18 and older, any sex, with Mental Health Issue or Alcohol Use Disorder. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Proportion of Participants Who Schedule Professional TreatmentPrimary· 1 month
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.
Group
Value
95% CI
All Participants
8
Mean Change in Attitudes About TreatmentPrimary· baseline to 1 month
The Deaf Perceptions About Services Scale (PASS-D) Attitude scale. The Attitude scale contains 4 items assessing individuals' attitudes about behavioral health treatment. The items are rated on a Likert scale ranging from 1 - 7. Scores are averaged across the items for a total score of 1 - 7 with higher scores indicating more favorable attitudes about treatment.
Baseline Attitude
Group
Value
95% CI
All Participants
4.93
± 1.26
1-month Attitude
Group
Value
95% CI
All Participants
5.40
± 1.25
Mean Change in Subjective Norm About TreatmentPrimary· baseline to 1 month
The Deaf Perceptions About Services Scale (PASS-D) Subjective Norm scale. The Subjective Norm scale contains 3 items assessing individuals' perceptions of the subjective norm in their community about behavioral health treatment. The items are rated on a Likert scale ranging from 1-7. Scores are averaged across the items for a total score of 1 - 7 with higher scores indicating more favorable perceptions about treatment.
Baseline Norms
Group
Value
95% CI
All Participants
5.18
± 1.39
1-month Norms
Group
Value
95% CI
All Participants
5.51
± 0.88
Mean Change in Perceived Behavioral Control About Seeking TreatmentPrimary· baseline to 1 month
The Deaf Perceptions About Services Scale (PASS-D) Perceived Behavioral Control scale. The Perceived Behavioral Control scale contains 3 items assessing individuals' perceived behavioral control to seek behavioral health treatment. The items are rated on a Likert scale ranging from 1 - 7. Scores are averaged across the items for a total score of 1 - 7 with higher scores indicating more perceived behavioral control to seek treatment.
Baseline Perceived Behavioral Control
Group
Value
95% CI
All Participants
6.10
± 1.01
1-month Perceived Behavioral Control
Group
Value
95% CI
All Participants
6.14
± 1.15
Mean Change in Intention to Seek TreatmentPrimary· baseline to 1 month
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 Intention
Group
Value
95% CI
All Participants
4.62
± 1.79
1-month Intention
Group
Value
95% CI
All Participants
4.92
± 2.06
Mean Change in Past Month Drinks Per DaySecondary· Baseline to 1-month
The National Survey on Drug Use and Health (NSDUH) 30-day alcohol consumption: drinks per day question will assess the average number of drinks per day an individual consumed on days with alcohol consumption in the past month.
Baseline drinks per day
Group
Value
95% CI
All Participants
1.42
± 1.95
1-month drinks per day
Group
Value
95% CI
All Participants
0.88
± 1.58
Mean Change in Past Month Alcohol Drinking DaysSecondary· Baseline to 1-month
The National Survey on Drug Use and Health (NSDUH) 30-day alcohol consumption: drinking days question will assess the number of days the individual consumed alcohol in the past month.
Baseline drinking days
Group
Value
95% CI
All Participants
4.06
± 7.08
1-month drinking days
Group
Value
95% CI
All Participants
2.64
± 0.88
Mean Change in Past Month Binge Drinking DaysSecondary· Baseline to 1-month
The National Survey on Drug Use and Health (NSDUH) 30-day alcohol consumption: binge drinking days question will assess the number of days with binge drinking episodes in the past month.
Baseline binge drinking days
Group
Value
95% CI
All Participants
1.15
± 4.39
1-month binge drinking days
Group
Value
95% CI
All Participants
0.24
± 1.39
DepressionSecondary· Baseline to 1-month
The Patient Health Questionnaire - 9 (PHQ-9). The PHQ-9 is a 9-item self-report scale assessing the presence and severity of symptoms of depression. Each item is rated on a Likert scale of 0 (not at all) to 3 (nearly every day). Total scores range from 0 - 27 with higher scores indicating more severe depression.
Baseline depression
Group
Value
95% CI
All Participants
13.39
± 6.17
1-month depression
Group
Value
95% CI
All Participants
7.88
± 5.73
AnxietySecondary· Baseline to 1-month follow-up
Generalized Anxiety Scale- 7 (GAD-7). The GAD-7 is a self-report measure of the presence and severity of anxiety symptoms. It contains 7 items rated on a Likert scale ranging from 0 (not at all) to 3 (nearly every day). Total scores range from 0 - 21 with higher scores indicating more severe anxiety symptoms.
Baseline anxiety
Group
Value
95% CI
All Participants
11.64
± 5.61
1-month anxiety
Group
Value
95% CI
All Participants
7.27
± 1.06
Post-traumatic Stress DisorderSecondary· Baseline to 1-month
PTSD Checklist for DSM-5 (PCL-5). The PCL-5 is a 20-item self-report measure of that assesses the 20 DSM-5 symptoms of PTSD. Items are rated on a Likert scale ranging from 0 (not at all) to 4 (Extremely). Total scores range from 0 to 80 with higher scores indicating more severe symptoms of PTSD.
Baseline PTSD
Group
Value
95% CI
All Participants
36.48
± 18.06
1-month PTSD
Group
Value
95% CI
All Participants
21.94
± 16.06
InsomniaSecondary· Baseline to 1-month
Insomnia Severity Index (ISI). The ISI is a self-report measure of sleep problems. The scale contains 7 items rated on a Likert scale ranging from 0 to 4. Total scores range from 0 - 28 with higher scores indicating more severe sleep disturbance.
Baseline insomnia
Group
Value
95% CI
All Participants
15.36
± 5.99
1-month insomnia
Group
Value
95% CI
All Participants
11.93
± 7.01
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by University of Rochester
Last refreshed: 10 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05520190.