The Development of a Personalized, Real-time Intervention

Not Applicable

Completed

• Conditions: Drinking, Alcohol
• Interventions: Behavioral: PFIcope+EMI

• Registration Number: NCT03518619
• Lead Sponsor: Butler Hospital

Brief Summary

The investigators propose to enhance our existing coping motive-specific normative feedback intervention (PFIcope intervention) by capitalizing on EMA/EMI technology to pair real-time affective monitoring with tailored real-time relapse prevention texts for individuals with anxiety and depression who drink to cope. The goals of the PFIcope+EMI study are to help individuals to identify motives for drinking and to utilize alternate coping strategies for negative affect in place of alcohol.

Detailed Description

Emerging adulthood (ages 18-25) represents and common and problematic time for alcohol use and mental health issues, particularly anxiety and depression. Anxiety and depression increase the likelihood of developing risky patterns of alcohol use. Indeed, individuals who drink alcohol to cope with negative affect, such as anxiety and depression, report more alcohol use and more severe use-related consequences. As such, it is important to address alcohol use, particularly among a psychiatric population of emerging adults. Despite their co-occurrence, treatment as usual for anxiety and depression typically does not address alcohol use, and alcohol interventions for emerging adults largely ignore anxiety and depression. Emerging research suggests interventions that specifically focus on drinking to cope with negative affect are promising in reducing problematic outcomes. For example, the investigators previously developed a brief, personalized feedback intervention that specifically targeted use of alcohol to cope with negative affect among a normative sample of emerging adults (Personalized Feedback Intervention for Coping - PFIcope), which resulted in decreased drinking to cope. In order to adapt PFIcope for a psychiatric population and augment treatment effects, the investigators propose adding ecological momentary assessment (EMA) and intervention (EMI) in order to identify when emerging adults are at most risk for problematic alcohol use and intervene when needed. EMA can assess symptoms in real time and identify high-risk situations for problematic use (i.e., when experiencing negative affect and reports intention to use), which can trigger an in-the-moment EMI during that high-risk situation (i.e., individually-chosen relapse prevention coping skills messages).

The investigators propose to develop a 6-week PFIcope+EMI intervention for 20 emerging adults in a psychiatric partial hospitalization program who report drinking alcohol to cope with negative affect. This will include: 1) an in-person personalized feedback session to present normative information and feedback on problems associated with drinking to cope, to discuss the individual's use of alcohol to cope, and to generate relapse prevention coping skills messages to be used in the EMI text intervention; 2) EMA to monitor affect and intention to drink after discharge; 3) tailored text messages (EMI) based on EMA responses (i.e., individualized coping skills messages when individuals report negative affect and intention to drink); and 4) additional EMA to monitor coping skills usage, alcohol use, and drinking to cope. The PFIcope+EMI intervention, including its associated real-time assessment and messaging systems, is low-cost, easy to program, and can deliver an intervention when individuals are at most risk for engaging in problematic alcohol use.

Study Timeline

• Study First Submitted: 2018-04-25
• Study First Submitted QC: 2018-05-07
• Study First Posted: 2018-05-08
• Study Start: 2018-09-24
• Primary Completion: 2019-05-01
• Study Completion: 2019-05-01
• Results First Submitted: 2022-08-10
• Status Verified: 2022-10
• Results First Submitted QC: 2022-10-24
• Last Update Submitted: 2022-10-24
• Results First Posted: 2022-11-16
• Last Update Posted: 2022-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

(a) between 18 and 25 years of age, (b) reported alcohol use at least 3x weekly over past month, (c) self-reported use of coping motive (mean of 2+ on coping subscale of MDMQ-R), (d) current anxiety and/or depression symptomatology (as assessed CES-D score of 16+ and GAD-7 scores 10+), (e) has access to a smartphone capable of receiving EMA and text, and access to email.

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Exclusion Criteria

(a) current DSM-5 diagnosis of moderate/severe other substance use disorder (i.e., other than alcohol), (b) a history of psychotic disorder or current psychotic symptoms, (c) current suicidal/homicidal ideation.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PFIcope+EMI	PFIcope+EMI	This will include: 1) an in-person personalized feedback session to present normative information and feedback on problems associated with drinking to cope, to discuss the individual's use of alcohol to cope, and to generate relapse prevention coping skills messages to be used in the EMI text intervention; 2) EMA to monitor affect and intention to drink after discharge; 3) tailored text messages (EMI) based on EMA responses (i.e., individualized coping skills messages when individuals report negative affect and intention to drink); and 4) additional EMA to monitor coping skills usage, alcohol use, and drinking to cope.

Primary Outcome Measures

Name	Time	Method
Drinking Motives Questionnaire-Revised (DMQ-R) Coping Motive	6 weeks	Drinking to cope with negative affect, 5 items on scale of 1-5 with higher values meaning more use
Percentage of Days of Alcohol Use in the Last Month	6 weeks	Alcohol use, yes/no for each day of past 30

Trial Locations

Locations (1)

Butler Hospital; 🇺🇸 Providence, Rhode Island, United States