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Exploratory Study for Toivoa-001 on Human Factors

CompletedNA

Sponsor: Toivoa Inc

Conditions: Anxiety Depression, Disability Physical

Interventions: Rauha

Countries: United States

The Study will evaluate Rauha as an experimental digital therapeutic for persons with Disabilities suffering from anxiety and/or depression. The study will evaluate completion rates of the 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 self-reported hearing or mobility disability.
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. Score of 10 or greater on the Patient Health Questionnaire-9 (PHQ-9) or Generalized Anxiety Disorder-7 (GAD-7) (to be assessed post-study-specific screening consent).
6. Willingness to adhere to the study regiment.
7. Access to necessary resources for participating in a technology-based intervention (i.e., iPhone, internet access).
8. Treatment stability (no changes in psychotropic medication or psychotherapy treatment in the 30 days before study entry).
9. Able to read and speak English fluently.
10. Resident of the US and living in the US for the duration of the trial. -

Exclusion Criteria:

1. Medical diagnosis of psychotic disorder or bipolar disorder.
2. Participation in another treatment trial at the time of study.
3. Substance use disorder. In the past 12 months (not including tobacco).
4. Suicide attempt 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).
5. Currently pregnant or planning to become pregnant during the treatment period. -

Locations (1)

San Antonio, Texas, United States