Trial Outcomes & Findings for Acceptability and Feasibility of Cognitive Behavioral Therapy for Treatment-Seeking (CBT-TS) With Deaf Individuals (NCT NCT05520190)

Results Overview

We will use a validated treatment utilization survey that will assess subjects' use of 12 treatment services, their reasons for seeking/not seeking treatment, and any barriers they experienced through a series of structured questions. Treatment-seeking will be coded as a binary variable representing those who scheduled or attended any professional treatment service and those who did not.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

42 participants

Primary outcome timeframe

1 month

Results posted on

2025-01-10

Participant Flow

Participant milestones

Participant milestones
Measure	All Participants Cognitive Behavioral Therapy for Treatment Seeking (CBT-TS): The intervention will consist of 1 - 2 sessions. The first session is approximately 60 - 90 minutes and will be structured in 4 phases 1) subject's history of symptoms and current functioning, 2) their coping methods, 3) modification of treatment beliefs, 4) action planning. The interventionist will provide the subject with a list of resources for seeking treatment. All subjects will be offered an optional second session with the interventionist. The second session will consist of a 60-minute appointment focused on providing practical assistance to identify available treatment options in the subject's area, scheduling treatment sessions, and problem-solving barriers to treatment.
Overall Study STARTED	42
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Reasons for withdrawal
Measure	All Participants Cognitive Behavioral Therapy for Treatment Seeking (CBT-TS): The intervention will consist of 1 - 2 sessions. The first session is approximately 60 - 90 minutes and will be structured in 4 phases 1) subject's history of symptoms and current functioning, 2) their coping methods, 3) modification of treatment beliefs, 4) action planning. The interventionist will provide the subject with a list of resources for seeking treatment. All subjects will be offered an optional second session with the interventionist. The second session will consist of a 60-minute appointment focused on providing practical assistance to identify available treatment options in the subject's area, scheduling treatment sessions, and problem-solving barriers to treatment.
Overall Study Lost to Follow-up	7
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Acceptability and Feasibility of Cognitive Behavioral Therapy for Treatment-Seeking (CBT-TS) With Deaf Individuals

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=40 Participants Cognitive Behavioral Therapy for Treatment Seeking (CBT-TS): The intervention will consist of 1 - 2 sessions. The first session is approximately 60 - 90 minutes and will be structured in 4 phases 1) subject's history of symptoms and current functioning, 2) their coping methods, 3) modification of treatment beliefs, 4) action planning. The interventionist will provide the subject with a list of resources for seeking treatment. All subjects will be offered an optional second session with the interventionist. The second session will consist of a 60-minute appointment focused on providing practical assistance to identify available treatment options in the subject's area, scheduling treatment sessions, and problem-solving barriers to treatment.
Age, Continuous	43.33 years STANDARD_DEVIATION 13.99 • n=5 Participants
Sex/Gender, Customized Female	26 Participants n=5 Participants
Sex/Gender, Customized Male	13 Participants n=5 Participants
Sex/Gender, Customized Nonbinary	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	33 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants
Race (NIH/OMB) More than one race	6 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month

We will use a validated treatment utilization survey that will assess subjects' use of 12 treatment services, their reasons for seeking/not seeking treatment, and any barriers they experienced through a series of structured questions. Treatment-seeking will be coded as a binary variable representing those who scheduled or attended any professional treatment service and those who did not.

Outcome measures

Outcome measures
Measure	All Participants n=33 Participants Cognitive Behavioral Therapy for Treatment Seeking (CBT-TS): The intervention will consist of 1 - 2 sessions. The first session is approximately 60 - 90 minutes and will be structured in 4 phases 1) subject's history of symptoms and current functioning, 2) their coping methods, 3) modification of treatment beliefs, 4) action planning. The interventionist will provide the subject with a list of resources for seeking treatment. All subjects will be offered an optional second session with the interventionist. The second session will consist of a 60-minute appointment focused on providing practical assistance to identify available treatment options in the subject's area, scheduling treatment sessions, and problem-solving barriers to treatment.
Proportion of Participants Who Schedule Professional Treatment	8 Participants

PRIMARY outcome

Timeframe: baseline to 1 month

The Deaf Perceptions About Services Scale (PASS-D) Attitude scale. The Attitude scale contains 4 items assessing individuals' attitudes about behavioral health treatment. The items are rated on a Likert scale ranging from 1 - 7. Scores are averaged across the items for a total score of 1 - 7 with higher scores indicating more favorable attitudes about treatment.

Outcome measures

Outcome measures
Measure	All Participants n=33 Participants Cognitive Behavioral Therapy for Treatment Seeking (CBT-TS): The intervention will consist of 1 - 2 sessions. The first session is approximately 60 - 90 minutes and will be structured in 4 phases 1) subject's history of symptoms and current functioning, 2) their coping methods, 3) modification of treatment beliefs, 4) action planning. The interventionist will provide the subject with a list of resources for seeking treatment. All subjects will be offered an optional second session with the interventionist. The second session will consist of a 60-minute appointment focused on providing practical assistance to identify available treatment options in the subject's area, scheduling treatment sessions, and problem-solving barriers to treatment.
Mean Change in Attitudes About Treatment Baseline Attitude	4.93 score on a scale Standard Deviation 1.26
Mean Change in Attitudes About Treatment 1-month Attitude	5.40 score on a scale Standard Deviation 1.25

PRIMARY outcome

Timeframe: baseline to 1 month

The Deaf Perceptions About Services Scale (PASS-D) Subjective Norm scale. The Subjective Norm scale contains 3 items assessing individuals' perceptions of the subjective norm in their community about behavioral health treatment. The items are rated on a Likert scale ranging from 1-7. Scores are averaged across the items for a total score of 1 - 7 with higher scores indicating more favorable perceptions about treatment.

Outcome measures

Outcome measures
Measure	All Participants n=33 Participants Cognitive Behavioral Therapy for Treatment Seeking (CBT-TS): The intervention will consist of 1 - 2 sessions. The first session is approximately 60 - 90 minutes and will be structured in 4 phases 1) subject's history of symptoms and current functioning, 2) their coping methods, 3) modification of treatment beliefs, 4) action planning. The interventionist will provide the subject with a list of resources for seeking treatment. All subjects will be offered an optional second session with the interventionist. The second session will consist of a 60-minute appointment focused on providing practical assistance to identify available treatment options in the subject's area, scheduling treatment sessions, and problem-solving barriers to treatment.
Mean Change in Subjective Norm About Treatment Baseline Norms	5.18 score on a scale Standard Deviation 1.39
Mean Change in Subjective Norm About Treatment 1-month Norms	5.51 score on a scale Standard Deviation 0.88

PRIMARY outcome

Timeframe: baseline to 1 month

The Deaf Perceptions About Services Scale (PASS-D) Perceived Behavioral Control scale. The Perceived Behavioral Control scale contains 3 items assessing individuals' perceived behavioral control to seek behavioral health treatment. The items are rated on a Likert scale ranging from 1 - 7. Scores are averaged across the items for a total score of 1 - 7 with higher scores indicating more perceived behavioral control to seek treatment.

Outcome measures

Outcome measures
Measure	All Participants n=33 Participants Cognitive Behavioral Therapy for Treatment Seeking (CBT-TS): The intervention will consist of 1 - 2 sessions. The first session is approximately 60 - 90 minutes and will be structured in 4 phases 1) subject's history of symptoms and current functioning, 2) their coping methods, 3) modification of treatment beliefs, 4) action planning. The interventionist will provide the subject with a list of resources for seeking treatment. All subjects will be offered an optional second session with the interventionist. The second session will consist of a 60-minute appointment focused on providing practical assistance to identify available treatment options in the subject's area, scheduling treatment sessions, and problem-solving barriers to treatment.
Mean Change in Perceived Behavioral Control About Seeking Treatment Baseline Perceived Behavioral Control	6.10 score on a scale Standard Deviation 1.01
Mean Change in Perceived Behavioral Control About Seeking Treatment 1-month Perceived Behavioral Control	6.14 score on a scale Standard Deviation 1.15

PRIMARY outcome

Timeframe: baseline to 1 month

The D-PASS will be administered pre-and-post-treatment to collect information about subjects' intention to seek treatment. The scale ranges from 3 to 21 with higher scores indicating more favorable attitudes.

Outcome measures

Outcome measures
Measure	All Participants n=33 Participants Cognitive Behavioral Therapy for Treatment Seeking (CBT-TS): The intervention will consist of 1 - 2 sessions. The first session is approximately 60 - 90 minutes and will be structured in 4 phases 1) subject's history of symptoms and current functioning, 2) their coping methods, 3) modification of treatment beliefs, 4) action planning. The interventionist will provide the subject with a list of resources for seeking treatment. All subjects will be offered an optional second session with the interventionist. The second session will consist of a 60-minute appointment focused on providing practical assistance to identify available treatment options in the subject's area, scheduling treatment sessions, and problem-solving barriers to treatment.
Mean Change in Intention to Seek Treatment Baseline Intention	4.62 score on a scale Standard Deviation 1.79
Mean Change in Intention to Seek Treatment 1-month Intention	4.92 score on a scale Standard Deviation 2.06

POST_HOC outcome

Timeframe: Baseline to 1-month

The National Survey on Drug Use and Health (NSDUH) 30-day alcohol consumption: drinks per day question will assess the average number of drinks per day an individual consumed on days with alcohol consumption in the past month.

Outcome measures

Outcome measures
Measure	All Participants n=33 Participants Cognitive Behavioral Therapy for Treatment Seeking (CBT-TS): The intervention will consist of 1 - 2 sessions. The first session is approximately 60 - 90 minutes and will be structured in 4 phases 1) subject's history of symptoms and current functioning, 2) their coping methods, 3) modification of treatment beliefs, 4) action planning. The interventionist will provide the subject with a list of resources for seeking treatment. All subjects will be offered an optional second session with the interventionist. The second session will consist of a 60-minute appointment focused on providing practical assistance to identify available treatment options in the subject's area, scheduling treatment sessions, and problem-solving barriers to treatment.
Mean Change in Past Month Drinks Per Day Baseline drinks per day	1.42 drinks per day Standard Deviation 1.95
Mean Change in Past Month Drinks Per Day 1-month drinks per day	0.88 drinks per day Standard Deviation 1.58

POST_HOC outcome

Timeframe: Baseline to 1-month

The National Survey on Drug Use and Health (NSDUH) 30-day alcohol consumption: drinking days question will assess the number of days the individual consumed alcohol in the past month.

Outcome measures

Outcome measures
Measure	All Participants n=33 Participants Cognitive Behavioral Therapy for Treatment Seeking (CBT-TS): The intervention will consist of 1 - 2 sessions. The first session is approximately 60 - 90 minutes and will be structured in 4 phases 1) subject's history of symptoms and current functioning, 2) their coping methods, 3) modification of treatment beliefs, 4) action planning. The interventionist will provide the subject with a list of resources for seeking treatment. All subjects will be offered an optional second session with the interventionist. The second session will consist of a 60-minute appointment focused on providing practical assistance to identify available treatment options in the subject's area, scheduling treatment sessions, and problem-solving barriers to treatment.
Mean Change in Past Month Alcohol Drinking Days Baseline drinking days	4.06 days Standard Deviation 7.08
Mean Change in Past Month Alcohol Drinking Days 1-month drinking days	2.64 days Standard Deviation 0.88

POST_HOC outcome

Timeframe: Baseline to 1-month

The National Survey on Drug Use and Health (NSDUH) 30-day alcohol consumption: binge drinking days question will assess the number of days with binge drinking episodes in the past month.

Outcome measures

Outcome measures
Measure	All Participants n=33 Participants Cognitive Behavioral Therapy for Treatment Seeking (CBT-TS): The intervention will consist of 1 - 2 sessions. The first session is approximately 60 - 90 minutes and will be structured in 4 phases 1) subject's history of symptoms and current functioning, 2) their coping methods, 3) modification of treatment beliefs, 4) action planning. The interventionist will provide the subject with a list of resources for seeking treatment. All subjects will be offered an optional second session with the interventionist. The second session will consist of a 60-minute appointment focused on providing practical assistance to identify available treatment options in the subject's area, scheduling treatment sessions, and problem-solving barriers to treatment.
Mean Change in Past Month Binge Drinking Days Baseline binge drinking days	1.15 days Standard Deviation 4.39
Mean Change in Past Month Binge Drinking Days 1-month binge drinking days	0.24 days Standard Deviation 1.39

POST_HOC outcome

Timeframe: Baseline to 1-month

The Patient Health Questionnaire - 9 (PHQ-9). The PHQ-9 is a 9-item self-report scale assessing the presence and severity of symptoms of depression. Each item is rated on a Likert scale of 0 (not at all) to 3 (nearly every day). Total scores range from 0 - 27 with higher scores indicating more severe depression.

Outcome measures

Outcome measures
Measure	All Participants n=33 Participants Cognitive Behavioral Therapy for Treatment Seeking (CBT-TS): The intervention will consist of 1 - 2 sessions. The first session is approximately 60 - 90 minutes and will be structured in 4 phases 1) subject's history of symptoms and current functioning, 2) their coping methods, 3) modification of treatment beliefs, 4) action planning. The interventionist will provide the subject with a list of resources for seeking treatment. All subjects will be offered an optional second session with the interventionist. The second session will consist of a 60-minute appointment focused on providing practical assistance to identify available treatment options in the subject's area, scheduling treatment sessions, and problem-solving barriers to treatment.
Depression Baseline depression	13.39 score on a scale Standard Deviation 6.17
Depression 1-month depression	7.88 score on a scale Standard Deviation 5.73

POST_HOC outcome

Timeframe: Baseline to 1-month follow-up

Generalized Anxiety Scale- 7 (GAD-7). The GAD-7 is a self-report measure of the presence and severity of anxiety symptoms. It contains 7 items rated on a Likert scale ranging from 0 (not at all) to 3 (nearly every day). Total scores range from 0 - 21 with higher scores indicating more severe anxiety symptoms.

Outcome measures

Outcome measures
Measure	All Participants n=33 Participants Cognitive Behavioral Therapy for Treatment Seeking (CBT-TS): The intervention will consist of 1 - 2 sessions. The first session is approximately 60 - 90 minutes and will be structured in 4 phases 1) subject's history of symptoms and current functioning, 2) their coping methods, 3) modification of treatment beliefs, 4) action planning. The interventionist will provide the subject with a list of resources for seeking treatment. All subjects will be offered an optional second session with the interventionist. The second session will consist of a 60-minute appointment focused on providing practical assistance to identify available treatment options in the subject's area, scheduling treatment sessions, and problem-solving barriers to treatment.
Anxiety Baseline anxiety	11.64 score on a scale Standard Deviation 5.61
Anxiety 1-month anxiety	7.27 score on a scale Standard Deviation 1.06

POST_HOC outcome

Timeframe: Baseline to 1-month

PTSD Checklist for DSM-5 (PCL-5). The PCL-5 is a 20-item self-report measure of that assesses the 20 DSM-5 symptoms of PTSD. Items are rated on a Likert scale ranging from 0 (not at all) to 4 (Extremely). Total scores range from 0 to 80 with higher scores indicating more severe symptoms of PTSD.

Outcome measures

Outcome measures
Measure	All Participants n=33 Participants Cognitive Behavioral Therapy for Treatment Seeking (CBT-TS): The intervention will consist of 1 - 2 sessions. The first session is approximately 60 - 90 minutes and will be structured in 4 phases 1) subject's history of symptoms and current functioning, 2) their coping methods, 3) modification of treatment beliefs, 4) action planning. The interventionist will provide the subject with a list of resources for seeking treatment. All subjects will be offered an optional second session with the interventionist. The second session will consist of a 60-minute appointment focused on providing practical assistance to identify available treatment options in the subject's area, scheduling treatment sessions, and problem-solving barriers to treatment.
Post-traumatic Stress Disorder Baseline PTSD	36.48 score on a scale Standard Deviation 18.06
Post-traumatic Stress Disorder 1-month PTSD	21.94 score on a scale Standard Deviation 16.06

POST_HOC outcome

Timeframe: Baseline to 1-month

Insomnia Severity Index (ISI). The ISI is a self-report measure of sleep problems. The scale contains 7 items rated on a Likert scale ranging from 0 to 4. Total scores range from 0 - 28 with higher scores indicating more severe sleep disturbance.

Outcome measures

Outcome measures
Measure	All Participants n=33 Participants Cognitive Behavioral Therapy for Treatment Seeking (CBT-TS): The intervention will consist of 1 - 2 sessions. The first session is approximately 60 - 90 minutes and will be structured in 4 phases 1) subject's history of symptoms and current functioning, 2) their coping methods, 3) modification of treatment beliefs, 4) action planning. The interventionist will provide the subject with a list of resources for seeking treatment. All subjects will be offered an optional second session with the interventionist. The second session will consist of a 60-minute appointment focused on providing practical assistance to identify available treatment options in the subject's area, scheduling treatment sessions, and problem-solving barriers to treatment.
Insomnia Baseline insomnia	15.36 score on a scale Standard Deviation 5.99
Insomnia 1-month insomnia	11.93 score on a scale Standard Deviation 7.01

POST_HOC outcome

Timeframe: baseline to 1-month

The Alcohol Use Disorder Identification Test (AUDIT) is a 10-item screening tool that assesses alcohol consumption, drinking behaviors, and alcohol-related problems. Scores range from 0 - 40 with greater scores indicating higher levels of consumption and alcohol-related problems.

Outcome measures

Outcome measures
Measure	All Participants n=33 Participants Cognitive Behavioral Therapy for Treatment Seeking (CBT-TS): The intervention will consist of 1 - 2 sessions. The first session is approximately 60 - 90 minutes and will be structured in 4 phases 1) subject's history of symptoms and current functioning, 2) their coping methods, 3) modification of treatment beliefs, 4) action planning. The interventionist will provide the subject with a list of resources for seeking treatment. All subjects will be offered an optional second session with the interventionist. The second session will consist of a 60-minute appointment focused on providing practical assistance to identify available treatment options in the subject's area, scheduling treatment sessions, and problem-solving barriers to treatment.
Mean Change in Symptoms of Alcohol Use Disorder Baseline Alcohol Screen	4.61 score on a scale Standard Deviation 5.49
Mean Change in Symptoms of Alcohol Use Disorder 1-month Alcohol Screen	2.39 score on a scale Standard Deviation 4.34

POST_HOC outcome

Timeframe: Baseline to 1-month

The Deaf Perceptions About Services Scale (PASS-D) Behavioral beliefs scale. The Behavioral Beliefs Scale contains 10 items that assess individuals' behavioral beliefs about seeking behavioral health treatment. The items are rated on a Likert scale ranging from 1 - 7. Scores are averaged across the items for a total score of 1 - 7 with higher scores indicating more positive behavioral beliefs about seeking treatment.

Outcome measures

Outcome measures
Measure	All Participants n=33 Participants Cognitive Behavioral Therapy for Treatment Seeking (CBT-TS): The intervention will consist of 1 - 2 sessions. The first session is approximately 60 - 90 minutes and will be structured in 4 phases 1) subject's history of symptoms and current functioning, 2) their coping methods, 3) modification of treatment beliefs, 4) action planning. The interventionist will provide the subject with a list of resources for seeking treatment. All subjects will be offered an optional second session with the interventionist. The second session will consist of a 60-minute appointment focused on providing practical assistance to identify available treatment options in the subject's area, scheduling treatment sessions, and problem-solving barriers to treatment.
Mean Change in Behavioral Beliefs About Treatment Baseline behavioral beliefs	4.88 score on a scale Standard Deviation 0.99
Mean Change in Behavioral Beliefs About Treatment 1-month behavioral beliefs	5.31 score on a scale Standard Deviation 0.70

POST_HOC outcome

Timeframe: Baseline to 1-month

The Deaf Perceptions About Services Scale (PASS-D) Normative Beliefs scale. The Normative Beliefs Scale contains 7 items that assess individuals' normative beliefs about behavioral health treatment. The items are rated on a Likert scale ranging from 1 - 7. Scores are averaged across the items for a total score of 1 - 7 with higher scores indicating more positive normative beliefs about treatment.

Outcome measures

Outcome measures
Measure	All Participants n=33 Participants Cognitive Behavioral Therapy for Treatment Seeking (CBT-TS): The intervention will consist of 1 - 2 sessions. The first session is approximately 60 - 90 minutes and will be structured in 4 phases 1) subject's history of symptoms and current functioning, 2) their coping methods, 3) modification of treatment beliefs, 4) action planning. The interventionist will provide the subject with a list of resources for seeking treatment. All subjects will be offered an optional second session with the interventionist. The second session will consist of a 60-minute appointment focused on providing practical assistance to identify available treatment options in the subject's area, scheduling treatment sessions, and problem-solving barriers to treatment.
Mean Change in Normative Beliefs About Treatment Baseline normative beliefs	5.13 score on a scale Standard Deviation 1.00
Mean Change in Normative Beliefs About Treatment 1-month normative beliefs	5.68 score on a scale Standard Deviation 0.90

POST_HOC outcome

Timeframe: Baseline to 1-month

The Deaf Perceptions About Services Scale (PASS-D) Control Beliefs scale. The Control Beliefs Scale contains 26 items that assess individuals' control beliefs about seeking behavioral health treatment. The items are rated on a Likert scale ranging from 1 - 7. Scores are averaged across the items for a total score of 1 - 7 with higher scores indicating more positive control beliefs about seeking treatment.

Outcome measures

Outcome measures
Measure	All Participants n=33 Participants Cognitive Behavioral Therapy for Treatment Seeking (CBT-TS): The intervention will consist of 1 - 2 sessions. The first session is approximately 60 - 90 minutes and will be structured in 4 phases 1) subject's history of symptoms and current functioning, 2) their coping methods, 3) modification of treatment beliefs, 4) action planning. The interventionist will provide the subject with a list of resources for seeking treatment. All subjects will be offered an optional second session with the interventionist. The second session will consist of a 60-minute appointment focused on providing practical assistance to identify available treatment options in the subject's area, scheduling treatment sessions, and problem-solving barriers to treatment.
Mean Change in Control Beliefs About Seeking Treatment Baseline control beliefs	4.26 score on a scale Standard Deviation 0.71
Mean Change in Control Beliefs About Seeking Treatment 1-month control beliefs	4.94 score on a scale Standard Deviation 0.93

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Aileen Aldalur

University of Rochester

Phone: (585) 371-6125

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place