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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a simple smartphone task can help reduce alcohol use and risky sexual behavior. It focuses on women aged 18 to 25 who have experienced unwanted sexual experiences and consume at least seven alcoholic drinks a week. Participants will either perform a specific task designed to change their responses to alcohol and condom-related images (Training Group) or a sham version (Sham Training Group). By comparing the two groups, researchers will assess if the task effectively shifts behaviors and attitudes. The trial involves completing surveys and tasks over a few days, with follow-ups to track changes over time. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new strategies for reducing risky behaviors.

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 prior data suggests that this smartphone task is safe for reducing alcohol consumption and risky sexual behavior?

Research has shown that cognitive bias modification (CBM) interventions, like the one used in this trial, are generally easy for participants to handle. In past studies, participants significantly reduced their alcohol consumption. No major differences in results appeared between those who underwent the training and those who did not, indicating the treatment did not cause harmful effects. Since this intervention uses a smartphone task instead of medication, the risk of side effects is likely lower than with drug treatments. Overall, evidence suggests that this type of smartphone-based training is safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a novel way to reduce alcohol consumption and risky sexual behavior using a smartphone-based Approach Bias Modification (ABM) intervention. Unlike traditional treatments that might involve counseling or medication, this technique specifically retrains implicit biases by using a task where target stimuli are predominantly presented in one format, like pushing or pulling. This method is unique because it leverages technology to potentially bring about behavioral change in a more direct and user-friendly manner. The approach could offer a convenient and accessible alternative to help individuals modify their behaviors right from their smartphones.

What evidence suggests that this smartphone task is effective for reducing alcohol use and risky sexual behavior?

This trial will compare two groups: a Training Group and a Control Group. Research has shown that Approach Bias Modification (ABM) training, which participants in the Training Group will receive, can alter responses to alcohol. One study found that people who used a similar method drank less alcohol. Another study demonstrated that these methods can change instinctive reactions to alcohol or related images. These changes might lead to reduced drinking and safer behavior. Overall, promising evidence suggests that this type of training can help reduce alcohol use. ^{1 2 3 4 6}

Who Is on the Research Team?

Austin Hahn, PhD

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

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 am an adult woman who has experienced sexual assault.

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

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Published Research Related to This Trial

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6936737/

Can cognitive bias modification simultaneously target two ... This study tested the effectiveness of a cognitive bias modification (CBM) intervention to simultaneously reduce approach biases toward alcohol and increase ...

2. journals.sagepub.com journals.sagepub.com/doi/10.1177/2167702619834570

Can Cognitive Bias Modification Simultaneously Target ... Participants in both conditions had significant reductions in alcohol consumption following the intervention and did not differ by training ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/npr2.70002

Effectiveness of Attentional Bias Modification Combined ... This study investigates the effect of combining ABM with cognitive behavioral therapy (CBT) to reduce relapse risk and cravings in male patients with AUD.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11814518/

Approach Bias Modification for reducing Co-Occurring ... These studies use time-to-relapse as the primary outcome, due to the emphasis on abstinence. In fact, a meta-analysis found no significant ...

5. researchgate.net researchgate.net/publication/388394418_Approach_Bias_Modification_for_Reducing_Co-Occurring_Alcohol_and_Cannabis_Use_among_Treatment-Seeking_Adolescents_Protocol_of_a_Randomized_Controlled_Trial

Approach Bias Modification for Reducing Co-Occurring ... This protocol paper describes a NIDA-funded randomized control trial (RCT) to evaluate an integrated mobile ApBM intervention to target co- ...

6. researchgate.net researchgate.net/publication/306074409_Approach_bias_modification_training_and_consumption_A_review_of_the_literature

Approach bias modification training and consumption Secondary outcome variables will include alcohol consumption, and behavioral indicators of alcohol approach bias. ... drinking, drug abuse, and sexual behavior.