Reduction of Anxiety in People With Disabilities Through Dual Treatment: Digital CBT & NBHWC Coaching - A Randomized Clinical Trial

Официальное название

Reduction of Anxiety Through Dual Mental Health Treatment: Digital-Based Cognitive Behavioral Therapy (CBT) and National Board for Health and Wellness Coaching (NBHWC) Mental Health Coaches for People With Disabilities (RADD)

Обзор

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.

Подробное описание

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.

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 mental health coaching, for anxiety reduction in people with disabilities, with potential implications for scalable, accessible mental health care delivery.

Вмешательства

• Устройство Sham Digital Program - General health education and interactive quizzes unrelated to anxiety or CBT.
  General health and wellness information with interactive quizzes. This content is not related to anxiety treatment or CBT techniques.
• Устройство Toivoa-001 - A digital Cognitive Behavioral Therapy program combined with NBHWC-certified coaching.
  A dual mental health treatment consisting of digitally-administered Cognitive Behavioral Therapy combined with National Board Health and Wellness Coach (NBHWC) trained Coaches

Первичные конечные точки

• Change in Hamilton Anxiety Rating Scale (HAM-A) from Baseline to Week 8 [Срок оценки: From Baseline to end of treatment (8 weeks)]

Вторичные конечные точки (4)

• Change in Hamilton Anxiety Rating Scale (HAM-A) from Baseline to Week 12 [Срок оценки: From Baseline to 4 weeks after treatment (12 weeks)]
• Clinical Global Impression for Improvement (CGI-I) at Week 8 [Срок оценки: From Baseline to end of treatment (8 weeks)]
• Clinical Global Impression for Improvement (CGI-I) at Week 12 [Срок оценки: 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 [Срок оценки: From Baseline to end of treatment (8 weeks)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 4 центра

• Delaware State University — Dover
• New Jersey Department of Veterans Health — East Orange
• Louis Stokes Cleveland VAMC — Cleveland
• South Texas Veterans Health Care System — San Antonio

Публикации

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• Ten Have TR, Kunselman AR, Pulkstenis EP, Landis JR. Mixed effects logistic regression models for longitudinal binary response data with informative drop-out. Biometrics. 1998 Mar;54(1):367-83. PMID 9544529
• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092. PMID 16717171
• Segal ZV, Dimidjian S, Beck A, Boggs JM, Vanderkruik R, Metcalf CA, Gallop R, Felder JN, Levy J. Outcomes of Online Mindfulness-Based Cognitive Therapy for Patients With Residual Depressive Symptoms: A Randomized Clinical Trial. JAMA Psychiatry. 2020 Jun 1;77(6):563-573. doi: 10.1001/jamapsychiatry.2019.4693. PMID 31995132
• Scott KM, Von Korff M, Alonso J, Angermeyer MC, Bromet E, Fayyad J, de Girolamo G, Demyttenaere K, Gasquet I, Gureje O, Haro JM, He Y, Kessler RC, Levinson D, Medina Mora ME, Oakley Browne M, Ormel J, Posada-Villa J, Watanabe M, Williams D. Mental-physical co-morbidity and its relationship with disability: results from the World Mental Health Surveys. Psychol Med. 2009 Jan;39(1):33-43. doi: 10.101 PMID 18366819
• Reimherr FW, Amsterdam JD, Quitkin FM, Rosenbaum JF, Fava M, Zajecka J, Beasley CM Jr, Michelson D, Roback P, Sundell K. Optimal length of continuation therapy in depression: a prospective assessment during long-term fluoxetine treatment. Am J Psychiatry. 1998 Sep;155(9):1247-53. doi: 10.1176/ajp.155.9.1247. PMID 9734550
• Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, Currier GW, Melvin GA, Greenhill L, Shen S, Mann JJ. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011 Dec;168(12):1266-77. doi: 10.1176/appi.ajp.2011.10111704. PMID 22193671

Идентификаторы

NCT: NCT07140497 · 00074059 · Private Funding

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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