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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05520190
• Other study ID #: STUDY00007447
• Status: Completed
• Phase: N/A
• Start date: April 3, 2023
• Est. completion date: February 9, 2024

Study information

• Verified date: April 2024
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: February 9, 2024
• Est. primary completion date: February 9, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Alcoholism
• Anxiety
• Depression
• Insomnia
• Mental Health Issue
• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.

Locations

Country	Name	City	State
United States	Aileen Aldalur	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	mean change in attitudes about treatment	The D-PASS will be administered pre-and-post-treatment to collect information about subjects' attitudes. The scale ranges from 4 to 28 with higher scores indicating more favorable attitudes.	baseline to 1 month
Primary	mean change in subjective norm about treatment	The D-PASS will be administered pre-and-post-treatment to collect information about subjects' subjective norm. The scale ranges from 3 to 21 with higher scores indicating more favorable attitudes.	baseline to 1 month
Primary	mean change in perceived behavioral control about seeking treatment	The D-PASS will be administered pre-and-post-treatment to collect information about perceived behavioral control for seeking treatment. The scale ranges from 3 to 21 with higher scores indicating more favorable attitudes.	baseline to 1 month
Primary	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