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Digital CBT and Coaching for Depression in People with Disabilities

This study is testing if a mobile program called Toivoa-002 can help reduce depression in adults with hearing or mobility disabilities. Toivoa-002 combines digital cognitive behavioral therapy (CBT), a type of talk therapy, with personal coaching from a National Board Health and Wellness Coach (NBHWC). We want to see if Toivoa-002 works better than a similar-looking digital program that offers general health information but no depression treatment. To join, you need to be at least 22 years old, have a self-reported hearing or mobility disability, and have a diagnosis of depression with a specific score on a depression scale (HAM-D score of 17 or higher). The main goal is to see how much depression symptoms improve after 8 weeks. The study plans to enroll 200 people, but its current status is unclear.

Study design
This is a randomized clinical trial with two groups, meaning participants will be randomly assigned to either the Toivoa-002 program or the general health program. The study plans to enroll 200 participants.
What's involved
You would participate in the digital program for 8 weeks and be available for the duration of the study.
Compensation
Not stated in the trial record.
Follow-up
Your depression symptoms will be checked again at 12 weeks after the start of the study to see if the benefits last.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07195292

Reduction of Depression in People With Disabilities Through Dual Treatment: Digital CBT & NBHWC Coaching

Not Yet Recruiting
NAAges 22+InterventionalTreatment
Toivoa Inc
~200 participants
Updated 2026-07-20 on ClinicalTrials.gov
What's tested:Sham Digital Program - General health education and interactive quizzes unrelated to depression or CBT.Toivoa-002 - A digital Cognitive Behavioral Therapy program combined with NBHWC-certified coaching.

At a glance

Recruiting sites
0 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Hamilton Depression Rating Scale (HAM-D) from Baseline to Week 8
Measured over From Baseline to end of treatment (8 weeks)

Conditions

Hearing Disability
Depression
Mobility Disability

Explore related trials

Ability to mobilizeDepressionLearning disability

Where it's being run

4 sites across 4 states
Delaware1
New Jersey1
Ohio1
Texas1

Who to contact

Laura Randa
[email protected]
612-237-5896
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Provision of signed and dated informed consent form
Presence of self-reported hearing or mobility disability
Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study
Male or female, age 22 years or older
A score of 17 or higher on the HAM-D
Clinical diagnosis of depression based on DSM-5 diagnostic criteria
Willingness to adhere to the Toivoa-002 or sham regimen once per week, including scheduling and weekly meetings with coaches
Access to necessary resources for participating in a technology-based intervention (e.g., Android phone, iPhone, iPad, internet access)
Treatment stability (no changes in psychotropic medication or psychotherapy treatment in the 30 days prior to study entry)
Able to read and speak English fluently
Resident of the United States and living in the United States for the duration of the trial

Exclusion

Medical diagnosis of psychotic disorder or bipolar disorder
Participation in another treatment trial at the time of study
Substance use disorder in the past 12 months (excluding tobacco)
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).
Currently pregnant, breastfeeding, or planning to become pregnant during the treatment period

What this trial measures

  • Change in Hamilton Depression Rating Scale (HAM-D) from Baseline to Week 8From Baseline to end of treatment (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. Analyses will use a mixed model for repeated measures (MMRM) in the Intent-to-Treat (ITT) population including Baseline and Weeks 4 and 8 as repeated post-baseline measurements. The model will include fixed effects for treatment group, visit, treatment-by-visit interaction, study site, and Baseline HAM-D as a covariate. Within-participant correlation across repeated measurements will be modeled using a covariance structure. The primary treatment comparison will be the difference between treatment groups in least squares mean change from Baseline to Week 8. Statistical significance will be assessed based on the Week 8 treatment contrast from the MMRM. The estimated treatment difference, 95% confidence interval, and two-sided p-value will be reported.