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Development of an Accessible Cognitive Behavioral Therapy Digital Therapeutic for Individuals With Long COVID

Not Yet RecruitingNA

Sponsor: Toivoa Inc

Conditions: Long Covid, Depression, Anxiety

Interventions: Rauha® Digital Therapeutic Platform (Toivoa-004)

This study will evaluate Toivoa-004 as an experimental digital therapeutic for persons with Long COVID suffering from anxiety or depression. This study will evaluate the completion rates of the Toivoa-004 program and survey the user's experience upon completion. Changes in anxiety and depression scores will be monitored during the study.

Eligibility overview

Sex: ALL

Age: 22 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Provision of signed and dated informed consent form.
2. Presence of clinically diagnosed Long COVID.
3. Stated willingness to comply with all study procedures and lifestyle considerations, and availability for the duration of the study.
4. Males and females; Age 22 and above.
5. Clinical Diagnosis of Long COVID
6. Willingness to adhere to the study regiment.
7. Access to necessary resources for participating in a technology-based intervention (i.e., Phone, internet access).
8. Able to read and speak English fluently.
9. Resident of the US and living in the US for the duration of the study.

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Exclusion Criteria:

1. Self-reported substance use disorder. In the past 12 months (not including tobacco).
2. Self-reported suicide attempts in the past year or elevated suicide risk other than passive ideation (i.e., endorsing items reflecting intent, identifying means, suicide planning, or suicide-related preparations).
3. Currently pregnant or planning to become pregnant during the treatment period.