARGET (Trauma Affect Regulation)Affect regulation psychotherapy for PTSD |
| Prolonged Exposure | Active comparator | Behavioral: Prolonged ExposureCognitive behavioral therapy for PTSD with trauma memory exposure |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- be a returning OEF/OIF military personnel or veteran
- have experienced PTSD for the past month
- have experienced anger and at least one act of aggression in the last month
- be mentally able to provide a valid consent
Key exclusion criteria (3 listed)
- currently be danger of suicide
- currently abusing alcohol or other substances
- been in an inpatient psychiatric or addiction treatment program in the past month
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 |
|---|---|---|
| TARGET (Trauma Affect Regulation)Also: TARGETTARGET teaches a skill sequence for affect regulation and social/interpersonal information processing. | Behavioural | TARGET |
| Prolonged ExposureCognitive behavior therapy with trauma memory exposure | Behavioural | Prolonged Exposure |
Primary outcome
Severity of PTSD symptoms
Time frame: Post-therapy
Clinician Administered PTSD Scale Ordinal Scores Posttraumatic Cognitions Inventory Trauma Memory Questionnaire Interpretation of PTSD Symptoms Scale
2 secondary outcomes
Anger/aggression problems
Time frame: Post-therapy
Emotion Regulation
Time frame: Post-therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2013.
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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.
Julian Ford, Ph.D. principal investigator
UConn Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TARGET (Trauma Affect Regulation) and Prolonged Exposure in people with PTSD and Anger, run by UConn Health at 1 site 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 4 inclusion and 3 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 13 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Severity of PTSD symptoms (time frame: Post-therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2013.