Clinical trial NCT05520190: 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
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Issue
Alcohol Use Disorder
Depression
Anxiety
Insomnia
Post Traumatic Stress Disorder
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2022-08-29
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Proportion of Participants Who Schedule Professional Treatment
timeFrame: 1 month
measure: Mean Change in Attitudes About Treatment
timeFrame: baseline to 1 month
measure: Mean Change in Subjective Norm About Treatment
timeFrame: baseline to 1 month
measure: Mean Change in Perceived Behavioral Control About Seeking Treatment
timeFrame: baseline to 1 month
measure: Mean Change in Intention to Seek Treatment
timeFrame: baseline to 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Aileen Aldalur
state: New York
Study officials:
References: