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PFI Hazardous Drinkers With Subclinical PTSD

NCT04836442 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-07-25

No results posted yet for this study

Summary

The objective of the present study is to assist on a randomized controlled trial (RCT), aimed at developing and testing the efficacy of a novel computer based PFI among hazardous drinkers with at least subclinical posttraumatic stress disorder (PTSD) (i.e., endorsing at least two symptoms in each PTSD symptom cluster) and elevated anxiety sensitivity (AS). The objective of this trial is to examine the feasibility, acceptability, and efficacy of this novel PFI on (1) primary outcomes including drinking motivational factors and alcohol-related behaviors and (2) secondary outcomes including changes in AS and PTSD, and (3) exploring theoretically relevant mediators/moderators. Follow-up assessments will occur at post-test, one-week, and one-month post-intervention. Hazardous drinkers with at least subclinical PTSD and elevated AS (N=100) recruited from the community will be randomly assigned to receive Alcohol-PTSD-PFI (AP-PFI) or an active comparison condition (C-PFI).

Conditions

Interventions

OTHER

Alcohol-PTSD-PFI (AP-PFI)

Integrated computer-based personalized feedback intervention to specifically target anxiety sensitivity in the context of hazardous drinking and PTSD symptoms. The AP-PFI will focus on feedback about alcohol behavior in the context of PTSD symptoms, AS, and coping-oriented alcohol use.

OTHER

Active Comparison Condition (C-PFI)

Participants in the time-matched comparison condition will receive personalized feedback on alcohol use but will not receive PTSD or AS-related personalized feedback. C-PFI will include alcohol-focused components identical to those provided in AP-PFI (e.g., alcohol profiles, normative feedback). Therefore, it will be possible to isolate the impact of personalized PTSD and AS feedback versus personalized alcohol feedback.

Sponsors & Collaborators

  • University of Houston

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-31
Primary Completion
2022-12-31
Completion
2023-07-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04836442 on ClinicalTrials.gov