Deaf CBT-TS to Reduce Suicide Risk

University of Rochester

Status: Not yet enrolling

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

Treatments: Behavioral: Deaf CBT-TS

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07279363

1K23MH137406-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Waitlist Control Group

No Intervention group

Description:

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 group

Description:

Intervention Group

Treatment:

Behavioral: Deaf CBT-TS