NCT07279363

Deaf CBT-TS to Reduce Suicide Risk

Cognitive Behavioral Therapy for Treatment-Seeking to Improve Treatment Engagement and Reduce Suicide Risk Among Deaf Individuals

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if a short, Zoom-based intervention, Cognitive Behavioral Therapy for Treatment-Seeking for Deaf Individuals (Deaf CBT-TS) can change beliefs about mental health treatment and increase treatment-seeking behaviors in Deaf adults with untreated mental health or alcohol use problems. It will also see if Deaf CBT-TS may reduce suicide risk and explore factors that may increase the effectiveness of Deaf CBT-TS. The main questions it aims to answer are: * Does Deaf CBT-TS increase positive beliefs about treatment and increase treatment-seeking behaviors? * Does Deaf CBT-TS increase hope and reduce mental health symptoms, suicide ideation, and alcohol use? * Is Deaf CBT-TS more effective for individuals with less cultural stress compared to those with high levels of cultural stress? * Is Deaf CBT-TS more effective for Deaf individuals in residential areas with more Deaf resources than those with less Deaf resources? Researchers will compare individuals who complete Deaf CBT-TS to those on a waitlist to see if Deaf CBT-TS works to increase positive beliefs about treatment and treatment-seeking behaviors. Participants will: * Complete a baseline assessment including demographic information, measures of hope, general mental health and functioning, alcohol use, suicide ideation, cultural stress, and beliefs about treatment. * Receive Deaf CBT-TS (2 sessions) or be placed on a waitlist with the option of receiving Deaf CBT-Ts after 4 months * Complete two follow-up assessments in 2 and 4 months.

Detailed description

The proposed project is a two-arm randomized controlled trial of a zoom-based intervention, Cognitive Behavioral Therapy for Treatment-Seeking for Deaf Individuals (Deaf CBT-TS) vs. a waitlist control, with follow-up at 2 and 4 months to assess the intervention's ability to modify beliefs about treatment (intervention principles) and increase treatment-seeking behaviors (target mechanism), as well as explore its potential to increase hope and reduce indicators of suicide risk. The investigators will also examine factors that may impact the efficacy of the intervention including levels of Deaf acculturative stress and subject residential location (Rochester, access to URMC resources vs. other locations across the U.S. with less Deaf resources). Subjects are 110 Deaf adults who report American Sign Language as their primary method of communication, have clinically significant symptoms of a mental health disorder (depression, anxiety, PTSD, insomnia, or alcohol use disorder), and are not engaged in professional mental health or alcohol specialty treatment (e.g., counseling, psychiatric services). The investigators will oversample subjects with recent suicide ideation (50%). Half of the subjects will be recruited from Rochester and the other half nationally. The Specific Aims include (1) to test whether Deaf CBT-TS engages the intervention principles and target mechanism (co-primary outcomes: changes in behavioral, normative, and control beliefs about treatment; and initiation of professional treatment); (2) to explore changes in hope and reductions in indicators of suicide risk (mental health symptoms, alcohol use, and severity of suicide ideation); and (3) to identify factors that could impact the efficacy of Deaf CBT-TS (Deaf acculturative stress and residential location). Subjects will complete a baseline assessment including demographic information, measures of Deaf acculturative stress, hope, general mental health and functioning, alcohol use, suicide ideation, and beliefs about treatment. Subjects who complete the baseline assessment will be randomized to Deaf CBT-TS or a waitlist control, using stratified randomization based on sex assigned at birth, prior suicide attempt, and residential location (Rochester vs. other U.S. locations). During study assessments, all subjects will receive suicide risk assessments using the Columbia-Suicide Severity Rating Scale (C-SSRS), with actions commensurate with risk level, and a list of Deaf crisis intervention resources. The study coordinator will review each resource on the list and explain how to use them. Study conditions are Deaf CBT-TS (2 sessions) and waitlist control. Deaf CBT-TS involves 2 intervention sessions lasting up to 90 minutes each. The follow-up assessments (2 and 4 months) include the baseline measures of hope, general mental health and functioning, alcohol use, suicide ideation, and beliefs about treatment, as well as a treatment utilization survey to assess the subjects' use of professional mental health and alcohol specialty treatment since their last study visit. Subjects in the waitlist control group who have not engaged in professional mental health or alcohol treatment will be offered the Deaf CBT-TS intervention after their 4-month follow-up assessment.

Conditions

• Depression - Major Depressive Disorder
• Anxiety
• PTSD - Post Traumatic Stress Disorder
• Insomnia
• Alcohol Use Disorder (AUD)
• Suicide Ideation

Interventions

Type	Name	Description
BEHAVIORAL	Deaf CBT-TS	Deaf CBT-TS is a two-session (90 minutes each) Zoom-based intervention designed to target a change in the beliefs that influence whether or not someone initiates mental health treatment. The intervention works by modifying problematic beliefs, providing accurate information about treatment, and problem-solving barriers. The first session is structured in four phases: (1) history of symptoms and current functioning, (2) coping strategies, (3) evaluation and modification of treatment beliefs using CBT strategies, and (4) action planning. Subjects are provided a list of resources for seeking treatment, as well as a personalized search of treatment options (conducted by the interventionist) in their area based on their insurance and language preference. The second session occurs within 3 weeks and is designed to check in with subjects regarding progress on their action plan, provide assistance in identifying treatment options, and problem-solve barriers

Timeline

• Start date: 2026-06-01
• Primary completion: 2029-06-01
• Completion: 2029-06-01
• First posted: 2025-12-12
• Last updated: 2026-04-08

Locations

1 site across 1 country: United States