PFI Hazardous Drinkers With Subclinical PTSD

NCT04836442 | Unknown

• 1 other identifier: STUDY2021001-AP-PFI
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Hazardous Drinking; Posttraumatic Stress Disorder

Outcome Measures

Primary Outcomes (5)

• Changes in anxiety sensitivity levels: Short Scale Anxiety Sensitivity Index (SSASI)

  The Short Scale Anxiety Sensitivity Index utilizes a 5-item Likert scale to measure anxiety sensitivity. The minimum value is "very little" and the maximum value is "Very much". Higher score indicate higher levels of anxiety sensitivity. This index will be used to assess changes in levels of anxiety sensitivity throughout the study. Hypothesis 1b: At post-test, participants randomized to AP-PFI (vs. C-PFI) will report lower levels of anxiety sensitivity.

  administered at one-week and one-month follow-ups

• Changes in motivation/intention to reduce drinking: The Alcohol Ladder

  The Alcohol Ladder is a one-item, reliable measure that assesses an individual's motivation to change their alcohol use. The ladder includes 10 rungs and asks participants to rate readiness to change their drinking habits by asking "Each rung of this ladder shows where a person might be in thinking about changing their drinking. Select the number that best matches where you are now.". The higher participants rate themselves on the ladder, the higher their readiness to change their drinking. This measure will be used to assess changes in motivation to reduce drinking throughout the study. Hypothesis 1a: At post-test, participants randomized to AP-PFI (vs. C-PFI) will report greater motivation/intention to reduce (i.e., from hazardous to non-hazardous) drinking.

  administered at one-week and one-month follow-ups

• Changes in hazardous drinking patterns: Alcohol Use Disorders Identification Test

  The alcohol use disorder identification test assesses drinking patterns and related consequences, and is valid, reliable, and demonstrates excellent sensitivity to detect potentially hazardous drinkers. Although all participants will be screened with the full measure, the first three items will be administered at follow-ups to evaluate hazardous alcohol use over time. Hypothesis 2a: At one-week and one-month follow-up, participants randomized to AP-PFI (vs. C-PFI) will evince greater change in rates from hazardous to non-hazardous drinking.

  administered at baseline, one-week and one-month follow-ups

• Changes in frequency and quantity of alcohol consumption: Timeline Follow-Back

  The Timeline Follow-Back (TLFB) is a calendar-based questionnaire that collects information regarding alcohol consumption over the past 30 days and is a reliable measure. It will be used to assess the changes in frequency and quantity of alcohol consumption throughout the study. Hypothesis 2b: at one-week and one-month follow-up, participants randomized to AP-PFI (vs. C-PFI) will evince lower frequency and quantity of alcohol consumption and reduced negative consequences of drinking.

  administered at baseline, one-week and one-month follow-ups

• Changes in PTSD symptom severity: The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)

  The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) measures PTSD symptom severity as it relates to the "worst" traumatic event endorsed throughout the participant's lifespan. The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items, whereas higher scores represent higher symptom severity. It will be administered to participant throughout the study in order to assess changes in posttraumatic stress disorder symptom severity. Hypothesis 2c: At one-week and one-month follow-up, participants randomized to AP-PFI (vs. C-PFI) will evince lower PTSD symptom severity

  administered at baseline, one-week and one-month follow-ups

Secondary Outcomes (2)

• Evaluate the feasibility and acceptability of AP-PFI vs. C-PFI: Treatment Credibility/Expectancy Questionnaire

  administered at one-month follow-up

• Evaluate the moderating role of family history of AUD on PTSD and alcohol-related outcomes

  Administered at baseline

Study Arms (2)

Alcohol-PTSD-PFI (AP-PFI)

EXPERIMENTAL

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 control condition (C-PFI).

Other: Alcohol-PTSD-PFI (AP-PFI)

Active Comparison Condition (C-PFI)

OTHER

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.

Other: Active Comparison Condition (C-PFI)

Interventions

Alcohol-PTSD-PFI (AP-PFI) OTHER

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.

Alcohol-PTSD-PFI (AP-PFI)

Active Comparison Condition (C-PFI) OTHER

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.

Active Comparison Condition (C-PFI)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 21 years of age
• Current hazardous drinking pattern (AUDIT scores ≥ 8 for males and ≥ 7 for females; this approach does not exclude persons with alcohol use disorder)
• Lifetime exposure to a DSM-5 Criterion A traumatic event and endorsing at least two symptoms in each DSM-5 PTSD symptom cluster.
• Elevated AS score (1 SD above normative mean)
• Fluent in English

You may not qualify if:

• Concurrent alcohol or other substance use treatment
• Current/past bipolar or psychotic disorder
• Current imminent risk of suicidality (i.e., past month ideation with intent or plan)
• Current stable use of prescription opioids/ benzodiazepines/positive urine drug screen
• Current pregnancy
• Inability to provide verbal or written consent
• Breath analysis (Alco-Sensor FST) estimating blood alcohol concentration (BAC) above 0

Sponsors & Collaborators

• University of Houston: lead

Study Sites (1)

Anxiety and Health Research Lab- Substance Use Treatment Clinic

Houston, Texas, 77204, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Central Study Contacts

Antoine Lebeaut, M.A.

CONTACT

713-743-8056; amlebeaut@uh.edu

Andre Bizier, B.S.

CONTACT

713-743-0946; abizier@central.uh.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hugh Roy and Lillie Cranz Cullen Distinguished University Professor

Study Record Dates

• First Submitted: April 5, 2021
• First Posted: April 8, 2021
• Study Start: July 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: July 1, 2023
• Last Updated: July 25, 2022

Record last verified: 2022-07

Locations

US (1)