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

NCT ID: NCT05520190

Last Updated: 2025-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-03
• Study Completion Date: 2024-02-09

Brief Summary

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.

Conditions

Mental Health Issue; Alcohol Use Disorder; Depression; Anxiety; Insomnia; Post Traumatic Stress Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

All Participants

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy for Treatment Seeking (CBT-TS)

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Aileen Aldalur

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Aileen Aldalur

Rochester, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STUDY00007447

Identifier Type: -

Identifier Source: org_study_id