The Development of a Personalized, Real-time Intervention

NCT03518619 | Completed Results

• 2 other identifiers: 1803-002U54GM115677
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Drinking, Alcohol

Outcome Measures

Primary Outcomes (2)

• Drinking Motives Questionnaire-Revised (DMQ-R) Coping Motive

  Drinking to cope with negative affect, 5 items on scale of 1-5 with higher values meaning more use

  6 weeks

• Percentage of Days of Alcohol Use in the Last Month

  Alcohol use, yes/no for each day of past 30

  6 weeks

Study Arms (1)

PFIcope+EMI

EXPERIMENTAL

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.

Behavioral: PFIcope+EMI

Interventions

PFIcope+EMI BEHAVIORAL

The intervention will be comprised of (1) an initial orientation session where the intervention is introduced, receipt of personalized normative information, motives feedback, and the development of an individual's personalized relapse prevention coping skills messages to be utilized through the course of the intervention; (2) EMA for monitoring of affect, drinking intention, alcohol use, and coping skills use; (3) EMI-tailored text messages sent based on EMA responses: individualized, self-chosen relapse prevention coping skills messages when participants report negative affect and intent to drink.

PFIcope+EMI

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Butler Hospital: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Results Point of Contact

• Title: Ana M. Abrantes, Ph.D.
• Organization: Butler Hospital

Ana_Abrantes@Brown.edu

401-455-6440

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2018
• First Posted: May 8, 2018
• Study Start: September 24, 2018
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: November 16, 2022
• Results First Posted: November 16, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)