What side effects are associated with this type of intervention?

The use of wearable activity trackers and cell phone applications for behavioral monitoring and feedback in couples has been studied for its usability, feasibility, and acceptability. Common side effects or issues may include technical difficulties with the devices, privacy concerns, and potential discomfort or inconvenience of wearing the trackers continuously. Additionally, there may be challenges related to adherence to the intervention protocols and the potential for increased anxiety or stress due to constant monitoring and feedback.

What prior FDA approvals exist?

The FDA has approved various treatments that involve behavioral monitoring and feedback, particularly in the context of managing conditions like opioid use disorder and mental health issues. For instance, technology-enhanced delivery of CBT-based interventions, such as web-based training and smartphone applications, has shown promise in clinical trials. These interventions often aim to improve treatment adherence and outcomes by providing real-time feedback and support. While specific FDA approvals for wearable activity trackers and cell phone applications for couples are not detailed, the use of such technology in behavioral health is an emerging field with growing evidence supporting its efficacy.

What other types of research exist?

Promising alternatives to wearable activity trackers and cell phone applications for couples therapy in 2024 include: 1) Virtual Reality (VR) therapy, which can provide immersive experiences for behavioral modification and conflict resolution; 2) Telehealth platforms offering remote counseling and therapy sessions, which can increase accessibility and convenience; 3) Online-based Acceptance and Commitment Therapy (ACT), which has shown efficacy in managing chronic pain and could be adapted for couples therapy; and 4) Guided web-based self-help interventions, which have been effective in preventing depression and could be tailored for couples dealing with AUD and IPV.

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Behavioural Intervention

Smartwatch Biofeedback for Intimate Partner Violence (START Trial)

N/A

Waitlist Available

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least one partner within each dyad must meet DSM-V diagnostic criteria for current AUD (assessed by the QuickSCID) and consume ≥ 2 hazardous drinking episodes (i.e., 4 or more drinks for women, 5 or more for men in ≤ 2 hours) per month in the past three months

Be older than 18 years old

Must not have

Serious cardiovascular health conditions (e.g., pacemaker, cardiac arrhythmia, hypertension) because the safety of HRV-B has not yet been established in these populations

Current neurologic conditions or history of traumatic brain injury

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 days

Awards & highlights

No Placebo-Only Group

Summary

This trial uses smartwatches and a mobile app to help couples dealing with alcohol use disorder (AUD) and intimate partner violence (IPV). The smartwatch tracks heart rate changes to monitor stress, while the app provides feedback to help manage stress and reduce alcohol cravings.

Who is the study for?

This trial is for couples aged 21-70 where at least one partner has been involved in intimate partner violence (IPV) and meets criteria for alcohol use disorder (AUD). Participants must be fluent in English, mentally capable of consent, and have stable psychotropic medication if applicable. Couples should not have severe cardiovascular conditions, current pregnancy, acute alcohol withdrawal, suicidal or homicidal thoughts, certain medications affecting heart rate, severe brain injuries or unilateral IPV.

What is being tested?

The study tests a smartwatch device with Heart Rate Variability-Biofeedback (HRV-B) and a cell phone app to see if they can help reduce alcohol consumption and conflict among couples. Over a period of 28 days, participants will wear the smartwatch to monitor their activities while using the app designed to support treatment.

What are the potential side effects?

Since this intervention involves wearable technology rather than medication or invasive procedures, side effects are minimal but may include discomfort from wearing the device or stress from monitoring symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I or my partner have been diagnosed with alcohol use disorder and have had multiple heavy drinking episodes recently.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have serious heart conditions like arrhythmia or high blood pressure.

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I have a neurological condition or a history of traumatic brain injury.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability of Heart Rate Variability-Biofeedback Intervention

Feasibility of Heart Rate Variability-Biofeedback Intervention

Heart Rate Variability in Alcohol-Facilitated Intimate Partner Violence

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Heart Rate Variability-Biofeedback via Smartwatch Device InterventionExperimental Treatment1 Intervention

Participants will wear activity trackers equipped with continuous ambulatory physiological monitoring and geolocation. Ecological momentary assessment (EMA; 4 times daily plus optional event-triggered reports) of alcohol use, couple conflict including IPV, and affect will be completed via smartphone application for 28 days. During days 21-28, participants will also be prompted to complete a 10 minute self-administered HRV-B session at least once daily. Subjective usability, feasibility, and acceptability of HRV-B will be assessed.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for couples, such as time-limited psychodynamic psychotherapy and behavioral interventions using wearable activity trackers and cell phone applications, focus on improving communication, emotional understanding, and conflict resolution. The mechanisms of action for these treatments often involve real-time monitoring and feedback, which help couples become more aware of their behaviors and emotional responses. This increased awareness can lead to more constructive interactions and a deeper understanding of each other's needs and perspectives. For couples, these mechanisms are crucial as they provide tangible data and insights that can facilitate positive changes in their relationship dynamics.

Electronic behavioral interventions for headache: a systematic review.An evaluation of time-limited psychodynamic psychotherapy for couples: a pilot study.