Deaf CBT-TS to Reduce Suicide Risk

NCT07279363 | Not Yet Recruiting DMC

• 2 other identifiers: STUDY000101521K23MH137406-01A1
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Deaf; Mental Health; Treatment-Seeking; Suicide; Cognitive Behavioral Therapy for Treatment-Seeking

Outcome Measures

Primary Outcomes (4)

• Beliefs About Treatment

  The Perceptions About Services Scale for the Deaf (PASS-D) will be used to assess participants' behavioral, normative, and control beliefs about treatment. The Behavioral Belief subscale has 10 items assessing advantages vs. disadvantages of seeking treatment, the Normative Belief subscale has 7 items assessing community support vs. opposition to seeking treatment, and the Control Beliefs subscale has 26 items assessing facilitators vs. barriers to seeking treatment. Each item is rated on a Likert scale ranging from 1 (Strongly Disagree) to 7 (Strongly Agree) with higher scores indicating more positive beliefs. Items for each subscale will be totaled.

  Baseline to 2-month follow-up

• Beliefs About Treatment (4 months)

  The Perceptions About Services Scale for the Deaf (PASS-D) will be used to assess participants' behavioral, normative, and control beliefs about treatment. The Behavioral Belief subscale has 10 items assessing advantages vs. disadvantages of seeking treatment, the Normative Belief subscale has 7 items assessing community support vs. opposition to seeking treatment, and the Control Beliefs subscale has 26 items assessing facilitators vs. barriers to seeking treatment. Each item is rated on a Likert scale ranging from 1 (Strongly Disagree) to 7 (Strongly Agree) with higher scores indicating more positive beliefs. Items for each subscale will be totaled.

  Baseline to 4-month follow-up

• Treatment Initiation

  A Treatment Utilization Survey will assess use of 12 treatment services, number of sessions attended, current treatment status (active vs. completed), reasons for seeking/not seeking treatment, and any barriers experienced. Treatment Initiation will be measured with a binary variable. Subjects who have attended or scheduled professional treatment services will be coded as 1 (initiated treatment) and those who have not attended or scheduled professional treatment services will be coded as 0 (not initiated).

  Baseline to 2-month follow-up

• Treatment Initiation (4 months)

  A Treatment Utilization Survey will assess use of 12 treatment services, number of sessions attended, current treatment status (active vs. completed), reasons for seeking/not seeking treatment, and any barriers experienced. Treatment Initiation will be measured with a binary variable. Subjects who have attended or scheduled professional treatment services will be coded as 1 (initiated treatment) and those who have not attended or scheduled professional treatment services will be coded as 0 (not initiated).

  Baseline to 4-month follow-up

Secondary Outcomes (10)

• Hope

  Baseline to 2-months follow-up

• Hope (4-months)

  Baseline to 4-months follow-up

• General Mental Health

  Baseline to 2-months follow-up

• General Mental Health (4 months)

  Baseline to 4-month follow-up

• Physical Functioning

  Baseline to 2-month follow-up

Study Arms (2)

Waitlist Control Group

NO INTERVENTION

During study assessments, subjects will receive a suicide risk assessment, with actions commensurate with risk level, and a list of Deaf crisis intervention resources with instructions provided on how to use them. The list of resources contains crisis hotlines that are accessible for Deaf individuals including text-based options (e.g., Crisis Text line, 988 text number) and options to talk with counselors in ASL (e.g., 988 ASL services, DeafLEAd Crisis Line). The study coordinator will review each resource and explain their use. Subjects will be emailed this list of resources after their assessment. Other brief interventions that could be provided based on subject presentation include encouraging subjects to seek social support and share their thoughts with others; elicitation of coping strategies; and lethal means safety planning.

Deaf CBT-TS Intervention Group

EXPERIMENTAL

Intervention Group

Behavioral: Deaf CBT-TS

Interventions

Deaf CBT-TS BEHAVIORAL

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

Deaf CBT-TS Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult (aged 18 years or older)
• Self-identify as Deaf or hard of hearing (any degree of hearing loss)
• Primary method of communication is American Sign Language
• Positive screen for one or more mental health disorders including depression (PHQ-9 \> 10), anxiety (GAD-7 \> 10), posttraumatic stress disorder (PCL-5 \> 31), insomnia (ISI \> 15), or alcohol use disorder (AUDIT \> 16)
• No current professional mental health or alcohol specialty treatment (e.g., counseling, psychiatric services) per standardized self-report
• Access to video chat technology with internet and webcam.

You may not qualify if:

• unable to communicate with the researcher in American Sign Language
• current alcohol withdrawal necessitating medical evaluation
• current psychiatric impairment necessitating emergency services or inpatient admission (i.e., imminent danger of harm to self or others)
• unable to comprehend the nature of the study

Sponsors & Collaborators

• University of Rochester: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Combat Disorders; Sleep Initiation and Maintenance Disorders; Alcoholism; Psychological Well-Being; Suicide

Condition Hierarchy (Ancestors)

Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Personal Satisfaction; Behavior; Self-Injurious Behavior; Behavioral Symptoms

Central Study Contacts

Aileen Aldalur, Ph.D. Clinical Psychology

CONTACT

585-371-6125 (call only); aileen_aldalur@urmc.rochester.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 12, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)