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.
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
13
A dual mental health treatment consisting of digitally-administered Cognitive Behavioral Therapy combined with National Board Health and Wellness Coach (NBHWC) trained Mental Health Coaches
The Steven A. Cohen Military Family Clinic at Endeavors
San Antonio, Texas, United States
Completion Rates as a Percentage of Enrolled Participants
Assess the proportion of the Intent to Treat population who remain active users of the program at the end of the 8-week primary study period. Completion rates will be reported as the percentage of enrolled users who continue to engage with the digital therapy per week.
Time frame: 8 weeks
Changes in Hamilton Anxiety Rating Scale (HAM-A) Scores Following Therapy
The Hamilton Anxiety Rating Scale (HAM-A) is a structured interview assessing anxiety symptoms using 14 items, each rated from 0 ("not present") to 4 ("severe"). Scores range from 0 to 56 with higher scores indicating more severe anxiety. Changes in HAM-A scores will be measured between two timepoints at Baseline and 8 weeks.
Time frame: 8 weeks
Changes in Hamilton Depression Rating Scale (HAM-D) Scores Following Therapy
The Hamilton Depression Rating Scale (HAM-D) is a structured interview assessing depression based on 17 items; items range from 0 ("not present") to 4 ("severe") and 0 ("absent") to 2 ("severe"). Total scores range 0 to 54 with higher scores indicating more severe depression. Changes in HAM-D scores will be measured between two timepoints at Baseline and 8 weeks.
Time frame: 8 weeks
Changes in Hamilton Anxiety Rating Scale (HAM-A) Scores 4 Weeks Post-therapy
The Hamilton Anxiety Rating Scale (HAM-A) is a structured interview assessing anxiety symptoms using 14 items, each rated from 0 ("not present") to 4 ("severe"). Scores range from 0 to 56 with higher scores indicating more severe anxiety. Changes in HAM-A scores will be measured between two timepoints at Baseline and 12 weeks.
Time frame: 12 weeks
Changes in Hamilton Depression Rating Scale (HAM-D) Scores 4 Weeks Post-therapy
The Hamilton Depression Rating Scale (HAM-D) is a structured interview assessing depression based on 17 items; items range from 0 ("not present") to 4 ("severe") and 0 ("absent") to 2 ("severe"). Total scores range 0 to 54 with higher scores indicating more severe depression. Changes in HAM-D scores will be measured between two timepoints at Baseline and 12 weeks.
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Time frame: 12 weeks