Alcohol Use Disorder, Anxiety, Depression, Insomnia, Mental Health Issue, Post Traumatic Stress Disorder
Conditions
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.
Interventions
BEHAVIORALCognitive 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.
Sponsors
University of Rochester
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Who Schedule Professional Treatment | 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. |
| Mean Change in Attitudes About Treatment | 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. |
| Mean Change in Subjective Norm About Treatment | 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. |
| Mean Change in Perceived Behavioral Control About Seeking Treatment | 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. |
| Mean Change in Intention to Seek Treatment | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants 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. | 40 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 7 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 43.33 years STANDARD_DEVIATION 13.99 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 33 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 27 Participants |
| Region of Enrollment United States | 40 participants |
| Sex/Gender, Customized Female | 26 Participants |
| Sex/Gender, Customized Male | 13 Participants |
| Sex/Gender, Customized Nonbinary | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 42 |
| other Total, other adverse events | 0 / 42 |
| serious Total, serious adverse events | 0 / 42 |
Outcome results
Primary
Mean Change in Attitudes About Treatment
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.
Time frame: baseline to 1 month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Mean Change in Attitudes About Treatment | Baseline Attitude | 4.93 score on a scale | Standard Deviation 1.26 |
| All Participants | Mean Change in Attitudes About Treatment | 1-month Attitude | 5.40 score on a scale | Standard Deviation 1.25 |
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.
Time frame: baseline to 1 month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Mean Change in Intention to Seek Treatment | Baseline Intention | 4.62 score on a scale | Standard Deviation 1.79 |
| All Participants | Mean Change in Intention to Seek Treatment | 1-month Intention | 4.92 score on a scale | Standard Deviation 2.06 |
Primary
Mean Change in Perceived Behavioral Control About Seeking Treatment
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.
Time frame: baseline to 1 month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Mean Change in Perceived Behavioral Control About Seeking Treatment | Baseline Perceived Behavioral Control | 6.10 score on a scale | Standard Deviation 1.01 |
| All Participants | Mean Change in Perceived Behavioral Control About Seeking Treatment | 1-month Perceived Behavioral Control | 6.14 score on a scale | Standard Deviation 1.15 |
Primary
Mean Change in Subjective Norm About Treatment
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.
Time frame: baseline to 1 month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Mean Change in Subjective Norm About Treatment | Baseline Norms | 5.18 score on a scale | Standard Deviation 1.39 |
| All Participants | Mean Change in Subjective Norm About Treatment | 1-month Norms | 5.51 score on a scale | Standard Deviation 0.88 |
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.
Time frame: 1 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants | Proportion of Participants Who Schedule Professional Treatment | 8 Participants |
Post Hoc
Anxiety
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.
Time frame: Baseline to 1-month follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Anxiety | Baseline anxiety | 11.64 score on a scale | Standard Deviation 5.61 |
| All Participants | Anxiety | 1-month anxiety | 7.27 score on a scale | Standard Deviation 1.06 |
Post Hoc
Depression
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.
Time frame: Baseline to 1-month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Depression | Baseline depression | 13.39 score on a scale | Standard Deviation 6.17 |
| All Participants | Depression | 1-month depression | 7.88 score on a scale | Standard Deviation 5.73 |
Post Hoc
Insomnia
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.
Time frame: Baseline to 1-month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Insomnia | Baseline insomnia | 15.36 score on a scale | Standard Deviation 5.99 |
| All Participants | Insomnia | 1-month insomnia | 11.93 score on a scale | Standard Deviation 7.01 |
Post Hoc
Mean Change in Behavioral Beliefs About Treatment
The Deaf Perceptions About Services Scale (PASS-D) Behavioral beliefs scale. The Behavioral Beliefs Scale contains 10 items that assess individuals' behavioral beliefs about seeking 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 positive behavioral beliefs about seeking treatment.
Time frame: Baseline to 1-month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Mean Change in Behavioral Beliefs About Treatment | Baseline behavioral beliefs | 4.88 score on a scale | Standard Deviation 0.99 |
| All Participants | Mean Change in Behavioral Beliefs About Treatment | 1-month behavioral beliefs | 5.31 score on a scale | Standard Deviation 0.7 |
Post Hoc
Mean Change in Control Beliefs About Seeking Treatment
The Deaf Perceptions About Services Scale (PASS-D) Control Beliefs scale. The Control Beliefs Scale contains 26 items that assess individuals' control beliefs about seeking 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 positive control beliefs about seeking treatment.
Time frame: Baseline to 1-month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Mean Change in Control Beliefs About Seeking Treatment | Baseline control beliefs | 4.26 score on a scale | Standard Deviation 0.71 |
| All Participants | Mean Change in Control Beliefs About Seeking Treatment | 1-month control beliefs | 4.94 score on a scale | Standard Deviation 0.93 |
Post Hoc
Mean Change in Normative Beliefs About Treatment
The Deaf Perceptions About Services Scale (PASS-D) Normative Beliefs scale. The Normative Beliefs Scale contains 7 items that assess individuals' normative beliefs 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 positive normative beliefs about treatment.
Time frame: Baseline to 1-month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Mean Change in Normative Beliefs About Treatment | Baseline normative beliefs | 5.13 score on a scale | Standard Deviation 1 |
| All Participants | Mean Change in Normative Beliefs About Treatment | 1-month normative beliefs | 5.68 score on a scale | Standard Deviation 0.9 |
Post Hoc
Mean Change in Past Month Alcohol Drinking Days
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.
Time frame: Baseline to 1-month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Mean Change in Past Month Alcohol Drinking Days | Baseline drinking days | 4.06 days | Standard Deviation 7.08 |
| All Participants | Mean Change in Past Month Alcohol Drinking Days | 1-month drinking days | 2.64 days | Standard Deviation 0.88 |
Post Hoc
Mean Change in Past Month Binge Drinking Days
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.
Time frame: Baseline to 1-month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Mean Change in Past Month Binge Drinking Days | Baseline binge drinking days | 1.15 days | Standard Deviation 4.39 |
| All Participants | Mean Change in Past Month Binge Drinking Days | 1-month binge drinking days | 0.24 days | Standard Deviation 1.39 |
Post Hoc
Mean Change in Past Month Drinks Per Day
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.
Time frame: Baseline to 1-month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Mean Change in Past Month Drinks Per Day | Baseline drinks per day | 1.42 drinks per day | Standard Deviation 1.95 |
| All Participants | Mean Change in Past Month Drinks Per Day | 1-month drinks per day | 0.88 drinks per day | Standard Deviation 1.58 |
Post Hoc
Mean Change in Symptoms of Alcohol Use Disorder
The Alcohol Use Disorder Identification Test (AUDIT) is a 10-item screening tool that assesses alcohol consumption, drinking behaviors, and alcohol-related problems. Scores range from 0 - 40 with greater scores indicating higher levels of consumption and alcohol-related problems.
Time frame: baseline to 1-month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Mean Change in Symptoms of Alcohol Use Disorder | Baseline Alcohol Screen | 4.61 score on a scale | Standard Deviation 5.49 |
| All Participants | Mean Change in Symptoms of Alcohol Use Disorder | 1-month Alcohol Screen | 2.39 score on a scale | Standard Deviation 4.34 |
Post Hoc
Post-traumatic Stress Disorder
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.
Time frame: Baseline to 1-month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Post-traumatic Stress Disorder | Baseline PTSD | 36.48 score on a scale | Standard Deviation 18.06 |
| All Participants | Post-traumatic Stress Disorder | 1-month PTSD | 21.94 score on a scale | Standard Deviation 16.06 |