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

The current study aims to assess the acceptability and feasibility of an adapted version of Cognitive Behavioral Therapy for Treatment Seeking (CBT-TS) for use with signing Deaf adults. This is a Stage 1A intervention refinement study consisting of a single-arm open pilot trial. Thirty Deaf adults with clinically significant symptoms of alcohol use disorder (AUD), post-traumatic stress disorder (PTSD), depression, anxiety, and/or insomnia, who are not currently engaged in treatment will be recruited from across the United States. All subjects will complete a baseline assessment of their behavioral health symptoms, perceptions towards treatment, and intent to seek treatment prior to engaging in the adapted CBT-TS intervention. The primary clinical outcome, assessed at one-month follow-up, will be whether subjects scheduled professional treatment. Secondary outcomes include changes in subjects' perceptions towards treatment, intentions to seek treatment, and symptom severity from baseline. During the one-month, follow-up assessment subjects will also complete a client satisfaction survey and open-ended questions to provide feedback about the CBT-TS intervention.

Study Overview

• Status: Completed
• Conditions: Depression; Insomnia; Anxiety; Post Traumatic Stress Disorder; Alcohol Use Disorder; Mental Health Issue
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy for Treatment Seeking (CBT-TS)

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14623
      • Aileen Aldalur

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 years of age or older
• self-identify as Deaf or hard-of-hearing (any degree of hearing loss)
• primary method of communication is ASL or PSE
• positive screen for one or more behavioral health disorders including: AUD (AUDIT > 16 and alcohol use in the past 30 days exceeds the limit for low-risk drinking established by the NIAAA), PTSD (PCL-5 > 31), depression (PHQ-9 > 10), anxiety (GAD-7 > 10), or insomnia (ISI > 15)
• no current behavioral health treatment per standardized self-report
• access to video chat technology with internet and webcam.

Exclusion Criteria:

• unable to communicate with the researcher in ASL or PSE
• 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
• currently receiving behavioral health treatment for their symptoms.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: All Participants

Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants Who Schedule Professional Treatment	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.	1 month
Mean Change in Attitudes About Treatment	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.	baseline to 1 month
Mean Change in Subjective Norm About Treatment	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.	baseline to 1 month
Mean Change in Perceived Behavioral Control About Seeking Treatment	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.	baseline to 1 month
Mean Change in Intention to Seek Treatment	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.	baseline to 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
proportion of participants eligible for the study		baseline
proportion of participants who complete the intervention		baseline
proportion of participants who complete the follow up assessments		1 month
proportion of eligible participant who enroll		baseline
mean satisfaction with the intervention	Satisfaction will be measured using the Client Satisfaction Questionnaire-8 (CSQ-8). The questionnaire ranges from 8-32 with higher numbers indicating greater satisfaction.	1 month

Collaborators and Investigators

• Sponsor: University of Rochester

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2023
• Primary Completion (Actual): February 9, 2024
• Study Completion (Actual): February 9, 2024

Study Registration Dates

• First Submitted: August 25, 2022
• First Submitted That Met QC Criteria: August 25, 2022
• First Posted (Actual): August 29, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Alcoholism; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: STUDY00007447

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No