search
Back to results

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

Primary Purpose

Anxiety Disorders and Symptoms, PTSD, Alcohol Use Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Personalized intervention condition: Cognitive Behavioral Therapy skills
Therapeutic control condition: Cognitive Behavioral Therapy skills
Tracking control condition: Supportive counseling
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders and Symptoms

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    Personalized intervention condition

    Therapeutic control condition

    Tracking control condition

    Arm Description

    This experimental condition will test a data-driven, person-specific intervention using CBT skills.

    This control condition will provide an experimental comparison to test the process of personalization.

    This second control condition will provide an experimental comparison to test the effects of health-related tracking and therapeutic contact.

    Outcomes

    Primary Outcome Measures

    Change in psychiatric diagnoses as measured using the Mini Neuropsychiatric Interview
    This diagnostic interview will be used to assess change in psychiatric diagnoses at the beginning and end of research participation.
    Change in anxiety or anxiety-related symptom severity at 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.
    Change in alcohol use/AUD symptoms as measured using the Alcohol Use Disorder Identification Test
    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

    Number of sessions attended
    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.
    Utility of therapy skills: 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).
    Utility of Treatment Inventory
    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).
    Utility of Treatment Inventory
    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).
    Utility of Treatment Inventory
    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).
    Utility of Treatment Inventory
    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).
    Utility of Treatment Inventory
    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).
    Utility of Treatment Inventory
    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).
    Utility of Treatment Inventory
    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).
    Utility of Treatment Inventory
    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).
    Utility of Treatment Inventory
    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).
    Utility of Treatment Inventory
    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).
    Utility of Treatment Inventory
    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).
    Change in therapeutic alliance as measured using the Working Alliance Inventory - Self report
    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.

    Full Information

    First Posted
    March 26, 2023
    Last Updated
    May 8, 2023
    Sponsor
    University of Washington
    Collaborators
    National Institute on Alcohol Abuse and Alcoholism (NIAAA)
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05821634
    Brief Title
    Digital Phenotyping of Anxiety and Anxiety-Related Alcohol Co-occurrence: Pilot Study
    Official Title
    Digital Phenotyping of Anxiety and Anxiety-Related Alcohol Co-occurrence: Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 2024 (Anticipated)
    Primary Completion Date
    May 2026 (Anticipated)
    Study Completion Date
    April 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Washington
    Collaborators
    National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anxiety Disorders and Symptoms, PTSD, Alcohol Use Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    81 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Personalized intervention condition
    Arm Type
    Experimental
    Arm Description
    This experimental condition will test a data-driven, person-specific intervention using CBT skills.
    Arm Title
    Therapeutic control condition
    Arm Type
    Active Comparator
    Arm Description
    This control condition will provide an experimental comparison to test the process of personalization.
    Arm Title
    Tracking control condition
    Arm Type
    Active Comparator
    Arm Description
    This second control condition will provide an experimental comparison to test the effects of health-related tracking and therapeutic contact.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Personalized intervention condition: Cognitive Behavioral Therapy skills
    Intervention Description
    A Cognitive Behavioral Therapy (CBT) skills based intervention will be delivered to participants randomized to the personalized intervention. Influential constructs driving alcohol use will be identified using the person specific digital phenotyping model, will be targeted using CBT skills, and will be tracked across sessions. Results from the person-specific model will be reviewed each week. This iterative, data-driven, decision-making process will continue for 12 sessions.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Therapeutic control condition: Cognitive Behavioral Therapy skills
    Intervention Description
    Participants randomized to this condition will receive a 12-session CBT skills based treatment targeting a non-personalized construct selected from the person-specific digital phenotyping model.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Tracking control condition: Supportive counseling
    Intervention Description
    Participants randomized to this condition will receive 12 supportive counseling sessions that are non-directive in nature (providing support and validation for non-acute weekly stressors). Participants will continue digital phenotyping but will not discuss their person-specific model during session, controlling for the effect of therapist contact and digital phenotyping.
    Primary Outcome Measure Information:
    Title
    Change in psychiatric diagnoses as measured using the Mini Neuropsychiatric Interview
    Description
    This diagnostic interview will be used to assess change in psychiatric diagnoses at the beginning and end of research participation.
    Time Frame
    Baseline, Week 12
    Title
    Change in anxiety or anxiety-related symptom severity at Week 12
    Description
    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.
    Time Frame
    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
    Title
    Change in alcohol use/AUD symptoms as measured using the Alcohol Use Disorder Identification Test
    Description
    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.
    Time Frame
    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
    Secondary Outcome Measure Information:
    Title
    Number of sessions attended
    Description
    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.
    Time Frame
    Up to 12 weeks
    Title
    Utility of therapy skills: Week 1
    Description
    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).
    Time Frame
    Week 1
    Title
    Utility of Treatment Inventory
    Description
    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).
    Time Frame
    Week 2
    Title
    Utility of Treatment Inventory
    Description
    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).
    Time Frame
    Week 3
    Title
    Utility of Treatment Inventory
    Description
    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).
    Time Frame
    Week 4
    Title
    Utility of Treatment Inventory
    Description
    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).
    Time Frame
    Week 5
    Title
    Utility of Treatment Inventory
    Description
    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).
    Time Frame
    Week 6
    Title
    Utility of Treatment Inventory
    Description
    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).
    Time Frame
    Week 7
    Title
    Utility of Treatment Inventory
    Description
    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).
    Time Frame
    Week 8
    Title
    Utility of Treatment Inventory
    Description
    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).
    Time Frame
    Week 9
    Title
    Utility of Treatment Inventory
    Description
    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).
    Time Frame
    Week 10
    Title
    Utility of Treatment Inventory
    Description
    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).
    Time Frame
    Week 11
    Title
    Utility of Treatment Inventory
    Description
    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).
    Time Frame
    Week 12
    Title
    Change in therapeutic alliance as measured using the Working Alliance Inventory - Self report
    Description
    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.
    Time Frame
    Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Marilyn Piccirillo, PhD
    Phone
    (646) 481-0175
    Email
    piccirim@uw.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marilyn Piccirillo, PhD
    Organizational Affiliation
    University of Washington
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs