Posttraumatic Stress DisorderNCT00701064
Bright Light: An Adjunct Treatment for Combat Posttraumatic Stress Disorder (PTSD)
A study testing Bright Light Exposure and Negative Ion Generator in people with Posttraumatic Stress Disorder, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The investigators are testing novel treatments for combat PTSD: bright light exposure and negation ion exposure. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Bright Light Exposure and Negative Ion Generator
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2009to 2 Sep 2019
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Veteran of Operation Iraqi Freedom or Operation Enduring Freedom with Posttraumatic Stress Disorder
- receiving other treatment or stopped other treatment prior to study
Who cannot join
- bipolar disorder
- psychosis
- alcohol/drug abuse
Trial locations and contacts
1 site in 1 country.
United States1 site
Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC
Columbia, Arizona, 29209
About this study
Official title: Bright Light: An Adjunct Treatment for Combat PTSD
The investigators are testing novel treatments for combat PTSD: bright light exposure and negation ion exposure.
Read the detailed description
Seventy Operation Iraqi Freedom (OIF)/Operation Enduring Freedom (OEF) Veterans with posttraumatic stress disorders (PTSD) will be randomly assigned to one of two 4-week treatments (45 min/day): (1) bright light exposure or (2) a negative ion generator. Clinical assessments ,as well as self-reported measures of PTSD, anxiety, depression, and sleep will be assessed
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Bright Light Exposure, Negative Ion Generator
- Keywords
- posttraumatic stress disorder, phototherapy, anxiety, depression, sleep, negative ion generator
- Medical subject headings
- Stress Disorders, Post-Traumatic, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bright Light ExposureOther
Administered via bright light box
Negative Ion GeneratorOther
Administered via Negative Ion Generatore
| Study group | Role | What they receive |
|---|---|---|
| Bright Light Exposure | Experimental | Bright Light (30 min/day) Receives: Other: Bright Light Exposure |
| Negative Ion Generator | Placebo comparator | Negative Ion Generator (30 min/day) Receives: Other: Negative Ion Generator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Assessed PTSD Scale (CAPS-2)
The CAPS-2 is administered by a trained clinician. It is designed to assess changes in PTSD severity over time, the scale ranges from 0-136. Higher levels indicate greater severity of PTSD.
Measured: Mean change from baseline to post-treatment (5-6 weeks later)
Clinical Global Impressions Scale (CGI)
The CGI assesses baseline severity on a 7-point scale, and change on 7-point scale. (1=normal; 4=moderately ill; 7= among the most severely ill). Change: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse
Measured: Baseline severity to post-treatment (4 weeks later) Change
Secondary outcomes (1)
Posttraumatic Stress Disorder Checklist (PCL-M)
Self-rated PTSD scale with 17 items (rated 1-5) with range of 17-85. Higher score = worse severity of PTSD. Reported are decreases from baseline to end-of-study.
Measured: Baseline to following 4-week treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2008 (estimated)
- Study start1 Jan 2009
- Primary completion21 Nov 2012
- Study completion2 Sep 2019
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.
- 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
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Arizona State University
- Responsible party
- Sponsor
- Investigators
- Shawn D. Youngstedt, PhD, Principal investigator, Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00701064
- Sponsor's protocol ID
- MHBA-008-08S
- Status last verified
- Sep 2019
- First submitted
- 17 Jun 2008
- Last updated
- 24 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bright Light: An Adjunct Treatment for Combat PTSD
- ClinicalTrials.gov ID
- NCT00701064
- Acronym / sponsor ID
- MHBA-008-08S
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- posttraumatic stress disorder, phototherapy, anxiety, depression, sleep, negative ion generator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Arizona State University
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 21 Nov 2012 (actual)
- Study completion
- 2 Sep 2019 (actual)
- First posted
- 19 Jun 2008 (estimated)
- Results
- Posted 29 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators are testing novel treatments for combat PTSD: bright light exposure and negation ion exposure.
Detailed description
Seventy Operation Iraqi Freedom (OIF)/Operation Enduring Freedom (OEF) Veterans with posttraumatic stress disorders (PTSD) will be randomly assigned to one of two 4-week treatments (45 min/day): (1) bright light exposure or (2) a negative ion generator. Clinical assessments ,as well as self-reported measures of PTSD, anxiety, depression, and sleep will be assessed
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bright Light Exposure | Experimental | Other: Bright Light ExposureBright Light (30 min/day) |
| Negative Ion Generator | Placebo comparator | Other: Negative Ion GeneratorNegative Ion Generator (30 min/day) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Veteran of Operation Iraqi Freedom or Operation Enduring Freedom with Posttraumatic Stress Disorder
- receiving other treatment or stopped other treatment prior to study
Key exclusion criteria (3 listed)
- bipolar disorder
- psychosis
- alcohol/drug abuse
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 |
|---|---|---|
| Bright Light ExposureAdministered via bright light box | Other | Bright Light Exposure |
| Negative Ion GeneratorAdministered via Negative Ion Generatore | Other | Negative Ion Generator |
Primary outcome
Clinical Assessed PTSD Scale (CAPS-2)
Time frame: Mean change from baseline to post-treatment (5-6 weeks later)
The CAPS-2 is administered by a trained clinician. It is designed to assess changes in PTSD severity over time, the scale ranges from 0-136. Higher levels indicate greater severity of PTSD.
Clinical Global Impressions Scale (CGI)
Time frame: Baseline severity to post-treatment (4 weeks later) Change
The CGI assesses baseline severity on a 7-point scale, and change on 7-point scale. (1=normal; 4=moderately ill; 7= among the most severely ill). Change: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse
1 secondary outcome
Posttraumatic Stress Disorder Checklist (PCL-M)
Time frame: Baseline to following 4-week treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Shawn D. Youngstedt, PhD principal investigator
Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bright Light Exposure and Negative Ion Generator 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 2 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 24 Sep 2019. 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 29 Apr 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?
Clinical Assessed PTSD Scale (CAPS-2) (time frame: Mean change from baseline to post-treatment (5-6 weeks later)). The study lists 2 primary outcomes in all. 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 24 Sep 2019.