Acceptability and Feasibility of Cognitive Behavioral Therapy for Treatment-Seeking (CBT-TS) With Deaf Individuals

NCT05520190 | Completed Results

• 1 other identifier: STUDY00007447
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Health Issue; Alcohol Use Disorder; Depression; Anxiety; Insomnia; Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (5)

• 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.

  1 month

• 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.

  baseline to 1 month

• 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.

  baseline to 1 month

• 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.

  baseline to 1 month

• 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.

  baseline to 1 month

Study Arms (1)

All Participants

EXPERIMENTAL

Behavioral: Cognitive Behavioral Therapy for Treatment Seeking (CBT-TS)

Interventions

Cognitive Behavioral Therapy for Treatment Seeking (CBT-TS) BEHAVIORAL

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.

All Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

Aileen Aldalur

Rochester, New York, 14623, United States

Location

MeSH Terms

Conditions

Alcoholism; Depression; Anxiety Disorders; Sleep Initiation and Maintenance Disorders; Stress Disorders, Post-Traumatic

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Aileen Aldalur
• Organization: University of Rochester

aileen_aldalur@urmc.rochester.edu

(585) 371-6125

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: August 29, 2022
• Study Start: April 3, 2023
• Primary Completion: February 9, 2024
• Study Completion: February 9, 2024
• Last Updated: January 10, 2025
• Results First Posted: January 10, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)