Smartphone Task for Reducing Alcohol Consumption and Risky Sexual Behavior

Overseen By Amy Boatright

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Disqualifiers: Psychotic disorders, Pervasive Developmental Disability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

46 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn if a brief task completed on a smartphone can reduce alcohol use and risky sexual behavior among women between the ages of 18 and 25 who have a history of experiencing sexual assault or an unwanted sexual experience. The main questions it aims to answer are: * Does the smartphone task change approach biases for alcohol and condom-related images? * Does the smartphone task reduce alcohol use and risky sexual behavior? Researchers will compare the smartphone task to a sham control to see if the smartphone task changes biases and behavior. Participants will: * Complete a baseline assessment battery of questionnaires * Complete either the intervention smartphone task or the sham smartphone task on four consecutive days. * Complete a follow-up assessment one week after finishing the four tasks * Complete a three-month follow-up

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment for reducing alcohol consumption and risky sexual behavior?

Research shows that digital interventions, like smartphone apps, can help reduce alcohol use and risky sexual behavior. For example, a study found that a web-based intervention reduced alcohol-related risky sexual behavior among young adults, and another study showed that a smartphone app helped reduce alcohol consumption in university students. ^{1 2 3 4 5}

Is the smartphone task for reducing alcohol consumption and risky sexual behavior safe for humans?

The research articles focus on the effectiveness of smartphone and text message interventions for reducing alcohol consumption and risky behaviors, but they do not provide specific safety data. Generally, these types of interventions are considered safe as they involve behavioral strategies rather than medications. ^{6 7 8 9 10}

How does the smartphone task treatment for reducing alcohol consumption and risky sexual behavior differ from other treatments?

This treatment is unique because it uses a smartphone app to deliver interventions like self-monitoring, feedback, and cognitive bias re-training, which are not typically part of traditional treatments. It leverages technology to provide real-time support and personalized feedback, making it more accessible and potentially more engaging than standard in-person therapies. ^{5 6 9 11 12}

Research Team

Austin Hahn, PhD

Principal Investigator

Medical University of South Carolina

Eligibility Criteria

This trial is for women aged 18-25 who have experienced sexual assault, drink moderately (at least seven drinks per week), and had unprotected sex with a casual partner at least three times in the past three months. It's not specified who can't join.

Inclusion Criteria

I drink at least seven alcoholic beverages a week.

I've had unprotected sex with a casual partner at least 3 times in the last 3 months.

I am an adult woman who has experienced sexual assault.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

Participants complete a baseline assessment battery of questionnaires

1 day

1 visit (virtual)

Intervention

Participants complete either the intervention smartphone task or the sham smartphone task on four consecutive days

4 days

4 sessions (virtual)

Follow-up

Participants complete a follow-up assessment one week after finishing the four tasks

1 week

1 visit (virtual)

Extended Follow-up

Participants complete a three-month follow-up to assess alcohol and condom use

3 months

1 visit (virtual)

Treatment Details

Interventions

• Sham Training Group
• Training Group

Trial Overview The study tests if a smartphone task can change biases towards alcohol and condoms, aiming to reduce alcohol consumption and risky sexual behavior. Participants will do either this task or a sham version over four days, with follow-ups after one week and three months.

Participant Groups

Group I: Training Group Experimental Treatment 1 Intervention

This arm receives a version of the AAT used as an Approach Bias Modification (ABM) intervention, to retrain participants' implicit biases toward or away from stimuli by presenting the target stimuli predominantly in one format (e.g., push or pull).

Group II: Control Placebo Group 1 Intervention

No treatment version of the AAT used as an Approach Bias Modification (ABM) intervention will be used in this group.

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Findings from Research

In a study involving 672 participants using the Drink Less app, older users and those with post-16 educational qualifications showed higher engagement and were more likely to respond to follow-up assessments after one month.

While higher baseline alcohol consumption was linked to greater reductions in alcohol intake, engagement with the app did not correlate with the extent of alcohol reduction, indicating that simply using the app more did not necessarily lead to better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of Engagement, Response to Follow Up, and Extent of Alcohol Reduction in Users of a Smartphone App (Drink Less): Secondary Analysis of a Factorial Randomized Controlled Trial. Garnett, C., Perski, O., Tombor, I., et al.[2022]

The pilot trial involving 89 participants showed that the TeleCoach app led to significant reductions in alcohol consumption over 6 weeks, with a large effect size (Cohen's d of 1.37) for the intervention group.

While the TeleCoach app demonstrated positive within-group effects, there were no significant differences between the app and the control group, suggesting further research with a larger sample size (up to 1,000 participants) is needed to fully evaluate its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing Risky Alcohol Use via Smartphone App Skills Training Among Adult Internet Help-Seekers: A Randomized Pilot Trial. Berman, AH., Molander, O., Tahir, M., et al.[2022]

The TRAC2 text message intervention effectively engaged nontreatment-seeking young adults, with an average response rate of 82% to ecological momentary assessments (EMAs) during the first 4-week block, indicating strong participant involvement.

Participants showed high commitment to drinking limit goals (96% commitment rate) and achieved their goals 89% of the time, suggesting that the intervention successfully supported self-regulation and reduced alcohol consumption over a 3-month follow-up period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Text Message Intervention with Adaptive Goal Support to Reduce Alcohol Consumption Among Non-Treatment-Seeking Young Adults: Non-Randomized Clinical Trial with Voluntary Length of Enrollment. Suffoletto, B., Chung, T., Muench, F., et al.[2020]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Computer delivered intervention for alcohol and sexual risk reduction among women attending an urban sexually transmitted infection clinic: A randomized controlled trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Evaluating Personalized Feedback Intervention Framing with a Randomized Controlled Trial to Reduce Young Adult Alcohol-Related Sexual Risk Taking. [2023]

3. Canada pubmed.ncbi.nlm.nih.gov

Predictors of Engagement, Response to Follow Up, and Extent of Alcohol Reduction in Users of a Smartphone App (Drink Less): Secondary Analysis of a Factorial Randomized Controlled Trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

A Brief Clinic-Based Intervention to Reduce Alcohol Misuse and Sexual Risk Behavior in Young Women: Results from an Exploratory Clinical Trial. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Reducing Risky Alcohol Use via Smartphone App Skills Training Among Adult Internet Help-Seekers: A Randomized Pilot Trial. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Effect of a smartphone intervention as a secondary prevention for use among university students with unhealthy alcohol use: randomised controlled trial. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Personalized normative feedback interventions targeting hazardous alcohol use and alcohol-related risky sexual behavior in Swedish university students: A randomized controlled replication trial. [2022]

8. Ireland pubmed.ncbi.nlm.nih.gov

Desire to get drunk partially mediates effects of a combined text message-based alcohol intervention for young adults. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Text messaging interventions for reducing alcohol consumption among risky drinkers: systematic review and meta-analysis. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Using online crowdsourcing to understand young adult attitudes toward expert-authored messages aimed at reducing hazardous alcohol consumption and to collect peer-authored messages. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Evaluating the effectiveness of a smartphone app to reduce excessive alcohol consumption: protocol for a factorial randomised control trial. [2022]

12. Canada pubmed.ncbi.nlm.nih.gov

A Text Message Intervention with Adaptive Goal Support to Reduce Alcohol Consumption Among Non-Treatment-Seeking Young Adults: Non-Randomized Clinical Trial with Voluntary Length of Enrollment. [2020]