Clinical trial NCT04836442: PFI Hazardous Drinkers With Subclinical PTSD
Official title: An Integrated Personalized Feedback Intervention for Hazardous Drinkers With Subclinical PTSD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hazardous Drinking
Posttraumatic Stress Disorder
Lead sponsor: University of Houston
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed description: Hazardous drinking (i.e., a pattern of alcohol use that increases risk for adverse health consequences) and posttraumatic stress disorder (PTSD) are highly prevalent and commonly co-occurring conditions that are associated with greater disability, mortality, and poor health outcomes as compared to either condition alone. More than 25% of U.S. adults endorse hazardous drinking, which is one of the leading causes of preventable death in the U.S. and globally. Among individuals who engage in hazardous drinking, the prevalence of PTSD is 27% (reflecting 5.81 million people) and individuals who experience PTSD symptoms are roughly three times more likely to endorse hazardous drinking compared to those without PTSD symptomatology. Hazardous drinking-PTSD comorbidity evince bidirectional and transactional effects between PTSD and the maintenance and/or exacerbation of alcohol use. Yet, no empirically supported "gold standard" treatments are available and the most promising interventions are marked by substantive attrition and small effect sizes. Therefore, it is important to consider malleable factors that underlie hazardous drinking-PTSD relations to inform personalized evidence-based interventions among this underserved population.

A transdiagnostic factor for hazardous drinking and PTSD is anxiety sensitivity (AS). AS, defined as the fear of anxiety-related sensations and cognitions, has been positively related to hazardous drinking and coping-oriented drinking motives. Elevated AS has also been implicated in the development and maintenance of PTSD. AS may underlie (i.e., help explain) hazardous drinking-PTSD comorbidity by amplifying PTSD symptomatology and motivating drinking to down regulate such affect. Despite the efficacy of AS interventions for reducing hazardous drinking and PTSD symptoms, an integrated intervention to specifically target AS in the context of hazardous drinking and PTSD symptoms has not been developed or tested. Personalized feedback interventions (PFI) may help to address this gap as they have demonstrated efficacy in reducing hazardous drinking and alcohol-related consequences across various populations. PFI's target misperceptions regarding an individual's behaviors and actual normative behaviors, highlight consequences of these behaviors, and offer strategies for modifying them. Thus, PFIs are brief, cost-effective, easily disseminable, and clinically relevant given low treatment-seeking rates found among hazardous drinkers with PTSD.

Concordant with NIAAA's 2017-2021 Strategic Plan, 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 PTSD (i.e., endorsing at least two symptoms in each PTSD symptom cluster) and elevated AS. The objective of this proposal 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).

The AP-PFI will focus on feedback about alcohol behavior in the context of PTSD symptoms, AS, and coping-oriented alcohol use, to address the following aims:

Aim 1. Assist on evaluating the feasibility and acceptability of AP-PFI vs. C-PFI.

Evaluate initial metrics of feasibility and efficacy focused on the following:

1. Recruitment/retention rates throughout the duration of the study.
2. Treatment acceptability at post-test, treatment utilization at one-week and one-month follow-up.
3. Initial efficacy at post-test, one-week, and one-month follow-up.

Aim 2. Assist on conducting a RCT to examine the efficacy of AP-PFI vs. C-PFI.

At post-test, participants randomized to AP-PFI (vs. C-PFI) will report:

H1A: Greater motivation/intention to reduce (i.e., from hazardous to non-hazardous) drinking.

H1B: Lower levels of AS.

At one-week and one-month follow-up, participants randomized to AP-PFI (vs. C-PFI) will evince:

H2A: Greater change in rates from hazardous to non-hazardous drinking. H2B: Lower frequency and quantity of alcohol consumption and reduced negative consequences of drinking.

H2C: Lower PTSD symptom severity.

Exploratory Aim 3. Explore mediators and moderators. H3: Effects of AP-PFI (vs. C-PFI) on follow-up outcomes (H2A; H2B; H2C) will be mediated by: (1) motivation/intention to reduce drinking (H1A) and (2) lower levels of AS (H1B).

H4: The effects of AP-PFI (vs. C-PFI) on post-test and one-week and one-month follow-up outcomes will be larger among female (relative to male) participants.

H5: Associations between PTSD and alcohol-related outcomes (e.g., urges, cravings, motivation to reduce drinking, hazardous drinking levels) will be moderated by family history of AUD.

Eligibility criteria: Inclusion Criteria:

* ≥ 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Changes in anxiety sensitivity levels: Short Scale Anxiety Sensitivity Index (SSASI)
timeFrame: administered at one-week and one-month follow-ups
measure: Changes in motivation/intention to reduce drinking: The Alcohol Ladder
timeFrame: administered at one-week and one-month follow-ups
measure: Changes in hazardous drinking patterns: Alcohol Use Disorders Identification Test
timeFrame: administered at baseline, one-week and one-month follow-ups
measure: Changes in frequency and quantity of alcohol consumption: Timeline Follow-Back
timeFrame: administered at baseline, one-week and one-month follow-ups
measure: Changes in PTSD symptom severity: The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
timeFrame: administered at baseline, one-week and one-month follow-ups
Secondary outcomes:
measure: Evaluate the feasibility and acceptability of AP-PFI vs. C-PFI: Treatment Credibility/Expectancy Questionnaire
timeFrame: administered at one-month follow-up
measure: Evaluate the moderating role of family history of AUD on PTSD and alcohol-related outcomes
timeFrame: Administered at baseline
Other outcomes:
Locations:
city: Houston
country: United States
facility: Anxiety and Health Research Lab- Substance Use Treatment Clinic
state: Texas
Study officials:
References: