Clinical trial NCT06477913: Exploratory Study for Toivoa-001 on Human Factors
Official title: Exploratory Study for Reduction of Anxiety and Depression Through Dual Mental Health Treatment: Digital-Based Cognitive Behavioral Therapy and National Board Health and Wellness Coaches (NBHWC) For People With Disabilities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Depression
Disability Physical
Keywords: Digital Therapeutics
Lead sponsor: Toivoa Inc
Sponsor class: INDUSTRY
Collaborators: name: Family Endeavors, Inc DBA Endeavors
name: Advarra
First posted: 2024-06-27
Enrollment: 13
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

Detailed description: The Investigators propose a single-arm controlled trial evaluating (Rauha) plus usual care as an intervention for persons actively seeking treatment for anxiety and/or depression. Recruitment will occur at a single US health facility where approximately 30 adults with disabilities and clinically elevated anxiety and/or depressive symptoms will be we will recruited and enrolled. Eligible participants will be administered Rauha as a remote app with site oversight. Patients will be monitored and encouraged by Mental Health Coaches to complete the therapy. Mental Health Coaches will also provide instruction on completion of modules. Patients will engage with the Rauha app, have the opportunity to complete all 33 modules, receive Mental Health Coach support, and engage with the online community for a total of 8 weeks. The community forum feature will provide patients access to a community forum that understands the specific struggles of the condition, allowing users to interact with one another via an online community designed for empowerment and support. Support from a Mental Health Coach will be provided at prescribed intervals and will also be available to each participant in addition to access to the online community. A participant is considered to have completed the study if he or she has completed all assessments. The end of the study is defined as completion of the 4 week follow-up assessment

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. -

Primary outcomes:
measure: Therapy dropout rates as a percentage of enrolled participants
timeFrame: 8 weeks
Secondary outcomes:
measure: Changes in numeric GAD-7 Assessment scores following therapy.
timeFrame: 8 weeks
measure: Changes in numeric PHQ-9 Assessment scores following therapy.
timeFrame: 8 weeks
measure: Changes of numeric GAD-7 Assessment scores from completion through 4-weeks post therapy.
timeFrame: 12 weeks
measure: Changes of numeric PHQ-9 Assessment scores from completion through 4-weeks post therapy.
timeFrame: 12 weeks
Other outcomes:
measure: User Experience Survey
timeFrame: 8 weeks
measure: User Acceptability Survey
timeFrame: 8 weeks
measure: System Usability Survey
timeFrame: 8 weeks
Locations:
city: San Antonio
country: United States
facility: The Steven A. Cohen Military Family Clinic at Endeavors
state: Texas
Study officials:
affiliation: Collaborator
name: Jill Palmer
role: PRINCIPAL_INVESTIGATOR
References: