Reduction of Anxiety Through Dual Mental Health Treatment: Digital-Based Cognitive Behavioral Therapy and National Board for Health and Wellness Coaching (NBHWC) Mental Health Coaches
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Toivoa Inc
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Change in Evaluator-Administered Hamilton Anxiety Rating Scale (HAM-A) from Baseline to Week 8.
研究概览
简要总结
The purpose of this study is to see if a mobile-delivered mental health program called Toivoa-001, which combines digital cognitive behavioral therapy (CBT) with personal mental health coaching, can effectively reduce anxiety in adults with hearing or mobility disabilities. The study aims to answer whether this dual-intervention digital service is more effective at lowering anxiety 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-001 program will show significantly greater reductions in anxiety 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 anxiety. By offering a fully remote and accessible mobile tool, this study seeks to determine if a digital health service can deliver scalable, effective anxiety relief tailored to the lived experiences of people with disabilities.
详细描述
This pivotal, two-arm randomized clinical trial (RCT) will assess the efficacy of Toivoa-001, a mobile-delivered cognitive behavioral therapy (CBT) program tailored for people with disabilities, combined with National Board for Health and Wellness Coaching (NBHWC)-certified mental health coaching, in reducing anxiety 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 anxiety, and common co-morbidities. Anxiety 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 Anxiety Rating Scale (HAM-A) 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 depression (HAM-D) and self-reported anxiety (GAD-7) 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The randomization allocation of UC+Toivoa-001 versus UC+Sham will be done in random blocks of 2, 4, 6, and 8 subjects. As the study progresses, the blocking will be reduced to 2 and 4. This will provide relative balance over the course of the study while minimizing study personnel ability to predict the next randomization assignment. Monthly balance of randomization assignments will be reported, although the randomization assignments will be coded as A versus B to maintain blinding. Each site will randomize independently from other sites & maintain its own randomization schedule.
The study will be conducted as a double-blind study where both the participant & evaluators will not be aware of which study arm they have been assigned. Blinding assignments and onboarding instructions will be generated by the Site Administrator for a particular location. Blinding assignments will be made per site using procedures outside of the Rauha data platform and visible only to the Site Administrator.
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Males and females; Age 22 years and above
- •Score of 15 or higher on the HAM-A
- •Clinical diagnosis of anxiety based on DSM-5 diagnostic criteria
- •Willingness to adhere to the Toivoa-001 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
排除标准
- •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
研究组 & 干预措施
Toivoa-001 Digital CBT + NBHWC Coaching
Participants in this arm receive a dual mental health treatment via a secure mobile app, including 8 psychoeducational modules and weekly one-on-one sessions with a National Board for Health & Wellness Coaching (NBHWC)-certified coach. Modules focus on goal-setting, behavioral activation, cognitive restructuring, and interpersonal skill-building, with interactive exercises and opportunities for reinforcement. While the program is structured for one module per week over 8 consecutive weeks, participants may engage more flexibly in as little as 5-minute increments.
ALL INVITED PARTICIPANTS:
Following baseline assessments, study participants will be randomized by the site administrator and then invited to join either the Toivoa-001 (therapy) or sham (control) through a meeting invitation. The invitation will include instructions to download and register for the app, and contact information for their coach or assessor.
干预措施: Toivoa-001 - A digital Cognitive Behavioral Therapy program combined with NBHWC-certified coaching. (Device)
General Health Education + Interactive Quizzes
Participants randomized to the sham comparator receive an 8-week digital program featuring general health and wellness information with interactive quizzes. This content is not related to anxiety treatment or CBT techniques. The arm is designed to mirror the Toivoa-001 arm in duration and engagement, ensuring parity in attention without therapeutic intent.
干预措施: Sham Digital Program - General health education and interactive quizzes unrelated to anxiety or CBT. (Device)
结局指标
主要结局
Change in Evaluator-Administered Hamilton Anxiety Rating Scale (HAM-A) from Baseline to Week 8.
时间窗: Change in evaluator-administered Hamilton Anxiety Rating Scale (HAM-A) between baseline and Week 8.
The analysis of the primary endpoint, i.e., change in HAM-A @ Week 8, will be based on a MMRM (mixed model of repeated measures) in the enrolled population, where site \& participant are random effects \& assessment (Week 4 versus Week 8) \& randomization arm (Toivoa-001 vs Sham) \& the assessment-by-arm interaction are fixed effects. Additionally, the baseline assessment will be included as a fixed effect covariate. The model will include up to 2 outcomes per participant (change @ Week 4 \& change @ Week 8). The hypothesis of equal mean change will be evaluated based on the t-test corresponding to the difference in least square means at Week 8, where both the point estimate \& the variance of the difference in least square means will be estimated using multiple imputation. Details regarding the number of multiple imputation datasets, the method of obtaining a combined point estimate and variance from the MMRM evaluations of the multiple imputation datasets will be pre-specified in the plan
Change in Hamilton Anxiety Rating Scale (HAM-A) from Baseline to Week 8
时间窗: From Baseline to end of treatment (8 weeks)
The Hamilton Anxiety Rating Scale (HAM-A) is a structured interview using 14 items, each rated from 0 ("not present") to 4 ("severe"). Scores range from 0 to 56. Analyses will use a mixed model for repeated measures (MMRM) in the Intent-to-Treat (ITT) population. The MMRM will model change from 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-A total score as a covariate. Within-participant correlation across repeated measurements will be modeled using an appropriate 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 for the primary endpoint 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.
次要结局
- Changes in Hamilton Anxiety Rating Scale (HAM-A) at Week 12, Clinical Global Impression for Improvement (CGI-I) at Week 8 and Week 12, and proportion of participants achieving clinically meaningful response at Week 8 on HAM-A.(8 or 12 Weeks)
- Changes in Hamilton Anxiety Rating Scale (HAM-A) at Week 12, Clinical Global Impression for Improvement (CGI-I) at Week 8 and Week 12, and proportion of participants achieving clinically meaningful response at Week 8 on HAM-A.(From enrollment to 4 weeks after treatment (12 weeks))
- Changes in Hamilton Anxiety Rating Scale (HAM-A) at Week 12(From enrollment to 4 weeks after treatment (12 weeks))
- Clinical Global Impression for Improvement (CGI-I) at Week 8(From enrollment to post-treatment (8 weeks))
- Clinical Global Impression for Improvement (CGI-I) at Week 12(From enrollment to 4 weeks after treatment (12 weeks))
- Proportion of participants achieving clinically meaningful response on HAM-A at Week 8(From enrollment to post-treatment (8 weeks))
- Change in Hamilton Anxiety Rating Scale (HAM-A) from Baseline to Week 12(From Baseline to 4 weeks after treatment (12 weeks))
- Clinical Global Impression for Improvement (CGI-I) at Week 8(From Baseline to end of treatment (8 weeks))
- Clinical Global Impression for Improvement (CGI-I) at Week 12(From Baseline to 4 weeks after treatment (12 weeks))
- Proportion of participants achieving clinically meaningful response on Hamilton Anxiety Rating Scale (HAM-A) at Week 8(From Baseline to end of treatment (8 weeks))