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Completed

NCT Number: NCT05520190

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

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.

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Key information

Conditions

Mental Health Issue Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Anxiety Anxiety Disorders Behavior Behavioral Symptoms Chemically-Induced Disorders Depression Dyssomnias Insomnia Mental Disorders Nervous System Diseases Post Traumatic Stress Disorder Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Substance-Related Disorders Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aileen Aldalur

Rochester, New York, 14623, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Proportion of Participants Who Schedule Professional Treatment

    Time frame: 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.

  2. Mean Change in Attitudes About Treatment

    Time frame: 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.

  3. Mean Change in Subjective Norm About Treatment

    Time frame: 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.

  4. Mean Change in Perceived Behavioral Control About Seeking Treatment

    Time frame: 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.

  5. Mean Change in Intention to Seek Treatment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 29, 2022
Registry last updated
Jan 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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