Light + Online Therapy for ADHD

Overseen By Maya Tooker, B.S.

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Must not be taking: Sleep medications, Photosensitizing medications

Disqualifiers: Bipolar, Psychosis, Autism, others

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

Compensation: Varies

Number of Visits: 8

6 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for teens with ADHD who struggle with late bedtimes and early waking. The treatment combines flashed light therapy, where participants receive daily light flashes, with online cognitive behavioral therapy sessions focused on sleep patterns. It targets teens aged 14-17 with ADHD who have difficulty going to bed before 11 p.m. and waking up in time for school. Participants should not have other severe mental health conditions or use medications that affect sleep. As an unphased trial, this study offers teens a unique opportunity to explore innovative treatments that could improve their sleep and daily functioning.

Will I have to stop taking my current medications?

The trial requires that you do not change any psychiatric medications within one month before starting the study and during the study. Also, you cannot use any over-the-counter or prescribed sleep medications in the past month or during the study.

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

Research has shown that light therapy, commonly used for seasonal depression, is generally safe. Studies have examined its effects and found it well-tolerated, with few side effects. Videoconference-based cognitive behavioral therapy (CBT) has also been used successfully for various mental health issues, such as anxiety and depression. Evidence from past patients indicates that this method is safe and practical, even when done remotely. Overall, both light therapy and online CBT have strong safety records, making them promising options for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Flashed Light Therapy for ADHD because it offers a non-invasive alternative to traditional medications and behavioral therapies. Unlike standard treatments that often rely on medications like stimulants, this therapy uses timed light flashes to potentially regulate circadian rhythms, which could enhance focus and attention. Additionally, when combined with cognitive-behavioral therapy delivered via videoconference, it may provide a comprehensive approach to managing ADHD symptoms, making it more accessible and flexible for participants. This dual approach has the potential to address both biological and behavioral aspects of ADHD in a novel way.

What evidence suggests that this trial's treatments could be effective for ADHD?

This trial will evaluate the effectiveness of Flashed Light Therapy and its combination with Cognitive Behavioral Therapy (CBT) for managing ADHD symptoms. Studies have shown that flashed light therapy can improve sleep patterns and reduce ADHD symptoms by using light exposure to reset the body's internal clock, often off-balance in people with ADHD. Research on adults with ADHD has found that using bright light in the morning significantly reduces ADHD symptoms and improves mood. In this trial, some participants will receive only Flashed Light Therapy, while others will receive both Flashed Light Therapy and CBT. Evidence suggests that combining CBT, which teaches new ways to handle thoughts and behaviors, leads to even more improvement. Specifically, CBT has been shown to reduce ADHD symptoms by 33% and also help with anxiety and depression in adults. Overall, these treatments show promise in managing ADHD symptoms and improving sleep. ^{1 2 3 5 6}

Who Is on the Research Team?

Emily J Ricketts, Ph.D.

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

This trial is for adolescents aged 14-17 with ADHD-combined type and delayed sleep-wake schedules. They must have trouble sleeping early, difficulty waking up, significant ADHD severity, an evening chronotype, and moderate to severe global functioning impairment. Participants need to be attending school during the study and fluent in English.

Inclusion Criteria

Age of 14 to 17 years

Current DSM-5 diagnosis of ADHD-combined presentation

Self-reported average bedtime of 11:00 pm or later, with difficulty shifting bedtime earlier and difficulty waking up early enough in the morning

Exclusion Criteria

Use of photosensitizing medication within one month of study enrollment or planned during the study

Travel across > 2 time zones in the past month or planned travel outside of the time zone of participation during the study

Structural barriers to sleep (e.g., night shift work, extracurriculars scheduled until late in the evening, early rising for sports practice)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Baseline Assessment

Participants undergo an 8-hour baseline assessment involving interviews, questionnaires, and saliva sampling to assess the internal body clock.

1 day

1 visit (in-person)

Treatment Phase 1

Participants receive daily flashed light therapy for 60 minutes, beginning 75 minutes prior to average morning wake time, for two weeks.

2 weeks

Daily self-administered

Mid-treatment Assessment

Participants complete an 8-hour mid-treatment assessment involving interviews, questionnaires, and saliva sampling.

1 day

1 visit (in-person)

Treatment Phase 2

Participants continue daily flashed light therapy combined with weekly 50-minute videoconference-delivered cognitive behavioral therapy for four weeks.

4 weeks

4 visits (virtual)

Post-treatment Assessment

Participants undergo an 8-hour post-treatment assessment involving interviews, questionnaires, and saliva sampling.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment.

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Flashed Light Therapy
• Videoconference-delivered Cognitive Behavioral Therapy

Trial Overview The study tests flashed light therapy alone for two weeks followed by a combination of daily light therapy with weekly videoconference-delivered cognitive behavioral therapy sessions targeting circadian rhythms and sleep over four weeks.

How Is the Trial Designed?

Group I: 1) Flashed Light Therapy, 2) Flashed Light Therapy with Cognitive Behavioral Therapy Experimental Treatment 2 Interventions

Treatment Phase 1 (2 weeks duration): light flashes administered for 60 minutes daily beginning 75 minutes prior to the participant's average morning wake time and ending 15 minutes before average morning wake time. Treatment Phase 2 (4 weeks duration): will begin immediately following phase 1 and involve daily light flashes (as described above) combined with weekly 50-minute videoconference-delivered cognitive-behavioral therapy.

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Published Research Related to This Trial

A randomized controlled trial with 22 participants showed that group parent training for ADHD delivered via videoconferencing is as effective as traditional face-to-face training, improving parents' disciplinary practices and children's global functioning.

Parents in the videoconference group reported statistically greater improvements in hyperactive symptoms compared to the face-to-face group, indicating that this method is not only effective but also well-accepted by parents, making it a valuable option for areas lacking ADHD treatment services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A study on the effectiveness of videoconferencing on teaching parent training skills to parents of children with ADHD. Xie, Y., Dixon, JF., Yee, OM., et al.[2013]

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06036420

Flashed Light Therapy for Adolescents with ADHD and ... The primary aim of the present research project is to examine the feasibility, as measured by treatment perceptions, and tolerability, as measured by adherence ...

2. withpower.com withpower.com/trial/phase-attention-deficit-disorder-with-hyperactivity-8-2023-0da83

Light + Online Therapy for ADHD Flashed Light Therapy is unique because it uses light exposure to help realign the body's internal clock, which can improve sleep patterns and reduce ADHD ...

3. trialx.com trialx.com/clinical-trials/listings/290881/flashed-light-therapy-for-adolescents-with-adhd-and-delayed-sleep-timing/?&geo_lat=34.1517492&geo_lng=-118.5214282&radius=10&place=Encino&user_country=United%20States

Flashed Light Therapy for Adolescents With ADHD and ... Clinical trial for ADHD , Flashed Light Therapy for Adolescents With ADHD and Delayed Sleep Timing.

4. ucla.clinicaltrials.researcherprofiles.org ucla.clinicaltrials.researcherprofiles.org/trial/NCT06036420

Flashed Light Therapy for Adolescents with ADHD and ... The primary aim of the present research project is to examine the feasibility, as measured by treatment perceptions, and tolerability, ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/17107243/

An open trial of light therapy in adult attention-deficit ... Results: Morning bright light therapy was associated with a significant decrease in both subjective and objective measures of core ADHD pathology, improved mood ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10434636/

Efficacy, safety and methodological quality of light therapy ... Reduction in ADHD symptom severity and improvement of sleep quality served as primary outcomes for the efficacy analysis. Any adverse events were recorded.