Acceptability and Feasibility of Cognitive Behavioral Therapy for Treatment-Seeking (CBT-TS) With Deaf Individuals
Primary Purpose
Mental Health Issue, Alcohol Use Disorder, Depression
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy for Treatment Seeking (CBT-TS)
Sponsored by
About this trial
This is an interventional treatment trial for Mental Health Issue
Eligibility Criteria
Inclusion Criteria:
- age > 18 years
- 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.
Sites / Locations
- Aileen AldalurRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
All Participants
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05520190
Brief Title
Acceptability and Feasibility of Cognitive Behavioral Therapy for Treatment-Seeking (CBT-TS) With Deaf Individuals
Official Title
Acceptability and Feasibility of Cognitive Behavioral Therapy for Treatment-Seeking (CBT-TS) With Deaf Individuals
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 3, 2023 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health Issue, Alcohol Use Disorder, Depression, Anxiety, Insomnia, Post Traumatic Stress Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
All Participants
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy for Treatment Seeking (CBT-TS)
Intervention Description
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.
Primary Outcome Measure Information:
Title
proportion of participants who schedule professional treatment
Description
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.
Time Frame
1 month
Title
mean change in attitudes about treatment
Description
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.
Time Frame
baseline to 1 month
Title
mean change in subjective norm about treatment
Description
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.
Time Frame
baseline to 1 month
Title
mean change in perceived behavioral control about seeking treatment
Description
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.
Time Frame
baseline to 1 month
Title
mean change in intention to seek treatment
Description
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.
Time Frame
baseline to 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aileen Aldalur, PhD
Phone
585-371-6125 (call only)
Email
aileen_aldalur@urmc.rochester.edu
Facility Information:
Facility Name
Aileen Aldalur
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aileen Aldalur, PhD
Phone
585-371-6125
Email
Aileen_Aldalur@URMC.Rochester.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Acceptability and Feasibility of Cognitive Behavioral Therapy for Treatment-Seeking (CBT-TS) With Deaf Individuals
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