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

Официальное название

Reduction of Depression 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 (ReDu)

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Sham Digital Program - General health education and interactive quizzes unrelated to depression or CBT.
  General health and wellness information with interactive quizzes. This content is not related to depression treatment or CBT techniques.
• Устройство Toivoa-002 - 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 Depression Rating Scale (HAM-D) from Baseline to Week 8 [Срок оценки: From Baseline to end of treatment (8 weeks)]

Вторичные конечные точки (4)

• Change in Hamilton Depression Rating Scale (HAM-D) 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 Depression Rating Scale (HAM-D) 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
• 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

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

• Andersson G, Cuijpers P, Carlbring P, Riper H, Hedman E. Guided Internet-based vs. face-to-face cognitive behavior therapy for psychiatric and somatic disorders: a systematic review and meta-analysis. World Psychiatry. 2014 Oct;13(3):288-95. doi: 10.1002/wps.20151. PMID 25273302
• Chen LH, Lee WC. Two-way minimization: a novel treatment allocation method for small trials. PLoS One. 2011;6(12):e28604. doi: 10.1371/journal.pone.0028604. Epub 2011 Dec 7. PMID 22163317
• DeRubeis RJ, Hollon SD, Amsterdam JD, Shelton RC, Young PR, Salomon RM, O'Reardon JP, Lovett ML, Gladis MM, Brown LL, Gallop R. Cognitive therapy vs medications in the treatment of moderate to severe depression. Arch Gen Psychiatry. 2005 Apr;62(4):409-16. doi: 10.1001/archpsyc.62.4.409. PMID 15809408
• Dimidjian S, Hollon SD, Dobson KS, Schmaling KB, Kohlenberg RJ, Addis ME, Gallop R, McGlinchey JB, Markley DK, Gollan JK, Atkins DC, Dunner DL, Jacobson NS. Randomized trial of behavioral activation, cognitive therapy, and antidepressant medication in the acute treatment of adults with major depression. J Consult Clin Psychol. 2006 Aug;74(4):658-70. doi: 10.1037/0022-006X.74.4.658. PMID 16881773
• Gallop R, Tasca GA. Multilevel modeling of longitudinal data for psychotherapy researchers: II. The complexities. Psychother Res. 2009 Jul;19(4-5):438-52. doi: 10.1080/10503300902849475. PMID 20183399
• Gibbons RD, Hedeker D, Elkin I, Waternaux C, Kraemer HC, Greenhouse JB, Shea MT, Imber SD, Sotsky SM, Watkins JT. Some conceptual and statistical issues in analysis of longitudinal psychiatric data. Application to the NIMH treatment of Depression Collaborative Research Program dataset. Arch Gen Psychiatry. 1993 Sep;50(9):739-50. doi: 10.1001/archpsyc.1993.01820210073009. PMID 8357299
• Gottfredson NC, Bauer DJ, Baldwin SA, Okiishi JC. Using a shared parameter mixture model to estimate change during treatment when termination is related to recovery speed. J Consult Clin Psychol. 2014 Oct;82(5):813-27. doi: 10.1037/a0034831. Epub 2013 Nov 25. PMID 24274626
• Han B, Enas NH, McEntegart D. Randomization by minimization for unbalanced treatment allocation. Stat Med. 2009 Nov 30;28(27):3329-46. doi: 10.1002/sim.3710. PMID 19739238

Идентификаторы

NCT: NCT07195292 · 00084427

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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