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

Trial Summary

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 data supports the effectiveness of the treatment Morning Bright Light Therapy for PTSD?

Research shows that morning bright light therapy can improve sleep and mood in veterans with traumatic brain injury, which often co-occurs with PTSD. This suggests it might also help with PTSD symptoms, as better sleep and mood are important for managing PTSD. ^{1 2 3 4 5}

Is bright light therapy safe for humans?

Bright light therapy is generally considered safe for humans, with few side effects reported. Some studies noted minor issues like blurring, but no serious side effects were observed. ^{6 7 8 9 10}

How is Morning Bright Light Therapy different from other treatments for PTSD?

Morning Bright Light Therapy is unique because it uses light exposure to help manage PTSD symptoms, particularly by addressing related issues like depression, anxiety, and sleep disturbances, with minimal side effects compared to traditional treatments. ^{6 8 9 11 12}

What is the purpose of this trial?

The "polytrauma clinical triad" (PCT), a highly disabling constellation of factors, is defined by the coexistence of traumatic brain injury, post-traumatic stress disorder, and chronic pain. Veterans with the PCT are medically complex, often refractory to conventional therapies, and suffer from additional related chronic sequela. Notably, sleep disturbances and cognitive impairment, which the investigators hypothesize are significant contributing factors to these functional impairments and an impediment toward rehabilitation. Thus, the investigators' research aims to intervene "at the level of sleep", and by improving sleep, improve these interconnected, disabling, and difficult to treat enduring complexities associated with the PCT - ultimately to improve Veteran quality of life, functional independence, and restorative function. The investigators predict that the proposed intervention, morning bright light therapy, which is cost-effective, rapidly deployable and home-based, will be effective in improving sleep and overall PCT symptom management, thereby, resulting in a measurable and impactful improvement in quality of life.

Research Team

Jonathan E Elliott, PhD

Principal Investigator

VA Portland Health Care System, Portland, OR

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Evaluation of cognitive restructuring for post-traumatic stress disorder in people with severe mental illness. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Evidence-based treatment of post-traumatic stress disorder. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Interdisciplinary residential treatment of posttraumatic stress disorder and traumatic brain injury: effects on symptom severity and occupational performance and satisfaction. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Factors Associated With Response to Pilot Home-Based Light Therapy for Fatigue Following Traumatic Brain Injury and Stroke. [2021]

5. United States 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. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Bright Light Treatment of Combat-related PTSD: A Randomized Controlled Trial. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Bright light therapy: Minimizing light induced side effects with an innovative light setup. [2014]

8. Netherlands pubmed.ncbi.nlm.nih.gov

A sham-controlled randomized trial of adjunctive light therapy for non-seasonal depression. [2019]

9. Poland pubmed.ncbi.nlm.nih.gov

[Bright light therapy in pregnant women depression--3 case studies]. [2006]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Is there a difference in clinical efficacy of bright light therapy for different types of depression? A pilot study. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Paranoid delusions and hallucinations and bright light therapy in Alzheimer's disease. [2022]

12. Switzerland pubmed.ncbi.nlm.nih.gov

The Efficacy of Light Therapy in the Treatment of Seasonal Affective Disorder: A Meta-Analysis of Randomized Controlled Trials. [2020]