Bright Light Therapy for PTSD

(LIONv2 Trial)

Overseen By Joshua P Kreider

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Dementia, Bipolar, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 4 weeks

96 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether morning bright light therapy can help veterans manage symptoms related to the polytrauma clinical triad (PCT), which includes traumatic brain injury, post-traumatic stress disorder, and chronic pain. The main goal is to determine if improving sleep with bright light therapy can enhance quality of life and independence by reducing these interconnected challenges. Participants will sit in front of either a lightbox or a sham device (a fake treatment) every morning. Veterans with a history of brain injury and sleep disturbances might be suitable for this study. As an unphased trial, this study offers veterans the chance to explore a non-invasive treatment option that could improve their daily lives.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should be clinically stable on their current treatments for depression, anxiety, sleep, and pain.

What prior data suggests that bright light therapy is safe for treating PTSD?

Research shows that bright light therapy is generally easy for people to handle. It is safe and effective for treating conditions like seasonal affective disorder (SAD) and some types of depression. One study found that using morning light therapy for four weeks lowered stress and boosted mood. Another study reported better sleep and reduced PTSD symptoms with morning blue light therapy.

Most people experience no trouble with bright light therapy, and only a few report mild side effects like eye strain or headaches, which typically resolve quickly. Bright light therapy is non-invasive, meaning it doesn't involve surgery or needles, making it a comfortable choice for many. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Morning Bright Light Therapy for PTSD because it introduces a non-invasive and drug-free approach, unlike standard treatments that often involve medications like SSRIs or therapy sessions. This therapy involves sitting in front of a lightbox for an hour each morning, which may help regulate sleep patterns and improve mood by mimicking natural sunlight. Additionally, it offers a simple and accessible option with potentially fewer side effects, making it an appealing alternative or complement to existing treatments. The excitement stems from its potential to provide quick relief and enhance the quality of life for those with PTSD.

What evidence suggests that Morning Bright Light Therapy is effective for improving sleep and managing PCT symptoms?

Research has shown that bright light therapy in the morning can improve symptoms of post-traumatic stress disorder (PTSD). In one study, four weeks of morning light therapy reduced stress-related symptoms and decreased activity in the amygdala, the brain region associated with stress. Another study found that light therapy significantly improved PTSD symptoms. Additionally, bright light therapy has proven helpful as an adjunct treatment for other mood disorders, such as depression. In this trial, participants will receive either Morning Bright Light Therapy or a sham comparator using a Negative Ion Generator. These findings suggest that morning bright light therapy could help manage PTSD symptoms and enhance overall quality of life. ^{1 2 3 4 6}

Who Is on the Research Team?

Jonathan E Elliott, PhD

Principal Investigator

VA Portland Health Care System, Portland, OR

Are You a Good Fit for This Trial?

This trial is for veterans with the 'polytrauma clinical triad'—a combination of traumatic brain injury, post-traumatic stress disorder (PTSD), and chronic pain. Participants should be experiencing sleep disturbances and cognitive impairment related to these conditions.

Inclusion Criteria

I am currently experiencing problems with my sleep.

Veteran

English speaking with phone and internet access

Exclusion Criteria

Substance abuse within the past 6-12 months

I have significant weakness on one side of my body after a stroke.

Current usage of a lightbox or negative ion generator

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive morning bright light therapy or a sham treatment for 4 weeks

4 weeks

Daily home-based sessions

Follow-up

Participants are monitored for sleep, cognition, and PCT symptom management post-treatment

12 weeks

Assessments at 6 and 12 weeks post-intervention

What Are the Treatments Tested in This Trial?

Interventions

• Morning Bright Light Therapy

Trial Overview The study tests morning bright light therapy as a home-based treatment aimed at improving sleep quality in order to alleviate symptoms associated with the polytrauma clinical triad and enhance overall quality of life for veterans.

How Is the Trial Designed?

Group I: Morning Bright Light Therapy Experimental Treatment 1 Intervention

Morning bright light: Sitting in front of a lightbox for 60 minutes every morning within 120 minutes of waking up.

Group II: Negative Ion Generator Placebo Group 1 Intervention

Negative ion generator: Sitting in front of a modified negative ion generator for 60 min every morning within 120 minutes of waking up.

Morning Bright Light Therapy is already approved in United States, European Union for the following indications:

Approved in United States as Bright Light Therapy for:

• Seasonal Affective Disorder
• Nonseasonal Depression
• Circadian Rhythm Disorders
• Sleep Disturbances in Traumatic Brain Injury

Approved in European Union as Light Therapy for:

• Seasonal Affective Disorder
• Nonseasonal Depression
• Circadian Rhythm Disorders

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

In a study involving 24 individuals with traumatic brain injury or stroke, light therapy showed potential benefits in improving sleep quality, particularly for younger participants and those with an evening chronotype.

While no demographic or clinical variables significantly affected fatigue outcomes, the type of injury influenced reaction times, with stroke patients experiencing greater improvements than those with TBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors Associated With Response to Pilot Home-Based Light Therapy for Fatigue Following Traumatic Brain Injury and Stroke. Connolly, LJ., Rajaratnam, SMW., Spitz, G., et al.[2021]

Bright light therapy (BLT) can be beneficial for some patients with Alzheimer's-type dementia, as it may help reduce delusions and agitation, but caution is necessary due to potential adverse effects.

In one case, an 80-year-old woman experienced increased agitation and developed delusional symptoms after 14 days of BLT, leading to the treatment's discontinuation, which resulted in the rapid resolution of her symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paranoid delusions and hallucinations and bright light therapy in Alzheimer's disease. Schindler, SD., Graf, A., Fischer, P., et al.[2022]

Bright light therapy (BLT) showed significant antidepressant effects in three pregnant women, with a 33% improvement in depressive symptoms after 2 weeks and a 55% improvement after 4 weeks of treatment.

No side effects were reported during the BLT treatment, indicating it is a well-tolerated option for treating non-seasonal depression in pregnant women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Bright light therapy in pregnant women depression--3 case studies]. Krzystanek, M., Krupka-Matuszczyk, I.[2006]

In a study involving 20 healthy participants, a new bright light therapy (BLT) cabin showed no reports of headaches, which are a common side effect of conventional BLT devices.

While some participants experienced blurring of vision (21.1% prevalence), the absence of headaches suggests that this new technology may improve patient adherence to treatment for seasonal depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bright light therapy: Minimizing light induced side effects with an innovative light setup. Leichtfried, V., Kantner-Rumplmair, W., Bartenbach, C., et al.[2014]

A study involving 33 Veterans with mild traumatic brain injury (TBI) found that morning bright light therapy was feasible and well-accepted, with about 75% of participants rating the protocol favorably and high adherence rates (87% for lightbox use and 97% for sleep tracking).

Post-treatment, participants reported significant improvements in insomnia, mood, and pain, along with better sleep measured by actigraphy and favorable changes in blood biomarkers, suggesting that bright light therapy could be an effective intervention for sleep disturbances in TBI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and preliminary efficacy for morning bright light therapy to improve sleep and plasma biomarkers in US Veterans with TBI. A prospective, open-label, single-arm trial. Elliott, JE., McBride, AA., Balba, NM., et al.[2022]

In a study involving 95 patients with bipolar and unipolar depression, morning bright light therapy (BLT) showed significantly higher response (50% vs. 27.9%) and remission rates (28.8% vs. 11.6%) compared to a placebo after 14 days of treatment, indicating its potential efficacy for drug-resistant depression.

While the overall improvement in depression scores (HDRS-21) was not significantly different between the BLT and placebo groups, BLT was particularly effective in patients whose previous treatments had not worked well, suggesting it may be beneficial for a specific subset of patients with non-seasonal depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A sham-controlled randomized trial of adjunctive light therapy for non-seasonal depression. Chojnacka, M., Antosik-Wójcińska, AZ., Dominiak, M., et al.[2019]

In a pilot study involving 48 outpatients with major depressive disorder, Bright Light Therapy (BLT) significantly improved depressive symptoms after 3 weeks of daily treatment, with effects lasting for at least 4 weeks.

The study found no significant differences in the efficacy of BLT between patients with melancholic versus atypical features of depression, suggesting that BLT may be a versatile treatment option for various mood disorder subtypes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is there a difference in clinical efficacy of bright light therapy for different types of depression? A pilot study. Naus, T., Burger, A., Malkoc, A., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6721597/

A placebo-controlled pilot study of a wearable morning bright ... This study provides initial proof-of-concept that light treatment can improve PTSD. A larger trial is warranted to establish treatment efficacy. Keywords: ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165178124004943

A 4-week morning light treatment reduces amygdala ... The results suggest that 4 weeks of morning light treatment of at least 30 min per day can reduce amygdala reactivity and symptoms of traumatic stress.

3. mdpi.com mdpi.com/2077-0383/13/13/3926

Light Therapy in Post-Traumatic Stress Disorder LT was associated with a significant improvement in PTSD symptom severity in the single-arm study and two RCTs, as well as a greater retention of extinction ...

4. psychiatry.org psychiatry.org/news-room/apa-blogs/bright-light-therapy-beyond-seasonal-depression

Bright Light Therapy: Growing Evidence Beyond Seasonal ... A study published in JAMA Psychiatry in late 2024, found that bright light therapy was an effective supplementary treatment for depressive disorders other than ...

5. academic.oup.com academic.oup.com/milmed/article/187/3-4/e435/6122902

Bright Light Treatment of Combat-related PTSD The primary aims of this research were to examine the effects of bright light treatment for combat-related PTSD and associated morbidity.

6. frontiersin.org frontiersin.org/journals/behavioral-neuroscience/articles/10.3389/fnbeh.2022.886816/full

Morning blue light treatment improves sleep complaints ... BLUE light therapy was associated with improvements relative to correlated decreases between PTSD symptoms and sleep-related complaints.