Deaf CBT-TS to Reduce Suicide Risk

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Rochester

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Waitlist Control GroupNo intervention 0 interventions
Group B: Deaf CBT-TS Intervention GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline to 2-month follow-up
2

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.

Time frame
Baseline to 4-month follow-up
3

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).

Time frame
Baseline to 2-month follow-up
4

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).

Time frame
Baseline to 4-month follow-up

Secondary outcomes

1

Hope

Hope will be assessed via the Beck Hopelessness Scale. The scale has 20 items scored as True or False. Scores of 1 or 0 are assigned to each item depending on the subject's response and the directionality of the item. The scores are summed with for a total score ranging from 0 - 20 and higher scores indicating more hopelessness.

Time frame
Baseline to 2-months follow-up
2

Hope (4-months)

Hope will be assessed via the Beck Hopelessness Scale. The scale has 20 items scored as True or False. Scores of 1 or 0 are assigned to each item depending on the subject's response and the directionality of the item. The scores are summed with for a total score ranging from 0 - 20 and higher scores indicating more hopelessness.

Time frame
Baseline to 4-months follow-up
3

General Mental Health

General mental health will be assessed via the PROMIS-29 V2.0. The scale has 29 items divided across 8 subscales. Three of the subscales are focused on general mental health: Anxiety, Depression, and Ability to Participate in Social Roles. These subscales each have four items rated on a Likert scale ranging from 1 (not at all) to 5 (very much) with higher scores indicating worse mental health functioning. Scores for each of the subscales will be summed and converted to T-scores. The T-scores for the three subscales will then be summed for a total score representing general mental health functioning.

Time frame
Baseline to 2-months follow-up
4

General Mental Health (4 months)

General mental health will be assessed via the PROMIS-29 V2.0. The scale has 29 items divided across 8 subscales. Three of the subscales are focused on general mental health: Anxiety, Depression, and Ability to Participate in Social Roles. These subscales each have four items rated on a Likert scale ranging from 1 (not at all) to 5 (very much) with higher scores indicating worse mental health functioning. Scores for each of the subscales will be summed and converted to T-scores. The T-scores for the three subscales will then be summed for a total score representing general mental health functioning.

Time frame
Baseline to 4-month follow-up

Other outcomes

Sponsors and contacts

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University of Rochester

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

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