Anxiety Depression, Disability Physical
Conditions
Keywords
Digital Therapeutics
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
Interventions
DEVICERauha
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
Sponsors
Toivoa Inc
Family Endeavors, Inc DBA Endeavors
Advarra
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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. -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion Rates as a Percentage of Enrolled Participants | 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Hamilton Anxiety Rating Scale (HAM-A) Scores Following Therapy | 8 weeks | 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. |
| Changes in Hamilton Depression Rating Scale (HAM-D) Scores Following Therapy | 8 weeks | 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. |
| Changes in Hamilton Anxiety Rating Scale (HAM-A) Scores 4 Weeks Post-therapy | 12 weeks | 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. |
| Changes in Hamilton Depression Rating Scale (HAM-D) Scores 4 Weeks Post-therapy | 12 weeks | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJill Palmer
Collaborator
Participant flow
Recruitment details
Participants were recruited through approved study flyers at Endeavors Programs in San Antonio, Texas, as well as through other approved recruitment channels, including clinical and community referrals.
Pre-assignment details
No one enrolled in the study dropped from participating prior to initiating (and completing) the intervention.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 34.42 Years STANDARD_DEVIATION 13.51 |
| Hamilton Anxiety Rating Scale (HAM-A) | 21.69 Scores on a scale STANDARD_DEVIATION 9.35 |
| Hamilton Depression Rating Scale (HAM-D) | 19.92 Scores on a scale STANDARD_DEVIATION 5.14 |
| Race/Ethnicity, Customized Race/ethnicity Black or African descent | 1 Participants |
| Race/Ethnicity, Customized Race/ethnicity Declined to disclose race/ethnicity | 4 Participants |
| Race/Ethnicity, Customized Race/ethnicity Hispanic | 1 Participants |
| Race/Ethnicity, Customized Race/ethnicity Two or more races | 2 Participants |
| Race/Ethnicity, Customized Race/ethnicity White | 5 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 13 |
| other Total, other adverse events | 0 / 13 |
| serious Total, serious adverse events | 0 / 13 |
Outcome results
None listed