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Completed

NCT Number: NCT06333288

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

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.

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Key information

Conditions

Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois at Chicago

Chicago, Illinois, 60608, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PST-APPLE Watch group

Behavioral

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 group

Behavioral

Education-only control group receives Quit Drinking Motivation 20-min video created by the MotivationHub, followed by a 30-minute group discussion.

Primary outcomes

  1. Alcohol abstinence

    Time frame: Up to 3 months

    Participants will be monitored for 3 months to assess alcohol abstinence by blood alcohol content.

Secondary outcomes

  1. 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.

  2. 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.

  3. Change in Alcohol-related negative consequences at 3 months.

    Time frame: Baseline, 3 months.

    Measured by Rutgers Alcohol Problem Index (RAPI).

  4. Change in Alcohol use at 3 months.

    Time frame: Baseline, 3 months.

    Measured by 90-day Timeline Followback (TLFB).

  5. Change in Reasons for drinking at 3 months.

    Time frame: Baseline, 3 months

    Measured by Drinking Motives Questionnaire Revised (DMQ-R).

  6. Change in negative affect at 3 months.

    Time frame: Baseline, 3 months

    Measured by Positive and Negative Affect Schedule (PANAS).

  7. Change in positive affect at 3 months.

    Time frame: Baseline, 3 months.

    Measured by Positive and Negative Affect Schedule (PANAS).

  8. 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

  9. Change in the quality of life at 3 months.

    Time frame: Baseline, 3 months.

    Measured by Quality of Life Scale (QOLS).

  10. Percent heavy drinking days at 3 months.

    Time frame: Baseline, 3 months.

    Measured by 90-day Timeline Followback (TLFB).

  11. Percent binge drinking days at 3 months.

    Time frame: Baseline, 3 months.

    Measured by 90-day Timeline Followback (TLFB).

  12. Percent days abstinence at 3 months.

    Time frame: Baseline, 3 months.

    Measured by 90-day Timeline Followback (TLFB).

Other outcomes

  1. Intervention Acceptability

    Time frame: 3 months.

    Measured by the Client Counseling Satisfaction Scale(CCSS).

  2. Intervention Fidelity

    Time frame: 3 months.

    Participant adherence to the PST-APPLE intervention schedule will be assessed by documented session attendance.

  3. 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.

  4. 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).

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 27, 2024
Registry last updated
Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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