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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: PTSD; Alcohol Use Disorder; Anxiety Disorders and Symptoms
• Intervention / Treatment: Behavioral: Personalized intervention condition: Cognitive Behavioral Therapy skills; Behavioral: Therapeutic control condition: Cognitive Behavioral Therapy skills; Behavioral: Tracking control condition: Supportive counseling

• Study Type: Interventional
• Enrollment (Anticipated): 81
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marilyn Piccirillo, PhD; Phone Number: (646) 481-0175; Email: piccirim@uw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Study Population

Participants in the proposed research will include adult individuals from a diversity of racial and ethnic backgrounds who report clinically significant anxiety and anxiety-related symptoms, engage in problematic alcohol use, and who are seeking psychological treatment.

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Personalized intervention condition; This experimental condition will test a data-driven, person-specific intervention using CBT skills.	Behavioral: Personalized intervention condition: Cognitive Behavioral Therapy skills; 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.
Active Comparator: Therapeutic control condition; This control condition will provide an experimental comparison to test the process of personalization.	Behavioral: Therapeutic control condition: Cognitive Behavioral Therapy skills; 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.
Active Comparator: Tracking control condition; This second control condition will provide an experimental comparison to test the effects of health-related tracking and therapeutic contact.	Behavioral: Tracking control condition: Supportive counseling; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Week 12
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.	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
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.	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 Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 12 weeks
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).	Week 1
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).	Week 2
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).	Week 3
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).	Week 4
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).	Week 5
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).	Week 6
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).	Week 7
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).	Week 8
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).	Week 9
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).	Week 10
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).	Week 11
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).	Week 12
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.	Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Marilyn Piccirillo, PhD, University of Washington

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2024
• Primary Completion (Anticipated): May 1, 2026
• Study Completion (Anticipated): April 1, 2027

Study Registration Dates

• First Submitted: March 26, 2023
• First Submitted That Met QC Criteria: April 6, 2023
• First Posted (Actual): April 20, 2023

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Alcohol-Related Disorders; Substance-Related Disorders; Alcoholism; Disease; Anxiety Disorders
• Other Study ID Numbers: STUDY00013899; 1K99AA029459-01 (U.S. NIH Grant/Contract); 5T32AA007455 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No