Acceptability and Feasibility of Cognitive Behavioral Therapy for Treatment-Seeking (CBT-TS) With… (NCT05520190) | Clinical Trial Compass
CompletedNot Applicable
Acceptability and Feasibility of Cognitive Behavioral Therapy for Treatment-Seeking (CBT-TS) With Deaf Individuals
United States42 participantsStarted 2023-04-03
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of Participants Who Schedule Professional Treatment
Timeframe: 1 month
2
Mean Change in Attitudes About Treatment
Timeframe: baseline to 1 month
3
Mean Change in Subjective Norm About Treatment
Timeframe: baseline to 1 month
4
Mean Change in Perceived Behavioral Control About Seeking Treatment