NCT03518619: PFIcope+EMI

The Development of a Personalized, Real-time Intervention

Completed NA Results posted Last updated 16 November 2022

What this trial tests

NA trial testing PFIcope+EMI in Drinking, Alcohol in 20 participants. Completed in 1 May 2019.

Timeline

24 September 2018

Primary endpoint
1 May 2019

1 May 2019

Quick facts

Lead sponsor	Butler Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	24 September 2018
Primary completion	1 May 2019
Estimated completion	1 May 2019
Sites	1 location across United States

Drugs / interventions tested

• PFIcope+EMI

Conditions studied

• Drinking, Alcohol — all drugs for Drinking, Alcohol →

Sponsor

Butler Hospital

Who can join

Adults 18 to 25, any sex, with Drinking, Alcohol. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Drinking Motives Questionnaire-Revised (DMQ-R) Coping Motive Primary · 6 weeks

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

Group	Value	95% CI
PFIcope+EMI	2.15	± .82

Percentage of Days of Alcohol Use in the Last Month Primary · 6 weeks

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

Group	Value	95% CI
PFIcope+EMI	19	± 22

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

PFIcope+EMI

Serious: 2/20 (10%)

Deaths: 0/20

Serious adverse events (1 terms)

Reaction	System	PFIcope+EMI
Psychiatric Inpatient Hospitalization	Psychiatric disorders	—

Most-reported serious reactions: Psychiatric Inpatient Hospitalization.

Data from ClinicalTrials.gov NCT03518619 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.