Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03518619 |
| Other study ID # |
1803-002 |
| Secondary ID |
U54GM115677 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 24, 2018 |
| Est. completion date |
May 1, 2019 |
Study information
| Verified date |
October 2022 |
| Source |
Butler Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
