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

N/ANot Yet RecruitingNCT07195292

Toivoa Inc200 enrolled

Overview

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.

This pivotal, two-arm randomized clinical trial (RCT) will assess the efficacy of Toivoa-002, a mobile-delivered cognitive behavioral therapy (CBT) program tailored for people with disabilities, combined with National Board for Health and Wellness Coaching (NBHWC)-certified coaching, in reducing depression symptoms compared to a sham digital program. Recruitment will focus on adults with hearing or mobility disabilities, chosen to represent the broader U.S. disability community due to shared barriers to social participation, high prevalence of depression, and common co-morbidities. Depression in these populations often stems from environmental and societal barriers, such as limited accessibility, transportation challenges, and workplace inflexibility, rather than the medical condition alone. Participants will be randomized to either intervention or control group. The primary endpoint is change in evaluator-administered Hamilton Depression Rating Scale (HAM-D) from baseline to Week 8. Secondary endpoints include durability of effect at Week 12, Clinical Global Impression of Improvement (CGI-I) at Weeks 8 and 12, and proportion achieving a clinically meaningful response. Exploratory endpoints assess changes in anxiety (HAM-A) and self-reported depression (PHQ-9) at Week 8. Assessments will be conducted at baseline, mid-treatment, end of treatment (Week 8), and follow-up (Week 12). Self-report measures (PHQ-9, GAD-7) will be collected at baseline and biweekly during the intervention. Recruitment will occur at up to 10 geographically dispersed U.S. sites, including Veterans Affairs healthcare facilities and academic institutions, using outreach through specialty clinics, events, and online platforms. The trial aims to enroll a diverse participant population without restrictions on gender, race, ethnicity, religion, or sexual orientation. The study is designed to generate evidence on the effectiveness and durability of a dual-intervention approach, digital CBT plus coaching, for depression reduction in people with disabilities, with potential implications for scalable, accessible mental health care delivery.

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in Hamilton Depression Rating Scale (HAM-D) from Baseline to Week 8

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.

Time frame: From Baseline to end of treatment (8 weeks)

Secondary Outcomes

Change in Hamilton Depression Rating Scale (HAM-D) from Baseline to Week 12

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. Change from Baseline Assessment to Week 12 in HAM-D total score will be analyzed using an MMRM analogous to that used for the primary endpoint. The model will include fixed effects for treatment group, visit, treatment-by-visit interaction, and study site, with Baseline Assessments HAM-D total score included as a covariate. Post-baseline assessments at Weeks 4, 8, and 12 will be included in the model. The treatment comparison of interest will be the between-group difference in least squares mean change from Baseline Assessments at Week 12. The estimated treatment difference, 95% confidence interval, and two-sided p-value will be reported.

Time frame: From Baseline to 4 weeks after treatment (12 weeks)

Clinical Global Impression for Improvement (CGI-I) at Week 8

The Clinical Global Impression for Improvement (CGI-I) is a evaluator-rated scale to assess how much a patient's illness has improved or worsened relative to baseline. It assesses overall clinical change based on a single item rated from 1 ("very much improved") to 7 ("very much worse"). CGI-I at Week 8 will be analyzed using an MMRM including fixed effects for treatment group, visit, treatment-by-visit interaction, and study site. Because CGI-I is not measured at baseline, no baseline covariate will be included in the model. Post-baseline assessments at Weeks 4 and 8 will be included. Although CGI-I is an ordinal endpoint, it will be analyzed as a continuous variable for this study. The treatment comparison of interest will be the between-group difference in least squares mean score at Week 8. The estimated treatment difference, 95% confidence interval, and two-sided p-value will be reported.

Time frame: From Baseline to end of treatment (8 weeks)

Clinical Global Impression for Improvement (CGI-I) at Week 12

The Clinical Global Impression for Improvement (CGI-I) is a evaluator-rated scale to assess how much a patient's illness has improved or worsened relative to baseline. It assesses overall clinical change based on a single item rated from 1 ("very much improved") to 7 ("very much worse"). CGI-I at Week 12 will be analyzed using an MMRM including fixed effects for treatment group, visit, treatment-by-visit interaction, and study site. Because CGI-I is not measured at baseline, no baseline covariate will be included in the model. Post-baseline assessments at Weeks 4, 8 and 12 will be included. Although CGI-I is an ordinal endpoint, it will be analyzed as a continuous variable for this study. The treatment comparison of interest will be the between-group difference in least squares mean score at Week 8. The estimated treatment difference, 95% confidence interval, and two-sided p-value will be reported.

Time frame: From Baseline to 4 weeks after treatment (12 weeks)

Proportion of participants achieving clinically meaningful response on Hamilton Depression Rating Scale (HAM-D) at Week 8

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. HAM-D response at Week 8, defined as a reduction of at least 4 points from Baseline Assessments in HAM-D total score, will be analyzed using Week 8 data only. Participants without a Week 8 assessment will be classified as non-responders. Response rates will be summarized by treatment group and compared using Pearson's chi-square test. The between-group difference in response rate and its 95% confidence interval will also be provided.

Time frame: From Baseline to end of treatment (8 weeks)

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

Overview

Conditions

Interventions

Eligibility

Locations (4)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts