Alcohol Use DisorderNCT06333288
Pilot Trial to Evaluate PROblem Solving Therapy and APPLE Watch for College Students
A study testing PST-APPLE Watch group in people with Alcohol Use Disorder, run by University of Illinois at Chicago at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- PST-APPLE Watch group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2024to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60608
About this study
Official title: 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.
Read the 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).
- Conditions
- Alcohol Use Disorder
- Being tested
- PST-APPLE Watch group, Education-only control group
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PST-APPLE Watch groupBehavioural
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.
Education-only control groupBehavioural
Education-only control group receives Quit Drinking Motivation 20-min video created by the MotivationHub, followed by a 30-minute group discussion.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Other | 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. Receives: Behavioral: PST-APPLE Watch group |
| Control group | Other | 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. Receives: Behavioral: Education-only control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol abstinence
Participants will be monitored for 3 months to assess alcohol abstinence by blood alcohol content.
Measured: Up to 3 months
Secondary outcomes (12)
Change in AUD severity at 3 months.
Measured by Alcohol Use Disorder and Associated Disabilities Interview Schedule-5(AUDADIS-5). Change in AUD severity from baseline to 3 months.
Measured: Baseline, 3 months.
Change in AUD frequency status.
Measured by AUDIT. Participants will be monitored for up to 3 months. This is the number of participants who screen positive for AUD.
Measured: Baseline, 3 months.
Change in Alcohol-related negative consequences at 3 months.
Measured by Rutgers Alcohol Problem Index (RAPI).
Measured: Baseline, 3 months.
Change in Alcohol use at 3 months.
Measured by 90-day Timeline Followback (TLFB).
Measured: Baseline, 3 months.
Change in Reasons for drinking at 3 months.
Measured by Drinking Motives Questionnaire Revised (DMQ-R).
Measured: Baseline, 3 months
Change in negative affect at 3 months.
Measured by Positive and Negative Affect Schedule (PANAS).
Measured: Baseline, 3 months
Change in positive affect at 3 months.
Measured by Positive and Negative Affect Schedule (PANAS).
Measured: Baseline, 3 months.
Change in Cognitive performance (executive cognitive ability and attention and working memory) at 3 months.
Compensatory Measured by Compensatory Cognitive Strategies Scale
Measured: Baseline, 3 months.
Change in the quality of life at 3 months.
Measured by Quality of Life Scale (QOLS).
Measured: Baseline, 3 months.
Percent heavy drinking days at 3 months.
Measured by 90-day Timeline Followback (TLFB).
Measured: Baseline, 3 months.
Percent binge drinking days at 3 months.
Measured by 90-day Timeline Followback (TLFB).
Measured: Baseline, 3 months.
Percent days abstinence at 3 months.
Measured by 90-day Timeline Followback (TLFB).
Measured: Baseline, 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start15 Apr 2024
- Primary completion30 Sep 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- PRO-APPLE Study is a 2-arm pilot Randomized Control Trial (RCT).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hagar Hallihan, University of Illinois at Chicago
- Investigators
- Hallihan Hagar, PhD, RN, Principal investigator, Department of Medicine, University of Illinois at Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06333288
- Sponsor's protocol ID
- 2024-0268
- Status last verified
- Dec 2024
- First submitted
- 20 Mar 2024
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial to Evaluate PROblem Solving Therapy and APPLE Watch for College Students (PRO-APPLE)
- ClinicalTrials.gov ID
- NCT06333288
- Acronym / sponsor ID
- 2024-0268
- Conditions
- Alcohol Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of Illinois at ChicagoUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 27 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- PRO-APPLE Study is a 2-arm pilot Randomized Control Trial (RCT).
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Other | Behavioral: PST-APPLE Watch groupThe 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. |
| Control group | Other | Behavioral: Education-only control groupParticipants 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PST-APPLE Watch groupPST 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. | Behavioural | Treatment group |
| Education-only control groupEducation-only control group receives Quit Drinking Motivation 20-min video created by the MotivationHub, followed by a 30-minute group discussion. | Behavioural | Control group |
Primary outcome
Alcohol abstinence
Time frame: Up to 3 months
Participants will be monitored for 3 months to assess alcohol abstinence by blood alcohol content.
12 secondary outcomes
Change in AUD severity at 3 months.
Time frame: Baseline, 3 months.
Change in AUD frequency status.
Time frame: Baseline, 3 months.
Change in Alcohol-related negative consequences at 3 months.
Time frame: Baseline, 3 months.
Change in Alcohol use at 3 months.
Time frame: Baseline, 3 months.
Change in Reasons for drinking at 3 months.
Time frame: Baseline, 3 months
Change in negative affect at 3 months.
Time frame: Baseline, 3 months
Change in positive affect at 3 months.
Time frame: Baseline, 3 months.
Change in Cognitive performance (executive cognitive ability and attention and working memory) at 3 months.
Time frame: Baseline, 3 months.
Change in the quality of life at 3 months.
Time frame: Baseline, 3 months.
Percent heavy drinking days at 3 months.
Time frame: Baseline, 3 months.
Percent binge drinking days at 3 months.
Time frame: Baseline, 3 months.
Percent days abstinence at 3 months.
Time frame: Baseline, 3 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hallihan Hagar, PhD, RN principal investigator
Department of Medicine, University of Illinois at Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PST-APPLE Watch group in people with Alcohol Use Disorder, run by University of Illinois at Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol abstinence (time frame: Up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.