Pilot Trial to Evaluate PROblem Solving Therapy and APPLE Watch for College Students

December 9, 2024 updated by: Hagar Hallihan, University of Illinois at Chicago

Pilot Trial to Evaluate PROblem Solving Therapy and APPLE Watch for College Students (PRO-APPLE)

The goals of this Pilot Trial are to test the preliminary efficacy of Problom-Solving Therapy (PST)-APPLE Watch in a 2-arm pilot Randomized Control Trial (RCT), vs education only-control to reduce alcohol use disorder symptoms and improve alcohol abstinence.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The aims of this study are (1) to test feasibility & acceptability of screening for AUD symptoms/alcohol misuse and recruitment among college students, and (2) to test preliminary efficacy of PST-APPLE Watch in a 2-arm pilot Randomized Control Trial (RCT).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Hallihan Hagar, PhD, RN
  • Phone Number: 312-413-5361
  • Email: hhalli2@uic.edu

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60608
        • University of Illinois at Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Male and female college students aged 18-25 yr
  • English-speaking
  • Current alcohol use more than or equal to 2 days/week via phone screening
  • Completion of AUDIT screening and meet criteria for (past year) mild, moderate or severe AUD during AUDADIS-5 interview
  • Completion of written informed consent
  • Interested in cutting back alcohol intake or changing his/her drinking
  • Baseline screening study visit

Exclusion Criteria:

  • Participation in past 6 months in AUD or substance use treatment
  • Current use of medications used to treat AUD (e.g., naltrexone)
  • Lifetime Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 diagnosis of schizophrenia, bipolar disorder, or any psychotic disorder
  • Current use of psychoactive drugs
  • Not currently enrolled in college
  • Not interested in cutting back alcohol intake or changing his/her drinking
  • Pregnancy or intention to become pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Treatment group
The intervention group will receive individual PST (60 min individual sessions for 6 weeks, in addition to engaging with APPLE Watch features including fitness tracking (such as regular walks), heart rate, and sleep management on a daily basis. Throughout the final 6 individual self-engaged sessions, participants will persist in engaging and utilizing APPLE Watch features, incorporating daily fitness tracking (such as regular walks), wellness applications, and sleep management and apply PST.
Behavioral: PST-APPLE Watch group
PST combined APPLE Watch is a tailored behavioral intervention that enables college students with AUD to successfully manage and overcome everyday life challenges influencing their alcohol intake and teach problem-solving skills.
Other: Control group
Participants assigned to Education-only control will be asked to watch "Quit Drinking Motivation," a 20-min video created by the MotivationHub. This video consists of a speech and conversation discussing the negative consequences resulting from their alcohol misuse and the importance of getting sober. The video will be followed by a 30-minute group discussion via zoom.
Behavioral: Education-only control group
Education-only control group receives Quit Drinking Motivation 20-min video created by the MotivationHub, followed by a 30-minute group discussion.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Alcohol abstinence
Time Frame: Up to 3 months
Participants will be monitored for 3 months to assess alcohol abstinence by blood alcohol content.
Up to 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Alcohol-related negative consequences at 3 months.
Time Frame: Baseline, 3 months.
Measured by Rutgers Alcohol Problem Index (RAPI).
Baseline, 3 months.
Change in Alcohol use at 3 months.
Time Frame: Baseline, 3 months.
Measured by 90-day Timeline Followback (TLFB).
Baseline, 3 months.
Change in Reasons for drinking at 3 months.
Time Frame: Baseline, 3 months
Measured by Drinking Motives Questionnaire Revised (DMQ-R).
Baseline, 3 months
Change in negative affect at 3 months.
Time Frame: Baseline, 3 months
Measured by Positive and Negative Affect Schedule (PANAS).
Baseline, 3 months
Change in AUD severity at 3 months.
Time Frame: Baseline, 3 months.
Measured by Alcohol Use Disorder and Associated Disabilities Interview Schedule-5(AUDADIS-5). Change in AUD severity from baseline to 3 months.
Baseline, 3 months.
Change in AUD frequency status.
Time Frame: Baseline, 3 months.
Measured by AUDIT. Participants will be monitored for up to 3 months. This is the number of participants who screen positive for AUD.
Baseline, 3 months.
Change in positive affect at 3 months.
Time Frame: Baseline, 3 months.
Measured by Positive and Negative Affect Schedule (PANAS).
Baseline, 3 months.
Change in the quality of life at 3 months.
Time Frame: Baseline, 3 months.
Measured by Quality of Life Scale (QOLS).
Baseline, 3 months.
Percent heavy drinking days at 3 months.
Time Frame: Baseline, 3 months.
Measured by 90-day Timeline Followback (TLFB).
Baseline, 3 months.
Percent binge drinking days at 3 months.
Time Frame: Baseline, 3 months.
Measured by 90-day Timeline Followback (TLFB).
Baseline, 3 months.
Percent days abstinence at 3 months.
Time Frame: Baseline, 3 months.
Measured by 90-day Timeline Followback (TLFB).
Baseline, 3 months.
Change in Cognitive performance (executive cognitive ability and attention and working memory) at 3 months.
Time Frame: Baseline, 3 months.
Compensatory Measured by Compensatory Cognitive Strategies Scale
Baseline, 3 months.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Intervention Acceptability
Time Frame: 3 months.
Measured by the Client Counseling Satisfaction Scale(CCSS).
3 months.
Intervention Fidelity
Time Frame: 3 months.
Participant adherence to the PST-APPLE intervention schedule will be assessed by documented session attendance.
3 months.
Participant Retention
Time Frame: 3 months.
Participant retention will be assessed throughout the study by monitoring the proportion of the sample retained at 3-month.
3 months.
Protocol Acceptability
Time Frame: 3 months.
PI or a trained research team member will conduct semi-structured interviews 3-month post-intervention with each participant and will adapt the semi-structured interview guide approach from the previous research study (Study named: Study of a PST-Trained Voice-Enabled Artificial Intelligence Counselor [SPEAC] and DEDICATE study).
3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Illinois at Chicago

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hallihan Hagar, PhD, RN, Department of Medicine, University of Illinois at Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 20, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 13, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024-0268

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We will adhere to the University of Illinois Chicago (UIC) Grant Policy on Sharing of Unique Research Resources including the Principles and Guidelines for Recipients of UIC Research Grants. Data from this research will be shared and the results of this research will be made available via publication in scientific journals and through scientific meetings where our findings are reported. Publication of data shall occur during the project, if appropriate, or at the end of the project, consistent with typical scientific practices. All publications will be made publicly available consistent with UIC policies.

IPD Sharing Time Frame

After analyzing.

IPD Sharing Supporting Information Type

  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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