Digital Phenotyping of Anxiety and Anxiety-Related Alcohol Co-occurrence: Pilot Study

Sponsor
University of Washington (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05821634
Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
81
35

Study Details

Study Description

Brief Summary

Anxiety and anxiety-related disorders frequently co-occur with alcohol use problems resulting in an enormous humanitarian and economic cost to society. The proposed research will use digital technology to examine person-specific risk factors predicting problematic alcohol use in individuals vulnerable to anxiety and anxiety-related disorders and will use this information to design a personalized intervention for individuals seeking psychological treatment. Results from this research will integrate output from novel and innovative digital technology methods into psychotherapy, advancing research on personalized treatment and prevention efforts.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    81 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Digital Phenotyping of Anxiety and Anxiety-Related Alcohol Co-occurrence: Pilot Study
    Anticipated Study Start Date :
    May 1, 2024
    Anticipated Primary Completion Date :
    May 1, 2026
    Anticipated Study Completion Date :
    Apr 1, 2027

    Outcome Measures

    Primary Outcome Measures

    1. Change in psychiatric diagnoses as measured using the Mini Neuropsychiatric Interview [Baseline, Week 12]

      This diagnostic interview will be used to assess change in psychiatric diagnoses at the beginning and end of research participation.

    2. Change in anxiety or anxiety-related symptom severity at Week 12 [Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12]

      A series of self-report measures specific to each individual's symptom profile will be used to assess changes in anxiety (e.g., generalized anxiety, panic, agoraphobia, social anxiety) or anxiety-related (e.g., post-traumatic stress) symptom severity over the course of the study. In general, higher scores indicate greater symptom severity; whereas lower scores indicate lower symptom severity.

    3. Change in alcohol use/AUD symptoms as measured using the Alcohol Use Disorder Identification Test [Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12]

      The Alcohol Use Disorder Identification Test (AUDIT) self-report measure will be used to assess changes in alcohol use and AUD symptoms over the course of the study. Scores on the AUDIT range from 0 to 40, with higher scores indicating greater alcohol use risk.

    Secondary Outcome Measures

    1. Number of sessions attended [Up to 12 weeks]

      The number of sessions completed during the 12- week pilot randomized clinical trial will be used to assess treatment retention. Scores on this measure range from 0 to 12, with 12 representing the maximal number of sessions attended.

    2. Utility of therapy skills: Week 1 [Week 1]

      The Utility of Treatment Inventory self-report measure will be used to assess perceived helpfulness of therapy skills presented during Week 1. Scores will range from 0 (Not at all helpful) to 7 (Very helpful).

    3. Utility of Treatment Inventory [Week 2]

      The Utility of Treatment Inventory self-report measure will be used to assess perceived helpfulness of therapy skills presented during Week 2. Scores will range from 0 (Not at all helpful) to 7 (Very helpful).

    4. Utility of Treatment Inventory [Week 3]

      The Utility of Treatment Inventory self-report measure will be used to assess perceived helpfulness of therapy skills presented during Week 3. Scores will range from 0 (Not at all helpful) to 7 (Very helpful).

    5. Utility of Treatment Inventory [Week 4]

      The Utility of Treatment Inventory self-report measure will be used to assess perceived helpfulness of therapy skills presented during Week 4. Scores will range from 0 (Not at all helpful) to 7 (Very helpful).

    6. Utility of Treatment Inventory [Week 5]

      The Utility of Treatment Inventory self-report measure will be used to assess perceived helpfulness of therapy skills presented during Week 5. Scores will range from 0 (Not at all helpful) to 7 (Very helpful).

    7. Utility of Treatment Inventory [Week 6]

      The Utility of Treatment Inventory self-report measure will be used to assess perceived helpfulness of therapy skills presented during Week 6. Scores will range from 0 (Not at all helpful) to 7 (Very helpful).

    8. Utility of Treatment Inventory [Week 7]

      The Utility of Treatment Inventory self-report measure will be used to assess perceived helpfulness of therapy skills presented during Week 7. Scores will range from 0 (Not at all helpful) to 7 (Very helpful).

    9. Utility of Treatment Inventory [Week 8]

      The Utility of Treatment Inventory self-report measure will be used to assess perceived helpfulness of therapy skills presented during Week 8. Scores will range from 0 (Not at all helpful) to 7 (Very helpful).

    10. Utility of Treatment Inventory [Week 9]

      The Utility of Treatment Inventory self-report measure will be used to assess perceived helpfulness of therapy skills presented during Week 9. Scores will range from 0 (Not at all helpful) to 7 (Very helpful).

    11. Utility of Treatment Inventory [Week 10]

      The Utility of Treatment Inventory self-report measure will be used to assess perceived helpfulness of therapy skills presented during Week 10. Scores will range from 0 (Not at all helpful) to 7 (Very helpful).

    12. Utility of Treatment Inventory [Week 11]

      The Utility of Treatment Inventory self-report measure will be used to assess perceived helpfulness of therapy skills presented during Week 11. Scores will range from 0 (Not at all helpful) to 7 (Very helpful).

    13. Utility of Treatment Inventory [Week 12]

      The Utility of Treatment Inventory self-report measure will be used to assess perceived helpfulness of therapy skills presented during Week 12. Scores will range from 0 (Not at all helpful) to 7 (Very helpful).

    14. Change in therapeutic alliance as measured using the Working Alliance Inventory - Self report [Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12]

      This self-report measure will be used to assess the working therapeutic alliance at each session to measure changes in therapeutic alliance. Scores on this measure range from 36 to 252 with higher scores representing stronger therapeutic alliance.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Access to a smartphone

    • Between 18 and 65 years

    • Clinically significant anxiety and anxiety-related disorder (AARD) symptoms

    • Problematic alcohol use

    • Interest in telehealth psychotherapy

    • Residence within the state in which the PI is licensed

    Exclusion Criteria:
    • Demonstrated indicators of more intensive or acute care

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Washington
    • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    Investigators

    • Principal Investigator: Marilyn Piccirillo, PhD, University of Washington

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Marilyn Piccirillo, Postdoctoral Scholar, University of Washington
    ClinicalTrials.gov Identifier:
    NCT05821634
    Other Study ID Numbers:
    • STUDY00013899
    • 1K99AA029459-01
    • 5T32AA007455
    First Posted:
    Apr 20, 2023
    Last Update Posted:
    Apr 20, 2023
    Last Verified:
    Apr 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Apr 20, 2023