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

Study Overview
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Brief Summary
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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.

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

Conditions
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PTSD, Anxiety Disorders and Symptoms, Alcohol Use Disorder

Intervention / Treatment
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* Behavioral: Personalized intervention condition: Cognitive Behavioral Therapy skills
* Behavioral: Therapeutic control condition: Cognitive Behavioral Therapy skills
* Behavioral: Tracking control condition: Supportive counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Personalized intervention condition<br>This experimental condition will test a data-driven, person-specific intervention using CBT skills. | Behavioral: Personalized intervention condition: Cognitive Behavioral Therapy skills<br>* 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.<br>|
| Active Comparator: Therapeutic control condition<br>This control condition will provide an experimental comparison to test the process of personalization. | Behavioral: Therapeutic control condition: Cognitive Behavioral Therapy skills<br>* 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.<br>|
| Active Comparator: Tracking control condition<br>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<br>* 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.<br>|

What is the study measuring?
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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 |