Drinking, AlcoholPFIcope+EMINCT03518619
The Development of a Personalized, Real-time Intervention
A study testing PFIcope+EMI in people with Drinking, Alcohol, run by Butler Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Drinking, Alcohol
- What is being tested?
- PFIcope+EMI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2018to 1 May 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Development of a Personalized, Real-time Intervention for Substance-using Emerging Adults Leaving Psychiatric Partial Hospitalization
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.
Read the 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.
- Conditions
- Drinking, Alcohol
- Being tested
- PFIcope+EMI
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PFIcope+EMIBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: PFIcope+EMI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks
Percentage of Days of Alcohol Use in the Last Month
Alcohol use, yes/no for each day of past 30
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study start24 Sep 2018
- Primary completion1 May 2019
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Drinking, AlcoholStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03518619
- Sponsor's protocol ID
- 1803-002
- Other IDs
- U54GM115677
- Acronym
- PFIcope+EMI
- Status last verified
- Oct 2022
- First submitted
- 25 Apr 2018
- Last updated
- 16 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development of a Personalized, Real-time Intervention for Substance-using Emerging Adults Leaving Psychiatric Partial Hospitalization
- ClinicalTrials.gov ID
- NCT03518619
- Acronym / sponsor ID
- PFIcope+EMI / 1803-002
- Conditions
- Drinking, Alcohol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 24 Sep 2018 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 8 May 2018 (actual)
- Results
- Posted 16 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PFIcope+EMI | Experimental | Behavioral: PFIcope+EMIThis 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PFIcope+EMIThe 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. | Behavioural | PFIcope+EMI |
Primary outcome
Drinking Motives Questionnaire-Revised (DMQ-R) Coping Motive
Time frame: 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
Time frame: 6 weeks
Alcohol use, yes/no for each day of past 30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PFIcope+EMI in people with Drinking, Alcohol, run by Butler Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drinking Motives Questionnaire-Revised (DMQ-R) Coping Motive (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2022.