Is Daylight suitable for you?

Daylight is a digital therapeutic intended for the improvement of worry and anxiety and the management of Generalized Anxiety Disorder (GAD) in adults aged 18 years and older, as an adjunct to their usual medical care.

For adults diagnosed with GAD, Daylight should be used under the supervision of a healthcare professional.

For otherwise healthy adults who have difficulty with worry and anxiety, Daylight may be used as a non-prescription self-help tool to improve overall mental health and wellbeing.

Daylight may be suitable for you if:

• You are experiencing difficulties with worry and anxiety or Generalized Anxiety Disorder symptoms
• You are able to read, hear, and understand English
• You have been diagnosed with Generalized Anxiety Disorder and are under the care of a doctor
• You have stable physical and mental health
• You have regular access to a computer or mobile device with periodic access to the internet

Please read the Instructions for Use (IFU) document to review Daylight’s intended use, safety information, and further resources. The IFU document is provided during the signup process. If you have been previously diagnosed with Generalized Anxiety Disorder (GAD), you should contact your doctor before using Daylight.

Daylight is a fully automated digital worry and anxiety improvement program based on CBT

Daylight is a fully automated digital worry and anxiety improvement program based on techniques from cognitive behavioral therapy (CBT) for worry and anxiety. CBT techniques have been studied in many different formats, including in-person therapy, self-help books, and digital programs. These techniques have been shown to be effective in helping many people reduce their worry and anxiety^1-4.

Daylight is a personalized self-help program with specific guidance based on your particular problematic thoughts, behaviors, and responses to worry and anxiety. Daylight is designed to be like CBT in that it is “collaborative.” The program guides you through a range of techniques and you decide what to put into practice. One of the key features of Daylight is that it is designed for you to use how you want, when you want.

For best results, we recommend using the program for a few minutes each day. This will speed up your learning and help you feel better faster. Our research indicates that many people begin to see benefits after using the program consistently for 3 to 4 weeks, and see more lasting changes after 6 weeks of regular use.

Daylight is not a replacement or substitute for other medical or mental health treatment.

Daylight is not a replacement for other medical or mental health care and should not be solely or primarily relied upon to treat psychiatric conditions. Do not disregard professional medical advice or delay seeking care because of information you encounter within Daylight. We do not advise making any changes to your current mental health treatment (e.g., changes to therapy or medication) before or while using Daylight without the consultation of your doctor. If you are currently taking antidepressant medication for mood or anxiety disorders, there is no need to make any changes prior to using Daylight. Research has shown that these medications do not compromise the potential benefit of the CBT techniques that Daylight is based on⁵. There is some evidence that regular use of anti-anxiety medications classified as benzodiazepines (e.g., Xanax, Klonopin, Valium) can dampen the experience of emotions and interfere with memory, both of which research suggests may render CBT techniques less effective⁶. Please be aware, however, that abrupt discontinuation or tapering (i.e., suddenly stopping or decreasing the amount taken) of these medications requires extreme caution, and should never be done without the aid of a doctor. Always seek advice from your doctor before making any changes to your current treatments. We strongly recommend that you consult a doctor if at any time you are concerned about your physical or mental health.

Daylight is not intended for crisis support

Daylight is not intended to provide crisis support. If you are experiencing a crisis or medical emergency, including suicidal thoughts:

• In the United States, call 911 or go to your nearest emergency room. For the National Suicide Lifeline call 988.
• In the United Kingdom, call NHS 111, call your GP, or go to your nearest A&E department.
• For other regions, please contact your local emergency services, or go to your nearest hospital emergency room.

Daylight may not be suitable for everyone.

Daylight may not be suitable for individuals with certain mental health symptoms, such as thoughts of self-harm, suicide, or violence toward others; substance use problems; psychosis or mania; or symptoms that compromise thinking and decision-making (e.g., dementia or other cognitive impairments). If you experience any of these symptoms, consult with a doctor before using Daylight.

Daylight is not a 'magic bullet' solution for worry and anxiety.

The CBT techniques that Daylight is based on have been shown to be highly effective in providing long-term relief from worry and anxiety. However, they are not a 'passive' solution, nor is Daylight. CBT techniques require sustained and significant effort for improvements to be achieved. Daylight can teach you about these techniques, but it will be up to you to practice them. We recommend starting Daylight when you are prepared to make a commitment of a few minutes each day for at least a month.

Worry and anxiety are very common in conjunction with a range of health conditions including cancer, pain, as well as during periods of hormonal changes (e.g., during and after pregnancy, menopause). There is good evidence that the CBT techniques within Daylight can help people improve their feelings of worry and anxiety even in the context of such health conditions. However, it is recommended that you consult with a doctor before using Daylight if you have an existing health condition, are pregnant or recently have been pregnant.

The Daylight program is not recommended for people under the age of 18.

Although adverse events from CBT techniques are rare, there are some potential risks and thus Daylight may not be suitable for everyone. For CBT to work well, it does involve facing your worries and fears. So, there is a risk that you may feel some discomfort and anxiety as you use Daylight. This is actually how CBT works, and is quite normal. Of course, Daylight is there to support you. The program takes things a step at a time and at your own pace. You can also change some of the exercises to suit you better. For example, there is a relaxation program where you tense your muscles before relaxing them. If you find that too painful, you can modify it, or skip it altogether.

Daylight should not be used to confront or challenge fears related to traumatic experiences or memories. Consult your doctor if you need help with difficulties related to a trauma. If you find that any part of the program is too much, or that you are getting more anxious, you should take it more slowly and gradually. It is also okay to stop completely. In that case we advise that you speak to your doctor about getting further help.

Technology requirements

If you have any questions, please contact our team at hello@trydaylight.com.

In accordance with FDA’s Current Enforcement Discretion Policy for Digital Health Devices for Psychiatric Disorders, for patients aged 18 years and older, who are followed by and diagnosed with Generalized Anxiety Disorder (GAD) by a medical provider, Daylight is available as an adjunct to their usual medical care for GAD. Daylight does not replace the care of a medical provider or the patient’s medication. Daylight has not been cleared by the U.S. Food and Drug Administration (FDA) for this indication.

1 Andrews, G., Basu, A., Cuijpers, P., Craske, M. G., McEvoy, P., English, C. L., & Newby, J. M. (2018). Computer therapy for the anxiety and depression disorders is effective, acceptable and practical health care: an updated meta-analysis. Journal of Anxiety Disorders, 55, 70-78.

2 Carpenter, J. K., Andrews, L. A., Witcraft, S. M., Powers, M. B., Smits, J. A., & Hofmann, S. G. (2018). Cognitive behavioral therapy for anxiety and related disorders: A meta‐analysis of randomized placebo‐controlled trials. Depression and Anxiety, 35(6), 502-514.

3 Loerinc, A. G., Meuret, A. E., Twohig, M. P., Rosenfield, D., Bluett, E. J., & Craske, M. G. (2015). Response rates for CBT for anxiety disorders: Need for standardized criteria. Clinical Psychology Review, 42, 72-82.

4 Stewart, R. E., & Chambless, D. L. (2009). Cognitive–behavioral therapy for adult anxiety disorders in clinical practice: A meta-analysis of effectiveness studies. Journal of Consulting and Clinical Psychology, 77(4), 595.

5 Power, K. G., Simpson, R. J., Swanson, V., Wallace, L. A., Feistner, A. T. C., & Sharp, D. (1990). A controlled comparison of cognitive-behaviour therapy, diazepam, and placebo, alone and in combination, for the treatment of generalised anxiety disorder. Journal of Anxiety Disorders, 4(4), 267-292.

6 Otto, M. W., Smits, J. A., & Reese, H. E. (2006). Combined psychotherapy and pharmacotherapy for mood and anxiety disorders in adults: review and analysis. Focus, 12(2), 72-214.