Posttraumatic Stress Disorder Clinical Trial
Official title:
An Integrated Personalized Feedback Intervention for Hazardous Drinkers With Subclinical PTSD
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).
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | July 2023 |
Est. primary completion date | December 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Anxiety and Health Research Lab- Substance Use Treatment Clinic | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Houston |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Evaluate the feasibility and acceptability of AP-PFI vs. C-PFI: Treatment Credibility/Expectancy Questionnaire | The acceptability of the intervention (i.e., AP-PFI) will be assessed via the Treatment Credibility/Expectancy Questionnaire (TCEQ). This measure is a reliable index that will be used to assess perceptions of treatment credibility/expectancies about treatment, including satisfaction, acceptability of AP-PFI relative to control. Additionally, it will assess how participants think the intervention will be successful in terms of reducing alcohol use, PTSD symptoms, and anxiety sensitivity, while also assessing anticipated reductions in alcohol use, PTSD symptoms, and anxiety sensitivity (0-100%). | administered at one-month follow-up | |
Secondary | Evaluate the moderating role of family history of AUD on PTSD and alcohol-related outcomes | Will be assessed via the Alcohol History Measure (AHM), a 11-item questionnaire that collects information on a participant's history of alcohol use, including familial history, consequences associated with use, and age of first use. | Administered at baseline |
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