Cognitive and Light Therapy for Post-Traumatic Stress Disorder

Not yet recruiting at 1 trial location

Overseen By Amy J Jak, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Substance use disorder, Psychotic disorder, Severe TBI, Macular degeneration, Bipolar, others

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

Compensation: Varies

Number of Visits: 8

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to assist Veterans with both PTSD (post-traumatic stress disorder) and mild TBI (traumatic brain injury). It tests two treatment combinations: one merges Compensatory Cognitive Training with Morning Bright Light Therapy, while the other pairs the training with a Negative Ion Generator. The aim is to determine which treatment more effectively improves thinking, mood, sleep, and overall daily life. Veterans who served after 9/11, have PTSD and mild TBI, and experience mood or sleep difficulties may be suitable for this study. As an unphased trial, it offers Veterans the chance to explore innovative treatments that could enhance their quality of life.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Compensatory Cognitive Training (CCT) and Morning Bright Light Therapy (MBLT) may help reduce PTSD symptoms. Studies have found that light therapy can significantly lessen the severity of these symptoms. For example, one study discovered that bright light therapy was more effective in treating PTSD symptoms than other treatments. Another study indicated that patients with PTSD generally found light therapy acceptable and easy to use, suggesting it is usually well-tolerated.

Further research on morning bright light therapy has shown positive results for people with PTSD symptoms, confirming its safety and effectiveness. Most participants experience few side effects, indicating the treatment is safe for use. While these findings are encouraging, individual experiences can differ. Consulting a healthcare provider before joining a clinical trial is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer new approaches to managing PTSD symptoms. Unlike most treatments that focus on psychotherapy or medications like SSRIs, Compensatory Cognitive Training (CCT) combined with Morning Bright Light Therapy (MBLT) uses a non-pharmaceutical approach by enhancing cognitive skills and leveraging natural light to potentially boost mood and cognitive function. The CCT with a Negative Ion Generator (ION) arm explores the impact of air quality on mental health, aiming to improve symptoms through environmental changes. These innovative methods could provide alternative or complementary options to traditional PTSD treatments, potentially offering faster or more sustainable relief.

What evidence suggests that this trial's treatments could be effective for PTSD and mTBI?

This trial will compare two treatment combinations for PTSD: Compensatory Cognitive Training (CCT) with Morning Bright Light Therapy (MBLT) and CCT with a Negative Ion Generator (ION). Research has shown that CCT and MBLT can benefit people with PTSD. Several studies have proven that light therapy significantly reduces PTSD symptoms, making it easier for individuals to feel better and manage stress. It also improves sleep, which is often challenging for those with PTSD. The combination of CCT and MBLT aims to enhance thinking skills and overall mental health. These therapies offer promising improvements in both mental performance and quality of life. ^{1 2 5 6 7}

Who Is on the Research Team?

Elizabeth W. Twamley, PhD

Principal Investigator

VA San Diego Healthcare System, San Diego, CA

Are You a Good Fit for This Trial?

This trial is for post-9/11 Veterans with mild traumatic brain injury (mTBI) and PTSD, who are experiencing cognitive concerns, depression, or sleep disturbances. They must be able to consent and live independently. Exclusions include substance abuse, severe TBI, psychotic disorders, untreated sleep apnea, macular degeneration or bipolar disorder.

Inclusion Criteria

Post 9/11 Veterans enrolled at VA San Diego or VA Portland

Ability to provide informed consent

History of mTBI confirmed by OSU-TBI

Exclusion Criteria

Current substance use disorder with less than 30 days abstinence

History of primary psychotic disorder

Not working night or swing shift schedules

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Compensatory Cognitive Training combined with either Morning Bright Light Therapy or Negative Ion Generator for 10 weeks

10 weeks

Baseline, mid-treatment (5 weeks), post-treatment (10 weeks)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

3-month follow-up

What Are the Treatments Tested in This Trial?

Interventions

• Compensatory Cognitive Training (CCT) and Morning Bright Light Therapy (MBLT)
• Compensatory Cognitive Training (CCT) and Negative Ion Generator (ION)

Trial Overview The study compares two treatments: Compensatory Cognitive Training (CCT) combined with Morning Bright Light Therapy (MBLT), versus CCT paired with a Negative Ion Generator (ION). It aims to improve cognition and mental health in Veterans by addressing depression and sleep issues.

How Is the Trial Designed?

Group I: CCT+MBLT Experimental Treatment 1 Intervention

Compensatory Cognitive Training + Morning Bright Light Therapy

Group II: CCT+ION Placebo Group 1 Intervention

Compensatory Cognitive Training + Negative Ion Generator

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Portland VA Medical Center

Collaborator

Trials

44

Recruited

7,800+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07055633

Improving Cognitive Rehabilitation Outcomes The investigators aim to compare CCT+MBLT with CCT+ION for improving cognition, functioning, and secondary outcomes in Veterans with mTBI+PTSD.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11242885/

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 ...

3. bbrfoundation.org bbrfoundation.org/content/early-morning-bright-light-therapy-helped-patients-ptsd-symptoms

Early-Morning Bright-Light Therapy Helped Patients with ... Researchers have obtained encouraging results in using bright-light therapy to treat people with symptoms of post-traumatic stress disorder (PTSD).

4. ohsu.edu ohsu.edu/school-of-medicine/psychiatry-research/compensatory-cognitive-training-research-program-cctrp

Compensatory Cognitive Training Research Program ... This program aims to address the growing need for cognitive rehabilitation interventions and looks to understand the efficacy of treatments.

5. news.arizona.edu news.arizona.edu/news/morning-blue-light-treatment-improves-sleep-patients-ptsd

Morning blue light treatment improves sleep in patients ... The results of a recent study suggest that blue-wavelength light therapy may be useful for improving sleep and reducing PTSD symptoms.

6. researchgate.net researchgate.net/publication/348884626_Bright_Light_Treatment_of_Combat-related_PTSD_A_Randomized_Controlled_Trial

(PDF) Bright Light Treatment of Combat-related PTSD The bright light also elicited a significantly greater rate of treatment response (reduction ≥33%) for the CAPS (44.1% vs. 8.6%) and PCL-M (33% ...

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

A placebo-controlled pilot study of a wearable morning bright ... A wearable morning light treatment was acceptable and feasible for patients with probable PTSD. This study provides initial proof-of-concept that light ...