Depression - Major Depressive DisorderNCT07279363
Deaf CBT-TS to Reduce Suicide Risk
A study testing Deaf CBT-TS in people with Depression - Major Depressive Disorder and Anxiety, run by University of Rochester at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression - Major Depressive Disorder, Anxiety, PTSD - Post Traumatic Stress Disorder
- What is being tested?
- Deaf CBT-TS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Aileen Aldalur, Ph.D. Clinical Psychology contact
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
Aileen Aldalur, Ph.D. Clinical Psychology, 585-371-6125, aileen_aldalur@urmc.rochester.edu
Aileen Aldalur, Ph.D. Clincial Psychology
About this study
Official title: Cognitive Behavioral Therapy for Treatment-Seeking to Improve Treatment Engagement and Reduce Suicide Risk Among Deaf Individuals
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.
Read more
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.
Read the 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
- Being tested
- Deaf CBT-TS
- Keywords
- Deaf, Mental Health, Treatment-Seeking, Suicide, Cognitive Behavioral Therapy for Treatment-Seeking
- Medical subject headings
- Anxiety Disorders, Combat Disorders, Sleep Initiation and Maintenance Disorders, Alcoholism, Psychological Well-Being, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deaf CBT-TSBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Deaf CBT-TS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Baseline to 4-month follow-up
Secondary outcomes (10)
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.
Measured: Baseline to 2-months follow-up
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.
Measured: Baseline to 4-months follow-up
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.
Measured: Baseline to 2-months follow-up
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.
Measured: Baseline to 4-month follow-up
Physical Functioning
Physical functioning will be assessed via the PROMIS-29 V2.0. The scale has 29 items divided across 8 subscales. Five of the subscales are focused on physical functioning: Physical Function, Fatigue, Sleep Disturbance, Pain Interference, and Pain Intensity. The subscales Physical Function, Fatigue, Sleep Disturbance, Pain Interference each have four items rated on a Likert scale ranging from 1 (not at all) to 5 (very much) with higher scores indicating worse physical functioning. The Pain Interference subscale is a single item rated on a Likert scale ranging from 0 (no pain) to 10 (worst imaginable pain). Scores for each of the subscales will be summed and converted to T-scores. The T-scores for the five subscales will then be summed for a total score representing physical functioning.
Measured: Baseline to 2-month follow-up
Physical Functioning (4 months)
Physical functioning will be assessed via the PROMIS-29 V2.0. The scale has 29 items divided across 8 subscales. Five of the subscales are focused on physical functioning: Physical Function, Fatigue, Sleep Disturbance, Pain Interference, and Pain Intensity. The subscales Physical Function, Fatigue, Sleep Disturbance, Pain Interference each have four items rated on a Likert scale ranging from 1 (not at all) to 5 (very much) with higher scores indicating worse physical functioning. The Pain Interference subscale is a single item rated on a Likert scale ranging from 0 (no pain) to 10 (worst imaginable pain). Scores for each of the subscales will be summed and converted to T-scores. The T-scores for the five subscales will then be summed for a total score representing physical functioning.
Measured: Baseline to 4-month follow-up
Alcohol Use
The National Survey on Drug Use and Health (NSDUH) 30-day alcohol consumption will be used to assess alcohol use including total number of drinking days, number of drinks per drinking day, and number of heavy episodes of drinking.
Measured: Baseline to 2-month follow-up
Alcohol Use (4 months)
The National Survey on Drug Use and Health (NSDUH) 30-day alcohol consumption will be used to assess alcohol use including total number of drinking days, number of drinks per drinking day, and number of heavy episodes of drinking.
Measured: Baseline to 4-month follow-up
Suicide Ideation
Suicide Ideation will be assessed via the Depressive Symptom Index Suicidality Scale. The scale has four items rated on a Likert scale from 0 - 3, with higher scores indicating a higher intensity of suicide ideation.
Measured: Baseline to 2-month follow-up
Suicide Ideation (4 months)
Suicide Ideation will be assessed via the Depressive Symptom Index Suicidality Scale. The scale has four items rated on a Likert scale from 0 - 3, with higher scores indicating a higher intensity of suicide ideation.
Measured: Baseline to 4-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study startSep 2026 (estimated)
- Primary completionMay 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression - Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Aileen Aldalur, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07279363
- Sponsor's protocol ID
- STUDY00010152
- Other IDs
- 1K23MH137406-01A1
- Status last verified
- Jun 2026
- First submitted
- 8 Dec 2025
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Therapy for Treatment-Seeking to Improve Treatment Engagement and Reduce Suicide Risk Among Deaf Individuals
- ClinicalTrials.gov ID
- NCT07279363
- Acronym / sponsor ID
- STUDY00010152
- Conditions
- Depression - Major Depressive Disorder, Anxiety, PTSD - Post Traumatic Stress Disorder, Insomnia, Alcohol Use Disorder (AUD), Suicide Ideation
- Keywords
- Deaf, Mental Health, Treatment-Seeking, Suicide, Cognitive Behavioral Therapy for Treatment-Seeking
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2026 (estimated)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 12 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Deaf CBT-TSIntervention Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deaf CBT-TSDeaf 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 | Behavioural | Deaf CBT-TS Intervention Group |
Primary outcome
Beliefs About Treatment
Time frame: Baseline to 2-month follow-up
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.
Beliefs About Treatment (4 months)
Time frame: Baseline to 4-month follow-up
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.
Treatment Initiation
Time frame: Baseline to 2-month follow-up
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).
Treatment Initiation (4 months)
Time frame: Baseline to 4-month follow-up
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).
10 secondary outcomes
Hope
Time frame: Baseline to 2-months follow-up
Hope (4-months)
Time frame: Baseline to 4-months follow-up
General Mental Health
Time frame: Baseline to 2-months follow-up
General Mental Health (4 months)
Time frame: Baseline to 4-month follow-up
Physical Functioning
Time frame: Baseline to 2-month follow-up
Physical Functioning (4 months)
Time frame: Baseline to 4-month follow-up
Alcohol Use
Time frame: Baseline to 2-month follow-up
Alcohol Use (4 months)
Time frame: Baseline to 4-month follow-up
Suicide Ideation
Time frame: Baseline to 2-month follow-up
Suicide Ideation (4 months)
Time frame: Baseline to 4-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aileen Aldalur, Ph.D. Clinical Psychology contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deaf CBT-TS in people with Depression - Major Depressive Disorder and Anxiety, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aileen Aldalur, Ph.D. Clinical Psychology (585-371-6125 (call only), aileen_aldalur@urmc.rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beliefs About Treatment (time frame: Baseline to 2-month follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.