Psychological TraumaNCT01559688
Accelerated Resolution Therapy (ART) for Psychological Trauma
A study testing Accelerated Resolution Therapy (ART) and Waitlist in people with Psychological Trauma and PTSD, run by University of South Florida at 1 site in United States.
Trial summary
Service members and veterans often experience symptoms of psychological trauma following combat deployments. While efforts are being made in the military and at the Veteran's Affairs to meet the large number of soldiers and veterans experiencing symptoms of psychological trauma, there remains a need to evaluate new… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychological Trauma, PTSD
- What is being tested?
- Accelerated Resolution Therapy (ART) and Waitlist
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Oct 2013
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-active duty U.S. veteran of any prior deployment(s) with recruitment emphasis on those who previously served in Iraq and/or Afghanistan (OIF and OEF).
- At least 18 years of age.
- Symptoms indicative of psychological trauma. This includes a score of >40 on the PCL-M Checklist, or in the absence of a score >40, therapist assessment of symptoms of PTSD, as determined from the Checklist for Accelerated Resolution Therapy (ART) Standard Protocol. Individuals with previous treatment for psychological trauma, yet with residual symptoms, will be eligible.
- Ability to read and speak English to complete survey questions.
- Denial of suicidal ideation or intent, including homicidal ideation or intent, and no evidence of psychotic behavior or being in psychological crisis
Who cannot join
- Brain injury prohibiting speech, writing, and purposeful actions
- Identified to have current suicidal ideation
- Major psychiatric disorder concomitant to symptoms of psychological trauma
- Currently undergoing substance abuse treatment
- Previous diagnosis of eye movement disorder
- Any medical condition that, in the judgment of the Principal Investigator and/or ART therapist, may place the individual at high risk due to a potential heightened emotional reaction
Trial locations and contacts
1 site in 1 country.
About this study
Service members and veterans often experience symptoms of psychological trauma following combat deployments. While efforts are being made in the military and at the Veteran's Affairs to meet the large number of soldiers and veterans experiencing symptoms of psychological trauma, there remains a need to evaluate new treatments, particularly those that are designed to be brief in length.
A new therapy, known as Accelerated Resolution Therapy (ART), is a type of psychological therapy that is designed for rapid resolution of symptoms of psychological trauma. This approach uses a combination of talking and sets of eye movements guided by the therapist. During therapy, this interactive personal guidance is thought to be helpful in resolving problems (such as bad memories).
Read more
The purpose of this study is to:
- Evaluate how effective ART is in treating symptoms of psychological trauma among non-active duty veterans who served in Operation Iraqi Freedom and Operation Enduring Freedom in Iraq and in Afghanistan or other combat conflicts.
- Learn if there is improvement in symptoms of psychological trauma (such as bad memories, anxiety, depression, and guilt) after receiving Accelerated Resolution Therapy (ART).
- Conditions
- Psychological Trauma, PTSD
- Being tested
- Accelerated Resolution Therapy (ART), Waitlist
- Medical subject headings
- Psychological Trauma, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accelerated Resolution Therapy (ART)Behavioural
ART is a cognitive based therapy which integrates an eye movement technique while focusing on a problem (traumatic experience) during the therapy session.
WaitlistBehavioural
Fitness assessment or career counseling
| Study group | Role | What they receive |
|---|---|---|
| ART therapy group | Experimental | Participants in this arm will receive 2-5 sessions of ART therapy, depending on individual progress. Each session will last 60-90 minutes over a 2-week period. Receives: Behavioral: Accelerated Resolution Therapy (ART) |
| Waitlist | Active comparator | Participants in this group will receive 2 fitness assessment or career counseling sessions. Each session will last 60-90 minutes over a 2-week period. Upon completion of this arm, participants will be offered the choice to start ART therapy. Receives: Behavioral: Waitlist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PTSD Checklist (PCL-M) score from baseline to end of treatment
This questionnaire asks about symptoms in response to "stressful military experiences."
Measured: approximately 2 weeks
Secondary outcomes (7)
Change in psychological wellness as measured by Brief Symptom Inventory from baseline to endpoint
Measured: approximately 2 weeks
Change in trauma-related guilt as measured by Trauma-Related Guilt Inventory from baseline to endpoint
Measured: approximately 2 weeks
Change in depressive symptoms as measured by the Center for Epidemiologic Depression (CES-D) scale from baseline to endpoint
Measured: approximately 2 weeks
Change in anxiety symptoms as measured by State-Trait Inventory from baseline to endpoint
Measured: approximately 2 weeks
Change in anger as measured by Aggression Questionnaire from baseline to endpoint
Measured: approximately 2 weeks
Change in sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI) from baseline to endpoint
Measured: approximately 2 weeks
Change in self-compassion scale score from baseline to endpoint
Measured: approximately 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2012 (estimated)
- Study startJul 2011
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Psychological TraumaStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- 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
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Kevin Kip, PhD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01559688
- Sponsor's protocol ID
- TATRC-01
- Status last verified
- Oct 2013
- First submitted
- 19 Oct 2011
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Kip KE, Shuman A, Hernandez DF, Diamond DM, Rosenzweig L. Case report and theoretical description of accelerated resolution therapy (ART) for military-related post-traumatic stress disorder. Mil Med. 2014 Jan;179(1):31-7. doi: 10.7205/MILMED-D-13-00229.
PubMed 24402982Kip KE, Rosenzweig L, Hernandez DF, Shuman A, Sullivan KL, Long CJ, Taylor J, McGhee S, Girling SA, Wittenberg T, Sahebzamani FM, Lengacher CA, Kadel R, Diamond DM. Randomized controlled trial of accelerated resolution therapy (ART) for symptoms of combat-related post-traumatic stress disorder (PTSD). Mil Med. 2013 Dec;178(12):1298-309. doi: 10.7205/MILMED-D-13-00298.
PubMed 24306011
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated Resolution Therapy (ART) for Psychological Trauma
- ClinicalTrials.gov ID
- NCT01559688
- Acronym / sponsor ID
- TATRC-01
- Conditions
- Psychological Trauma, PTSD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Jul 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 21 Mar 2012 (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.
Service members and veterans often experience symptoms of psychological trauma following combat deployments. While efforts are being made in the military and at the Veteran's Affairs to meet the large number of soldiers and veterans experiencing symptoms of psychological trauma, there remains a need to evaluate new treatments, particularly those that are designed to be brief in length.
A new therapy, known as Accelerated Resolution Therapy (ART), is a type of psychological therapy that is designed for rapid resolution of symptoms of psychological trauma. This approach uses a combination of talking and sets of eye movements guided by the therapist. During therapy, this interactive personal guidance is thought to be helpful in resolving problems (such as bad memories).
The purpose of this study is to:
- Evaluate how effective ART is in treating symptoms of psychological trauma among non-active duty veterans who served in Operation Iraqi Freedom and Operation Enduring Freedom in Iraq and in Afghanistan or other combat conflicts.
- Learn if there is improvement in symptoms of psychological trauma (such as bad memories, anxiety, depression, and guilt) after receiving Accelerated Resolution Therapy (ART).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ART therapy group | Experimental | Behavioral: Accelerated Resolution Therapy (ART)Participants in this arm will receive 2-5 sessions of ART therapy, depending on individual progress. Each session will last 60-90 minutes over a 2-week period. |
| Waitlist | Active comparator | Behavioral: WaitlistParticipants in this group will receive 2 fitness assessment or career counseling sessions. Each session will last 60-90 minutes over a 2-week period. Upon completion of this arm, participants will be offered the choice to start ART therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Non-active duty U.S. veteran of any prior deployment(s) with recruitment emphasis on those who previously served in Iraq and/or Afghanistan (OIF and OEF).
- At least 18 years of age.
- Symptoms indicative of psychological trauma. This includes a score of >40 on the PCL-M Checklist, or in the absence of a score >40, therapist assessment of symptoms of PTSD, as determined from the Checklist for Accelerated Resolution Therapy (ART) Standard Protocol. Individuals with previous treatment for psychological trauma, yet with residual symptoms, will be eligible.
- Ability to read and speak English to complete survey questions.
- Denial of suicidal ideation or intent, including homicidal ideation or intent, and no evidence of psychotic behavior or being in psychological crisis
Key exclusion criteria (6 listed)
- Brain injury prohibiting speech, writing, and purposeful actions
- Identified to have current suicidal ideation
- Major psychiatric disorder concomitant to symptoms of psychological trauma
- Currently undergoing substance abuse treatment
- Previous diagnosis of eye movement disorder
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 |
|---|---|---|
| Accelerated Resolution Therapy (ART)ART is a cognitive based therapy which integrates an eye movement technique while focusing on a problem (traumatic experience) during the therapy session. | Behavioural | ART therapy group |
| WaitlistFitness assessment or career counseling | Behavioural | Waitlist |
Primary outcome
Change in PTSD Checklist (PCL-M) score from baseline to end of treatment
Time frame: approximately 2 weeks
This questionnaire asks about symptoms in response to "stressful military experiences."
7 secondary outcomes
Change in psychological wellness as measured by Brief Symptom Inventory from baseline to endpoint
Time frame: approximately 2 weeks
Change in trauma-related guilt as measured by Trauma-Related Guilt Inventory from baseline to endpoint
Time frame: approximately 2 weeks
Change in depressive symptoms as measured by the Center for Epidemiologic Depression (CES-D) scale from baseline to endpoint
Time frame: approximately 2 weeks
Change in anxiety symptoms as measured by State-Trait Inventory from baseline to endpoint
Time frame: approximately 2 weeks
Change in anger as measured by Aggression Questionnaire from baseline to endpoint
Time frame: approximately 2 weeks
Change in sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI) from baseline to endpoint
Time frame: approximately 2 weeks
Change in self-compassion scale score from baseline to endpoint
Time frame: approximately 2 weeks
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 29 Jul 2020.
- Derived from this study: PubMed 24402982Kip KE, Shuman A, Hernandez DF, Diamond DM, Rosenzweig L. Case report and theoretical description of accelerated resolution therapy (ART) for military-related post-traumatic stress disorder. Mil Med. 2014 Jan;179(1):31-7. doi: 10.7205/MILMED-D-13-00229.
- Derived from this study: PubMed 24306011Kip KE, Rosenzweig L, Hernandez DF, Shuman A, Sullivan KL, Long CJ, Taylor J, McGhee S, Girling SA, Wittenberg T, Sahebzamani FM, Lengacher CA, Kadel R, Diamond DM. Randomized controlled trial of accelerated resolution therapy (ART) for symptoms of combat-related post-traumatic stress disorder (PTSD). Mil Med. 2013 Dec;178(12):1298-309. doi: 10.7205/MILMED-D-13-00298.
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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.
Kevin Kip, PhD principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accelerated Resolution Therapy (ART) and Waitlist in people with Psychological Trauma and PTSD, run by University of South Florida 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 5 inclusion and 6 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 29 Jul 2020. 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?
Change in PTSD Checklist (PCL-M) score from baseline to end of treatment (time frame: approximately 2 weeks). 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 NCT01559688, which also lists 2 linked publications.
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 29 Jul 2020.