Guilt and Expressive Writing for Reducing Alcohol Use in College Students

Alcohol Consumption Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02927132
• Other study ID #: 3660702
• Secondary ID: 1R01AA023495-01
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 2016
• Est. completion date: August 2020

Study information

• Verified date: June 2018
• Source: University of Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research seeks to evaluate expressive writing as a novel intervention for problem drinking among college students. The vast majority of individually focused brief interventions targeting college drinking have focused on personalized feedback approaches and recent innovations have largely been limited to finer distinctions of these, which require assessment and programming for implementation. The present research proposes expressive writing as a novel alternative, which has been used extensively in other domains but not as an alcohol intervention strategy.

H1a: Participants writing about negative drinking events will show reduced drinking and drinking-related negative consequences relative to students in the neutral control group.

H1b: Participants writing about distressing non-alcohol events will show increased psychological wellbeing relative to students in the neutral control group.

H1c: Participants writing about negative drinking events will show reduced drinking and consequences compared with an empirically-supported brief intervention (i.e., PNF). This is an exploratory hypothesis.

H2a: Alcohol narratives will have stronger effects on alcohol outcomes relative to distress narratives.

H2b: Alcohol guilt narratives will have the strongest effect on alcohol outcomes relative to all other conditions.

H3a: Expression of guilt, assessed by self-report and by content coding with LIWC, will mediate intervention effects on drinking outcomes.

H3b: Change thought, assessed by LIWC coding, will mediate intervention effects on drinking.

Description:

The current research builds on previous research targeting heavy drinking among college students. A large volume of research has provided an impressive data base supporting one type of individually-focused alcohol intervention for this population (i.e., personalized feedback). The success of this paradigm has probably contributed to the dearth of consideration of alternative paradigms. Expressive writing is one such alternative, which has received extensive support in other domains but has only recently been considered as a potential intervention for heavy drinking. The preliminary data examining this approach is promising and provides a firm foundation for this efficacy trial. Further, this research incorporates novel theoretical constructs including the specific focus on guilt in expressive writing content as well as "change thought," as an analogue to the mechanism presumed to underlie motivational treatments for alcohol and other substance use disorders. The investigators plan to employ similar methods which have been used successfully in other large NIAAA funded trials evaluating brief interventions for heavy drinking college students.

This research consists of an intervention study to evaluate expressive writing as a brief intervention in reducing drinking and improving psychological well-being among college students. Participation in the study involves completion of a screening assessment, a baseline assessment, the intervention procedure, post-intervention assessment, and follow-up assessments at 1-, 3-, 6-, and 12-months. Heavy drinking college students (N = 600) will be randomly assigned to one of six conditions based on the 2 (alcohol vs. distress topics) × 2 (guilt vs. no guilt focus) + 1 (neutral control) + 1 (personalized normative feedback) design. Before completing the baseline survey, students will be randomly assigned to one of six study conditions, five of which involve writing during three sessions over the course of one month. Specifically, participants will be assigned to write about a heavy drinking event, a heavy drinking event that elicited guilt, a distressing event, a distressing event that elicited guilt, or their first day of college (neutral control condition).

Participants randomly assigned to the PNF condition will receive traditional personalized normative feedback regarding how their drinking compares with other students of the same gender at the university. The norms will come from a large recently completed alcohol survey conducted at the University of Houston examining social norms and alcohol prevention (R01AA014576). To maintain consistency across conditions, participants in the PNF condition will still come into the lab three times. They will receive feedback during the first intervention session and will be asked to complete the same narrative prompts as the neutral control condition for their second and third session. For individuals in the expressive writing conditions, there will be three narrative prompts to complete every week for three weeks, the first of which will occur following the baseline assessment. All baseline assessments, narrative intervention assignments, and immediate post-tests for all conditions will be conducted in-lab. All other assessments including screening and follow-up assessments will be completed remotely by web. The rationale for including a personalized normative feedback condition is to be able to compare the efficacy of expressive writing interventions with existing brief alcohol interventions. Thus, the present design allows not only for evaluation of efficacy relative to a control condition but also will evaluate comparative efficacy relative to an existing empirically-supported brief alcohol intervention.

Aims will be evaluated using multi-level regression analyses, often referred to as Hierarchical Linear Modeling (HLM) or mixed-effects modeling. With respect to evaluating main effects of experimental conditions on drinking, each participant will provide baseline, post-intervention, 1-month, 3-month, 6-month, and 12-month follow-up data. Hypotheses will be tested using specific contrast vectors, using a general linear hypothesis framework. The study consists of a (2×2+1+1) design, represented as a factorial design with the addition of a control group that will write about their first day of school and a computer-based PNF comparison group. Hypotheses will be tested with contrasts corresponding to the questions of interest. The first two hypotheses represent contrasts between the alcohol narrative conditions and the neutral control condition (H1a) and between the guilt narrative conditions and the neutral control condition (H1b). In examining these hypotheses, the investigators will construct two dummy coded variables reflecting alcohol versus non-alcohol narratives conditions and between guilt and non-guilt narrative conditions with the reference group being the neutral control condition. Thus, the PNF group will not be included in the tests of these two hypotheses. Dependent variables will include alcohol outcomes for H1a and psychological well-being for H1b. For these analyses each participant will provide up to 5 repeated measures (i.e., baseline, 1-month, 3-months, 6-months, and 12-months), yielding up to 3000 Level 1 cases (repeated-measures) across 600 Level 2 cases.

The investigators will also evaluate mediators of intervention effects. Additionally, the investigators will follow procedures to assess mediation. Mediation will test indirect effects using the AB products method where A will represent effects of intervention contrasts by time interactions on mediators (expression of guilt and change thought). B will represent the associations of mediators on subsequent drinking outcomes. Both A and B paths will control for baseline outcomes. Evaluation of hypotheses regarding the moderation effect will test whether individual differences in guilt-proneness interact with intervention contrasts. These will be tested by expanding the above model to add main effects and product terms of proposed moderators with intervention contrasts.

Power analyses focus on estimating a sample size large enough to detect "true" effects, thereby avoiding Type II errors. Sample size estimates were obtained for intervention contrasts. Necessary sample sizes were assessed via sample size and power equations for normally distributed outcomes. Effect-sizes and variance components were based on preliminary studies, and power was set at 0.80 for all estimates. Power was estimated using the Optimal Design software program. The investigators anticipate intervention effects relative to the neutral control condition on drinking to be in the range of delta =.30-.40). Based on the proposed sample size of 500 (~PNF not included in H1a and H1b), given five assessment points, the investigators anticipate the ability to detect main effects of intervention contrasts with power=.80. Considering maximum anticipated attrition rates of 20% the investigators will have .80 power to detect effects sizes of delta = .28 and greater.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 600
• Est. completion date: August 2020
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 26 Years

Eligibility

Inclusion Criteria:

Inclusion criteria for the screening survey include

• Being between 18-26 years of age

• Being a registered UH student.

Inclusion criteria for longitudinal participation include

• Scoring 5+ and 7+ on the AUDIT-C for women/men respectively

• Being 18-26 years of age

• Being a registered UH student

• Providing consent to participate in the study

Exclusion Criteria:

Exclusion criteria for the screening survey include

• Not meeting inclusion criteria (i.e., not between 18-26 years of age, not a registered UH student)or unwillingness to participate.

Exclusion criteria for baseline include

• Not meeting any of the inclusion criteria, unwillingness to participate, and failure to provide consent.

Related Conditions & MeSH terms

• Alcohol Consumption
• Alcohol Drinking

Intervention

Behavioral:
• Expressive Writing
Expressive writing is a brief intervention that has been linked to various health and social benefits. Expressing emotions through writing can lead to decreased levels of stress and negative affect, thereby serving as a coping mechanism. Furthermore, expressive writing allows participants to reconstruct their traumatic experiences and reorganize their memory of these events into a narrative. Expressive writing has been used to target drinking. Research has found that students have reduced drinking intentions after writing about a negative drinking event compared to control,suggesting that a narrative intervention may be effective in reducing drinking. Other research suggests that feelings of guilt were more strongly associated with intentions to reduce drinking after writing about a negative drinking event, and that this event-related guilt mediated intervention effects.
• Personalized Normative Feedback
PNF approaches use information designed to correct normative misperceptions to reduce heavy drinking. Three pieces of information are necessary when providing personalized normative feedback: information about a student's own drinking, information about the student's perceptions of others' drinking, and information about others' actual drinking. The presentation of this information is designed to change students' perceptions of "normal" drinking by exposing their misperceptions of the norm as well as by comparing their behavior with "normal" behavior.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Houston	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

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* Note: There are 53 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Alcohol Consumption measured by The Timeline Follow-Back (TLFB)	The TLFB is a calendar based measure assessing daily drinking (and abstinence) over a designated period of time.; Number of drinks in the past month will be calculated as the sum of drinks recorded each day of the past month on the TLFB.	Baseline, 1 month follow-up, 3 month follow-up, 6 month follow-up, 12 month follow-up
Primary	Change in Drinking Intentions as measured by a modified version of the Daily Drinking Questionnaire (DDQ).	Response options will be identical to the DDQ, but participants will be asked to indicate their intended drinking behaviors.; Participants fill in the average number of standard drinks they intend to consume for each day of the week over the next month. Typical number of intended drinks per week will be calculated as the sum of typical number of drinks intended per day on the Daily Drinking Questionnaire.	Baseline, 1 month follow-up, 3 month follow-up, 6 month follow-up, 12 month follow-up
Primary	Change in Alcohol Consumption measured by Alcohol Use Disorders Identification Test (AUDIT).	The AUDIT assesses for hazardous alcohol use, dependence symptoms, and harmful use. Scores for each question range from 0 to 4, with the first response for each question (e.g. never) scoring 0, the second (e.g. less than monthly) scoring 1, the third (e.g. monthly) scoring 2, the fourth (e.g. weekly) scoring 3, and the last response (e.g. daily or almost daily) scoring 4. For questions 9 and 10, which only have three responses, the scoring is 0, 2 and 4 (from left to right). A score of 8 or more is associated with harmful or hazardous drinking.	Baseline, 1 month follow-up, 3 month follow-up, 6 month follow-up, 12 month follow-up
Primary	Change in Alcohol Consumption measured by Quantity-Frequency-Peak Alcohol Use Index.	The Quantity-Frequency-Peak Alcohol Use Index is a five-item questionnaire that includes two items addressing the occasion where respondents drank the most during the previous three months, two items addressing typical weekend drinking in the previous three months, and one item addressing typical number of drinking days per week in the previous three months. Drinking frequency will be assessed by item #5 of the Quantity/Frequency Questionnaire, which asks how many days during the past week participants have consumed alcohol.	Baseline, 1 month follow-up, 3 month follow-up, 6 month follow-up, 12 month follow-up
Primary	Change in Alcohol Consumption measured by the Daily Drinking Questionnaire (DDQ.	Typical weekly drinking and typical drinks per occasion will be assessed with the DDQ. Participants fill in the average number of standard drinks they consumed and the time period of consumption for each day of the week over the previous three months. Typical number of drinks per week will be calculated as the sum of typical number of drinks per day on the Daily Drinking Questionnaire.	Baseline, 1 month follow-up, 3 month follow-up, 6 month follow-up, 12 month follow-up
Primary	Change in Drinking Intentions as measured by a modified version of the Quantity-Frequency-Peak Alcohol Use Index (QF).	Response options will be identical to the QF, but participants will be asked to indicate their intended drinking behaviors. Intended drinking frequency will be assessed by item #5 of the Quantity/Frequency Questionnaire, which asks how many days during the next week participants intend to consume alcohol.	Baseline, 1 month follow-up, 3 month follow-up, 6 month follow-up, 12 month follow-up
Primary	Changes in Psychological Well-being Outcomes as measured by the Center for Epidemiological Studies Depression Scale (CES-D)	Depression will be assessed by the Ces-D, a 20-item measure of depressive symptomatology in the general population. Answers are on a scale of 1 (rarely) to 4 (most or all of the time). A score of 11 is indicative of significant or mild depressive symptomology, and higher scores are indicative of greater symptoms.	Baseline, 1 month follow-up, 3 month follow-up, 6 month follow-up, 12 month follow-up
Primary	Changes in Psychological Well-being Outcomes as measured by Positive and Negative Affect Scale (PANAS)	Mood will be assessed by the PANAS, a 22-item measure of the degree to which one experiences positive and negative affective states on a regular basis.; For a positive affect score, items 1 (interested), 3 (excited), 5 (strong), 9 (enthusiastic), 10 (proud), 12 (alert), 14 (inspired), 16 (determined), 17 (attentive), and 19 (active) will be added, with higher scores representing higher levels of positive affect.; For a negative affect score, items 2 (distressed), 4 (upset), 6 (guilty), 7 (scared), 8 (hostile), 11 (irritable), 13 (ashamed), 15 (nervous), 18 (jittery) and 20 (afraid) will be added, with lower scores representing lower levels of negative affect.	Baseline, 1 month follow-up, 3 month follow-up, 6 month follow-up, 12 month follow-up
Primary	Changes in Psychological Well-being Outcomes as measured by Satisfaction with Life Scale (SWLS).	This short, 5-item measure is designed to measure cognitive judgments of satisfaction with one's life. Each item is rated on a scale of 1 (strongly disagree) to 7 (strongly agree). A score of 31-35 indicates that a participant is extremely satisfied, a score of 26-30 indicates that a participant is satisfied, a score of 21-25 indicates that a participant is slightly satisfied, a score of 20 indicates that a participant is neutral, a score of 15-19 indicates that a participant is slightly dissatisfied, a score of 10-14 indicates that a participant is dissatisfied, and a score of 5-9 indicates that a participant is extremely dissatisfied.	Baseline, 1 month follow-up, 3 month follow-up, 6 month follow-up, 12 month follow-up