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Reduction of Depression Through Dual Treatment: Digital CBT & NBHWC Coaching

Reduction of Depression Through Dual Mental Health Treatment: Digital-Based Cognitive Behavioral Therapy and National Board for Health and Wellness Coaching (NBHWC) Mental Health Coaches

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
22 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests Toivoa-002, a mobile program that combines therapy to help change thoughts and behaviors (CBT) with personal coaching. It is for adults age 22 or older who have depression and a hearing or movement disability. The study compares it with a similar-looking program without active treatment over 8 weeks, then checks whether benefits last through a 12-week follow-up.

The purpose of this study is to see if a mobile-delivered mental health program called Toivoa-002, which combines digital cognitive behavioral therapy (CBT) with personal coaching, can effectively reduce depression in adults with hearing or mobility disabilities. The study aims to answer whether this dual-intervention digital service is more effective at lowering depression symptoms over an 8-week period than a "sham" digital program that is developed to look similar but does not contain active therapeutic content. The investigators hypothesize that participants who use the Toivoa-002 program will show significantly greater reductions in depression compared to those using the sham program, and that these mental health benefits will last through a 12-week follow-up. Adults within the disability community frequently encounter unique environmental and societal barriers - such as limited physical accessibility, transportation challenges, and workplace inflexibility - that can directly drive or worsen depression. By offering a fully remote and accessible mobile tool, this study seeks to determine if a digital health service can deliver scalable, effective depression relief tailored to the lived experiences of people with disabilities.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 22 or older and report having a hearing or movement disability.
  • Have depression diagnosed by a clinician and score 17 or higher on the HAM-D, a scale that measures depression.
  • Sign and date a form agreeing to join the study.
  • Be willing to follow study rules and be available for the whole study.
  • Be willing to use the assigned program once a week and schedule and attend weekly coaching meetings.
  • Have access to a device, such as an Android phone, iPhone, or iPad, and the internet.
  • Have no changes to mental health medicines or talk therapy in the 30 days before joining.
  • Read and speak English fluently, be a U.S. resident, and live in the U.S. throughout the study.

Who can't join

  • Have bipolar disorder or a psychotic disorder, which can affect a person's sense of what is real.
  • Be taking part in another treatment study.
  • Have had a substance use disorder, involving problems with alcohol or drug use, in the past 12 months. Tobacco use does not count.
  • Have attempted suicide in the past year or have a raised suicide risk, such as intent, a plan, or preparations. Passive thoughts alone do not count.
  • Be pregnant, breastfeeding, or planning to become pregnant during treatment.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 Criteria: * 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

Study sites (4)

DE

NJ

OH

TX