Posttraumatic Stress DisorderNCT02869646
Acupuncture for PTSD
A study testing Procedure: Acupuncture in people with Posttraumatic Stress Disorder, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Current treatments for Veterans with PTSD include medications and therapy where the patient talks about traumatic events in order to desensitize to them. While these treatments work for many, a large minority of Veterans do not want medications or exposure therapy. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Procedure: Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2018to 30 Dec 2022
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Inclusion criteria are meant to recruit a relatively homogeneous yet generalizable sample of Veterans with at least moderate chronic PTSD due to combat trauma. Criteria are:
- Veterans age 18 to 55
- DSM-5 criteria for chronic PTSD on the Clinician Administered PTSD Scale (CAPS-5)
- At least moderate PTSD by having a total CAPS-5 score of > 26 and meeting criteria for each of 4 symptom clusters.
- Eligible persons will be allowed to have other symptoms that are commonly comorbid with PTSD. This strategy will provide a feasible and generalizable sample of those with chronic PSTD, but these will not be inclusion or exclusion criteria, e.g.,:
- anxiety
- mild to moderate depression
- Women and minorities will be recruited
Who cannot join
- Exclusion criteria are meant to keep out individuals with characteristics that are known to be PTSD treatment confounds, that may significantly affect biological assessment, that indicate past non-adherence or treatment resistance, or who may be put at risk of harm. Criteria are:
- Current and past six-months psychosis
- Substance dependence (evidence of tolerance and/or withdrawal) within the past 6 months
- Thyroid disease
- Decisional incapacity (e.g., dementia)
- Centrally acting medications that have a potential effect on biological expression, e.g.:,
Show all 32Show fewer
- beta-blockers
- opiates
- >10mg equivalent of diazepam/day
- Pain levels requiring opiate medications
- Known exposure to chemicals or physical trauma that cause neuropsychiatric sequelae
- Severe depression (Beck Depression Inventory-II score >30) that is deemed more clinically significant than PTSD, since this may bias accurate PTSD diagnosis and biological measures
- A diagnosed and untreated sleep breathing disorder (SBD) which is a treatment confound
- A high risk of a SBD as indicated by snoring >50 of nights plus one of:
- any witnessed apnea
- feeling non-refreshed in the morning >50 of mornings
- daytime sleepiness indicated by falling asleep with routine tasks such as watching TV or reading
- Non-response to >2 evidence-based PTSD treatments
- adequate medication of 12 weeks or completion of Prolonged Exposure (PE)
- Cognitive Processing Therapy (CPT)
- or an intensive program
- Treatment non-adherence indicated by stopping treatment or >3 missed appointments in the course of a PTSD Evidenced-Based Treatment (EBT)
- High dissociation as indicated by a score of >25 on the Dissociative Experiences Scale - II (Bernstein \& Putnam, 1986)
- Past chronic PTSD prior to military service
- Current active psychotherapy for PTSD
- Having acupuncture in the past year
- Pregnancy
- A person who is on a stable dose (8 weeks) of medication for:
- depression
- anxiety
- PTSD
- or for sleep, or any other psychoactive medication that may confound the study, and who meet entering criteria and will continue these medications for the duration of the trial will not be excluded (list in Appendix 5)
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, 90822
About this study
Official title: Acupuncture for PTSD in Combat Veterans
Current treatments for Veterans with PTSD include medications and therapy where the patient talks about traumatic events in order to desensitize to them. While these treatments work for many, a large minority of Veterans do not want medications or exposure therapy. The investigators developed an acupuncture (ACU) treatment for PTSD in order to broaden treatment options. The investigators' first study showed that it helped most people. However, the investigators need better scientific evidence that it works by comparing ACU to a placebo, such as "sham" acupuncture (fewer needles in non-important sites) and determining if ACU alters abnormal physiology in PTSD. In this study 90 Veterans will be randomly assigned (like a coin flip) to receive either ACU or sham. The investigators expect to find that the ACU treated patients have more improvement in PTSD and in physiology (less startle reaction - assessed non-invasively using skin sensors) than the patients in the sham group. This study will provide information to support the use of acupuncture for PTSD at the VA, which will expand treatment options.
Read the detailed description
Posttraumatic Stress Disorder (PTSD) is debilitating and common (up to 30% in Vietnam Veterans and 16% in Afghanistan and Iraq Veterans). A significant number of Veterans do not engage in or drop-out from effective trauma-focused therapies due to avoidance from trauma-related memories. Because of this limitation, and because scientific literature suggested that acupuncture might be effective for PTSD symptoms, the investigators developed an acupuncture intervention for PTSD and conducted a clinical trial that showed positive effects. This remains the only high quality trial of acupuncture for PTSD published, because of which the current VA/DoD guidelines for PTSD state that acupuncture is a "B" recommendation (fair evidence, provide service) for PTSD treatment. That civilian study compared acupuncture to an effective therapy (CBT) and a wait-list control, but did not have a placebo control. And, research has shown that Veterans may respond differently to therapies than civilians. More definitive data about the efficacy of acupuncture for PTSD is required in order to recommend it as an "A" evidence-based intervention for PTSD in Veterans. Specifically, it is important to show that acupuncture is better than a placebo control and that it has effects on biological abnormalities of PTSD. The aim of this study is to demonstrate efficacy of acupuncture for PTSD by showing clinical and biological effects that are statistically larger and clinically more important than effects of "sham" acupuncture. Given current knowledge and the need for efficient, ethical and best practices within an experimental design, the primary aim is best accomplished by a randomized controlled trial comparing verum acupuncture (ACU) to placebo minimal needling sham acupuncture (MIN). The goal is to evaluate ACU for a significant positive signal, not to compare ACU to other interventions or to evaluate treatment durability. Acupuncture is delivered in 24 sessions over 12 weeks. The primary hypothesis is that efficacy of ACU for PTSD symptom severity will be large (pre- to post-treatment Cohen's d > 0.8), and significantly better than MIN (between group Cohen's d > 0.30, with 80% probability of detecting a true group difference at p<0.05 (2-sided). The secondary hypothesis is that compared to MIN, ACU will be associated with a significantly larger change from pre- to post-treatment in psychophysiological response (decreased startle by EMG eyeblink during fear conditioning procedure). The study design is a two-arm, parallel-group, prospective randomized controlled trial (RCT). The sample frame is Veterans with chronic PTSD with a sample of convenience from those seeking care at the Long Beach VA. Exclusion criteria are meant to keep out individuals with characteristics that are known to be PTSD treatment confounds, associated with non-adherence or negative response to treatment, that may significantly affect biological assessment, or who may be put at risk of harm. The sample size (90) provides adequate power to test hypotheses. Subjects will be allocated to intervention group by computer-generated adaptive randomization. General linear mixed models will be used to evaluate hypothesized effects over time (mid treatment, end of treatment, 1-month follow-up), controlling for baseline severity of symptoms and demographic characteristics (e.g., age, gender) using intent-to-treat modeling. Outcome effect size (Cohen's d) within and between subjects will be calculated. Interaction terms will be included in the models to evaluate treatment fidelity and treatment expectancy as potential moderators. Study results will provide clinicians and policy makers with more information to make decisions about the rational use of acupuncture for PTSD. This is important because acupuncture is being touted for PTSD by many advocates. It has the potential to reach PTSD sufferers who are not willing to engage in trauma-focused psychotherapy, or for whom current therapies are ineffective. The objective of this project is consistent with priority research areas of specific interest to Clinical Science Research \& Development (CSR\&D) including PTSD and complementary medicine, and all participants are Veterans at a VA Hospital.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Procedure: Acupuncture, Procedure: Sham acupuncture
- Keywords
- PTSD, acupuncture, integrative medicine
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedure: AcupunctureProcedure or surgery
Also called Traditional Chinese Medicine
Acupuncture is a general term indicating the insertion and stimulation of needles at one or more prescribed points in order to effect the biology of the individual.
Procedure: Sham acupunctureProcedure or surgery
Also called Placebo acupuncture
Sham acupuncture is a general term indicating the use of needles, whether inserted or not, at points on the body that are not expected to have a clinically significant biological effect.
| Study group | Role | What they receive |
|---|---|---|
| Verum acupuncture | Experimental | Traditional Chinese Medicine (TCM) based acupuncture at prescribed sites Receives: Procedure: Procedure: Acupuncture |
| Minimal needling | Sham comparator | shallow and non-acupoint needles at same number of sites Receives: Procedure: Procedure: Sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PTSD Symptom Severity on the Clinician Administered PSTD Scale - CAPS 5 From Before to After Treatment
The Clinician Administered PTSD Scale (CAPS) (Blake et al, 1995) is a structured diagnostic interview for PTSD. The CAPS-5 based on DSM-5 criteria will be used. CAPS-5 has 20 symptom items, each rated from 0 (absent) to 4 (severe). A rating of >2 is considered a positive score for diagnostic purposes. The DSM-5 diagnostic rule requires the presence of least one Criterion B symptom, one Criterion C symptom, two Criterion D symptoms, and two Criterion E symptoms in addition to other impairment criteria. The minimum score is 0; the maximum score is 80. A higher score is more severe symptoms and a worse outcome. A DSM-5 CAPS cutoff score of >26 AND meeting each of the 4 symptom cluster criterion will be used for study inclusion and outcomes.
Measured: Baseline and 12 weeks
Secondary outcomes (1)
Percentage Change From Baseline in Eyeblink Startle Potentiation
The startle response, measured with electromyography (EMG) of the eyeblink, provides an ideal translational tool to investigate fear conditioning and extinction, since the amygdala is directly connected with the startle circuit. The raw EMG signal will be recorded at a rate of 1000 Hz throughout the experimental session using a 28 Hz high pass and 500 Hz low pass filter (as recommended by guidelines for human eyeblink startle in Blumenthal et al., 2005; Psychophysiology, 42:1-15). Raw signals will be stored and exported for analysis in microvolt ( V) values.
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2016 (estimated)
- Study start5 Apr 2018
- Primary completion15 Jun 2022
- Study completion30 Dec 2022
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 (2)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Analydata, Inc.
- Responsible party
- Sponsor
- Investigators
- Michael Hollifield, MD, Principal investigator, VA Long Beach Healthcare System, Long Beach, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02869646
- Sponsor's protocol ID
- CLNA-02-15F
- Status last verified
- Apr 2024
- First submitted
- 9 Aug 2016
- Last updated
- 18 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hollifield M, Hsiao AF, Smith T, Calloway T, Jovanovic T, Smith B, Carrick K, Norrholm SD, Munoz A, Alpert R, Caicedo B, Frousakis N, Cocozza K. Acupuncture for Combat-Related Posttraumatic Stress Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2024 Jun 1;81(6):545-554. doi: 10.1001/jamapsychiatry.2023.5651.
PubMed 38381417Hollifield M, Hsiao AF, Carrick K, Gory Munoz A, Calloway T, Cocozza K, Smith B, Smith T, Jovanovic T, Norrholm S, Sokhadze E, Reist C. Acupuncture for combat post-traumatic stress disorder: trial development and methodological approach for a randomized controlled clinical trial. Trials. 2021 Sep 6;22(1):594. doi: 10.1186/s13063-021-05394-3.
PubMed 34488824
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for PTSD in Combat Veterans
- ClinicalTrials.gov ID
- NCT02869646
- Acronym / sponsor ID
- CLNA-02-15F
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- PTSD, acupuncture, integrative medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Analydata, Inc.
- Study start
- 5 Apr 2018 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 17 Aug 2016 (estimated)
- Results
- Posted 18 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Current treatments for Veterans with PTSD include medications and therapy where the patient talks about traumatic events in order to desensitize to them. While these treatments work for many, a large minority of Veterans do not want medications or exposure therapy. The investigators developed an acupuncture (ACU) treatment for PTSD in order to broaden treatment options. The investigators' first study showed that it helped most people. However, the investigators need better scientific evidence that it works by comparing ACU to a placebo, such as "sham" acupuncture (fewer needles in non-important sites) and determining if ACU alters abnormal physiology in PTSD. In this study 90 Veterans will be randomly assigned (like a coin flip) to receive either ACU or sham. The investigators expect to find that the ACU treated patients have more improvement in PTSD and in physiology (less startle reaction - assessed non-invasively using skin sensors) than the patients in the sham group. This study will provide information to support the use of acupuncture for PTSD at the VA, which will expand treatment options.
Detailed description
Posttraumatic Stress Disorder (PTSD) is debilitating and common (up to 30% in Vietnam Veterans and 16% in Afghanistan and Iraq Veterans). A significant number of Veterans do not engage in or drop-out from effective trauma-focused therapies due to avoidance from trauma-related memories. Because of this limitation, and because scientific literature suggested that acupuncture might be effective for PTSD symptoms, the investigators developed an acupuncture intervention for PTSD and conducted a clinical trial that showed positive effects. This remains the only high quality trial of acupuncture for PTSD published, because of which the current VA/DoD guidelines for PTSD state that acupuncture is a "B" recommendation (fair evidence, provide service) for PTSD treatment. That civilian study compared acupuncture to an effective therapy (CBT) and a wait-list control, but did not have a placebo control. And, research has shown that Veterans may respond differently to therapies than civilians. More definitive data about the efficacy of acupuncture for PTSD is required in order to recommend it as an "A" evidence-based intervention for PTSD in Veterans. Specifically, it is important to show that acupuncture is better than a placebo control and that it has effects on biological abnormalities of PTSD. The aim of this study is to demonstrate efficacy of acupuncture for PTSD by showing clinical and biological effects that are statistically larger and clinically more important than effects of "sham" acupuncture. Given current knowledge and the need for efficient, ethical and best practices within an experimental design, the primary aim is best accomplished by a randomized controlled trial comparing verum acupuncture (ACU) to placebo minimal needling sham acupuncture (MIN). The goal is to evaluate ACU for a significant positive signal, not to compare ACU to other interventions or to evaluate treatment durability. Acupuncture is delivered in 24 sessions over 12 weeks. The primary hypothesis is that efficacy of ACU for PTSD symptom severity will be large (pre- to post-treatment Cohen's d > 0.8), and significantly better than MIN (between group Cohen's d > 0.30, with 80% probability of detecting a true group difference at p<0.05 (2-sided). The secondary hypothesis is that compared to MIN, ACU will be associated with a significantly larger change from pre- to post-treatment in psychophysiological response (decreased startle by EMG eyeblink during fear conditioning procedure). The study design is a two-arm, parallel-group, prospective randomized controlled trial (RCT). The sample frame is Veterans with chronic PTSD with a sample of convenience from those seeking care at the Long Beach VA. Exclusion criteria are meant to keep out individuals with characteristics that are known to be PTSD treatment confounds, associated with non-adherence or negative response to treatment, that may significantly affect biological assessment, or who may be put at risk of harm. The sample size (90) provides adequate power to test hypotheses. Subjects will be allocated to intervention group by computer-generated adaptive randomization. General linear mixed models will be used to evaluate hypothesized effects over time (mid treatment, end of treatment, 1-month follow-up), controlling for baseline severity of symptoms and demographic characteristics (e.g., age, gender) using intent-to-treat modeling. Outcome effect size (Cohen's d) within and between subjects will be calculated. Interaction terms will be included in the models to evaluate treatment fidelity and treatment expectancy as potential moderators. Study results will provide clinicians and policy makers with more information to make decisions about the rational use of acupuncture for PTSD. This is important because acupuncture is being touted for PTSD by many advocates. It has the potential to reach PTSD sufferers who are not willing to engage in trauma-focused psychotherapy, or for whom current therapies are ineffective. The objective of this project is consistent with priority research areas of specific interest to Clinical Science Research \& Development (CSR\&D) including PTSD and complementary medicine, and all participants are Veterans at a VA Hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verum acupuncture | Experimental | Procedure: Procedure: AcupunctureTraditional Chinese Medicine (TCM) based acupuncture at prescribed sites |
| Minimal needling | Sham comparator | Procedure: Procedure: Sham acupunctureshallow and non-acupoint needles at same number of sites |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Inclusion criteria are meant to recruit a relatively homogeneous yet generalizable sample of Veterans with at least moderate chronic PTSD due to combat trauma. Criteria are:
- Veterans age 18 to 55
- DSM-5 criteria for chronic PTSD on the Clinician Administered PTSD Scale (CAPS-5)
- At least moderate PTSD by having a total CAPS-5 score of > 26 and meeting criteria for each of 4 symptom clusters.
- Eligible persons will be allowed to have other symptoms that are commonly comorbid with PTSD. This strategy will provide a feasible and generalizable sample of those with chronic PSTD, but these will not be inclusion or exclusion criteria, e.g.,:
Key exclusion criteria (32 listed)
- Exclusion criteria are meant to keep out individuals with characteristics that are known to be PTSD treatment confounds, that may significantly affect biological assessment, that indicate past non-adherence or treatment resistance, or who may be put at risk of harm. Criteria are:
- Current and past six-months psychosis
- Substance dependence (evidence of tolerance and/or withdrawal) within the past 6 months
- Thyroid disease
- Decisional incapacity (e.g., dementia)
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 |
|---|---|---|
| Procedure: AcupunctureAlso: Traditional Chinese MedicineAcupuncture is a general term indicating the insertion and stimulation of needles at one or more prescribed points in order to effect the biology of the individual. | Procedure or surgery | Verum acupuncture |
| Procedure: Sham acupunctureAlso: Placebo acupunctureSham acupuncture is a general term indicating the use of needles, whether inserted or not, at points on the body that are not expected to have a clinically significant biological effect. | Procedure or surgery | Minimal needling |
Primary outcome
Change in PTSD Symptom Severity on the Clinician Administered PSTD Scale - CAPS 5 From Before to After Treatment
Time frame: Baseline and 12 weeks
The Clinician Administered PTSD Scale (CAPS) (Blake et al, 1995) is a structured diagnostic interview for PTSD. The CAPS-5 based on DSM-5 criteria will be used. CAPS-5 has 20 symptom items, each rated from 0 (absent) to 4 (severe). A rating of >2 is considered a positive score for diagnostic purposes. The DSM-5 diagnostic rule requires the presence of least one Criterion B symptom, one Criterion C symptom, two Criterion D symptoms, and two Criterion E symptoms in addition to other impairment criteria. The minimum score is 0; the maximum score is 80. A higher score is more severe symptoms and a worse outcome. A DSM-5 CAPS cutoff score of >26 AND meeting each of the 4 symptom cluster criterion will be used for study inclusion and outcomes.
1 secondary outcome
Percentage Change From Baseline in Eyeblink Startle Potentiation
Time frame: Baseline, 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38381417Hollifield M, Hsiao AF, Smith T, Calloway T, Jovanovic T, Smith B, Carrick K, Norrholm SD, Munoz A, Alpert R, Caicedo B, Frousakis N, Cocozza K. Acupuncture for Combat-Related Posttraumatic Stress Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2024 Jun 1;81(6):545-554. doi: 10.1001/jamapsychiatry.2023.5651.
- Derived from this study: PubMed 34488824Hollifield M, Hsiao AF, Carrick K, Gory Munoz A, Calloway T, Cocozza K, Smith B, Smith T, Jovanovic T, Norrholm S, Sokhadze E, Reist C. Acupuncture for combat post-traumatic stress disorder: trial development and methodological approach for a randomized controlled clinical trial. Trials. 2021 Sep 6;22(1):594. doi: 10.1186/s13063-021-05394-3.
- Individual participant dataSharing planned: No
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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.
Michael Hollifield, MD principal investigator
VA Long Beach Healthcare System, Long Beach, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Procedure: Acupuncture in people with Posttraumatic Stress Disorder, run by VA Office of Research and Development 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 8 inclusion and 32 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 18 Apr 2024. 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. Some participants in this study may receive a placebo. 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 18 Apr 2024). 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?
Change in PTSD Symptom Severity on the Clinician Administered PSTD Scale - CAPS 5 From Before to After Treatment (time frame: Baseline and 12 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 NCT02869646, 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 18 Apr 2024.