Stress Disorders, Post-TraumaticNCT00371644
Treatment for Veterans With Military Sexual Trauma
A study testing Cognitive Processing Therapy and Present-Centered Therapy in people with Stress Disorders, Post-Traumatic and Depressive Symptoms, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of Cognitive Processing Therapy (CPT) versus Present-Centered Therapy (PCT) in treating current post-traumatic stress symptoms associated with sexual assault that occurred while veterans were serving in the military. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress Disorders, Post-Traumatic, Depressive Symptoms, Anxiety Symptoms
- What is being tested?
- Cognitive Processing 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
- 129 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Jun 2011
- 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
- Veteran (female or male) from any era with a current diagnosis of PTSD due to MST
- Experienced MST no less than 3 months prior to entering the trial
- Identify that MST is the trauma that is causing the worst current distress (if other traumas also experienced)
- Have at least one clear memory of the trauma (sufficient to write impact statement)
- Consent to be randomized into treatment
- Not receive other psychotherapy during the 6 weeks of active treatment
- (if on psychoactive medications) if new antidepressant, be on stable medication regimen for a minimum of 6 weeks prior to entering the trial (if recent changes to antidepressant dosage or additions or changes of antipsychotic or anti-anxiety medication, eligible immediately)
Who cannot join
- Current substance dependence
- Prior substance dependence that has not been in remission for at least 3 months
- Any current psychotic symptoms
- Current mania or unstable Bipolar Disorder
- Prominent current suicidal or homicidal features
- Any severe cognitive impairment or history of Organic Mental Disorder
- Current involvement in a violent relationship
Trial locations and contacts
1 site in 1 country.
United States1 site
VA North Texas Health Care System, Dallas
Dallas, Texas, 75216
About this study
Official title: Manualized Treatment for Veterans With Military Sexual Trauma
The purpose of this study is to evaluate the effectiveness of Cognitive Processing Therapy (CPT) versus Present-Centered Therapy (PCT) in treating current post-traumatic stress symptoms associated with sexual assault that occurred while veterans were serving in the military.
Read the detailed description
This study is designed to provide insight into effective treatment of veterans with current Post Traumatic Stress Disorder [PTSD] that resulted from sexual assault that occurred during their active military duty [MST]. This issue is of critical importance, as (1) Congress mandated VA to provide counseling to veterans with sexual trauma. (2) Based on the national MST surveillance data of 1.7 million VA patients, 22% of women and 1% of men have experienced MST. (3) With 20,000 Operation Iraqi Freedom [OIF] veterans having already sought healthcare since deployment, VA will begin to serve a higher percentage of women from combat zones, where the epidemiology of sexual assault and the efficacy of conventional treatments are essentially unknown. Finally, (4) findings from our MST-Study of 270 women veterans strongly suggests that MST is clinically different from civilian adult or child sexual trauma, bringing into question whether conventional civilian-based treatment will be effective with MST veterans.
Cognitive Processing Therapy (CPT) is a therapy developed to treat civilian rape-related PTSD. The efficacy of CPT has been shown with female civilians with sexual assault histories. However, there has not been any research examining the effectiveness of CPT in treating symptoms associated with sexual assault that occurs in military settings. The difference clinically between sexual assault in civilian and military settings is important, as revealed by our clinical experience and empirical findings. In working with veterans with MST for over 13 years we have noted that the assaults are often perpetrated by trusted military personnel and the victim is often without access to immediate treatment or care. Empirically, our research demonstrates that MST is associated with higher rates of PTSD compared to civilian sexual assault.
The primary goal of the study is to evaluate the effectiveness of CPT treatment versus Present Centered Therapy (PCT) for PTSD and associated symptoms resulting from MST. The study objectives will be met by three levels of hypotheses. Hypotheses focus on the primary outcome (PTSD symptoms), confirmatory outcomes (depression symptoms, quality of life), and exploratory outcomes (cost and utilization). Based on the results of the study, we intend to produce an educational CD-ROM, which will include a training manual to educate practitioners on the use of the more effective treatment with veterans. It will be designed for administration by clinicians who represent a range of disciplines (e.g., psychologists, nurses, social workers) and levels of training (e.g., bachelor through doctoral degrees).
This is a randomized controlled clinical trial involving veterans from the VA North Texas Healthcare System (VANTHCS). Data will be obtained from face-to-face interview and written questionnaires at baseline, treatment completion, 2-month, 4-month, and 6-month follow-ups. Patients will be randomized to one of two conditions (CPT or PCT). Patients will receive biweekly sessions of the respective individual therapy from trained therapists for a 6-week period (total of 12 sessions), followed by scheduled assessments. The primary endpoint is the CAPS score, a measure of PTSD severity. Secondary endpoints include anxiety, depression, quality of life, and healthcare utilization.
- Being tested
- Cognitive Processing Therapy, Present-Centered Therapy
- Keywords
- Stress Disorders, Post-Traumatic, Cognitive Processing Therapy, Military sexual trauma, Psychology, Military, Veterans, Rape, Veterans, psychology, Healthcare utilization
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression, Anxiety Disorders, Military Sexual Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Processing TherapyBehavioural
Also called CPT
CPT is a cognitive therapy based on information processing theory and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been altered because of the rape.
Present-Centered TherapyBehavioural
Also called PCT
PCT consists of general support and education focused on current issues in the patient's life. It emphasizes the focus on the individual's current life, and conceptualizes the problems addressed as manifestations of PTSD that, in some cases, may have been present for long periods of time. Emphasis is on problem solving and improving relationships. Connections are made between current problems and PTSD symptoms. PCT provides the emotional support for the trauma patient that is thought to help in recovery and helps the victim gain a better understanding of the nature of the patient's problems and connection with PTSD.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Participants receive 12 biweekly sessions of Cognitive Processing Therapy (CPT). Receives: Behavioral: Cognitive Processing Therapy |
| Arm 2 | Active comparator | Participants receive 12 biweekly sessions of Present Centered Therapy (PCT). Receives: Behavioral: Present-Centered Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Checklist (PCL)
The PCL is a 17-item self-report measure that is commonly used in clinical and research settings. All 17 items are summed to compute a total score of PTSD symptomatology. Scores for the PCL range from 17-85, with 85 indicating severe PTSD symptomatology. The PCL has strong psychometric properties and mirrors the symptomatology of the DSM.
Measured: Baseline assessment and then 4, follow-up assessments: at treatment completion, 2-month post treatment, 4-month post treatment, and 6-month post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2006 (estimated)
- Study startFeb 2007
- Primary completionJun 2010
- Study completionJun 2011
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 (9)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, Post-TraumaticStudies 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
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Alina M Suris, PhD, Principal investigator, VA North Texas Health Care System, Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00371644
- Sponsor's protocol ID
- D4445-R
- Other IDs
- IRB 06-036
- Status last verified
- Jan 2015
- First submitted
- 31 Aug 2006
- Last updated
- 15 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Suris A, Link-Malcolm J, Chard K, Ahn C, North C. A randomized clinical trial of cognitive processing therapy for veterans with PTSD related to military sexual trauma. J Trauma Stress. 2013 Feb;26(1):28-37. doi: 10.1002/jts.21765. Epub 2013 Jan 16.
PubMed 23325750Holliday R, Link-Malcolm J, Morris EE, Suris A. Effects of cognitive processing therapy on PTSD-related negative cognitions in veterans with military sexual trauma. Mil Med. 2014 Oct;179(10):1077-82. doi: 10.7205/MILMED-D-13-00309.
PubMed 25269124Mullen K, Holliday R, Morris E, Raja A, Suris A. Cognitive processing therapy for male veterans with military sexual trauma-related posttraumatic stress disorder. J Anxiety Disord. 2014 Dec;28(8):761-4. doi: 10.1016/j.janxdis.2014.09.004. Epub 2014 Sep 21.
PubMed 25260214O'Doherty L, Whelan M, Carter GJ, Brown K, Tarzia L, Hegarty K, Feder G, Brown SJ. Psychosocial interventions for survivors of rape and sexual assault experienced during adulthood. Cochrane Database Syst Rev. 2023 Oct 5;10(10):CD013456. doi: 10.1002/14651858.CD013456.pub2.
PubMed 37795783Holliday R, Holder N, Monteith LL, Suris A. Decreases in Suicide Cognitions After Cognitive Processing Therapy Among Veterans With Posttraumatic Stress Disorder Due to Military Sexual Trauma: A Preliminary Examination. J Nerv Ment Dis. 2018 Jul;206(7):575-578. doi: 10.1097/NMD.0000000000000840.
PubMed 29905663Wiblin J, Holder N, Holliday R, Suris A. Predictors of Unbearability, Unlovability, and Unsolvability in Veterans With Military-Sexual-Trauma-Related Posttraumatic Stress Disorder. J Interpers Violence. 2021 Apr;36(7-8):3814-3830. doi: 10.1177/0886260518777554. Epub 2018 May 31.
PubMed 29848187Holliday R, Holder N, Suris A. Reductions in self-blame cognitions predict PTSD improvements with cognitive processing therapy for military sexual trauma-related PTSD. Psychiatry Res. 2018 May;263:181-184. doi: 10.1016/j.psychres.2018.03.007. Epub 2018 Mar 14.
PubMed 29573657Holliday RP, Holder ND, Williamson MLC, Suris A. Therapeutic response to Cognitive Processing Therapy in White and Black female veterans with military sexual trauma-related PTSD. Cogn Behav Ther. 2017 Sep;46(5):432-446. doi: 10.1080/16506073.2017.1312511. Epub 2017 May 9.
PubMed 28485687Williams R, Holliday R, Clem M, Anderson E, Morris EE, Suris A. Borderline Personality Disorder and Military Sexual Trauma: Analysis of Previous Traumatization and Current Psychiatric Presentation. J Interpers Violence. 2017 Aug;32(15):2223-2236. doi: 10.1177/0886260515596149. Epub 2015 Jul 21.
PubMed 26198645
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manualized Treatment for Veterans With Military Sexual Trauma
- ClinicalTrials.gov ID
- NCT00371644
- Acronym / sponsor ID
- D4445-R
- Keywords
- Stress Disorders, Post-Traumatic, Cognitive Processing Therapy, Military sexual trauma, Psychology, Military, Veterans, Rape, Veterans, psychology, Healthcare utilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Feb 2007
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 4 Sep 2006 (estimated)
- Results
- Posted 16 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effectiveness of Cognitive Processing Therapy (CPT) versus Present-Centered Therapy (PCT) in treating current post-traumatic stress symptoms associated with sexual assault that occurred while veterans were serving in the military.
Detailed description
This study is designed to provide insight into effective treatment of veterans with current Post Traumatic Stress Disorder [PTSD] that resulted from sexual assault that occurred during their active military duty [MST]. This issue is of critical importance, as (1) Congress mandated VA to provide counseling to veterans with sexual trauma. (2) Based on the national MST surveillance data of 1.7 million VA patients, 22% of women and 1% of men have experienced MST. (3) With 20,000 Operation Iraqi Freedom [OIF] veterans having already sought healthcare since deployment, VA will begin to serve a higher percentage of women from combat zones, where the epidemiology of sexual assault and the efficacy of conventional treatments are essentially unknown. Finally, (4) findings from our MST-Study of 270 women veterans strongly suggests that MST is clinically different from civilian adult or child sexual trauma, bringing into question whether conventional civilian-based treatment will be effective with MST veterans.
Cognitive Processing Therapy (CPT) is a therapy developed to treat civilian rape-related PTSD. The efficacy of CPT has been shown with female civilians with sexual assault histories. However, there has not been any research examining the effectiveness of CPT in treating symptoms associated with sexual assault that occurs in military settings. The difference clinically between sexual assault in civilian and military settings is important, as revealed by our clinical experience and empirical findings. In working with veterans with MST for over 13 years we have noted that the assaults are often perpetrated by trusted military personnel and the victim is often without access to immediate treatment or care. Empirically, our research demonstrates that MST is associated with higher rates of PTSD compared to civilian sexual assault.
The primary goal of the study is to evaluate the effectiveness of CPT treatment versus Present Centered Therapy (PCT) for PTSD and associated symptoms resulting from MST. The study objectives will be met by three levels of hypotheses. Hypotheses focus on the primary outcome (PTSD symptoms), confirmatory outcomes (depression symptoms, quality of life), and exploratory outcomes (cost and utilization). Based on the results of the study, we intend to produce an educational CD-ROM, which will include a training manual to educate practitioners on the use of the more effective treatment with veterans. It will be designed for administration by clinicians who represent a range of disciplines (e.g., psychologists, nurses, social workers) and levels of training (e.g., bachelor through doctoral degrees).
This is a randomized controlled clinical trial involving veterans from the VA North Texas Healthcare System (VANTHCS). Data will be obtained from face-to-face interview and written questionnaires at baseline, treatment completion, 2-month, 4-month, and 6-month follow-ups. Patients will be randomized to one of two conditions (CPT or PCT). Patients will receive biweekly sessions of the respective individual therapy from trained therapists for a 6-week period (total of 12 sessions), followed by scheduled assessments. The primary endpoint is the CAPS score, a measure of PTSD severity. Secondary endpoints include anxiety, depression, quality of life, and healthcare utilization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Behavioral: Cognitive Processing TherapyParticipants receive 12 biweekly sessions of Cognitive Processing Therapy (CPT). |
| Arm 2 | Active comparator | Behavioral: Present-Centered TherapyParticipants receive 12 biweekly sessions of Present Centered Therapy (PCT). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Veteran (female or male) from any era with a current diagnosis of PTSD due to MST
- Experienced MST no less than 3 months prior to entering the trial
- Identify that MST is the trauma that is causing the worst current distress (if other traumas also experienced)
- Have at least one clear memory of the trauma (sufficient to write impact statement)
- Consent to be randomized into treatment
Key exclusion criteria (7 listed)
- Current substance dependence
- Prior substance dependence that has not been in remission for at least 3 months
- Any current psychotic symptoms
- Current mania or unstable Bipolar Disorder
- Prominent current suicidal or homicidal features
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 |
|---|---|---|
| Cognitive Processing TherapyAlso: CPTCPT is a cognitive therapy based on information processing theory and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been altered because of the rape. | Behavioural | Arm 1 |
| Present-Centered TherapyAlso: PCTPCT consists of general support and education focused on current issues in the patient's life. It emphasizes the focus on the individual's current life, and conceptualizes the problems addressed as manifestations of PTSD that, in some cases, may have been present for long periods of time. Emphasis is on problem solving and improving relationships. Connections are made between current problems and PTSD symptoms. PCT provides the emotional support for the trauma patient that is thought to help in recovery and helps the victim gain a better understanding of the nature of the patient's problems and connection with PTSD. | Behavioural | Arm 2 |
Primary outcome
PTSD Checklist (PCL)
Time frame: Baseline assessment and then 4, follow-up assessments: at treatment completion, 2-month post treatment, 4-month post treatment, and 6-month post treatment
The PCL is a 17-item self-report measure that is commonly used in clinical and research settings. All 17 items are summed to compute a total score of PTSD symptomatology. Scores for the PCL range from 17-85, with 85 indicating severe PTSD symptomatology. The PCL has strong psychometric properties and mirrors the symptomatology of the DSM.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23325750Suris A, Link-Malcolm J, Chard K, Ahn C, North C. A randomized clinical trial of cognitive processing therapy for veterans with PTSD related to military sexual trauma. J Trauma Stress. 2013 Feb;26(1):28-37. doi: 10.1002/jts.21765. Epub 2013 Jan 16.
- Results publication: PubMed 25269124Holliday R, Link-Malcolm J, Morris EE, Suris A. Effects of cognitive processing therapy on PTSD-related negative cognitions in veterans with military sexual trauma. Mil Med. 2014 Oct;179(10):1077-82. doi: 10.7205/MILMED-D-13-00309.
- Results publication: PubMed 25260214Mullen K, Holliday R, Morris E, Raja A, Suris A. Cognitive processing therapy for male veterans with military sexual trauma-related posttraumatic stress disorder. J Anxiety Disord. 2014 Dec;28(8):761-4. doi: 10.1016/j.janxdis.2014.09.004. Epub 2014 Sep 21.
- Derived from this study: PubMed 37795783O'Doherty L, Whelan M, Carter GJ, Brown K, Tarzia L, Hegarty K, Feder G, Brown SJ. Psychosocial interventions for survivors of rape and sexual assault experienced during adulthood. Cochrane Database Syst Rev. 2023 Oct 5;10(10):CD013456. doi: 10.1002/14651858.CD013456.pub2.
- Derived from this study: PubMed 29905663Holliday R, Holder N, Monteith LL, Suris A. Decreases in Suicide Cognitions After Cognitive Processing Therapy Among Veterans With Posttraumatic Stress Disorder Due to Military Sexual Trauma: A Preliminary Examination. J Nerv Ment Dis. 2018 Jul;206(7):575-578. doi: 10.1097/NMD.0000000000000840.
- Derived from this study: PubMed 29848187Wiblin J, Holder N, Holliday R, Suris A. Predictors of Unbearability, Unlovability, and Unsolvability in Veterans With Military-Sexual-Trauma-Related Posttraumatic Stress Disorder. J Interpers Violence. 2021 Apr;36(7-8):3814-3830. doi: 10.1177/0886260518777554. Epub 2018 May 31.
- Derived from this study: PubMed 29573657Holliday R, Holder N, Suris A. Reductions in self-blame cognitions predict PTSD improvements with cognitive processing therapy for military sexual trauma-related PTSD. Psychiatry Res. 2018 May;263:181-184. doi: 10.1016/j.psychres.2018.03.007. Epub 2018 Mar 14.
- Derived from this study: PubMed 28485687Holliday RP, Holder ND, Williamson MLC, Suris A. Therapeutic response to Cognitive Processing Therapy in White and Black female veterans with military sexual trauma-related PTSD. Cogn Behav Ther. 2017 Sep;46(5):432-446. doi: 10.1080/16506073.2017.1312511. Epub 2017 May 9.
- Derived from this study: PubMed 26198645Williams R, Holliday R, Clem M, Anderson E, Morris EE, Suris A. Borderline Personality Disorder and Military Sexual Trauma: Analysis of Previous Traumatization and Current Psychiatric Presentation. J Interpers Violence. 2017 Aug;32(15):2223-2236. doi: 10.1177/0886260515596149. Epub 2015 Jul 21.
Related trials for Stress Disorders, Post-Traumatic
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
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.
Alina M Suris, PhD principal investigator
VA North Texas Health Care System, Dallas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Processing Therapy and Present-Centered Therapy in people with Stress Disorders, Post-Traumatic and Depressive Symptoms, run by US Department of Veterans Affairs 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 7 inclusion and 7 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 15 Jan 2015. 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?
Yes. Results are posted in the registry (first posted 16 Dec 2014). 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?
PTSD Checklist (PCL) (time frame: Baseline assessment and then 4, follow-up assessments: at treatment completion, 2-month post treatment, 4-month post treatment, and 6-month post treatment). 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 NCT00371644, which also lists 9 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 15 Jan 2015.